Gentile 2009.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: all 10 elementary schools in Lakeville, Minnesota, and Cedar Rapids, Iowa, USA School exclusion criteria: — Student inclusion criteria: Grades 3, 4, and 5 Student exclusion criteria: — Setting: community, home, school Age group: children Gender distribution: females and males Country/Countries where trial was performed: USA |
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| Interventions |
Intervention: 'Switch’ programme, promoted healthy active lifestyles by encouraging students to 'Switch what you Do, Chew, and View’, including be active for 60 minutes or more/d, limit total screen time to 2 hours or fewer/d, and eat 5 fruits or vegetables or more/d. Community component: promotion of awareness of healthy lifestyles and prevention of childhood obesity included paid advertising (e.g. billboards) and unpaid media emphasising key messages. School component: teachers were provided materials and ways to integrate key concepts into their existing curricula. Family component: provided parents (and children) with materials and resources to facilitate adoption of healthy target behaviours. Monthly packets containing behavioural tools were provided to assist parents and children in modifying their behaviours Comparator: no intentional exposure to the Switch programme; may have been exposed to the community component of the intervention; did not receive any school materials; did not receive materials or resources, other than surveys Duration of intervention: 8 months Duration of follow‐up: 14 months Number of schools: 10 Theoretical framework: socioecological model |
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| Outcomes | BMI | |
| Study registration | NCT00685555 (retrospectively registered) | |
| Publication details |
Language of publication: English Funding: other funding (in Lakeville, Minnesota, Switch was sponsored by Medica Foundation, Healthy and Active America Foundation, and Fairview Health Services; in Cedar Rapids, Iowa, Switch was sponsored by Cargill, Inc, and the Healthy and Active America Foundation) Publication status: peer‐reviewed journal |
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| Stated aim for study | "The primary objectives of Switch were to: (1) increase the amount of PA; (2) reduce the amount of screen time (television and video game time); and (3) increase fruit and vegetable consumption among children from grade 3 to 5" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: random number generated; Excel [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 did not know about other conditions [author communication] |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: study personnel were not blinded [author communication] |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | High risk | Comment: incomplete outcome data; not adequately addressed |
| 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 randomisation |
| Cluster RCT ‐ Baseline imbalance | Low risk | Comment: no baseline differences apparent |
| Cluster RCT ‐ Loss of clusters | Low risk | Comment: no clusters lost to follow‐up |
| Cluster RCT ‐ Incorrect analysis | Low risk | Comment: clustering adjusted for in analysis |