Luepker 1996.

Study characteristics
Methods	Study design: cluster‐RCT
Participants	School inclusion criteria: recruitment of schools was based on their distance from 1 of the 4 study centres, their ethnic diversity, their food service's potential for intervention, and their commitment to offering at least 90 minutes/week of PE and to participating in a 3‐year study School exclusion criteria: — Student inclusion criteria: initially Grade 3 students who agreed to have a blood test Student exclusion criteria: — Setting: school, home, urban Age group: children Gender distribution: females and males Country/Countries where trial was performed: USA
Interventions	Intervention (overview): the Child and Adolescent Trial for Cardiovascular Health Intervention included school‐based (school food service, PE, classroom curricula) and family‐based (home curricula, family fun nights) components. School food service changes and PE enhancement were ongoing throughout the 3 school years, whereas classroom and home curricula were implemented (by classroom teachers) over a fixed time period during each school year and addressed eating habits (Grades 3 through 5), PA (Grades 4 and 5), and cigarette smoking (Grade 5 only). Eat Smart, the food service intervention, provided children with healthy meals that maintained recommended levels of essential nutrients and child participation in school meal programmes. Food service personnel attended a 1‐day training session at the beginning of each school year. They were provided more information, assistance in planning, and other support during monthly follow‐up visits to schools and booster sessions. PE specialists and teachers attended 1 to 1.5 days of training every school year. Classroom curricula included the Adventures of Hearty Heart and Friends (Grade 3; 15, 30‐ to 40‐minute classes during 5 weeks); Go for Healths (Grade 4; 24, 30‐ to 40‐minute classes during 12 weeks); Go for Health‐5 (Grade 5; 16; 30‐ to 40‐minute classes during 8 weeks); and F.A.C.T.S. for Five (Grade 5; 4‐session tobacco use prevention curriculum). Classroom teachers attended 1 to 1.5 days of training every year to learn how to implement the curricula. For the home curriculum, 19 activity packets (over the course of 3 school years) that complemented classroom curricula were sent home with students and required adult participation to complete. During Grades 3 and 4, students invited their family members to a "family fun night" (dance performances, food booths, recipe distribution, and games). Intervention schools were further randomised into 2 equal subgroups Intervention 1: 1 group received a school‐based programme consisting of school food service modifications, PE interventions, and Child and Adolescent Trial for Cardiovascular Health curricula Intervention 2: 1 group received the same school‐based programme plus a family‐based programme Comparator: control group received usual health curricula, PE, and food service programmes, but none of the Child and Adolescent Trial for Cardiovascular Health interventions Duration of intervention: 3 years Duration of follow‐up: 3 years Number of schools: 96 Theoretical framework: health belief model
Outcomes	BMI
Study registration	NCT00000467 (retrospectively registered)
Publication details	Language of publication: English Funding: non‐commercial funding (National Heart, Lung, and Blood Institute) Publication status: peer‐reviewed journal
Stated aim for study	"The Child and Adolescent Trial for Cardiovascular Health 22 was designed to augment the research of the 1980s in cardiovascular disease prevention among young people by using a sophisticated research design involving a large number of schools, a multi‐component behavioral health intervention over 3 grades, and children of diverse communities"
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: computer‐generated random numbers table [author communication]
Allocation concealment (selection bias)	Low risk	Comment: all participants were allocated at a single point in time following recruitment, so at time of recruitment, allocation was not known
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: no blinding [author communication]
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: no blinding [author communication]
Incomplete outcome data (attrition bias) Anthropometrics, Fitness	Low risk	Comment: outcome data complete
Selective reporting (reporting bias)	Low risk	Comment: all outcomes identified a priori were reported on
Cluster RCT ‐ Recruitment bias	Low risk	Comment: data collected before school randomisation [author communication]
Cluster RCT ‐ Baseline imbalance	Low risk	Comment: baseline group balance
Cluster RCT ‐ Loss of clusters	Low risk	Comment: no loss of clusters
Cluster RCT ‐ Incorrect analysis	Low risk	Comment: clustering adjusted for in the analysis