Barkin 2012.

Study characteristics
Methods	Study name: Salud con la familia Study design: RCT Intervention period: 12 weeks Follow‐up period (post‐intervention): nil Differences in baseline characteristics: reported Reliable outcomes: reported Protection against contamination: NR Unit of allocation: parent‐child dyads Unit of analysis: individual
Participants	N (controls baseline) = 52 N (controls follow‐up) = 40 N (interventions baseline) = 54 N (interventions follow‐up) = 35 Setting (and number by study group): 1 community recreation centre Recruitment: a bilingual research assistant approached individuals in the waiting areas of co‐operating community agencies (e.g. social service agencies, paediatric clinics, community centres), also advertised via multiple mechanisms: flyers at community organisations and businesses; Spanish language radio Geographic region: urban neighbourhood, Tennessee, USA Percentage of eligible population enrolled: 40% Mean age: intervention 4.2 ± 0.9; control 4.1 ± 0.9 Sex: intervention, 45.7% female; control, 55% female
Interventions	To test the effect of a culturally tailored, family‐centred, short‐term behavioural intervention on BMI in Latino‐American preschool‐aged children. 12 weekly, 90‐min group skills‐building sessions for parents and children designed to improve nutritional family habits, increase weekly PA, and decrease media use (sedentary activity), conducted in Spanish by trained facilitator and set in the community centre. Participants were randomly assigned to small social groups at each session (6–8 parent–child dyads), and assigned small group activities (engaging both parents and children as the focus of the intervention) and specific group roles. The content was based on a best‐practice culturally tailored programme for Latino‐American families developed by the National Latino Children’s Institute. Control group received a brief school readiness programme (3 times for 60 min each session during the 12 weeks) conducted in the same community centre, designed to improve school readiness in preschool‐aged children through increased parental verbal engagement (e.g. daily reading, playing word games, how to talk to children). The programme was based on the Dialogic Reading Model–C.A.R. (Comment and Wait, Ask Questions and Wait, and Respond by Adding More), an empirically tested curriculum that teaches parents to read picture books with their children. Dietary and PA intervention vs control
Outcomes	Outcome measures Primary outcome: BMI Secondary outcomes: none Process evaluation: reported (fidelity)
Implementation‐related factors	Theoretical basis: SCT and TTM of Change Resources for intervention implementation: reported Who delivered the intervention: reported PROGRESS categories assessed at baseline: child: gender, race/ethnicity (country of origin); parent: race/ethnicity (country of origin, acculturation), education PROGRESS categories analysed at outcome: NR Outcomes relating to harms/unintended effects: NR Intervention included strategies to address diversity or disadvantage: NR Economic evaluation: NR
Notes	NCT00808431 Funding: supported by a Project Diabetes Implementation grant from the State of Tennessee (GR‐09‐25517‐00) awarded to Dr Barkin and funds awarded to Dr Barkin from the Vanderbilt Clinical and Translational Science Award (National Center for Research Resources/NIH) (1 UL1 RR024975). Dr Gesell was supported by the American Heart Association Clinical Research grant Program (09CRP2230246). None of the funders contributed to the design and conduct of the study; collection, management, analysis, or interpretation of the data; or preparation, review, or approval of the manuscript. 42% of participating preschool‐aged children were overweight or obese at baseline. Both transportation to and from study sessions and on‐site child care services (for siblings) were provided free of charge to all study participants. Participants received small incentives after each wave of data collection (e.g. cutting board, kitchen timer, gift card to local supermarket), a total value of USD 60 per parent–child dyad over the study period.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation
Allocation concealment (selection bias)	Low risk	A biostatistician not otherwise involved in the study, generated the randomisation list, and condition assignments were placed in non‐transparent envelopes, which were sealed and numbered consecutively
Blinding (performance bias and detection bias) All outcomes	High risk	Neither research staff nor participants were blinded to other participants’ condition allocation.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition rate from initial exposure to 3‐month follow‐up was lower in the control group (15%) than in the intervention group (36%), (6 weeks between baseline data collection and first intervention and control sessions) but the groups of dyads who completed the intervention and control conditions did not significantly differ on demographic characteristics or anthropometric measurements at baseline.
Selective reporting (reporting bias)	Low risk	Trial register found. BMI mentioned as a primary outcome in the trial registration document.
Other bias	Low risk	No further bias identified