Watt 2009

Methods	Study design: Randomised controlled trial Funding: "This work was commissioned by the Food Standards Agency in 2009 and supported by the Department of Health (UK) from 2010."
Participants	Description: New mothers attending baby clinics in disadvantaged London neighbourhoods N (Randomised): 312 mothers Age: Children: mean = 10 weeks Parents: mean = 30 years % Female: Children = not stated Parents = 100% SES and ethnicity: 28% lone parents 57% living in social housing 33% receiving income support/job seeker's allowance Ethnicity: 50% from an ethnic minority Inclusion/exclusion criteria: Inclusion criteria: "Women from Registrar General occupational classes II‐V (non‐professional); babies born >/= 37 weeks; babies' birth weight above 2500g; singletons; women able to understand written and spoken English; and resident in the study area." Exclusion criteria: "Women aged under 17 years; infants were diagnosed with a serious medical condition or were on special diets; infants aged over 12 weeks; women or their partners were from social class I (professional). Originally their intention was to restrict the sample to first‐time mothers over the initial 12 week recruitment period. The inclusion criteria was therefore changed to include all new‐mothers." Recruitment: "Women were recruited from December 2002 to February 2004 at baby clinics located in the more disadvantaged neighbourhoods across Camden and Islington where Surestart (a national social welfare initiative targeting families with young children) programmes existed. A standardised technique was used to approach new mothers attending the baby clinics. An overview of the study was given and randomisation explained. If the women were interested, a short screening questionnaire was then used to assess their eligibility." Recruitment rate: Mothers: 82% Region: London, UK
Interventions	Number of experimental conditions: 2 Number of participants (analysed): Intervention = 124, Control = 115 (12 months) Intervention = 108, Control = 104 (18 months) Description of intervention: A monthly home visiting programme (from 3 to 12 months) delivered by trained local mothers, providing practical support on infant‐feeding practices. Duration: 9 months (duration of each visit = 60 min) Number of contacts: Monthly from 3 to 12 months (maximum = 10 contacts) Setting: The home Modality: Face‐to‐face, via home‐visiting Interventionist: Trained local volunteers "A group of local mothers were recruited and trained to provide the support in a 12‐session programme delivered over a 4‐week period." Integrity: "On average each woman in the intervention group received five volunteer home visits (range 1‐10). A small number of women were also contacted by telephone when home visits were not possible." Date of study: Recruited from Dec 2002 to Feb 2004 Description of control: Usual care. "Women in the control group only received standard professional support from health visitors and GPs."
Outcomes	Outcome relating to children's fruit and vegetable consumption: Children's intake of vitamin C from fruit Secondary outcome: Proportion of children who consumed specific fruits and vegetables more than once a week Length of follow‐up from baseline: 9 months and 15 months (when children aged 12 months and 18 months, respectively) Subgroup analyses: None Loss to follow‐up: (at 9 and 15 months) Intervention: 27%, 34% Control: 20%, 30% Analysis: Adjustment for clustering not applicable Sample size calculation was performed
Notes	Vitamin C (mg) from fruit at the longest follow‐up < 12 months (9 months ‐ children aged 12 months) and ≥ 12 months (15 months ‐ children aged 18 months old) was extracted for inclusion in meta‐analysis. Sensitivity analysis ‐ primary outcome: Vitamin C intake from fruit listed as primary outcome
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"A random allocation schedule was prepared in advance using random digit computer tables."
Allocation concealment (selection bias)	Low risk	"Those responsible for recruiting ... were all masked to group assignment."
Blinding of participants and personnel (performance bias) All outcomes	High risk	Contact with the author indicated that parent participants and intervention personnel were not blind to group allocation. Given that the trial outcome was based on parental reports of children's fruit intake, the review authors judged that there was a risk of performance bias in this study
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"Those responsible for ... assessing outcomes were all masked to group assignment."
Incomplete outcome data (attrition bias) All outcomes	High risk	Rates of loss to follow‐up were similar across intervention (27%, 34%) and control (20%, 30%) groups at both time points and were moderate. There were no substantial differences in the reasons for loss to follow‐up
Selective reporting (reporting bias)	Low risk	All primary or secondary outcomes of interest were reported according to the information provided in the trial register (ISRCTN 55500035)
Other bias	Low risk	Small deviation in protocol: The original sample was restricted to first‐time mothers but after 12 weeks of the 14‐month recruit this was broadened to all new mothers No further risks of bias identified