Overweight Clinical Trial
Official title:
Intervention Centered on Adolescents' Physical Activity and Sedentary Behavior (ICAPS)
Physical activity is thought to be a key element in preventing the obesity epidemic and the associated cardiovascular and metabolic diseases. However population-based studies directed at promoting physical activity in youth have shown limited success in obesity prevention. The aim of this study is to assess whether an intervention integrating socioecological changes, which has the potential to induce sustained changes in physical activity, prevents overweight and cardiovascular risk in adolescents.
Background
Physical activity is thought to be a key element in preventing the obesity epidemic and the
associated cardiovascular and metabolic diseases. However population-based studies directed
at promoting physical activity in youth have shown limited success in obesity prevention. The
aim of this study is to assess whether an intervention integrating socioecological changes,
which has the potential to induce sustained changes in physical activity, prevents overweight
and cardiovascular risk in adolescents.
Methods
Population and design: The Intervention Centered on Adolescents' Physical activity and
Sedentary behavior (ICAPS) is a 4-year randomized prevention study targeting 6th graders
(e.g. 12 year old adolescents). The study design is based on a randomization at school level
and follows the intention-to-treat principle. Eight schools (four intervention schools and
four controls) are randomly selected out of the 77 public middle schools of the Department of
Bas-Rhin (Eastern France). To balance potential confounding factors and to ensure a broad
socioeconomic context, randomization is done after stratification on sociogeographical
criteria. Intervention status of the schools is randomized in each pair of matched schools.
All initially first-level students of the randomized schools are eligible to participate.
Intervention: The 4-year intervention program is designed to promote physical activity by
changing attitudes through debates and access to attractive activities, and by providing
social support and environmental changes encouraging physical activity. The students of the
control schools follow their usual school curriculum and physical education classes and are
not be submitted to any intervention.
Outcomes and follow-up: The primary outcome is the subjects' body mass index (BMI).
Prespecified secondary end points include body composition, physical activity and sedentary
behaviors, attitudes towards physical activity, and various cardiovascular risk factors.
Surveys take place at baseline and annually at the end of each school year. Fasting blood is
sampled at baseline and every two years. Physical examinations are performed by qualified
professionals and questionnaires are administered to small groups of 3 to 6 students. All the
procedures are standardized among schools and the interviewers are be regularly trained to
assure the reliability of the measurements.
Statistical analysis: Outcome data are analyzed using mixed linear models taking into account
the cluster randomization design and the repeated individual data. Random effects are schools
within intervention group and individuals within schools. Possible heterogeneity of the
intervention's effect according to gender and initial weight status will be tested.
Perspectives This study will assess the feasibility and the efficacy of a multilevel
multipartnership prevention program targeting adolescents' physical activity.
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