Support for healthy breastfeeding mothers with healthy term babies

Anna Gavine; Shona C Shinwell; Phyll Buchanan; Albert Farre; Angela Wade; Fiona Lynn; Joyce Marshall; Sara E Cumming; Shadrach Dare; Alison McFadden

doi:10.1002/14651858.CD001141.pub6

. 2022 Oct 25;2022(10):CD001141. doi: 10.1002/14651858.CD001141.pub6

Support for healthy breastfeeding mothers with healthy term babies

Anna Gavine ^1,^✉, Shona C Shinwell ¹, Phyll Buchanan ², Albert Farre ¹, Angela Wade ³, Fiona Lynn ⁴, Joyce Marshall ⁵, Sara E Cumming ^1,⁶, Shadrach Dare ¹, Alison McFadden ¹

Editor: Cochrane Pregnancy and Childbirth Group

PMCID: PMC9595242 PMID: 36282618

Abstract

Background

There is extensive evidence of important health risks for infants and mothers related to not breastfeeding. In 2003, the World Health Organization recommended that infants be breastfed exclusively until six months of age, with breastfeeding continuing as an important part of the infant’s diet until at least two years of age. However, current breastfeeding rates in many countries do not reflect this recommendation.

Objectives

1. To describe types of breastfeeding support for healthy breastfeeding mothers with healthy term babies.

2. To examine the effectiveness of different types of breastfeeding support interventions in terms of whether they offered only breastfeeding support or breastfeeding support in combination with a wider maternal and child health intervention ('breastfeeding plus' support).

3. To examine the effectiveness of the following intervention characteristics on breastfeeding support:

a. type of support (e.g. face‐to‐face, telephone, digital technologies, group or individual support, proactive or reactive);

b. intensity of support (i.e. number of postnatal contacts);

c. person delivering the intervention (e.g. healthcare professional, lay person);

d. to examine whether the impact of support varied between high‐ and low‐and middle‐income countries.

Search methods

We searched Cochrane Pregnancy and Childbirth's Trials Register (which includes results of searches of CENTRAL, MEDLINE, Embase, CINAHL, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP)) (11 May 2021) and reference lists of retrieved studies.

Selection criteria

Randomised or quasi‐randomised controlled trials comparing extra support for healthy breastfeeding mothers of healthy term babies with usual maternity care. Support could be provided face‐to‐face, over the phone or via digital technologies. All studies had to meet the trustworthiness criteria.

Data collection and analysis

We used standard Cochrane Pregnancy and Childbirth methods. Two review authors independently selected trials, extracted data, and assessed risk of bias and study trustworthiness. The certainty of the evidence was assessed using the GRADE approach.

Main results

This updated review includes 116 trials of which 103 contribute data to the analyses. In total more than 98,816 mother‐infant pairs were included.

Moderate‐certainty evidence indicated that 'breastfeeding only' support probably reduced the number of women stopping breastfeeding for all primary outcomes: stopping any breastfeeding at six months (Risk Ratio (RR) 0.93, 95% Confidence Interval (CI) 0.89 to 0.97); stopping exclusive breastfeeding at six months (RR 0.90, 95% CI 0.88 to 0.93); stopping any breastfeeding at 4‐6 weeks (RR 0.88, 95% CI 0.79 to 0.97); and stopping exclusive breastfeeding at 4‐6 (RR 0.83 95% CI 0.76 to 0.90). Similar findings were reported for the secondary breastfeeding outcomes except for any breastfeeding at two months and 12 months when the evidence was uncertain if 'breastfeeding only' support helped reduce the number of women stopping breastfeeding.

The evidence for 'breastfeeding plus' was less consistent. For primary outcomes there was some evidence that 'breastfeeding plus' support probably reduced the number of women stopping any breastfeeding (RR 0.94, 95% CI 0.91 to 0.97, moderate‐certainty evidence) or exclusive breastfeeding at six months (RR 0.79, 95% CI 0.70 to 0.90). 'Breastfeeding plus' interventions may have a beneficial effect on reducing the number of women stopping exclusive breastfeeding at 4‐6 weeks, but the evidence is very uncertain (RR 0.73, 95% CI 0.57 to 0.95). The evidence suggests that 'breastfeeding plus' support probably results in little to no difference in the number of women stopping any breastfeeding at 4‐6 weeks (RR 0.94, 95% CI 0.82 to 1.08, moderate‐certainty evidence). For the secondary outcomes, it was uncertain if 'breastfeeding plus' support helped reduce the number of women stopping any or exclusive breastfeeding at any time points.

There were no consistent findings emerging from the narrative synthesis of the non‐breastfeeding outcomes (maternal satisfaction with care, maternal satisfaction with feeding method, infant morbidity, and maternal mental health), except for a possible reduction of diarrhoea in intervention infants.

We considered the overall risk of bias of trials included in the review was mixed. Blinding of participants and personnel is not feasible in such interventions and as studies utilised self‐report breastfeeding data, there is also a risk of bias in outcome assessment.

We conducted meta‐regression to explore substantial heterogeneity for the primary outcomes using the following categories: person providing care; mode of delivery; intensity of support; and income status of country. It is possible that moderate levels (defined as 4‐8 visits) of 'breastfeeding only' support may be associated with a more beneficial effect on exclusive breastfeeding at 4‐6 weeks and six months. 'Breastfeeding only' support may also be more effective in reducing women in low‐ and middle‐income countries (LMICs) stopping exclusive breastfeeding at six months compared to women in high‐income countries (HICs). However, no other differential effects were found and thus heterogeneity remains largely unexplained. The meta‐regression suggested that there were no differential effects regarding person providing support or mode of delivery, however, power was limited.

Authors' conclusions

When 'breastfeeding only' support is offered to women, the duration and in particular, the exclusivity of breastfeeding is likely to be increased. Support may also be more effective in reducing the number of women stopping breastfeeding at three to four months compared to later time points. For 'breastfeeding plus' interventions the evidence is less certain. Support may be offered either by professional or lay/peer supporters, or a combination of both. Support can also be offered face‐to‐face, via telephone or digital technologies, or a combination and may be more effective when delivered on a schedule of four to eight visits. Further work is needed to identify components of the effective interventions and to deliver interventions on a larger scale.

Plain language summary

Support for breastfeeding mothers

What is the issue?

The World Health Organization recommends that infants should be breastfed exclusively until six months of age with breastfeeding continuing as an important part of the infant’s diet until he or she is at least two years old. We know that breastfeeding is good for the short‐term and long‐term health of both infants and their mothers. Babies are less likely to develop lung or gut infections. They are also less likely to become overweight and develop diabetes later in life. The mothers are also less likely to develop diabetes and to experience breast or ovarian cancer. Many mothers may stop breastfeeding before they want to as a result of the problems they encounter. Good care and support may help women overcome difficulties and gain confidence so that they can continue to breastfeed.

This review looked at whether providing extra organised support for breastfeeding mothers would help mothers to continue to breastfeed when compared with standard maternity care. We were interested in support from health professionals including midwives, nurses and doctors, or from trained lay workers such as community health workers and volunteers.

Why is this important?

By knowing what kind of support can be provided to help mothers with breastfeeding, we can help them continue to breastfeed for as long as they want to, wherever they live. Stopping breastfeeding early may cause disappointment, depression and long‐lasting distress for mothers and health problems for themselves and their infants. Support can be in the form of giving reassurance, praise, information, and the opportunity for women to discuss concerns and ask questions as needed.

What evidence did we find?

We searched for evidence on 11 May 2021. This updated review now includes 116 randomised controlled studies, of which 103 trials have contributed to the analyses, from 42 countries and involved 98,816 women and their babies. Some 55% of the women were from high‐income countries, 37% from middle‐income countries and 8% from low‐income countries.

In this update of the review, we grouped interventions into two different categories. The first group, 'breastfeeding only', were interventions that only contained breastfeeding support. In the second group, breastfeeding support was one part of a larger intervention that also aimed to provide other health benefits for the mother or her infant (e.g. vaccinations, new baby care). We have called these 'breastfeeding plus' interventions.

Overall, these trials showed that it is probable that fewer women who received a ‘breastfeeding only’ support intervention stopped exclusively breastfeeding at all time points up to and including six months. The effect was largest from 4‐6 weeks to 3‐4 months where we estimate that 17% and 19% fewer women would probably stop exclusively breastfeeding. The effect was smaller at six months where we estimate 10% fewer women would probably stop exclusively breastfeeding.

The evidence also suggests that women receiving ‘breastfeeding only’ support were probably less likely to stop any breastfeeding at time points up to and including six months. Again, the effect was largest from 4‐6 weeks to 3‐4 months where we estimate that 12% and 13% less women would probably stop any breastfeeding. At six months we estimate that 7% less women would probably stop breastfeeding. There were not enough studies to show if ‘breastfeeding only’ support interventions could reduce the number of women who stop any breastfeeding at either nine months or 12 months.

For women who received 'breastfeeding plus' interventions the evidence is less clear. Women receiving ‘breastfeeding plus’ support may be 27% less likely to stop exclusive breastfeeding at 4‐6 weeks (very low‐certainty evidence). Similarly, the evidence suggests that 21% fewer women may stop exclusive breastfeeding at six months. The effect on any breastfeeding was smaller where we estimate that 6% less women probably stopped any breastfeeding at six months. It remains unclear if 'breastfeeding plus' interventions reduce the number of women who stop any or exclusive breastfeeding at the other time points examined.

There was a lack of clear evidence on the factors that may help women breastfeed for longer. However, a specific schedule of four to eight contacts may help increase the number of women exclusively breastfeeding at 4‐6 weeks or six months when receiving a 'breastfeeding only intervention'.

For ‘breastfeeding only’ support interventions, we generally judged the evidence to be of moderate certainty. This means that we are moderately confident in our findings. For ‘breastfeeding plus’ support interventions the quality of the evidence was more mixed and the certainty ranged from moderate to very low.

What does this mean?

Providing women with extra organised support helps them breastfeed their babies for longer. Breastfeeding support may be more helpful if it has 4‐8 scheduled visits. There does not appear to be a difference in who provides the support (i.e. professional or non‐professional) or how it is provided (face‐to‐face, phone, digital technologies or combinations). Indeed, different kinds of support may be needed in different geographical locations to meet the needs of the people within that locality. Further work is needed to identify components of the effective interventions and to deliver interventions on a larger scale.

Summary of findings

Summary of findings 1. Summary of findings table ‐ Breastfeeding support only compared to usual care.

Breastfeeding support only compared to usual care
Patient or population: healthy breastfeeding women with healthy term babies Setting: any setting  Intervention: Support Comparison: Usual care
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Outcomes	Risk with Usual care	Risk with Support	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Stopping breastfeeding (any) at 6 months	600 per 1000	558 per 1000 (534 to 582)	RR 0.93 (0.89 to 0.97)	14610 (30 RCTs)	⊕⊕⊕⊝ Moderate^a
Stopping exclusive breastfeeding at 6 months	847 per 1000	763 per 1000 (746 to 788)	RR 0.90 (0.88 to 0.93)	16332 (40 RCTs)	⊕⊕⊕⊝ Moderate^a
Stopping breastfeeding (any) at 4‐6 weeks	308 per 1000	271 per 1000 (244 to 299)	RR 0.88 (0.79 to 0.97)	11413 (36 RCTs)	⊕⊕⊕⊝ Moderate^a
Stopping exclusive breastfeeding at 4‐6 weeks	518 per 1000	430 per 1000 (394 to 466)	RR 0.83 (0.76 to 0.90)	14544 (42 RCTs)	⊕⊕⊕⊝ Moderate^a
Stopping breastfeeding (any) at 2 months	384 per 1000	357 per 1000 (295 to 426)	RR 0.93 (0.77 to 1.11)	3169 (13 RCTs)	⊕⊕⊝⊝ Low^a,^b
Stopping exclusive breastfeeding at 2 months	607 per 1000	491 per 1000 (449 to 540)	RR 0.81 (0.74 to 0.89)	4317 (17 RCTs)	⊕⊕⊕⊝ Moderate^a
Stopping breastfeeding (any) at 3‐4 months	462 per 1000	402 per 1000 (374 to 430)	RR 0.87 (0.81 to 0.93)	12054 (32 RCTs)	⊕⊕⊕⊝ Moderate^a
Stopping exclusive breastfeeding at 3‐4 months	731 per 1000	592 per 1000 (563 to 621)	RR 0.81 (0.77 to 0.85)	11575 (43 RCTs)	⊕⊕⊕⊝ Moderate^a
Stopping breastfeeding at 9 months	758 per 1000	660 per 1000 (592 to 736)	RR 0.87 (0.78 to 0.97)	552 (1 RCT)	⊕⊕⊝⊝ Low^c,^d
Stopping breastfeeding at 12 months	891 per 1000	846 per 1000 (802 to 891)	RR 0.95 (0.90 to 1.00)	1311 (2 RCTs)	⊕⊕⊝⊝ Low^b,^e
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).  CI: confidence interval; RR: risk ratio
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
See interactive version of this table: https://gdt.gradepro.org/presentations/#/isof/isof_question_revman_web_431686173574519163.

