Neumark‐Sztainer 2009.

Study characteristics
Methods	Study design: cluster‐RCT
Participants	School inclusion criteria: 4 urban schools in St. Paul, Minnesota, USA, in which 90% of students qualified for free or reduced price lunch School exclusion criteria: — Student inclusion criteria: all children in Grades 4 to 6 at intervention and control schools were eligible to participate and were selected on a first come, first served basis Student exclusion criteria: — Setting: school, community, theatre, urban Age group: children Gender distribution: females and males Country/Countries where trial was performed: USA
Interventions	Intervention: 3 components 14 × 2‐hour after‐school theatre sessions 8 weekly after‐school booster sessions Family outreach to enhance home support for behavioural changes through positive reinforcement of health behaviours, parent‐child participation in PAs, and availability of healthy foods Each theatre session included A 'check‐in' in which children were given an opportunity to share any behavioural changes they had made over the past week (e.g. eating more fruits and vegetables) and to talk about how take‐home packages were received by families Easy‐to‐prepare healthy snacks A movement component of fun and easy activities requiring minimal resources (e.g. dancing, walking) Theatrical ACTivities For the initial sessions, the ACTivities component included exercises to introduce children to theatre techniques and to build trust and cooperation. In later sessions, ACTivities focused on enhancing knowledge and skills related to PA and healthy eating and promoting a positive body image through interactive activities. Children were asked to share their personal experiences related to being active and eating healthfully. The content of the script for the Ready. Set. ACTION! play was developed through these activities. During final sessions, children were introduced to the script and began to rehearse for the final play performance. Booster sessions included activities such as creating advertisements for fruits and vegetables; painting positive affirmations (e.g. I am special) on a mirror to take home; brainstorming ways to be active while watching television (e.g. doing jumping jacks during commercials); teaching dance and strength training exercises to classmates; learning exercises to do at home with families; and rehearsing for school performance of the Ready. Set. ACTION! play. For the family outreach component, Weekly Fun and Fitness packs (i.e. a healthy food with a simple recipe or fitness incentives for the family) and a CD of the Ready. Set. ACTION! songs were sent home (each pack also included a parent postcard with information and interactive activities on a topic addressed in the after‐school programme). There were also 2 family events Students' performance of the play A 'Ready. Set. ACTION! DVD Release Party' (i.e. family viewing of the DVD recording of the play production, a short performance by children, and a communal family dinner) Comparator: theatre‐based intervention involving performing a play focused on environmental health issues using a prepared script Duration of intervention: 16 weeks Duration of follow‐up: 16 weeks Number of schools: 4 Theoretical framework: social cognitive theory
Outcomes	BMI
Study registration	NCT00604513 (retrospectively registered)
Publication details	Language of publication: English Funding: other funding (National Institutes of Health (R21 DK072972 to D.N.S.); National Institute of Diabetes and Digestive and Kidney Diseases; Illusion Theater received additional funding for theatre components from The Medica Foundation, The General Mills Communities of Color Project Grants, and The Best Buy Children’s Foundation) Publication status: peer‐reviewed journal
Stated aim for study	"Our primary aim was to develop and test the feasibility of implementing Ready. Set. ACTION!, developed in partnership between researchers at the University of Minnesota and artists/educators from Illusion Theater, a Minneapolis‐based theatre company with experience in educational theatre"
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: drawing names [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	Low risk	Comment: participants were not blinded but did not know of the study hypothesis [author communication]
Blinding of outcome assessment (detection bias) All outcomes	High risk	Comment: outcome assessors were not blinded [author communication]
Incomplete outcome data (attrition bias) Anthropometrics, Fitness	High risk	Comment: authors should have used intention‐to‐treat analysis. Although they did adjust for baseline differences, they adjusted for only certain characteristics like age and sex, and not for any of the outcome variables
Selective reporting (reporting bias)	Low risk	Comment: all outcomes identified a priori were reported on
Cluster RCT ‐ Recruitment bias	Low risk	Comment: baseline data were collected before school randomisation [author communication]
Cluster RCT ‐ Baseline imbalance	Low risk	Comment: no substantive baseline differences were found
Cluster RCT ‐ Loss of clusters	Low risk	Comment: no clusters were lost
Cluster RCT ‐ Incorrect analysis	High risk	Comment: clustering was not accounted for in statistical analysis