Keller 2012

Methods	Study design: Randomised controlled trial Funding: "Funding for this study came from NIH grant K01DK068008 and a St. Luke's Roosevelt Hospital Pilot Award. Additional support came from the Obesity Research Center Grant"
Participants	Description: Healthy children aged 4 to 5 years from diverse ethnic backgrounds N (Randomised): 19 children Age: 4 to 5 years % Female: Not specified SES and ethnicity: “from diverse ethnic backgrounds.” Inclusion/exclusion criteria: “All the children were “at risk for obesity,” based on having at least one parent with a BMI≥25 kg/m2, and they had to consume fewer than two servings of F&V per day, based on parental report during a screening phone call.” Recruitment: Not specified Recruitment rate: Unknown Region: Pennsylvania (USA)
Interventions	Number of experimental conditions: 2 Number of participants (analysed): Intervention = 7, Control = 9 Description of intervention: “Families in both groups attended weekly, small‐group sessions with the researchers where baseline measures were taken and family‐based nutrition education was delivered.” Children in the intervention group were “given F&V in containers decorated with their favorite cartoon characters. In addition, a sticker was included inside each decorated container to simulate the practice of premiums used by the food industry; children were allowed to collect these stickers on a game board to cash in for a prize the following week.” Duration: 7 weeks Number of contacts: Weekly group sessions and offered F&V containers 3 times a day Setting: Home + Lab Modality: Face‐to‐face Interventionist: Parents and researchers Integrity: No information provided Date of study: Unknown Description of control: “Children who were in the control group received F&V in plain plastic containers throughout the study”
Outcomes	Outcome relating to children's fruit and vegetable consumption: Child’s consumption of fruit and vegetables (grams, servings per day). F&V containers were stored by parents throughout the study period and taken back to the lab to be weighed Outcome relating to absolute costs/cost effectiveness of interventions: Not reported Outcome relating to reported adverse events: Not reported Length of follow‐up from baseline: 7 weeks Length of follow‐up post‐intervention: Immediately Subgroup analyses: None Loss to follow‐up: Overall = 16% (not specified by group) Analysis: Unknown if sample size calculations performed.
Notes	First reported outcome (grams vegetables/week) was extracted for inclusion in the meta‐analysis. Sensitivity analysis ‐ primary outcome: Primary outcome not stated, fruit or vegetable intake only outcome reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	There is not enough information to determine the sequence generation
Allocation concealment (selection bias)	Unclear risk	There is not enough information to determine allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	Low risk	The outcome is objective consumption of fruit & veg which is unlikely to be influenced by lack of participant & personnel blinding
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Objective assessment (weight) of fruit and vegetable consumption therefore low risk
Incomplete outcome data (attrition bias) All outcomes	High risk	16/19 (84%) children completed the 7‐week study, however 3 children were excluded from the analysis. Intention‐to‐treat analysis was not used, therefore high risk of bias
Selective reporting (reporting bias)	Unclear risk	There is not enough information to determine if there is any reporting bias
Other bias	Unclear risk	There is baseline imbalance between the study groups. Children in the intervention group consumed more servings of fruit & veg at baseline. Not clear of the impact this may have had on the results