Support plus compared to usual care for healthy breastfeeding women with healthy term babies
Patient or population: healthy breastfeeding women with healthy term babies Setting: any setting Intervention: Support plus Comparison: usual care
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Outcomes	Risk with usual care	Risk with Support plus	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Stopping breastfeeding (any) at 6 months	541 per 1000	508 per 1000 (492 to 524)	RR 0.94 (0.91 to 0.97)	4879 (11 RCTs)	⊕⊕⊕⊝ Moderate^a
Stopping exclusive breastfeeding at 6 months	685 per 1000	541 per 1000 (479 to 616)	RR 0.79 (0.70 to 0.90)	7650 (13 RCTs)	⊕⊕⊝⊝ Low^a,^b
Stopping breastfeeding (any) at 4‐6 weeks	433 per 1000	407 per 1000 (355 to 467)	RR 0.94 (0.82 to 1.08)	2325 (6 RCTs)	⊕⊕⊕⊝ Moderate^c
Stopping exclusive breastfeeding at 4‐6 weeks	542 per 1000	396 per 1000 (309 to 515)	RR 0.73 (0.57 to 0.95)	2402 (6 RCTs)	⊕⊝⊝⊝ Very low^b,^d
Stopping breastfeeding (any) at 2 months	363 per 1000	334 per 1000 (287 to 388)	RR 0.92 (0.79 to 1.07)	2089 (4 RCTs)	⊕⊕⊕⊝ Moderate^c
Stopping exclusive breastfeeding at 2 months	425 per 1000	382 per 1000 (331 to 437)	RR 0.90 (0.78 to 1.03)	4537 (9 RCTs)	⊕⊝⊝⊝ Very low^b,^c,^d
Stopping breastfeeding (any) at 3‐4 months	386 per 1000	374 per 1000 (312 to 443)	RR 0.97 (0.81 to 1.15)	2064 (5 RCTs)	⊕⊕⊝⊝ Low^b,^c
Stopping exclusive breastfeeding at 3‐4 months	587 per 1000	505 per 1000 (440 to 587)	RR 0.86 (0.75 to 1.00)	4766 (10 RCTs)	⊕⊕⊝⊝ Low^b,^c
Stopping breastfeeding (any) at 12 months	858 per 1000	823 per 1000 (780 to 858)	RR 0.96 (0.91 to 1.00)	1431 (2 RCTs)	⊕⊕⊕⊝ Moderate^c
Stopping breastfeeding (any) at 9 months ‐ not reported	‐	‐	‐	‐	‐
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).  CI: confidence interval; RR: risk ratio
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
See interactive version of this table: https://gdt.gradepro.org/presentations/#/isof/isof_question_revman_web_431754481798286092.

Factor	Number of studies	Number of women	RR (95% CI)	P value	Total model statistics
Factor	Number of studies	Number of women	RR (95% CI)	P value	Tau²	Chi²	df	P value	I²
	33
PERSON:					0.0074	83.1435	30	<0.0001	58.56
Professional	22	10214	1
Non‐Professional	8	3366	0.958 (0.866, 1.060)	0.406
Prof + Non‐prof	3	1030	1.037 (0.911, 1.181)	0.583
Unspecified	0	‐	‐

INTENSITY:					0.0060	74.3190	29	<0.0001	52.73
Low	5	2159	1
Moderate	5	962	0.913 (0.796, 1.047)	0.194
High	17	6276	0.939 (0.841, 1.048)	0.262
Unspecified	6	5213	0.989 (0.877, 1.115)	0.857

SUPPORT:					0.0072	81.8609	28	<0.0001	61.13
F2F	11	7508	1
F2F and phone	13	3681	1.009 (0.918, 1.109)	0.857
F2F, phone and digital	1	103	0.984 (0.710, 1.364)	0.924
Phone	6	2820	1.002 (0.888, 1.132)	0.972
Digital	2	498	0.845 (0.648, 1.102)	0.213

INCOME:
LMIC	7	3037	1		0.0052	81.7673	31	<0.0001	53.32
HMIC	26	11573	1.069 (0.967, 1.183)	0.193

					Total model statistics
Factor	Number of interventions	Number of women	RR (95% CI)	P value	Tau²	Chi²	P value	I²
	44
PERSON:					0.0251	233.3179	40	<0.0001	97.31
Professional	28	11780	1
Non‐Professional	12	3663	0.966 (0.853, 1.093)	0.583
Prof + Non‐prof	3	749	1.024 (0.832, 1.259)	0.826
Unspecified	1	140	0.345 (0.149, 0.799)	0.013

INTENSITY:					0.0233	244.6064	40	<0.0001	96.02
Low	7	5603	1
Moderate	14	2896	0.815 (0.696, 0.953)	0.010
High	18	6315	0.949 (0.822, 1.096)	0.476
Unspecified	5	1518	0.952 (0.789, 1.147)	0.603

SUPPORT:					0.0245	218.5338	39	<0.0001	96.37
F2F	20	6027	1
F2F and phone	13	6647	1.113 (0.982, 1.260)	0.093
F2F, phone and digital	1	20	1.199 (0.779, 1.845)	0.409
Phone	8	3043	1.059 (0.919, 1.220)	0.425
Digital	2	595	1.016 (0.793, 1.303)	0.898

INCOME:					0.0187	230.0321	42	<0.0001	96.31
LMIC	22	5622	1
HMIC	22	10710	1.151 (1.047, 1.265)	0.003

Date	Event	Description
11 May 2021	New citation required and conclusions have changed	The conclusions regarding 'breastfeeding only' support interventions is broadly similar to the previous updates of this review (where there was no distinction between 'breastfeeding only' and 'breastfeeding plus'). For 'breastfeeding plus' interventions the evidence is less certain.
11 May 2021	New search has been performed	Search updated and trustworthiness checklist applied to all studies identified in the update and all studies included in previous versions. PICO amended to include healthy women giving birth via Caesarean Section and support provided via digital technologies. Studies were no longer excluded from the meta‐analyses if attrition was greater than 25%. Worst case outcomes were imputted and sensitvity analyses were conduted to examine the impact excluding studies at high or unclear risk of bias of incomplete outcome reporting. Breastfeeding outcomes have been amended to only refer to women stopping breastfeeding at the specific time point and not stopping before and up to the time point. The main comparisons have changed to split the support interventions into 'breastfeeding only' and 'breastfeeding plus'. Secondary outcomes were included in this update and include a new secondary outcome of maternal mental health. Previous versions of the review have employed sub‐group analyses to investigate heterogenity. In this update we undertook a meta‐regression to evaluate heterogenity. A total of 116 studies were included in this update and 103 contributed data to the review.

Date	Event	Description
29 February 2016	New citation required but conclusions have not changed	Conclusions broadly similar.
29 February 2016	New search has been performed	Search updated and 31 new studies included. The review now includes a total of 100 studies, with 73 studies providing data. A 'Summary of findings' table has been incorporated in this update. In order to expedite this review rapidly to be ready to inform the World health Organisation recommendations on breastfeeding in maternity facilities, we have restricted the outcomes analysed in this update to the primary outcomes only. Secondary outcomes analysed in the previously published version of this review will be added in the next update of this review in two years time..
12 December 2011	New citation required but conclusions have not changed	The update was prepared by a new author team. Studies were carried out in 21 countries. Overall conclusions have not changed, but we include more evidence on the effect of interventions in different settings and for different types of interventions; proactive interventions that rely mainly on face‐to‐face support are more likely to succeed.
12 December 2011	New search has been performed	In the previous version of this review (Britton 2007) we included 34 trials in 14 countries. In this updated version, we assessed 218 reports; corresponding to 150 separate studies. We have included 67 studies and excluded 79. Four studies are still ongoing or awaiting further assessment. In this updated version we have added further subgroup analysis and discuss the impact of different types of support interventions.
27 July 2009	Amended	Search updated, 68 reports added to Studies awaiting classification.
6 November 2008	Amended	Converted to new review format.
30 January 2006	New search has been performed	Searches updated. We have included fourteen new studies and excluded an additional 30 studies.
30 January 2006	New citation required and conclusions have changed	New review team prepared this update. Previous versions of this review categorised support as 'professional' or 'lay'. This edition introduces a new category: combined lay and professional support. Studies in this category demonstrated a significant effect on duration of any breastfeeding, especially in the first two months.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Stopping breastfeeding (any) at 6 months	30	14610	Risk Ratio (M‐H, Random, 95% CI)	0.93 [0.89, 0.97]
1.2 Stopping exclusive breastfeeding at 6 months	40	16332	Risk Ratio (M‐H, Random, 95% CI)	0.90 [0.88, 0.93]
1.3 Stopping breastfeeding (any) at 4‐6 weeks	36	11413	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.79, 0.97]
1.4 Stopping exclusive breastfeeding at 4‐6 weeks	42	14544	Risk Ratio (M‐H, Random, 95% CI)	0.83 [0.76, 0.90]
1.5 Stopping breastfeeding (any) at 2 months	13	3169	Risk Ratio (M‐H, Random, 95% CI)	0.93 [0.77, 1.11]
1.6 Stopping exclusive breastfeeding at 2 months	17	4317	Risk Ratio (M‐H, Random, 95% CI)	0.81 [0.74, 0.89]
1.7 Stopping breastfeeding (any) at 3‐4 months	32	12054	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.81, 0.93]
1.8 Stopping exclusive breastfeeding at 3‐4 months	43	11575	Risk Ratio (M‐H, Random, 95% CI)	0.81 [0.77, 0.85]
1.9 Stopping any breastfeeding at 9 months	1	552	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.78, 0.97]
1.10 Stopping any breastfeeding at 12 months	2	1311	Risk Ratio (M‐H, Random, 95% CI)	0.95 [0.90, 1.00]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Stopping breastfeeding (any) at 6 months	11	4879	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.91, 0.97]
2.2 Stopping exclusive breastfeeding at 6 months	13	7650	Risk Ratio (M‐H, Random, 95% CI)	0.79 [0.70, 0.90]
2.3 Stopping breastfeeding (any) at 4‐6 weeks	6	2325	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.82, 1.08]
2.4 Stopping exclusive breastfeeding at 4‐6 weeks	6	2402	Risk Ratio (M‐H, Random, 95% CI)	0.73 [0.57, 0.95]
2.5 Stopping breastfeeding (any) at 2 months	4	2089	Risk Ratio (M‐H, Random, 95% CI)	0.92 [0.79, 1.07]
2.6 Stopping exclusive breastfeeding at 2 months	9	4537	Risk Ratio (M‐H, Random, 95% CI)	0.90 [0.78, 1.03]
2.7 Stopping breastfeeding (any) at 3‐4 months	5	2064	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.81, 1.15]
2.8 Stopping exclusive breastfeeding at 3‐4 months	10	4766	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.75, 1.00]
2.9 Stopping any breastfeeding at 12 months	2	1431	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.91, 1.00]

