Campbell 2013.

Study characteristics
Methods	Study design C‐RCT Funding “National Health and Medical Research Council Grant No. 425801"
Participants	Description First‐time mothers and their infants N (randomised) 62 parent groups, 542 parent‐child pairs Age Child (mean): intervention = 3.9 months, control = 3.9 months Parent (mean): intervention = 32.5 years, control = 32.1 years % female Child: Intervention = 48%, control = 47% Parent: 100% SES and ethnicityParent: education levels (has completed university degree or beyond) Intervention = 52%, control = 57% Born in Australia Intervention = 78%, control = 78% Inclusion/exclusion criteria Parent groups inclusion criteria: “Parent groups were eligible if ≥8 parents enrolled or ≥6 parents enrolled in areas of low socioeconomic position (SEP) because mothers in areas of low SEP are less likely to attend first‐time parent groups.” No explicit exclusion criteria stated for this trial Parents inclusion criteria: “Parents will be eligible to participate if they are able to freely give informed consent, are first‐time parents, members of a participating 'first‐time parents group' and are able to communicate in English.” Exclusion criteria: “Parents will be excluded from the study if they are unable to give informed consent or are unable to communicate in English. Infants with chronic health problems that are likely to influence height, weight, levels of physical activity or eating habits will be excluded from analyses but will be permitted to participate in the study.” Recruitment “A two‐stage random sampling process will be used to select first‐time parent groups. At the first stage, twelve local government areas within a 60 km radius of the research centre (Deakin University in Burwood, Victoria, Australia) will be randomly selected.” “At the second stage, first‐time parent groups within selected local government areas will be randomly selected, proportional to the total number of first‐time parent groups within each area. The first‐time parents group currently underway will then be invited to participate.” Recruitment rate Parent: 86% (542/630) Region Melbourne (Australia)
Interventions	Number of experimental conditions 2 Number of participants (analysed) Intervention = 195, control = 194 Description of intervention “The dietitian‐delivered intervention comprised six 2‐hour sessions delivered quarterly during the first‐time parents’ group regular meeting.” The intervention “sought to build knowledge, skills, and social support regarding infant feeding, physical activity, and sedentary behaviors. Messages were anticipatory in nature, such that concepts were presented before the associated child developmental phase.” “Intervention materials incorporated 6 purpose‐designed key messages (for example, “Color Every Meal With Fruit and Veg,” “Eat Together, Play Together,” “Off and Running”) within a purpose‐designed DVD and written materials. A newsletter reinforcing key messages was sent to participants between sessions.” Duration 15 months Number of contacts 6 sessions at 3‐monthly intervals (2 hours per session) Setting Parenting group Modality Multiple (face‐to‐face, visual and written materials) Interventionist Experienced Dietitian Integrity “Program fidelity was audited via checklists by researchers attending but not delivering the intervention.” No further information reported Date of study June 2008 to February 2010 Description of control “Control parents received usual care from their MCH nurse, who may have provided lifestyle advice.”
Outcomes	Outcome relating to children's fruit and vegetable consumption Child’s consumption of fruits and vegetable (grams) assessed using 3 x 24hr recalls (3 days, including 1 weekend day) conducted by trained nutritionists via telephone interview with parents Outcome relating to absolute costs/cost effectiveness of interventions Intervention cost per family reported that adjusted “for the fact that a trial setting sees an artificially small number of families included relative to the workforce employed” Outcome relating to reported adverse events Not reported Length of follow‐up from baseline 6 (mid‐intervention) and 15 months (postintervention) Length of follow‐up postintervention Immediately Subgroup analyses None Loss to follow‐up (Immediately postintervention) Intervention = 28% Control = 28% Analysis Adjusted for clustering. Sample size calculation was performed.
Notes	First reported outcome (grams fruit/day) was extracted for inclusion in the meta‐analysis. Sample size per group was not reported and instead calculated based on assumption of equal loss to follow‐up per group, and reported baseline sample per group and total sample for diet outcomes at follow‐up. Sensitivity analysis ‐ primary outcome: primary outcome not stated, however power calculation was conducted on fruit or vegetable intake
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomly allocated to condition using a computer‐generated random number schedule developed by a statistician with no contact with the centres
Allocation concealment (selection bias)	Unclear risk	There is no information provided about allocation concealment and therefore it is unclear if allocation was concealed
Blinding of participants and personnel (performance bias) All outcomes	High risk	24‐h dietary recall (parent reported) Parents were not blinded to group allocation and therefore the risk of performance bias is high
Blinding of outcome assessment (detection bias) All outcomes	High risk	24‐h dietary recall (parent reported) Parents were not blinded to group allocation and because this is a self‐reported measure the risk of detection bias is high, even though the dietary recalls were administered by telephone by staff blinded to participant’s group allocation
Incomplete outcome data (attrition bias) All outcomes	High risk	389/542 (72%) completed the diet outcomes during this long‐term assessment. However the number and reasons for dropout is not reported by study group and so cannot establish if reasons for dropouts are similar across groups. >20% attrition therefore high risk of bias.
Selective reporting (reporting bias)	High risk	There are physical activity outcomes referred to in the protocol that are not reported
Other bias	Low risk	There are no differences in baseline characteristics between trial arms and contamination and other bias unlikely to be an issue