Walter 1988.
Methods | Design: cluster randomized controlled trial
Theoretical framework: PRECEDE, Health Belief Model, Social Learning Theory Number of intervention groups: 2 Number of control groups: 2 Follow‐up: immediately post‐intervention |
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Participants | N (intervention in lower income inner city area): 1590 (14 schools)
N (intervention in middle/upper income suburb): 485 (8 schools)
N (control in lower income inner city area): 693 (8 schools)
N (control in middle/upper income suburb): 620 (7 schools) Age (mean): 9 years Sex: male and female Ethnicity: White, Hispanic, African‐American |
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Interventions | Country: US Setting: school, community, urban Provider: teachers Duration: 6 years Intervention: special curriculum targeting voluntary changes in risk behavior in the area of diet, physical activity, and smoking. Curriculum content was designed to provide the information and motivation necessary for behavioral changes, as well as training in the skills necessary to make such changes. The intervention foci (perceived susceptibility to, and severity of health problems, perceived benefits of and barriers to adopting and maintaining risk‐reduction types of behavior) were derived from the Health Belief Model, skills training strategies were derived from Social Learning Theory. Cognitive‐development theory provided a framework for the appropriate tailoring of these constructs to the children's changing maturational stages ad the study progressed over a 5‐year period. The physical activity component of the intervention fostered the adoption of a regular program of endurance exercise. The special curriculum was taught in classrooms by specially trained regular teachers for approximately 2 hours per week throughout each school year. Control: not specified | |
Outcomes | Mean systolic blood pressure (mmHg) Mean diastolic blood pressure (mmHg) Mean blood cholesterol level (mg/dL) Body mass index (kg/m2) Pulse rate (beats/minute) | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment randomization process not reported |
Allocation concealment (selection bias) | Low risk | Comment: criterion not applicable because all participants were allocated at 1 point in time following recruitment, so at time of recruitment allocation was not known |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Comment: no information given, likely not done |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: analyses were done to see if bias would be introduced due to attrition and average values of the risk values were imputed |
Selective reporting (reporting bias) | Low risk | Comment: all outcomes identified a priori were reported on |
Confounders controlled? | Low risk | Comment: all relevant confounders controlled for |
Data collection methods valid and reliable? | Unclear risk | Comment: reliability and validity of data collection methods not specifically stated |