*Study characteristics*
Methods	2‐arm RCT, single‐site, n = 214
Participants	Large urban teaching hospital in Toronto, Canada Background rates of breastfeeding initiation: 89% Inclusion criteria: primiparous mothers in the first 2 days postpartum, singleton birth, ≥ 18 years old, ≥ 37 weeks’ gestation at delivery, able to speak and read English, and living with a male partner Exclusion criteria: women sharing a hospital room with a current study participant, a medical problem that could interfere with breastfeeding, infant not discharged from hospital with them, no access to the Internet or a telephone, planning to breastfeed for < 12 weeks, and had a partner who would not be available to participate in the study
Interventions	Intervention: the trial intervention was a multifaceted coparenting breastfeeding support intervention, provided face‐to‐face on the postpartum unit, at which time the couples were provided with breastfeeding information, the information package was reviewed, and couples were given the option of watching a video. The session took ∼15 min in the majority of cases. Couples had a take‐home breastfeeding booklet, developed by Best Start: Ontarios Maternal, Newborn and Early Child Development Resource Centre, access to a secure study website that consisted of extensive information on breastfeeding and coparenting and contained links to related information and resources on the Internet including a copy of the video to watch at home. The couples were followed up at home with emails at 1 and 3 weeks postpartum and a telephone call at 2 weeks postpartum to answer any questions or concerns about the information provided. Control: couples received usual care, which included standard in‐hospital breastfeeding support and any breastfeeding assistance that was proactively sought in the community.
Outcomes	Primary: Exclusive breastfeeding at 6 weeks and 12 weeks postpartum Secondary: Breastfeeding duration at 6 and 12 weeks postpartum Maternal perceptions of breastfeeding support Maternal perception of the coparenting relationship at 12 weeks postpartum
Notes	Dates of the study: recruitment March ‐ July 2012 Funding sources: partial funding from Canadian Institutes of Health Research, Canada Research Chair Program Declarations of interest: none declared
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Intervention group by sequentially numbered randomly generated numbers
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes
Blinding of participants and personnel (performance bias) All outcomes	High risk	Envelopes were constructed by a research assistant who was not involved in any other trial procedure. Participants not blinded.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Participants in intervention group were known to assessors because they were interviewed.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Missing data were < 25%. Complete follow‐up data were collected from 87.9% (n = 188) of fathers at 6 weeks and 88.3% (n = 189) of mothers at 6 weeks and 91.6% (n = 196) at 12 weeks.
Selective reporting (reporting bias)	Low risk	Primary and secondary outcomes detailed in the study protocol were reported.
Other bias	Unclear risk	There were no significant differences in baseline characteristics between the groups except prenatal education. However, there was a non‐significant difference between the 2 groups in attendance at a prenatal breastfeeding class.

*Study characteristics*
Methods	2‐arm cluster RCT, n = 36 clusters, 468 participants
Participants	Rural. Manna district located in Jimma Zone in southwest Ethiopia. Health services are provided through 3 hospitals, 112 health centres and 498 health posts. Background breastfeeding rates: 58% of infants were exclusively breastfed for six months in 2016, giving a national average duration of EBF of 3.1 months Inclusion criteria: women in their second or third trimester of pregnancy, who were willing to participate with no intention of leaving the study area during the intervention period Exclusion criteria: severe mental illness that could interfere with consent and study participation, serious illness or clinical complications warranting hospitalisation, the occurrence of maternal death, abortion, stillbirth, infant death, twin gestation, pre term birth (at <37 weeks gestation), or any child congenital malformation that could interfere with breastfeeding Participant characteristics: 18.5% primiparous, 85.1% in age range 20‐34 years, 53.2% married. Education: Illiterate: 60.2%; can read and write 12.5%; Primary education: 7.63%; Secondary education: 19.7%
Interventions	Peer supporters made home visits to women in the intervention clusters according to a pre‐specified schedule ‐ two home visits in the last trimester of pregnancy and home visits after birth on 1st or 2nd, 6th or 7th and 15th day, and thereafter monthly until the infant was five months. Content of visits by peer supporters: in pregnancy ‐ encouraged delivery at the nearby health centre, emphasised the importance of initiating breastfeeding within 1 h of delivery, feeding colostrum first, discouraging the use of traditional pre‐lacteal foods. The discussions were combined with the use of educational materials and practical demonstrations on proper breastfeeding positioning and latching. First two weeks after delivery, emphasised frequent and on‐demand breastfeeding, encouraged stopping any traditional pre‐lacteal foods or post‐lacteal food items if already given and observed the positioning, latching, and feeding of the newborn, solving any breastfeeding problems and providing appropriate feedback, while encouraging the mothers to continue EBF for six months. From month one, peer‐supporters emphasised techniques for preparing for work and management of breast milk(breast‐milk expression, storing breast milk), discussed the lactation amenorrhoea method, and other family planning options. Mothers were encouraged to ask questions related to any topic discussed. Peer supporters also provided additional visits if women experienced breastfeeding problems. Women also received an emotional, appraisal, and instrumental support. The duration of each visit was typically 20–40 min. Control: women in the control group received the routine care offered by the Health Extension Workers (HEWs) and WDA leaders working in their cluster, similar to that received by women in the intervention group. This included four focused prenatal visits, developing an individualised birth preparedness and complication readiness plan, accompanying a woman to a health facility during delivery, and conducting four postnatal visits.
Outcomes	Exclusive breastfeeding at 6 months Stunting, fever, cough, diarrhoea
Notes	Dates of the study: enroled for the study between May and September 2017. Funding sources: support provided by NORAD(Norwegian Agency for Development Cooperation) under the NORHED‐Programme, the Jimma Zone Health Department and the local MOH office. Declarations of interest: none reported
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	We used simple randomization with a 1:1 allocation to allocate sub‐districts to either control or intervention. First, the 36 sub‐districts were listed alphabetically and then they were sequentially numbered starting from 01 to 36. Then we generated 18 random numbers from those 01 to 36 using MS Excel 2010 and the districts with the selected random numbers were assigned to the intervention group, while the rest were assigned to the control group.
Allocation concealment (selection bias)	Low risk	A statistician that is blinded to study groups and not participating in the research will do the generation of the allocation sequence and the randomization of clusters.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Allocation concealment was not done for study participants, as they would know if they were in the intervention group or not
Blinding of outcome assessment (detection bias) All outcomes	High risk	Self‐reprt data collected from mothers
Incomplete outcome data (attrition bias) All outcomes	Low risk	Drop‐off <20%: A total of 468 pregnant women (n intervention = 249; control = 219) were enrolled at baseline. Outcome data available for 421 (90.0%) mother‐child pairs (n intervention = 221; control = 200) at the one‐month postpartum follow‐up and from 409 (87.4%) mother‐child pairs (n intervention = 212; control = 197) at the six‐month postpartum follow‐up.
Selective reporting (reporting bias)	Low risk	All outcomes stated in the protocol are reported Protocol included and outcomes section pasted above. Final study agreed "The primary study outcomes were rates of EI and EBF for six months and infant growth."
Other bias	Low risk	Funded by NORAD No conflicts of interest declared Baseline characteristics look balanced but statistical significance not reported. Intra‐cluster correlation reported

*Study characteristics*
Methods	2‐arm RCT, with individual randomisation n = 141
Participants	Three Midwestern hospitals, USA. Background breastfeeding rates: Exclusive breastfeeding rate at 6 months of 11.4% in Indiana Inclusion criteria: ability to read and speak English, ≥ 18 years old, intention to continue breastfeeding after discharge, no serious medical condition, basic knowledge of Internet, and access to electronic mail and the Internet through either a standard PC or a smartphone. Infants ‐ singleton full‐term (≥37 gestational weeks). Exclusion criteria: infants born with cleft lip/palate, congenital heart defects, Down Syndrome, neural tube defects, or other conditions that either require the newborn's admission to a neonatal intensive care unit or interfere with breastfeeding.
Interventions	The intervention group received the same usual care support, but were also given access to an interactive web‐based breastfeeding monitoring system prior to discharge. Mothers were asked to enter breastfeeding and infant output data (along with any problems) for 30 days. The system automatically sent feedback via notifications with tailored interventions if the mother entered data that indicated breastfeeding problems including the inability to latch, latching with nipple shields, difficulty waking up for feedings, jaundice, mother's sore nipples, engorgement, or insufficient feeding (<6 times per day). The system provided positive notifications when a mother breastfed 8 to 10 times per day and read the notifications. Control: standard care which consisted of breastfeeding support and education before discharge, one phone call within the first week after hospital discharge, and a list of community breastfeeding resources. Mothers were encouraged to contact the lactation specialist with any breastfeeding problems.
Outcomes	Any and exclusive breastfeeding at 1,2,3 months Maternal satisfaction with feeding Postnatal depression (EPDS)
Notes	Dates of the study: not reported Funding sources: Indiana CTSI Collaboration in Biomedical/Translational Research (CBR/CTR) Pilot Program Grants. Declarations of interest: none declared.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were allocated to the usual care group and intervention group by computer‐generated random numbers using mode of delivery and parity as stratifying factors to control for these variables
Allocation concealment (selection bias)	Unclear risk	Unclear – not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not possible
Blinding of outcome assessment (detection bias) All outcomes	High risk	Self‐reported breastfeeding
Incomplete outcome data (attrition bias) All outcomes	High risk	1 month: I= 49/84, C= 55/57 2 month: I= 48/84, C= 54/57 3 month: I= 44/84, C= 52/57
Selective reporting (reporting bias)	Unclear risk	No published protocol to judge outcome
Other bias	Low risk	No industry funding reported. No conflicts of interest No significant differences at baseline

Factor	Number of studies	Number of women	RR (95% CI)	P value	Total model statistics
Factor	Number of studies	Number of women	RR (95% CI)	P value	Tau²	Chi²	df	P value	I²
	45
PERSON:
Professional	31	11266	1		0.0480	231.253	42	<00001	91.75
Non‐Professional	11	2529	0.853 (0.710, 1.025)	0.09
Prof + Non‐prof	3	749	1.288 (0.939, 1.766)	0.116
Unspecified	0	‐	‐	‐

INTENSITY:
Low	12	7327	1		0.0516	197.13	41	<0.0001	89.54
Moderate	13	2113	0.790 (0.633, 0.986)	0.037
High	17	4330	1.015 (0.836, 1.232)	0.879
Unspecified	3	774	1.067 (0.754, 1.511)	0.714

SUPPORT:					0.0612	207.04	40	<0.0001	90.91
F2F	17	4679	1
F2F and phone	17	6797	1.016 (0.837, 1.24)	0.869
F2F, phone and digital	1	20	1.193 (0.285, 4.991)	0.809
Phone	7	2312	0.925 (0.714, 1.199)	0.556
Digital	3	736	0.867 (0.591, 1.272)	0.464

