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Completed

NCT Number: NCT00498459

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Louis Pasteur University of Strasbourg

Strasbourg, 67200, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 6th graders (in 2002)
  • student in one of the eight randomised middle school (four pairs of middle-school located in Bas-Rhin, France)

Treatment and study plan

Physical activity

Behavioral

Physical promotion according to socio-ecological model Limitation of sedentary behaviour

Primary outcomes

  1. body-mass index

    Time frame: at the end of the second, third and fourth school years of intervention

Secondary outcomes

  1. fat mass (impedancemetry)

    Time frame: at the end of the second, third and fourth school years of intervention

  2. physical activity (MOSPA)

    Time frame: at the end of the second, third and fourth school years of intervention

  3. Attitudes and motivation toward physical activity

    Time frame: at the end of the second, third and fourth school years of intervention

  4. clinical and biological cardiovascular risk factors

    Time frame: at the end of the second, and fourth school years of intervention

Sponsors and collaborators

Lead sponsor

Louis Pasteur University, Strasbourg

Other

Collaborators

  • Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
  • Institut National de la Santé Et de la Recherche Médicale, France
  • Minister of Youth Affairs and Sports, France
  • National Nutritional Health Program, France

Registry information

Acronym: ICAPS

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Jul 10, 2007
Registry last updated
Mar 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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