Neumark‐Sztainer 2010.

Study characteristics
Methods	Study design: cluster‐RCT
Participants	School inclusion criteria: high schools in Minneapolis or St. Paul metropolitan area of Minnesota that agreed to participate as control or intervention sites. Participating schools were in urban and first‐ring suburban areas because of their diverse student bodies School exclusion criteria: — Student inclusion criteria: girls in intervention and control schools were invited to register for an all‐girls PE class as an alternative to the regular co‐educational class. In participating schools, students were required to take 1 or 2 PE classes to graduate from high school; participation in this class counted toward that requirement Student exclusion criteria: girls were screened for PA and eating disorder behaviours. 4 girls were excluded because of high levels of PA (1 hour/d) Setting: school, urban Age group: adolescents Gender distribution: females Country/Countries where trial was performed: USA
Interventions	Intervention: intervention group continued to participate in the all‐girls PE class during the first semester of the school year. Group members also received the New Moves curriculum during their PE class (approximately 16 weeks) and participated in New Moves activities throughout the rest of the school year (maintenance period). This programme included: New Moves PE class ‐ nutrition and social support or self‐empowerment sessions (PA (Be Fit) 4 days/week taught by school PE teachers (3 days) and community guest instructors (1 day) and nutrition (Be Fueled) or social support or self‐empowerment (Be Fab) classes 1 day/week); individual counselling sessions using motivation interviewing techniques (to set personal goals for behavioural change based on 8 New Moves objectives); lunch get‐together ("lunch bunches") once/week during maintenance period, where participants were served healthy food and engaged in informal discussions on New Moves topics; and minimal parent outreach activities (i.e. 6 postcards sent home to reinforce New Moves messages and a parent‐daughter retreat day focused on New Moves messages during the maintenance period). PE teachers attended full‐day training before intervention and half‐day training during intervention. They received regular, ongoing support from New Moves staff throughout the programme. New Moves intervention staff ran all programme components aside from the PE class. These staff received training and ongoing support in motivational interviewing techniques Comparator: control group continued to participate in the all‐girls PE class during the first semester of the school year. Teachers were free to conduct PE classes as they desired during the study period and did not receive training on New Moves until after the study period Duration of intervention: 16 weeks Duration of follow‐up: 16 weeks Number of schools: 12 Theoretical framework: social cognitive theory
Outcomes	BMI
Study registration	NCT00250497
Publication details	Language of publication: English Funding: non‐commercial funding (National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health) Publication status: peer‐reviewed journal
Stated aim for study	"This paper describes the main findings from a group‐RCT designed to evaluate the impact of a school‐based intervention aimed at preventing weight related problems in adolescent girls: New Moves"
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: random numbers table [author communication]
Allocation concealment (selection bias)	Low risk	Comment: all participants were allocated at 1 point in time following recruitment, so at time of recruitment, allocation was not known
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: blinding of participants not described
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: unclear whether trained staff taking measurements were blinded to intervention allocation
Incomplete outcome data (attrition bias) Anthropometrics, Fitness	Low risk	Comment: less than 10% dropout rate in intervention group; no details on reasons for dropout provided
Selective reporting (reporting bias)	Low risk	Comment: all main outcomes reported
Cluster RCT ‐ Recruitment bias	Low risk	Comment: baseline data collected before randomisation [author communication]
Cluster RCT ‐ Baseline imbalance	Low risk	Comment: differences adjusted for in analyses
Cluster RCT ‐ Loss of clusters	Low risk	Comment: no clusters lost
Cluster RCT ‐ Incorrect analysis	Low risk	Comment: clustering accounted for in analysis