Bush 1989.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: public elementary schools in Washington, DC School exclusion criteria: — Student inclusion criteria: students who were attending Grades 4 to 6 at 9 public elementary schools in 1983 Student exclusion criteria: — Setting: school, home, community, physician office, a mix of urban and rural Age group: children Gender distribution: females and males Country/Countries where trial was performed: USA |
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| Interventions |
Intervention 1: 'Know Your Body' curriculum. Focus on nutrition, fitness, and prevention of cigarette smoking. Curriculum to motivate students to attain and maintain lifestyles that will reduce students’ risk of developing heart disease and cancer. Includes a personalised health screening, with each student receiving results in a 'health passport'. Parents are involved through several mechanisms; they are mailed 2 copies of their children’s screening results ‐ 1 copy to keep and 1 for the child’s physician ‐ and copies of a quarterly 'Know Your Body' newsletter; the programme is introduced by staff at parent‐teacher association meetings Intervention 2: received the same intervention as Intervention 1, but only parents received the results of cholesterol tests and students were not provided these results to enter into their 'health passports’ with other screening results Comparator: did not receive the 'Know Your Body’ curriculum and were not provided any screening results. Only parents of control participants received screening results Duration of intervention: 4 years Duration of follow‐up: 4 years Number of schools: 9 Theoretical framework: PRECEDE and social learning theory |
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| Outcomes | BMI | |
| Study registration | — | |
| Publication details |
Language of publication: English Funding: non‐commercial funding (National Institutes of Health) Publication status: peer‐reviewed journal |
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| Stated aim for study | "The goals of the study were to evaluate the effects of the curriculum by measuring changes in the prevalence of risk factors and to evaluate the effectiveness of providing individual cholesterol results to students" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: no description of the randomisation process given |
| 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 | Unclear risk | Comment: no information given; likely not done |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: no information given; likely not done |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | High risk | Quote from publication: "only 431 (41.4%) participants were re‐screened 2 years after forming the cohort. Students who had moved from a control to an intervention school or vice versa were dropped from the analysis" (Bush 1989, p472) |
| Selective reporting (reporting bias) | Unclear risk | Comment: no protocol paper published nor trial registry |
| Cluster RCT ‐ Recruitment bias | Unclear risk | Comment: not described |
| Cluster RCT ‐ Baseline imbalance | Low risk | Comment: differences in baseline values adjusted for in analyses |
| Cluster RCT ‐ Loss of clusters | High risk | Comment: clusters lost to follow‐up |
| Cluster RCT ‐ Incorrect analysis | High risk | Comment: no adjustment for clustering in the analysis |