Martin 2015.
Methods | 3‐armed pilot RCT to examine the feasibility of recruiting and maintaining a cohort of pregnant overweight women and obese women with the view of reducing postpartum weight retention and improving breastfeeding outcomes | |
Participants | Setting: Teriary Obstetric Unit in New South Wales, Australia Recruitment: October 2010‐September 2011 Inclusion criteria: women with a pre‐pregnancy BMI between 23‐35 kg/m², women intending to breastfeed, ≥ 18 years old, singleton pregnancy, English‐speaking, < 26 weeks' gestation at the initial screening and agreeing not to participate in another weight loss programme in the postnatal period for the duration of the study. Exclusion criteria: not meeting the inclusion criteria above |
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Interventions | Dietary advice in the antenatal period and breastfeeding support n = 12 Dietary advice in the antenatal period n = 12 Dietary advice at 3 months postpartum n = 12 The dietary intervention was provided by an Accredited Practicing Dietician in the antenatal period (or for women on the 'waiting list' at 3 months postpartum). Women were directed to implement the “Total Eating Management System” in the postnatal period. Breastfeeding support was provided by an International Board Certified lactation consultant from 35/40. Breastfeeding support only provided advice on lactation issues. In the antenatal period 2 x 30 min face‐to‐face education sessions were provided to discuss the fundamentals of breastfeeding, previous experience of breastfeeding, infant feeding expectations, goals and to build up rapport. In the postnatal period a home visit was provided up to 2 weeks postnatal to ensure breastfeeding was established. At this meeting participants could also discuss concerns. Follow‐up phone calls were provided as required to address concerns raised by the participant. |
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Outcomes | Demographics and medical history were obtained. Infant feeding data were collected at 3 and 6 months (obtained by the dietician). This included an infant feeding recall questionnaire (initiation, duration and exclusivity) and current feeding practices to record the infants' breast milk and formula milk intake in the previous 24 h as well as the following: vitamins/minerals/medicine, water/flavoured water, fruit juice, tea, canned/powdered/fresh milk, solid or semi‐solid foods, oral rehydration salts and other foods/fluids Multiple blood bio‐markers were also collected at 35 weeks' gestation, 3 and 6 months postpartum |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Block randomisation (groups of three) using a computerised generated random number sequence was used to randomise women who were also stratified by pre‐pregnancy weight status categories of overweight (BMI 25–29.99 kg/m²) and obesity (BMI 30–35 kg/m²)." |
Allocation concealment (selection bias) | Low risk | Quote: "Numbered cards allocating women to an intervention group or the control group were placed in opaque, sequentially numbered envelopes. The person responsible for participant allocation (LMW) did not have direct contact with participants, therefore allocation concealment was maintained." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of participants and lactation consultants was not possible due to the nature of the study. This could have led to performance bias and affected outcomes as breastfeeding outcomes were self‐reported. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Breastfeeding outcomes were collected by the study dietician who was blinded to allocation to diet or diet and breastfeeding support. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 25/36 women enrolled in the study were still in the study at 6 months postpartum. This was 69% of those enrolled so attrition was > 20%. |
Selective reporting (reporting bias) | Unclear risk | This study was assessed from a published report without access to the protocol, therefore we cannot be certain whether all pre‐specified outcomes were reported. Breastfeeding outcomes only reported in brief. |
Other bias | Low risk | None noted |