Mauriello 2010.
Study characteristics | ||
Methods | Study design: cluster‐RCT Intervention period: 2 months Follow‐up period (post‐intervention): 10 months Differences in baseline characteristics: reported Reliable outcomes: NR Protection against contamination: NR Unit of allocation: schools Unit of analysis: individual accounting for clustering |
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Participants | N (control baseline) = 672 N (control follow‐up) = 457 N (intervention baseline) = 1128 N (intervention follow‐up) = 725 Setting (and number by study group): 8 high schools in 4 states in USA Recruitment: school administrators invited students from various classes to participate. Some schools over‐recruited students due to the ease of incorporating the research into their schedules, making it easier to retain students in the research in subsequent semesters Geographic region: Rhode Island, Massachusetts, New York, Tennessee, USA Percentage of eligible population enrolled: 97% participants Mean age: NR: (14‐17 years) Sex: intervention: 51.9% female; control: 50.8% female |
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Interventions | To report on effectiveness trial outcomes of Health in Motion, a computer‐tailored multiple behaviour intervention for adolescents. Multi‐media intervention for PA, fruit and vegetable consumption, and limited TV viewing. Interactive technology to provide individually tailored messages to high school students. Health in Motion addresses recommended guidelines for 3 target energy‐balance behaviours related to obesity risk:
Individualised tailoring is based on the theoretical constructs (stage of change, decisional balance, self‐efficacy, and processes of change) of the TTM of Behavior Change. The treatment group received 3 intervention sessions (baseline, 1 month, and 2 months), in addition to 6‐ and 12‐month follow‐up assessments. The control group completed assessments at baseline, 2, 6, and 12 months. All sessions were administered via computers in school computer laboratories. Control: no treatment Diet and PA intervention vs control (health education) |
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Outcomes | Outcome measures
Process evaluation: reported (dose) |
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Implementation‐related factors | Theoretical basis: TTM of Behaviour Change Resources for intervention implementation: reported Who delivered the intervention: reported PROGRESS categories assessed at baseline: gender, race/ethnicity PROGRESS categories analysed at outcome: NR Outcomes relating to harms/unintended effects: NR Intervention included strategies to address diversity or disadvantage: NR Economic evaluation: NR |
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Notes | Funding: funding for this research was provided by the National Heart, Lung, and Blood Institute (Grant # R43 HL074482). Most treatment participants (90.2%) received at least 3 intervention sessions. Due to a programming error discovered in the 1st week of the trial, some treatment group participants (21.5%) received an extra dose of the intervention. Overall, the average number of intervention sessions was 3.09. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Schools were stratified based on race/ethnicity, geographic location, and percentage of students receiving reduced priced lunches and then randomly assigned |
Allocation concealment (selection bias) | Unclear risk | NR |
Blinding (performance bias and detection bias) All outcomes | High risk | Quote: "Research assistants who were not blind to the group assignment" |
Incomplete outcome data (attrition bias) All outcomes | High risk | 34%‐36% attrition; multiple imputation for missing data done and complete datasets analysed |
Selective reporting (reporting bias) | Low risk | Trial registration found. All outcomes listed in the trial registration document were reported in results. |
Other bias | Low risk | No additional threats to validity |
Other bias‐ timing of recruitment of clusters | Low risk | No CONSORT figure; text indicates recruitment happened prior to randomisation |