Intervention Centered on Adolescents' Physical Activity and Sedentary Behavior (ICAPS) (ICAPS)

This study has been completed.
Sponsor:
Collaborators:
Health Care
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Recherche Agronomique
National Nutritional Health Program, France
Minister of Youth Affairs and Sports, France
Information provided by (Responsible Party):
Chantal Simon, Louis Pasteur University, Strasbourg
ClinicalTrials.gov Identifier:
NCT00498459
First received: July 9, 2007
Last updated: March 1, 2016
Last verified: March 2016

July 9, 2007
March 1, 2016
September 2002
June 2006   (final data collection date for primary outcome measure)
body-mass index [ Time Frame: at the end of the second, third and fourth school years of intervention ] [ Designated as safety issue: No ]
body-mass index [ Time Frame: at the end of the second, third and fourth school years of intervention ]
Complete list of historical versions of study NCT00498459 on ClinicalTrials.gov Archive Site
  • fat mass (impedancemetry) [ Time Frame: at the end of the second, third and fourth school years of intervention ] [ Designated as safety issue: No ]
  • physical activity (MOSPA) [ Time Frame: at the end of the second, third and fourth school years of intervention ] [ Designated as safety issue: No ]
  • Attitudes and motivation toward physical activity [ Time Frame: at the end of the second, third and fourth school years of intervention ] [ Designated as safety issue: No ]
  • clinical and biological cardiovascular risk factors [ Time Frame: at the end of the second, and fourth school years of intervention ] [ Designated as safety issue: No ]
  • fat mass (impedancemetry) [ Time Frame: at the end of the second, third and fourth school years of intervention ]
  • physical activity (MOSPA) [ Time Frame: at the end of the second, third and fourth school years of intervention ]
  • Attitudes and motivation toward physical activity [ Time Frame: at the end of the second, third and fourth school years of intervention ]
  • clinical and biological cardiovascular risk factors [ Time Frame: at the end of the second, and fourth school years of intervention ]
Not Provided
Not Provided
 
Intervention Centered on Adolescents' Physical Activity and Sedentary Behavior (ICAPS)
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Physical Activity
  • Overweight
  • Cardiovascular Disease
Behavioral: Physical activity
Physical promotion according to socio-ecological model Limitation of sedentary behaviour
  • Experimental: ICAPS
    Promotion Physical Activity
    Intervention: Behavioral: Physical activity
  • No Intervention: Control
    No specific physical activity promotion Ususal school program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
954
June 2006
June 2006   (final data collection date for primary outcome measure)

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)
Both
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00498459
2007_01
Yes
No
Not Provided
Chantal Simon, Louis Pasteur University, Strasbourg
Louis Pasteur University, Strasbourg
  • Health Care
  • Institut National de la Santé Et de la Recherche Médicale, France
  • Institut National de la Recherche Agronomique
  • National Nutritional Health Program, France
  • Minister of Youth Affairs and Sports, France
Study Chair: Chantal Simon, PhD, MD Louis Pasteur University of Strasbourg
Louis Pasteur University, Strasbourg
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP