Elder 2014.

Study characteristics
Methods	Study design: cluster‐RCT Intervention period: 24 months Follow‐up period (post‐intervention): nil Differences in baseline characteristics: reported Reliable outcomes: reported Protection against contamination: NR Unit of allocation: recreation centres Unit of analysis: families accounting for clustering
Participants	N (control baseline) = 270 N (control follow‐up) = 256 N (intervention baseline) = 271 N (intervention follow‐up) = 238 Setting (and number by study group): community: 30 recreation centres; intervention group N = 15 recreation centres and 271 families and control group N = 15 recreation centres and 270 families Recruitment: targeted phone calls; 8600 telephone numbers were obtained from a market research company. In addition, 1000 families were contacted at public locations, such as libraries, schools, community events (street fairs, special gatherings) and the 30 participating recreation centres Geographic region: San Diego County, USA Percentage of eligible population enrolled: 47% families screened Mean age: intervention + control: 6.6 ± 0.7 Sex: intervention + control: 54.9% female
Interventions	To promote healthy eating and PA among 5‐ to 8‐year‐old children The targeted nutrition behaviours addressed by the family health coaches included: increase consumption of vegetables and fruits through modifications in meal and snack purchasing and preparation decrease consumption of SSBs through changes in food purchasing and limit setting increase healthy portions by modifying food consumption behaviours reduce eating out and when eating out, select healthy options increase availability and accessibility of healthy foods and beverages in the home reduce screen time and avoid eating in front of the TV increase the number of meals eaten together as a family The targeted PA behaviours included: increase the amount of MVPA to 60 min/day on most days of the week increase availability and accessibility of PA opportunities in the home and community increase the variety of fun, and developmentally appropriate and culturally appropriate PA opportunities Interventions: Telephone survey about the family's recreation centre use (10 min; prior to introductory workshop) once; Introductory group workshop at the recreation centre (1.5 h; month 1 of intervention) once; Home visit (1 h; within the first 6 months of intervention) once; Mailed tip sheets (approximately monthly during intervention) 8 times; Phone consultations on tip sheet (10 min; twice per tip sheet) 18 times; Group workshops at the recreation centre (1.5 h; quarterly during intervention) three times. Providers: 2 full‐time family health coaches, a full‐time recreation specialist, a half‐time recreation assistant and a full‐time intervention coordinator. Control: at the 1‐year measurements, interactive booths were set up at the recreation centre for families to receive take‐home information and giveaways on non‐obesity‐related topics. Children participated in crafts and science experiments. Families received information on dental care, fire safety, environmental awareness and video Diet and PA combination intervention vs control
Outcomes	Outcome measures Primary outcome: BMI, BMI percentile, zBMI, waist circumference, % body fat Secondary outcomes: PA and sedentary time, dietary intake Process evaluation: reported (fidelity)
Implementation‐related factors	Theoretical basis: NR Resources for intervention implementation: reported Who delivered the intervention: reported PROGRESS categories assessed at baseline: child: gender, race/ethnicity; parent: gender, race/ethnicity (acculturation), education, occupation, SES (income), marital status PROGRESS categories analysed at outcome: child: gender; parent: acculturation Outcomes relating to harms/unintended effects: NR Intervention included strategies to address diversity or disadvantage: NR Economic evaluation: NR
Notes	Funding: this study was supported by the NIH grant NIDDK R01DK072994. NCC was supported by grants T32HL079891 and F31KD079345. KC was supported by the Medical Research Council Epidemiology Unit (Unit Programme number U106179474) and the Centre for Diet and Activity Research (CEDAR), a UKCRC Public Health Research: Centre of Excellence. Funding from the British Heart Foundation, Economic and Social Research Council, Medical Research Council, the National Institute for Health Research, and the Wellcome Trust, under the auspices of the UK Clinical Research Collaboration, is gratefully acknowledged. Context: recreation centres were affected by a municipal, then a statewide economic downturn resulting in increased responsibilities of recreational staff, and decreased staffing and reduced hours and programmes due to downsizing of municipal government. The overall dose was limited.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomised, no further details
Allocation concealment (selection bias)	Unclear risk	NR
Blinding (performance bias and detection bias) All outcomes	Unclear risk	NR
Incomplete outcome data (attrition bias) All outcomes	Low risk	Low attrition: 5% control and 12% intervention groups lost to follow‐up, baseline values adjusted for in follow‐up analyses
Selective reporting (reporting bias)	Unclear risk	Protocol/trial registration documents were unavailable
Other bias	Low risk	No additional threats to validity
Other bias‐ timing of recruitment of clusters	Low risk	Figure shows recruitment happened prior to randomisation