INCOME:					0.0508	223.312	43	<0.0001	93.12
LMIC	15	3223	1
HMIC	30	11321	1.126 (0.942, 1.347)	0.193

*Study characteristics*
Methods	3‐arm RCT, with individual randomisation n = 231
Participants	The study was carried out in the Tema area of Ghana (sub‐Saharan Africa). Women were recruited in prenatal clinics in 2 hospitals (1 government and 1 private) that served urban areas (an industrial city and a commercial town). Background breastfeeding rates: High baseline prevalence of breastfeeding in Ghana, the median duration of breastfeeding was reported as being 22 months and 53.4% of women with babies < 6 months breastfeed exclusively. It was reported that "almost all" mothers initiated breastfeeding. 231 women randomised (136 eligible at the beginning of the intervention period). Inclusion criteria: pregnant women in the last trimester planning delivery in the study hospitals and to stay in study area for 6 months after delivery. After delivery: singleton babies with normal birthweight (> 2500 g) and Apgar scores ≥ 6 at 1 min and 5 min Exclusion criteria: multiple birth, low Apgar score or planning to move out of area Participant characteristics: 38% of the women had only primary level or no formal education; 90% were married or living with a partner; 46% were primiparous; 73% had vaginal birth; 24% lived in households with access to a car; 74% were described as trader/artisan
Interventions	All 3 groups (intervention 1, intervention 2 and control) were allocated to 2 educational group sessions during pregnancy by trained nurses and 9 proactive home visits by trained nurse counsellors at 1, 2, 4, 6, 8, 12, 16, 20 and 24 weeks postpartum. These were in addition to standard care. The content of the sessions differed between the 3 groups. 63% of intervention 1, 73% of intervention 2 and 65% of the control group women received all 9 scheduled home follow‐up visits. Intervention 1 (n = 74): 43 followed up. Content of sessions was breastfeeding and exclusive breastfeeding. Trained local nurses with experience of breastfeeding gave 2 educational sessions, of approximately 20 min each, to groups of 2‐4 women during their third trimester. At postpartum home visits women received individual counselling and nurses were advised to respond to concerns. Materials were developed from WHO/UNICEF breastfeeding counselling training manual. Intervention 2 (n = 72): 44 followed up. Content of the pregnancy sessions was general health and childcare as for control group. Content of the postpartum home visits was breastfeeding and exclusive breastfeeding as for intervention 1. Control (n = 85): 49 followed up. Content of sessions was general health and childcare topics such as immunisation, HIV/AIDS, nutrition and family planning.
Outcomes	Breastfeeding status at 1, 2, 3, 4, 5, and 6 months, exclusive breastfeeding up to 6 months, infant morbidity and growth
Notes	We have not included data from this study in the review due to high levels of attrition (> 25% loss to follow‐up). Most data were reported in graphs and difficult to interpret. Several measures of exclusive breastfeeding were reported; at 1 and 6 months women were asked about breastfeeding since birth, during previous month and on previous day. In this review we have reported figures for exclusive breastfeeding since birth for both time points. Figures in the paper were expressed as percentage of women still exclusively breastfeeding; in order to use the data we used subtraction to calculate a figure for women who had stopped breastfeeding. Dates of the study: recruitment between May and September 2002 Funding sources: University of Connecticut Research Foundation and LINK‐AGES USAID Declarations of interest: not reported
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: “Randomization was achieved by writing numbers 1 to 3 on folded pieces of paper."
Allocation concealment (selection bias)	High risk	Quote: "The numbers were not viewed by either study staff or mothers and the pieces of paper looked the same on the outside. Before offering papers to mothers, they were shuffled in the interviewer’s palm.” Quote: “The randomisation scheme used was not a formal one. It was one that could be conducted easily in the field. Despite this, it functionally produced balanced groups with no evidence of bias.”
Blinding of participants and personnel (performance bias) All outcomes	High risk	It was stated that women were informed only that they would receive “health education” that would be beneficial to their infants and themselves, but were not aware of their group allocation or of differences in the content of the health education. However, it is not possible to blind.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "It was impossible to keep counsellors unaware of study design.... research assistants [collecting outcome data] were aware of mothers group allocation."
Incomplete outcome data (attrition bias) All outcomes	High risk	231 women randomized during the third trimester. At delivery 95 women were excluded as they were no longer eligible (41% lost before the intervention). A further 13 women were lost to follow‐up during the intervention period. 123 completed the final follow‐up at 6 months (i.e. 53% of the original randomized sample but 90% of those still eligible at delivery). Results were reported in graphs and percentages and it was not clear how many women commenced breastfeeding, so group denominators are not clear. Loss to follow‐up appeared balanced across groups.
Selective reporting (reporting bias)	Unclear risk	Failure to provide denominators for results means that they are very difficult to interpret.
Other bias	Unclear risk	Women in the 3 arms of the trial appeared similar at baseline. Analysis was according to group allocation.

*Study characteristics*
Methods	RCT, single site, a BFI hospital, n = 66
Participants	Urban state maternity hospital in Turkey Background rates of breastfeeding initiation: high Inclusion criteria: prima parous, live vaginal birth, healthy term singleton infant, living in study area, able to speak Turkish, no history of chronic diseases, non‐smoker, intending to breastfeed Exclusion criteria: infant birthweight < 2500 g, Apgar score ≤ 7, congenital anomalies, serious disease or needing intensive care Baseline prevalence of "ever breastfed" in Turkey: 96.7% (WHO Global data bank 2010, accessed 6 October 2011).
Interventions	Intervention: women received standard breastfeeding support plus support from trained lay supporters who had undergone WHO/UNICEF 18‐h training. The intervention was a single home visit on day 3 after the birth (in hospital), by 2 lay breastfeeding supporters, that lasted about 30 min and covered the same topics as routine support. Control: at this Baby‐Friendly hospital, a standard breastfeeding education session lasting 20‐30 min was provided to all mothers before standard discharge home at 24 h after the birth. The session included the topics covered by the 18‐h WHO/UNICEF training.
Outcomes	Exclusive breastfeeding at 2 and 6 weeks and 6 months postpartum; breastfeeding duration (any/exclusive) to 18 months; breastfeeding knowledge scores at 2 and 6 weeks postpartum
Notes	Dates of the study: study conducted between March and July 2008 Funding sources: not reported Declarations of interest: not reported
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random numbers
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Insufficient information provided to enable a judgement to be made
Blinding of outcome assessment (detection bias) All outcomes	High risk	Women were contacted either through home visits or via the phone and data on breastfeeding was collected, however, not reported whether the assessors were blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	82% follow‐up at 18 months. Reasons for loss were explained and were balanced across groups.
Selective reporting (reporting bias)	Low risk	Not apparent
Other bias	Low risk	Groups appeared similar at baseline.

*Study characteristics*
Methods	Primary care facilities, recruitment over 5 months, n = 169
Participants	3 hospitals in the city of Pelotas, in southern Brazil Background rates of breastfeeding initiation: 88% Ethnic composition not described. Inclusion criteria: term healthy baby, family income ≥ USD 500 per month (no economic constraints to baby's growth), mother intended to breastfeed and did not smoke. Exclusion criteria: multiple birth, gestational age not 37‐42 weeks, significant perinatal morbidity, maternal smoking and family income USD 500 per month.
Interventions	Intervention: hospital visit, home visits at 5, 15, 30, 45, 90 and 120 days, and 24‐h telephone hotline for help or to arrange visits. 2 members of the lactation support team had received the 40‐h WHO lactation support training course. Control: attended paediatric clinics where general advice on advantages of breastfeeding may have been offered, but specific lactation counselling was not provided.
Outcomes	Breastfeeding pattern and duration up to age of 4 months. Breast milk intake for a subgroup of 68 infants at 4 months
Notes	Dates of the study: recruitment from August 1999 to January 2000 Funding sources: not reported Declarations of interest: not reported
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated code
Allocation concealment (selection bias)	Low risk	Sealed envelopes
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Insufficient information provided to enable a judgement to be made
Blinding of outcome assessment (detection bias) All outcomes	High risk	The interviewers were not informed about the intervention or control status of each mother, and did not know the study's objectives.
Incomplete outcome data (attrition bias) All outcomes	High risk	188 women were randomized. 21 were excluded after 2 weeks as they had introduced formula milk. A further 26 withdrew (some data were available for some of these women). 141 women completed the trial (75%).
Selective reporting (reporting bias)	Unclear risk	We did not have access to the trial registration or protocol.
Other bias	Unclear risk	Excluding women who introduced formula within 2 weeks of randomisation is likely to have introduced bias although similar numbers were excluded from both groups (9 women lost from the intervention group for this reason and 11 women from the control group and an additional control was withdrawn for smoking).

*Study characteristics*
Methods	2‐arm RCT, n = 120
Participants	Four prenatal clinics in West Ahvaz, Iran selected because of its ethnically diverse population and low rates of exclusive breastfeeding. Background breastfeeding rates: 90% of women nationwide initiated breastfeeding and that 44% exclusively breastfeed at 6 months in 2000, decreasing to 27% exclusive breastfeeding at 6 months in 2005. Inclusion criteria: pregnant women who spoke Persian, and were: nulliparous, had singleton fetuses, intended to breastfeed, were between 35 and 37 weeks gestation, and had cell phones. Exclusion criteria: any health condition that could interfere with breastfeeding, such as a high‐risk pregnancy (e.g., antepartum bleeding, low amniotic fluid volume) or any breast surgery.
Interventions	Breastfeeding multifaceted self‐efficacy intervention provided 35 and 37 weeks gestation by a research nurse with extensive breastfeeding knowledge and experience in assisting breastfeeding women. Two 1‐hour small group‐breastfeeding education sessions, an information booklet with breastfeeding images, and biweekly text messages. Control: standard prenatal and postpartum care consisting of eight prenatal visits at a healthcare clinic with a midwife. In the hospital and postnatally, midwives also provide care, including lactation support, for all breastfeeding women.
Outcomes	Any and exclusive breastfeeding at 2 months
Notes	Dates of the study: Recruitment: April 2014 to October 2015. Funding sources: not reported but states no relevant financial relationships. Declarations of interest: none declared.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomiztaion was achieved using sealed, opaque, sequentially numbered envelopes developed from a random number generator.
Allocation concealment (selection bias)	Low risk	Randomiztaion was achieved using sealed, opaque, sequentially numbered envelopes developed from a random number generator. A midwife who was not involved in the recruitment of participants prepared the envelopes
Blinding of participants and personnel (performance bias) All outcomes	High risk	Women and staff were aware of group allocation
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcomes assessed by questionnaire ‐ self‐report
Incomplete outcome data (attrition bias) All outcomes	Low risk	Follow‐ up rates at 8 weeks postpartum were high, with 56 (93.3%) participants in the intervention group and 54 (90%) participants in the control group who completed the 8‐week postpartum questionnaire.
Selective reporting (reporting bias)	Low risk	All outcomes in the protocol are reported
Other bias	Unclear risk	No conflicts of interest declared Funding not reported No baseline imbalance

*Study characteristics*
Methods	2‐arm RCT, individually randomised n = 414
Participants	Urban Primary Care centres in Barcelona Spain. Background breastfeeding rates: EBF at 6 months in Spain is 28.5% In this region, the prevalence of EBF at 6 months of age is approximately 32%. Inclusion criteria: mothers of healthy infants delivered at term (≥37weeks) in the catchment population of participating centres and who were breastfeeding their children exclusive or partial breastfeeding Exclusion criteria: admission of infant or mother to ICU, multiple pregnancy, severe congenital malformation in the infant, maternal age of 18 years or less, or mother that lacked a phone or had a language barrier.
Interventions	A weekly phone call during the first 2 months and a call every other week between months 2 and 6 post birth by a nurse assigned to the infant who also carried out routine visits. During the first month: position of the newborn for breastfeeding, frequency of feeds, number and consistency of stools, general breast care, normal weight gain, and, in mothers that supplemented feedings, advice and support to try to re‐establish EBF. In months 2‐3: advice on expressing breast milk, with instructions on how to handle and store breast milk. In months 4‐6: how to use stored breast milk, administration of stored milk to infants, importance of maintaining EBF and avoiding administration of other types of milk or foods. Control: mothers in both the control and the experimental groups attended the visits included in the preventive care protocol ‐ postnatal visit with the paediatrician (between days 7 and 15 post birth), check‐ups at 1, 2, 4 and 6 months with the nurse assigned to the patient, under the supervision of the paediatrician. The nurse counselled the mother regarding nutrition during these visits. Mothers could schedule additional appointments or call the nurse on the phone to receive guidance regarding breastfeeding problems.
Outcomes	Any and exclusive breastfeeding at 1, 2, 3 and 6 months
Notes	Dates of the study: data collection between October 2014 and October 2016 Funding sources: not reported. Declarations of interest: none declared.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The mothers that agreed to participate were assigned to the experimental or the control group using a random number table generated by computer software after signing an informed consent form.
Allocation concealment (selection bias)	Unclear risk	There is no information about allocation concealment.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not possible
Blinding of outcome assessment (detection bias) All outcomes	High risk	Trial participants self‐reported their breastfeeding experiences. The data was collected by the professional doing the visit.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Intervention group drop‐off = 193/207 = 7% Control group drop‐off = 187/207 = 10% Low risk as symmetrical drop‐off and less than 20% All exclusions appear to have been accounted for
Selective reporting (reporting bias)	Unclear risk	Prospective protocol (Clinical Trials number NCT02186613). All outcomes are reported.
Other bias	Unclear risk	No industry funding No conflicts of interest No baseline imbalance Study was underpowered ‐ 67%

