Williamson 2007.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: 4 private Catholic schools School exclusion criteria: — Student inclusion criteria: students in Grades 2 to 6 during Year 1 were enrolled in the programme by written informed consent by students and their parents Student exclusion criteria: — Setting: school Age group: children Gender distribution: females and males Country/Countries where trial was performed: USA |
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| Interventions |
The Healthy Eating and Exercise and Alcohol/Tobacco/Drug abuse prevention programmes were developed as environmental approaches for weight gain. The primary components of the programmes were to alter the physical and social environment of schools. Both programmes were rationally linked to a “Wise Mind” concept, which was a central feature of both programs, thus allowing the use of Wise Mind as the name for the programme (as a whole), as opposed to just 1 intervention arm of the study. The Wise Mind concept represents the idea that with knowledge and environmental changes, students can make wise decisions about nutrition, PA, and substance use or abuse. Environmental changes were designed to alter the ecology of the school environment, including policy, personal, social, cultural, and physical environmental changes Intervention: Healthy Eating and Exercise programme, designed with the goal of preventing inappropriate weight gain by modifying the school environment to improve healthy eating habits, increase PA, and decrease sedentary behaviour at school, and to encourage these same behavioural changes outside the school environment. The goal of the PA programme was to increase PA during the school day and at home. Teachers were provided containers filled with indoor play supplies (e.g. balloons, bean bags) and outdoor play supplies (e.g. balls, jump ropes) to promote active play during class time and recess. Posters encouraged the use of these physical activity centres, and brief lesson plans provided academic games that used the supplies provided at physical activity centres Comparator: Alcohol/Tobacco/Drug abuse prevention programme, designed with the goal of modifying children's beliefs and attitudes regarding use and abuse of tobacco, alcohol, and illicit drugs, so that they reflected "healthier" values Duration of intervention: 2 years Duration of follow‐up: 2 years Number of schools: 4 Theoretical framework: — |
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| Outcomes | BMI | |
| Study registration | — | |
| Publication details |
Language of publication: English Funding: non‐commercial funding (National Institutes of Health Grant R01 DK063453–01) Publication status: peer‐reviewed journal |
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| Stated aim for study | "The primary aim of the Wise Mind pilot project was to test whether an environmental approach for weight gain prevention, delivered in schools, was more effective for weight gain prevention in comparison with an active control program that used an environmental approach to prevent substance use. Secondary aims were to test for changes in percentage body fat, dietary habits, PA, and psychosocial variables associated with the weight gain prevention program" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: random draw [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 blinded to group allocation [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 | Low risk | Comment: missing values were replaced with calculated estimates |
| Selective reporting (reporting bias) | Unclear risk | Comment: no protocol published; cannot assess |
| Cluster RCT ‐ Recruitment bias | Low risk | Comment: randomisation occurred after baseline data collected [author communication] |
| Cluster RCT ‐ Baseline imbalance | High risk | Comment: not compared [author communication] |
| Cluster RCT ‐ Loss of clusters | Low risk | Comment: no clusters lost to follow‐up [author communication] |
| Cluster RCT ‐ Incorrect analysis | Low risk | Comment: clustering accounted for in analysis |