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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00498459
First Posted: July 10, 2007
Last Update Posted: March 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose
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.

Condition Intervention
Physical Activity Overweight Cardiovascular Disease Behavioral: Physical activity

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Intervention Centered on Adolescents' Physical Activity and Sedentary Behavior (ICAPS)

Resource links provided by NLM:


Further study details as provided by Chantal Simon, Louis Pasteur University, Strasbourg:

Primary Outcome Measures:
  • body-mass index [ Time Frame: at the end of the second, third and fourth school years of intervention ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 954
Study Start Date: September 2002
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ICAPS
Promotion Physical Activity
Behavioral: Physical activity
Physical promotion according to socio-ecological model Limitation of sedentary behaviour
No Intervention: Control
No specific physical activity promotion Ususal school program

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00498459


Locations
France
Louis Pasteur University of Strasbourg
Strasbourg, France, 67200
Sponsors and Collaborators
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
Investigators
Study Chair: Chantal Simon, PhD, MD Louis Pasteur University of Strasbourg
  More Information

Responsible Party: Chantal Simon, Professor, Louis Pasteur University, Strasbourg
ClinicalTrials.gov Identifier: NCT00498459     History of Changes
Other Study ID Numbers: 2007_01
First Submitted: July 9, 2007
First Posted: July 10, 2007
Last Update Posted: March 3, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chantal Simon, Louis Pasteur University, Strasbourg:
Physical activity
Randomised trial
Prevention
Adolescents
Obesity
Cardiovascular risk factors

Additional relevant MeSH terms:
Cardiovascular Diseases
Overweight
Body Weight
Signs and Symptoms