*Study characteristics*
Methods	2‐arm RCT, individually randomised, n = 166
Participants	Young mothers in seven locations in England: London (two sites), the Midlands (two sites), the North East (one site) and the North West of England (two sites). Background breastfeeding rates: Not reported. Inclusion criteria: expectant mothers with a gestation of 16 to 20 weeks, with expected delivery dates (EDDs) within approximately 10 weeks of each other, for each group in each site. They were either aged below 20 years at their last menstrual period (LMP) with one or more previous live births, or aged 20–24 at LMP with no previous live births and with low educational qualifications, defined as neither mathematics nor English language GCSE at grade C or higher; if both, then no more than four GCSEs at grade C or higher. They had to be able to provide consent and to speak English. Exclusion criteria: women who had previously received FNP and those with psychotic mental illness.
Interventions	Group FNP (gFNP) is designed to run from the first trimester of pregnancy until infants are 12 months old with 44 group meetings in the curriculum, 14 covering pregnancy and 30 covering infancy. Delivered to a group of women living in relatively proximity to each other, with similar expected delivery dates (range 8–10 weeks). Meetings are around 2 h facilitated by two experienced FNP FNs one of whom had notified their intention to practice as a midwife. Includes content to: improve maternal health and pregnancy outcomes, improve child health and development by helping parents provide more sensitive and competent care; and to improve parental life course by helping parents develop effective support networks, plan future pregnancies, complete their education, and find employment. The curriculum domains are: mother’s personal health; the maternal role; maternal life course: family and friends; environmental health; and related health and human services, with referrals made when necessary. Control: usual care ‐ offers every family a program of screening tests, immunisations, developmental reviews, and information and guidance to support parenting and healthy choices. There are core universal elements provided for all families with additional progressive, preventive elements for those with medium or high risk. The universal program includes a neonatal examination, a new baby re‐ view at about 14 days, a 6‐ to 8‐week baby examination and a review by the time the child is 1 year old and at 2 to 2.5 years old.
Outcomes	Any breastfeeding at 6 months Postnatal depression (EPDS)
Notes	Dates of the study: the trial commenced in February 2013, recruitment and baseline data collection commenced in July 2013, continuing to September 2014. Funding sources: UK National Health Service (NHS) National Institute for Health Research (NIHR), Public Health program, grant number 11/3002/02 109425. Declarations of interest: none declared.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Allocation to one of two arms was securely computer‐generated and delivered by email to LSHTM which conveyed the information to study participants by post and conveyed to each gFNP team the names and contact details of women allocated to the intervention arm by fax or password‐protected email, receiving confirmation of receipt by email.
Allocation concealment (selection bias)	Low risk	Randomization was overseen by the London School of Hygiene and Tropical Medicine Clinical Trials Unit (LSHTM CTU). The unique identification number (which included a site identifier) and age at LMP of eligible consenting mothers‐to‐be were passed to the central randomization service at the Health Service Research Unit (HSRU), University of Aberdeen using an automated telephone procedure.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants could not be blind to allocation as they knew whether or not they had been offered gFNP, and gFNP practitioners were not blind to the intervention participants but had no knowledge of the control group.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Assessment of breastfeeding by sel‐report questionnaire
Incomplete outcome data (attrition bias) All outcomes	Low risk	Low and balanced loss to follow‐up at 2 months (85% retained in intervention group and 90% retained in control group) and at 6 months (83% retained in intervention group and 82% retained in control group). Low dropout pertains to breastfeeding outcomes. There was high dropout for the video element assessing mother‐infant interaction (17% refused to be videoed)
Selective reporting (reporting bias)	Low risk	Measures used at each time point are presented in Table 1 with full details in the published protocol [
Other bias	Low risk	Funded by NIHR Authors declare they have no competing interests Baseline characteristics balanced

*Study characteristics*
Methods	2‐arm RCT, single‐site, n = 900
Participants	Urban setting in Brazil: in‐patient maternity unit Background rates of breastfeeding initiation: high Ethnic composition not described Inclusion criteria: family income < twice the minimum Brazilian wage; hospital stay < 5 days; wanting to breastfeed: living within the city of Pelotas Baseline prevalence in Pelotas (1993) for any breastfeeding: 85% at 1 month, 66% at 3 months and 38% at 6 months.
Interventions	Intervention: 3 home visits at 5, 10 and 20 days postpartum by a social assistant or nutritionist. The visitor was required to have a personal history of successfully breastfeeding a child and received training in breastfeeding physiology and common breastfeeding problems and their solutions. Control: usual care, a social assistant would not normally make routine home visits but would visit only when requested to do so by the hospital team.
Outcomes	Breastfeeding at monthly intervals to 6 months and median duration of breastfeeding Time to introduction of artificial feeds Difficulties encountered during breastfeeding and reasons for weaning also recorded.
Notes	Dates of the study: January 1988 ‐ March 1989 Funding sources: information not included in translation Declarations of interest: information not included in translation
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Record in Portugese and no information in the translation regarding blinding of participants and personnel.
Blinding of outcome assessment (detection bias) All outcomes	High risk	The nurse collecting outcome data was not aware of previous contacts, but the authors stated that s/he may have been made aware of group assignment as women were likely to talk about the intervention.
Incomplete outcome data (attrition bias) All outcomes	Low risk	900 randomized, approximately 8% lost to follow‐up in the intervention and control groups.
Selective reporting (reporting bias)	Unclear risk	We did not have access to the trial registration or protocol.
Other bias	Unclear risk	No baseline imbalance apparent. Assessment of risk of bias was made from translation notes. The original paper is in Portuguese.

*Study characteristics*
Methods	Cluster‐randomised study with 8 sites, n = 1115
Participants	8 village communities located 3 km‐5 km from the main highway in Haryana, India Background rates of breastfeeding initiation: high Inclusion criteria: born in a study village within 9 months of start of intervention Exclusion criteria: not reported Baseline breastfeeding prevalence stated to be high
Interventions	Intervention: health and nutrition workers in the intervention communities received training based on Integrated Management of Childhood Illnesses Training Manual on Breastfeeding Counseling (WHO 1997). Messages ‐ feed only breast milk for first 6 months of life; breastfeed the infant day and night, at least 8 times in 24 h; possible adverse effects of other foods and fluids given to breastfeeding infants ‐ given to mothers at birth, plus monthly home visits, immunisation clinics and neighbourhood meetings. Control: at the control sites, the research team provided routine services, in which, according to national policy, workers are required to advise exclusive breastfeeding for 4‐6 months.
Outcomes	Feeding at 3 months Anthropometry and diarrhoea prevalence at 3 and 6 months
Notes	Dates of the study: 1st January 1998 to 31st March 2002 Funding sources: Department of Child and Adolescent Health and Development of WHO Declarations of interest: none declared
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Communities were paired on the basis of similar scores for socioeconomic, mortality and morbidity indicators. 1 of each pair was allocated to the intervention using a random number table. 8 areas were randomized (4 to each condition).
Allocation concealment (selection bias)	Low risk	Statistician independent of project carried out randomisation.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated whether participants and peer counsellors were blinded but unlikely.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Authors state "we attempted to keep to a minimum reporting bias by use of a separate team for assessment of outcomes; this team did not take part in the intervention and was unaware of the hypothesis being tested". However, data was self‐report.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Reasons for drop‐out recorded. 1151 births within the study period (not clear how many in each area). 588 families received the intervention and 527 no intervention. 895 completed 3 months follow‐up (80%) and 880 6 months (79%).
Selective reporting (reporting bias)	Unclear risk	We did not have access to the trial registration or protocol.
Other bias	Unclear risk	Areas were paired, but it was not clear whether this achieved similar baseline characteristics between groups. Results were reported to have been adjusted for clustering.

*Study characteristics*
Methods	2‐arm RCT, n = 382
Participants	From 2 prenatal care centres in the Bronx, New York (reported to be the county in the USA with the highest poverty rate) Background rates of breastfeeding initiation: low Inclusion criteria: able to speak English or Spanish, singleton or twin pregnancy < 24 weeks (twins subsequently excluded), intending to keep infant and attend for prenatal and postnatal care at centre and affiliated hospital, telephone contact numbers available Exclusion criteria: HIV‐positive status, chronic disease with medication not compatible with breastfeeding, diabetes, serious illness, or breast reduction surgery Participant characteristics: 57% Hispanic, 36% African‐American, 62% multiparous (70% of these had previous breastfeeding experience), mean age 25 years (SD 6.23), 51.5% married or living with a partner, 57% receiving Medicaid
Interventions	Intervention (n = 188): delivered by a trained LC. Women were recruited when < 24 weeks pregnant, and had 2 prenatal LC visits scheduled. During late pregnancy there was telephone contact, and hospital and home visits and telephone support (up to 12 months postpartum) were planned for the postnatal period. In the postnatal period 25% of the intervention group received at least 1 hospital contact; approximately 50% had telephone and/or home visits; but 36% received no home or hospital visits and no telephone support. Control (n = 194): women had no contact with the LC. Standard care varied between the sites and neither site followed an established protocol for breastfeeding. Women enroled in women and child nutrition programmes (WIC) had the opportunity to visit a breastfeeding co‐ordinator.
Outcomes	Infant health outcomes: Duration of breastfeeding and exclusive breastfeeding was presented mostly in graphical form and was difficult to interpret. Breastfeeding was categorised on a 7‐point scale from 7 = exclusive breastfeeding (which was defined as no other milk or food, but infants may have received water and other liquids) through to exclusive formula, between these extremes of the scale there were various 'intensities' of breastfeeding (e.g. > 50% breast milk). This meant that results were complicated and not easy to interpret. Women were followed up for up to 12 months and detailed (graphical) weekly data were reported for weeks 1‐26 postpartum.
Notes	Results estimated from graphs. Dates of the study: Recruitment August 2000 ‐ November 2002 Funding sources: supported by grants from the United States Department of Agriculture, the Maternal and Child Health Bureau, and the Agency for Healthcare Quality and Research. Declarations of interest: none declared
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “The project’s biostatistical office generated and maintained a list of random codes for subjects... undisclosed blocking factor and stratification according to center.”
Allocation concealment (selection bias)	Low risk	Sealed envelopes, numbered and opened sequentially.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	It was not stated whether the women were blinded. The LC providing the intervention was not blinded with respect to treatment group.
Blinding of outcome assessment (detection bias) All outcomes	High risk	The research assistant collecting breastfeeding outcome data was not blinded with respect to treatment group.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Women were recruited in the antenatal period. 382 women were randomized. Loss to follow‐up included 10 women who miscarried or terminated the pregnancy. 304 women were followed up into the postnatal period (80% of those randomized). There were further missing data for longer term follow‐up. Loss to follow‐up was balanced across groups.
Selective reporting (reporting bias)	Unclear risk	We did not have access to the trial registration or protocol.
Other bias	Unclear risk	The intervention did not appear to be standardised and many women in the intervention group (36%) did not receive any postnatal visits.

*Study characteristics*
Methods	Parallel 2‐arm participant‐level RCT, n = 666
Participants	Women who attended an urban medical centre providing prenatal care to a low income population in the Bronx, New York City. Background rates of breastfeeding initiation:79% Inclusion criteria: English‐ or Spanish‐speaking women aged ≥18 years, in the first or second trimester of a singleton pregnancy Exclusion criteria: risk factors for premature birth maternal or infant conditions that would preclude or complicate breastfeeding (e.g. mother HIV‐positive, infant congenital anomaly)
Interventions	666 women were randomised in a 1:3:3:1 ratio to: usual care, electronic prompt (EP) alone, Lactation Consultant (LC) + EP, or LC alone. Only the LC and EP+LC arms are included in this review as the EP arm (n = 253) was antenatal only and therefore does meet the review inclusion criteria for a breastfeeding support intervention. LC intervention (n= 80): Two LCs were allocated to this intervention.The LC protocol included 2 prenatal sessions, a hospital visit, and regular phone calls postpartum for 3 months or until breastfeeding ceased. The prenatal sessions occurred in the examination room, during the 30‐plus min of 'downtime' while waiting for the prenatal care provider. Attempts were made to complete interrupted sessions after the examination. The first session focused on rapport building and education, and the second was on the practical aspects of breastfeeding. The study provided nursing bras and breast pumps to LC group participants as needed. LCs met mothers and their infants at the 1‐week routine paediatric visit, modelling practice on a recent review. Postpartum home visits were optional, based upon participant and LC preference and comfort. LC + EP intervention (n=253): Included the LC protocol detailed above and electronic prompts for healthcare providers to ask three brief open‐ended questions which portrayed breastfeeding as the norm. This was done during pre‐natal care appointments. Control (n=80): usual care
Outcomes	For BINGO, the prespecified primary outcome measure was 3‐month breastfeeding intensity. Quote: "We categorised breastfeeding intensity as < 20% (low), 20% to 80% (medium), and greater than 80% (high) of all feeds from breast milk consistent with previous studies and Infant Feeding Practices Survey II analyses." Other analysis was planned. Power calculations were affected by the finding ‐quote: “we found that breastfeeding intensity was not normally distributed, and most women stopped breastfeeding altogether during follow‐up". Other outcomes: Quote: “Study staff assessed infant feeding at 1, 3, and 6 months postpartum during phone interviews using items adapted from the Infant Feeding Practices Survey II quote:”; exclusive breastfeeding, breastfeeding intensity (“defined as the percentage of all feedings in the past 7 days that were breast milk”), breastfeeding initiation, and total duration data collected.
Notes	The paper reported 2 trials that appear in this review (PAIRINGS and BINGO). Dates of the study: 2008‐2011 Funding sources: supported by the National Institute of Child Health and Human Development, and by the National Institute on Minority Health and Health Disparities. Declarations of interest: not reported
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Women were randomized using sequentially numbered opaque sealed envelopes, generated by the study’s biostatistician". Quote: "Randomization incorporated an undisclosed blocking factor and nativity status (US‐born vs foreign‐born)."
Allocation concealment (selection bias)	Low risk	Sequentially numbered opaque sealed envelopes.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "It was infeasible to blind participants and clinical staff to treatment group."
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "we sought to minimize bias by restricting access to allocation assignment, stripping group assignment from study databases to which research staff had access, and omitting group identifiers from participant interview form."
Incomplete outcome data (attrition bias) All outcomes	Low risk	The BINGO analytic sample included 94% of those randomized (628 of 666 participants).
Selective reporting (reporting bias)	Low risk	We checked the Clinicaltrials.gov record and the key breastfeeding outcome data seemed to be reported in this paper.
Other bias	Low risk	No baseline imbalance No industry funding No conflicts of interest

PERMALINK

Support for healthy breastfeeding mothers with healthy term babies

Anna Gavine

Shona C Shinwell

Phyll Buchanan

Albert Farre

Angela Wade

Fiona Lynn

Joyce Marshall

Sara E Cumming

Shadrach Dare

Alison McFadden

Abstract

Background

Objectives

Search methods

Selection criteria

Data collection and analysis

Main results

Authors' conclusions

Plain language summary

Summary of findings

Summary of findings 1. Summary of findings table ‐ Breastfeeding support only compared to usual care.

Summary of findings 2. Summary of findings table ‐ Support plus compared to usual care for healthy breastfeeding women with healthy term babies.

Background

Description of the condition

Description of the intervention

How the intervention might work

Why it is important to do this review

Objectives

Methods

Criteria for considering studies for this review

Types of studies

Types of participants

Types of interventions

Types of outcome measures

Primary outcomes

Secondary outcomes

Search methods for identification of studies

Electronic searches

Searching other resources

Data collection and analysis

Selection of studies

Screening eligible studies for scientific integrity/trustworthiness

1.

Data extraction and management

Assessment of risk of bias in included studies

(1) Random sequence generation (checking for possible selection bias)

(2) Allocation concealment (checking for possible selection bias)

(3.1) Blinding of participants and personnel (checking for possible performance bias)

(3.2) Blinding of outcome assessment (checking for possible detection bias)

(4) Incomplete outcome data (checking for possible attrition bias due to the amount, nature and handling of incomplete outcome data)

(5) Selective reporting (checking for reporting bias)

(6) Other bias (checking for bias due to problems not covered by (1) to (5) above)

(7) Overall risk of bias

2.

3.

Measures of treatment effect

Dichotomous data

Continuous data

Unit of analysis issues

Cluster‐randomised trials

Trials with multiple groups

Dealing with missing data

Assessment of heterogeneity

Assessment of reporting biases

Data synthesis

Subgroup analysis and investigation of heterogeneity

Sensitivity analysis

Summary of findings and assessment of the certainty of the evidence

Results

Description of studies

Results of the search

4.

Screening eligible studies for trustworthiness

Included studies

Description of included studies (n = 116)

Methods used in trials

Participants and setting

Socioeconomic and health status

*Study characteristics*
Methods	Parallel 2‐arm, participant‐level RCT, (n = 275)
Participants	Women who attended an urban medical centre providing prenatal care for an economically diverse population in the Bronx, New York City. Background rates of breastfeeding initiation:79% Inclusion criteria: English‐ or Spanish‐speaking women aged ≥18 years, in the first or second trimester of a singleton pregnancy Exclusion criteria: risk factors for premature birth maternal or infant conditions that would preclude or complicate breastfeeding (e.g. mother HIV‐positive, infant congenital anomaly)
Interventions	Intervention (n = 136): lactation counselling and electronic pumps. One LC was allocated to this intervention.The LC protocol included 2 prenatal sessions, a hospital visit, and regular phone calls postpartum for 3 months or until breastfeeding ceased. The prenatal sessions occurred in the examination room, during the 30‐plus min of 'downtime' while waiting for the prenatal care provider. Attempts were made to complete interrupted sessions after the examination. The first session focused on rapport building and education, and the second was on the practical aspects of breastfeeding. The study provided nursing bras and breast pumps to LC group participants as needed. LCs met mothers and their infants at the 1‐week routine paediatric visit, modelling practice on a recent review. Postpartum home visits were optional, based upon participant and LC preference and comfort. Electronic prompts for healthcare providers to ask three brief open‐ended questions which portrayed breastfeeding as the norm. This was done during pre‐natal care appointments. Control (n = 139): usual practice.
Outcomes	For PAIRINGS, the prespecified primary outcome was exclusive breastfeeding at 3 months. Other outcomes: Quote: “Study staff assessed infant feeding at 1, 3, and 6 months postpartum during phone interviews using items adapted from the Infant Feeding Practices Survey II”; exclusive breastfeeding, breastfeeding intensity (“defined as the percentage of all feedings in the past 7 days that were breast milk”), breastfeeding initiation, and total duration data collected.
Notes	The paper reported 2 trials that appear in this review (PAIRINGS and BINGO). Dates of the study: 2008‐2011 Funding sources: supported by the National Institute of Child Health and Human Development, and by the National Institute on Minority Health and Health Disparities. Declarations of interest: not reported
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were randomized using sequentially numbered opaque sealed envelopes, generated by the study’s biostatistician.
Allocation concealment (selection bias)	Low risk	Sequentially numbered opaque sealed envelopes.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "It was infeasible to blind participants and clinical staff to treatment group."
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "we sought to minimize bias by restricting access to allocation assignment, stripping group assignment from study databases to which research staff had access, and omitting group identifiers from participant interview form."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Analytic sample included 95% of those randomized (262 of 275 participants.
Selective reporting (reporting bias)	Unclear risk	Breastfeeding outcomes reported in Clinicaltrials.gov were reported in this paper. Other outcomes on weight and length were not reported in this paper, but they are not included as outcomes in this systematic review.
Other bias	Low risk	No baseline imbalance No industry funding No conflicts of interest

*Study characteristics*
Methods	2‐arm RCT with individual randomisation, single‐site, duration not stated, n = 115
Participants	Urban USA ‐ ambulatory care centre and in‐patient maternity unit Background rates of breastfeeding initiation: low Baseline prevalence of breastfeeding at birth in national WIC sample = 33% (1991) Inclusion criteria: English‐speaking; nulliparous Exclusion criteria: separated from child at birth; preterm delivery; child in NICU > 72 h Ethnic composition: described as 71% white 90% of participants were eligible for WIC programmes for those on low income. Study population not limited to those intending to breastfeed.
Interventions	Intervention: package of: 2‐4 prenatal sessions with LC (10 min‐15 min each); telephone call 48 h after discharge; visit to lactation clinic at 1 week postpartum (staffed by paediatrician or LC); contact with LC at each health supervision visit until weaning or 1 year; professional education of nursing and medical staff. Control: women were offered optional prenatal breastfeeding classes, postpartum breastfeeding instruction by nurses and physicians and outpatient follow‐up by nurses and physicians in the paediatric ambulatory department.
Outcomes	Rates of breastfeeding at 2 months and median duration of breastfeeding
Notes	Dates of the study: not reported Funding sources: The Mercy Foundation and by the Care of the Poor Fund, The Mercy Hospital of Pittsburgh Declarations of interest: not reported
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Sample stratified by age with block randomisation in blocks of 8.
Allocation concealment (selection bias)	Unclear risk	Not described.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Women and LC were not blinded.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcome data were collected by questionnaire administered by the LC who was not blinded to group allocation.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Follow‐up 94%. It appeared that 115 women were randomized. It was stated that 7 in the intervention group were excluded as they did not receive the intervention. 8 women in the control group were subsequently excluded from the analysis for at least some outcomes as the treatment they received deviated from protocol.
Selective reporting (reporting bias)	Unclear risk	We did not have access to the trial registration or protocol.
Other bias	Unclear risk	Potential confounders: women were excluded from intervention group following randomisation if they had received fewer than 2 prenatal lactation consultations; ITT analysis not performed (8 women in control group who met LC excluded); intervention included input by staff caring for both intervention and control groups.

*Study characteristics*
Methods	Cluster RCT, 47 communes randomised.
Participants	Setting: Burkina Faso is a low‐income setting with high infant mortality: an early neonatal mortality of 20 deaths per 1000 livebirths, a late neonatal mortality of nine deaths per 1000 livebirths, and a postneonatal mortality of 32 deaths per 1000 livebirths. Background breastfeeding rates: Burkina Faso had a national prevalence of exclusive breastfeeding of 25%, as reported in the 2010 Demographic and HealthSurvey, while a survey by the Ministry of Health found a prevalence of exclusive breastfeeding of 43% in 2016. Inclusion criteria: residing in a village selected for the study (had been members of households identified during household listing for at least 6 months or had the intention to stay there), had a livebirth in the 12 months preceding either of the two surveys and the infant was still alive and living with them, and gave informed consent to participate. The protocol also states inclusion criteria of being aged from 15 to 49 years old (women of reproductive age). Exclusion criteria: not clearly described.
Interventions	The Alive & Thrive initiative with randomisation of two components of the programme: (i) interpersonal communication activities, and (ii) mass communication activities. Interpersonal communication activities aimed to increase mothers’ knowledge about optimal breastfeeding practices and their benefits, to increase mothers’ expertise in breastfeeding, and to improve mothers’ perceptions about social norms relating to breastfeeding. These activities were delivered by existing structures within the public health system. Interpersonal communication activities were delivered by two cadres: government health workers during individual consultations for antenatal, delivery, and postnatal care and during women’s group discussions held at the local health centre; and community health volunteers during home visits that targeted pregnant and postnatal women who, during a visit to a health centre, expressed concerns or mentioned experiencing difficulties with breastfeeding. Community mobilisation activities were conducted to raise awareness of the benefits of breastfeeding primarily among partners, mothers‐in‐law, and grandmothers and to increase the support that they and the community provide to breastfeeding mothers. Community mobilisation activities consisted of community events and facilitated group discussions in public places in the villages to promote recommended breastfeeding practices. Some community health volunteers also received requests to support wives or daughters‐in‐law during their interactions with fathers and grandmothers at these events. The main messages of the Alive & Thrive intervention were: to place the baby to the breast within the first hour of birth, to give colostrum, to not give water, tisanes, or other liquids, and to breastfeed exclusively for 6 months. Control: home visits by community health volunteers to support health promotion in the community. Government health facilities and community health volunteers were also present in the control group, as part of the standard public health system, but did not benefit from any additional training, supervision, or community mobilisation activities of Alive & Thrive.
Outcomes	Exclusive breastfeeding among infants younger than 6 months
Notes	Dates of the study: training May 2016 to June 2017. Community mobilisation activities took place from December, 2015 to July 2017. Funding sources: Alive & Thrive is funded by the Bill & Melinda Gates Foundation and the governments of Canada and Ireland, and managed by FHI 360. This research was supported by funding from the Bill & Melinda Gates Foundation (grant number OPP50838). Declarations of interest: none declared.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The sequence generation process used a random component of computer generated pseudo‐random numbers through Stata software.
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the intervention, it was not feasible to blind participants and personnel.
Blinding of outcome assessment (detection bias) All outcomes	High risk	It was not feasible to blind outcome assessors due to self‐report of outcomes.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Four of 41 clusters were removed following randomisation, but prior to baseline data collection. The baseline and endline surveys were conducted with two independent, population‐representative samples within clusters; hence, no attrition due to the cross‐sectional nature of each survey
Selective reporting (reporting bias)	Low risk	Outcomes appear as in clinicaltrials.gov trial registration record
Other bias	Unclear risk	Clusters were accounted for in the analysis. No industry funding. No competing interests declared. The study design, using two independent, population representative samples of individual participants at baseline and endline may be a source of bias, but this is unclear. No imbalance was observed for the sample of participating women completing the baseline survey, but this was unclear for the sample of participating women completing the endline survey.

*Study characteristics*
Methods	2‐arm RCT, single‐site study, mothers recruited March 2000‐December 2001, n = 605
Participants	Urban Italy Background rates of breastfeeding initiation: intermediate Inclusion criteria: mothers in public maternity ward in Rome, intending to breastfeed Exclusion criteria: mothers who did not speak Italian, had no phone, breastfeeding medically contraindicated, baby in SCBU Ethnic composition not defined. Baseline national breastfeeding initiation rate 70%.
Interventions	Intervention (home visit and telephone contact): home visit, from 1 of the 6 midwives from the maternity ward of the study hospital, took place within 7 days of hospital discharge. Telephone breastfeeding counselling session provided by the same midwife. These midwives had attended the UNICEF 18‐h intensive training course on breastfeeding techniques and management. Control: standard care (not described)
Outcomes	Any breastfeeding up to 60 days
Notes	Extra information about reported numbers requested and received from author. Dates of the study: 08/03/2000 ‐ 08/12/2001 Funding sources: not reported Declarations of interest: not reported
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Sample was stratified "for age and parity, and finally randomly assigned to either the intervention or control group".
Allocation concealment (selection bias)	Unclear risk	Not described.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No details were provided about blinding of participants and personnel.
Blinding of outcome assessment (detection bias) All outcomes	High risk	A trained interviewer conducted the interviews, but was not blinded.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	605 women were randomized. Full data were available for 278 women (46%) and partial data available for a further 264 (44%). Follow‐up rates for breastfeeding outcomes collected up to 180 days, but after 60 days follow‐up rates were < 75% so only outcomes up to 60 days are included in this review. Reasons for drop‐out were reported by group.
Selective reporting (reporting bias)	Unclear risk	We did not have access to the trial registration or protocol.
Other bias	Unclear risk	Baseline characteristics similar and no apparent differences between those who refused intervention and those who received it, see Table 1.

*Study characteristics*
Methods	2‐arm RCT, single site, n = 248
Participants	A major USA urban university hospital community doula intervention Participant: low‐income, African‐American mothers < 22 years old Background breastfeeding rates: young African‐American mothers continue to breastfeed at low rates, and commonly introduce complementary foods earlier than recommended. In the 2006 National Health and Nutrition Study, for example, only 30% of black adolescent mothers had ever attempted to breastfeed their infants. Background rates of breastfeeding initiation:79% Inclusion criteria: women who were < 34 weeks pregnant, < 21 years of age, and planning to deliver at the affiliated hospital were eligible to participate in the study. Exclusion criteria: mothers who were aware at the time of recruitment that they would require a surgical delivery, who planned to move from the area, or who planned to give up custody of the infant
Interventions	Intervention (n = 124): Women received additional care from doulas who were women from the same communities as the women attending the clinic. During pregnancy women received weekly home visits (average = 10) where the doula focused on building a relationship with the mother and discussed pregnancy health, childbirth preparation, and bonding with the unborn infant.Doulas were present during labour to provide support and help initiate breastfeeding after birth.Doulas continued to provide face‐to‐face breastfeeding support in the post‐natal period (average 12 home visits). Doulas undertook a 20‐week doula training course provided by the Chicago Health Connection (Health Connect One) and a 10‐week breastfeeding peer counsellor training programme from the same organisation. Control (n=124): mothers received usual prenatal care; no doula input
Outcomes	Primary outcomes: data on breastfeeding attempts were collected by mother report at the hospital the second morning after the birth and from review of the nursing notes in the mothers medical chart after the mothers discharge. Mothers were considered to have attempted breastfeeding if breastfeeding was indicated by either self report or nursing notes. At 4 months postpartum, the mothers participated in an interview on feeding practices. Mothers reported on whether they were currently breastfeeding and, if not, when they had stopped breastfeeding. Secondary: mothers were also asked about whether they had started feeding their infants cereal, either in the bottle or by spoon, or other solid foods, and reported the infant age.
Notes	Dates of the study: recruitment Jannuary 2001 ‐ April 2004 Funding sources: Maternal and Child Health Bureau Research Program, HRSA, DHHS, grant R40 MC 00203. The intervention implementation was funded by grants from the Irving B. Harris Foundation, the Blowitz‐Ridgeway Foundation, the Prince Charitable Trusts, the Visiting Nurses Association Foundation, and the Michael Reese Health Trust. Declarations of interest: none declared
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Randomization took place in blocks of 4, 6, or 8, with equal numbers assigned to the intervention and control groups."
Allocation concealment (selection bias)	Low risk	Quote: "A biostatistician prepared a set of opaque envelopes, each labelled with a subject ID number and containing a group assignment. Envelopes were opened by the interviewer in the presence of the mother at the completion of the baseline interview."
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not possible to blind participants.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Data were collected by research staff through interviews with mothers and by chart review. Not stated whether research staff were blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	A total of 221 mothers,113 in the control group and 108 in the doula participated in the 4‐month interview. Attrition < 25% for both groups.
Selective reporting (reporting bias)	High risk	Breastfeeding at 12 months was reported as a secondary outcome in the Clinicaltrials.gov record, but this was not reported in the paper.
Other bias	Low risk	Mothers in the 2 groups were compared on a variety of demographic, psychological, and health variables measured before randomisation and no significant differences were found.

*Study characteristics*
Methods	Longitudinal study, 2‐arm cluster‐randomised trial, 10 Swedish municipalities randomised n = 540
Participants	Setting: Antenatal Centres and Child Health Centres in 10 municipalities in southwest Sweden Background rates of breastfeeding initiation: high Inclusion criteria: Swedish‐speaking mothers who gave birth to singleton, healthy, term infants spontaneously, by vacuum extraction or by caesarean section Participant characteristics: mean age approximately 27 years, married 61%‐69%, vaginal delivery 70%‐75%, university educated 36%
Interventions	Intervention: the intervention included continuity of care at the antenatal and child centres, and a process‐oriented training program of 7 sessions for health professionals. The staff training included reflection on personal experience of breastfeeding and breastfeeding counselling, management and promotion. Staff were encouraged to develop a common breastfeeding policy between the antenatal and child health centres. The family classes were also kept together before and after childbirth. Control: offered standard family classes, usually discontinued at birth
Outcomes	Maternal perceptions of the relationship with the infant, maternal feelings for the infant and duration of exclusive/any breastfeeding
Notes	10 centres randomised. A total of 540 women took part in the study (intervention group 206 women; 2 control groups 162 + 172 = 334 women). Data collection took place at different times for the 2 control groups. We have included data from 378 women; the intervention group (206 women) and 1 control group (172 women), from whom data were collected at the same time as from the intervention group. Dates of study: study conducted between April 2000 and January 2003 Funding sources: Board of Research for Health and Caring Sciences, Swedish Research Council Declarations of interest: none declared
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The 10 largest municipalities were classified in pairs that were similar in size and had similar figures of breastfeeding duration. The municipalities were randomized pair‐wise to either an intervention or control group.
Allocation concealment (selection bias)	Unclear risk	Trial report did not report.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No detail regarding blinding of participants or personnel, but appears unlikely.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Maternity staff distributed the first questionnaire. Follow‐up questionnaires were sent to women. It was not stated whether there were any blinding procedures.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	The sample included women cared for in intervention clinics and then 2 control groups. However, data collection in 1 of the control groups was carried out before the intervention period, so in the analyses we have included only the control group data that were collected simultaneously with the intervention group (total 540 women, 378 included in analysis). Response rates at 3 days 84% and 93% in the intervention and control groups, by 9 months postpartum 64% and 73%. There was no adjustment for cluster design.
Selective reporting (reporting bias)	Unclear risk	We did not have access to the trial registration or protocol.
Other bias	Unclear risk	No baseline imbalance was apparent, although duration of exclusive breastfeeding was presented as a baseline characteristic.

*Study characteristics*
Methods	2‐arm cluster‐RCT, n = 330 in 15 clusters
Participants	NSW, Australia, primary care setting of general practice in rural agricultural settings. Maternity hospitals were not Baby Friendly accredited, although at each hospital an International Board Certified LC and registered midwives encouraged mothers to breastfeed. 35.3% of infants were currently fed solids at 4 months, while 52.9% had received solids, infant formula or other nonhuman milk, at least once, by 4 months. Background rates of breastfeeding initiation:92% Inclusion criteria: all pregnant women who had registered to give birth at 1 of the 3 local hospitals (n = 3127) over 14 months, had reached 24–36 weeks of pregnancy, who planned to have their postnatal care at a participating general practice and who were still breastfeeding at8 weeks were randomised. Exclusion criteria: not reported
Interventions	Intervention (n = 154): a structured conversation to support continuation of breastfeeding following a Conversation Tool flowchart that used a motivational interviewing approach. The Conversation Tool was used with each breastfeeding mother who attended a general practice intervention site for her infant to be immunised at 2, 4 or 6 months. Mothers were informed of the recommendation for breastfeeding exclusively to 6 months and maintenance to 1‐2 years and asked ‘How would that work for you?’ According to the mother’s response, the practice nurse provided a targeted proactive conversational action. Intervention practice nurses attended 2 x 5‐h training workshops that were delivered by a team of a midwife/LC/trainer and a family doctor/breastfeeding counsellor and based on WHO‐based resource that presented breastfeeding maintenance as appropriate and physiological. In addition, training addressed motivational interviewing and reflective practice. Information about local government and community breastfeeding support services, and handout literature for mothers, were provided. Control (n = 176): mothers received usual care from nurses who had not received WHO breastfeeding support training, and who commonly asked whether the mother had any problems.
Outcomes	Outcomes not clearly stated Exclusive and full/predominant (substitution of breast milk with water‐based substances allowed) breastfeeding at 4 and 6 months
Notes	Dates of study:iIntervention run from August 2008 to October 2009 Funding sources: no specific funding other than a PhD scholarship from UNSW Declarations of interest: not reported
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Clusters were coded, computer randomized and assigned to the intervention or control group.
Allocation concealment (selection bias)	Low risk	Clusters randomized at same time, so concealment was not an issue.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding was not possible for the practice nurses. Participants were unaware of the group allocation process, but not clear if this was effective.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Research assistants, who were not otherwise associated with the study, collected blinded outcome data by telephone interview.
Incomplete outcome data (attrition bias) All outcomes	Low risk	2% attrition in intervention group and 3% in control group.
Selective reporting (reporting bias)	Unclear risk	The protocol did not state the predefined outcomes clearly.
Other bias	High risk	Difference in prenatal intentions to rejoin employment within 12 months between the 2 groups (70% intervention, 56% control).

*Study characteristics*
Methods	4‐arm (factorial design) RCT, single site, recruiting over 17 months, n = 343
Participants	Urban USA: inpatient maternity unit Background rates of breastfeeding initiation: low Inclusion criteria: breastfed once in hospital; able to speak Spanish or English; baby needed < 48 h on NICU; able to be contacted by telephone after discharge Participant characteristics: 57% primiparous Ethnic composition: black 65%, Hispanic 19%, white 13%, other 4% Socioeconomic status defined by: < 100% poverty level ‐ 69%; 100%‐200% poverty level ‐ 21%; > 200% poverty level ‐ 10% Mean age of participants 25.7 years
Interventions	Intervention: women received postpartum breastfeeding counselling in hospital by trained counsellor (20‐40 min) and by telephone at 5, 7, 14, 21, 28, days and 6, 8 and 12 weeks, also 24‐h advice by pager. Given research discharge pack in English and Spanish. Routine care consisted of postpartum staff nursing contacts (including discharge teaching session on infant care), infrequent breastfeeding classes, written information on breastfeeding management and the opportunity to access a midwife‐run telephone advice line.
Outcomes	Exclusive breastfeeding at 1, 2, 3 and 4 months Any breastfeeding at 4 months Median duration of breastfeeding Time to introduction of formula or solids Rehospitalisation of infants
Notes	Dates of study: study conducted from May 1984 to September 1985 Funding sources: National Institute of Child Health and Human Development grant Declarations of interest: not reported
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomised block design (block size 8) with computer‐generated list of random numbers
Allocation concealment (selection bias)	Low risk	Sequentially numbered opaque sealed envelopes
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Participants were aware of the overall goal of the interventions but not aware of the study hypotheses. It is not detailed whether personnel were blinded but appears unlikely.
Blinding of outcome assessment (detection bias) All outcomes	High risk	For follow‐up at 4 months it was stated that the investigator was not aware of group assignment.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Participants received a fee to minimise sample attrition. 343 women were recruited. There were a small number of protocol deviations (7 women received the wrong type of discharge pack and were analyzed according to treatment received rather than by randomisation group). 19 women were lost to follow‐up. Attrition and reasons for attrition were described as similar across groups. Follow‐up 94%. Appropriate randomisation procedures.
Selective reporting (reporting bias)	Unclear risk	We did not have access to the trial registration or protocol.
Other bias	Low risk	No baseline imbalance apparent.

*Study characteristics*
Methods	Multicentre, 3‐arm cluster‐RCT, n = 722 (clusters (hospitals) n = 3)
Participants	Mother–infant pairs were recruited from the postnatal units of 3 geographically distributed public hospitals providing obstetrical services in Hong Kong. Participants: 722 primiparous breastfeeding mothers with uncomplicated, full‐term pregnancies Background rates of breastfeeding initiation: 80% In Hong Kong current breastfeeding patterns are similar to those of other developed countries, with > 80% of women initiating breastfeeding, but with only 20% continuing to breastfeed exclusively for 3 months. Inclusion criteria (mother): Hong Kong Chinese primiparas, ≥ 18 years old, intending to breastfeed, and without any major obstetric complications (i.e. severe postpartum haemorrhage) or serious medical problems (i.e. psychiatric illness) Inclusion criteria (baby): gestational age ≥ 37 weeks; birthweight ≥ 2500 g, 5‐min Apgar score ≥ 8, and no physical anomalies that would contraindicate or complicate breastfeeding Exclusion criteria: mothers who were planning to live in mainland China after delivery
Interventions	Intervention 1: standard care plus 3 in‐hospital professional breastfeeding support sessions, of 30–45 min in duration. Intervention 2: standard care plus weekly postdischarge breastfeeding telephone support, of 20–30 min duration, for 4 weeks. Both interventions were delivered by 4 trained research nurses, who were either highly experienced registered midwives or certified LCs. Control: standard postnatal maternity care that consisted of routine perinatal care according to the type of delivery, group postnatal lactation education provided by a midwife or LC, 1‐on‐1 assistance with breastfeeding if problems arose and time permitted, and postdischarge follow‐up, either at the outpatient clinic of the delivery hospital or at the nearest Maternal and Child Health Centre. Information on available peer‐support groups was also provided upon hospital discharge.
Outcomes	Primary: prevalence of any and exclusive breastfeeding at 1, 2, and 3 months postpartum. Classified infant feeding status into 3 categories: exclusive breastfeeding; any breastfeeding; and exclusive formula feeding. Secondary: overall duration of any and exclusive breastfeeding. Measured the duration of any and exclusive breastfeeding as the age of the infant in weeks when the participant completely stopped breastfeeding and first introduced infant formula, respectively.
Notes	Dates of study: participants were recruited between November 2010 and September 2011 Funding sources: Health and Medical Research Fund of the Food and Health Bureau, Government of Hong Kong Special Administration Region. Declarations of interest: none declared
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The allocation sequence was generated using an online program (www.randomization.com). All participants at each study site were allocated to the intervention to which the hospital was randomly assigned for that week. Cluster‐randomisation was used, with hospitals being the unit of randomisation. Each week, a study hospital was randomly assigned each study hospital to 1 of the 3 treatment groups.
Allocation concealment (selection bias)	Low risk	Conducted by a person not involved in the subject recruitment or data collection. Assignments placed in sequentially numbered opaque sealed envelopes.
Blinding of participants and personnel (performance bias) All outcomes	High risk	The blinding of either participants or those delivering the intervention was not possible for this type of study design. For the control and telephone support group, a research nurse not involved with delivering the intervention, recruited the participants. However, authors state that for the inpatients, the same nurse who recruited the participants also delivered the intervention.
Blinding of outcome assessment (detection bias) All outcomes	High risk	A study research assistant, who was blinded to the participants’ treatment allocation, conducted the telephone follow‐up.
Incomplete outcome data (attrition bias) All outcomes	Low risk	97% of participants had complete follow‐up.
Selective reporting (reporting bias)	Unclear risk	No evidence of predefined outcome measures so unable to make a judgement.
Other bias	High risk	Not all intervention groups received the full intervention.Of the 191 participants allocated to the in‐hospital support group, 137 (71.7%) received all 3 sessions, 52 (27.2%) received 2 sessions, and 2 (1.0%) received only 1 session before hospital discharge. Of the 268 participants in the telephone support group, 199 (74.3%) received all support sessions for which they were eligible; 27 (10.1%), 24 (9.0%), 13 (4.9%), and 5 (1.9%). Baseline characteristics and maternal and birth data were similar across the 3 groups although there were some minor variations in maternal education, family income, intention to exclusively breastfeed, and antenatal breastfeeding class attendance.

*Study characteristics*
Methods	Cluster RCT of 16 health centres.
Participants	16 health centres in three districts in Lusaka Province, Zambia. Background breastfeeding rates: 73% exclusively breastfeed their infants aged 0–5 months, but 39% of infants aged 4–5 months are given complementary foods. Inclusion criteria: primary caregivers of children younger than 5 years, but the assessment was restricted to two specific populations: mothers of an infant younger than 6 months and primary caregivers of a child younger than 5 years with recent diarrhoea. Exclusion criteria: the follow‐up sample excluded individuals who had moved into the area since baseline.
Interventions	A campaign, developed with creative agency DDB Iris, centred on a group of women known as Adzimayi Bamu Komboni, meaning housewives of the slum community. This group gossiped about women whose behaviour was believed to deviate from the target behaviours, but they ultimately admitted women into their social circle (a reward) when it was proven that they were practising the correct behaviours. The motives of disgust (an adaptive mechanism that helps us to avoid disease) and nurture (a natural instinct to protect and care for one’s off spring) were also used to drive behaviour change through elicitation of strong emotional responses in connection with the targeted behaviours. The campaign had four components: women’s forums delivered in neighbourhoods; roadshows delivered in public gathering spaces; clinic‐based circle of mothers sessions with monthly prize draws; and call‐in programmes on local radio linked to the forums. Control: standard care at clinics. Radio adverts and call in‐show broadcast in control areas too.
Outcomes	Exclusive breastfeeding in all children under 5 months
Notes	Dates of the study: January 2014 to November 2014 Funding sources: Absolute Return for Kids (ARK) and Comic Relief. Declarations of interest: none declared.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Clusters were randomly selected within three strata based on district in a 2:1:1 ratio, resulting in a sample that was half peri‐urban (Lusaka district) and half rural (Chongwe and Kafue districts). A statistician unrelated to the study allocated half of the clusters in each district to intervention or control (no intervention, standard care at clinics) using a random number table
Allocation concealment (selection bias)	Low risk	Randomisation was done (by an independent statistican) before baseline data collection took place, but cluster allocation was concealed from the study team until after baseline data had been collected.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Due to the nature of the intervention, it was not feasible to blind participants or personnel to group allocatio
Blinding of outcome assessment (detection bias) All outcomes	High risk	While authors suggest outcome assessors were blind to group allocation, breastfeeding outcomes were self‐report by the women who were not blind to group allocation.
Incomplete outcome data (attrition bias) All outcomes	Low risk	None of the clusters were lost to follow up. It should be noted that the baseline and endline surveys were conducted with two independent, population‐representative samples within clusters; hence, no attrition due to the cross‐sectional nature of each survey.
Selective reporting (reporting bias)	Low risk	The clinicaltrials.gov trial registration record suggests no selective reporting for key breastfeeding outcomes
Other bias	Unclear risk	16 clusters randomised, with 16 clusters participating in baseline and endline surveys. ICC was calculated for each behavioural outcome. Clusters were accounted for in the analysis. No industry funding. Declaration of interests transparent, with statement that three authors have received funding from Unilever, a soap manufacturer. None of their time while working on this study was funded by Unilever. Baseline profiles of participants similar, but there were differences between the study groups in both study profiles with respect to educational level, employment status, prevalence of shared sanitation, awareness of zinc, and use of ORS and zinc. Unclear if this is a source of bias.