search
Back to results

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

Primary Purpose

Physical Activity, Overweight, Cardiovascular Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical activity
Sponsored by
Louis Pasteur University, Strasbourg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Physical Activity focused on measuring Physical activity, Randomised trial, Prevention, Adolescents, Obesity, Cardiovascular risk factors

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Louis Pasteur University of Strasbourg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ICAPS

Control

Arm Description

Promotion Physical Activity

No specific physical activity promotion Ususal school program

Outcomes

Primary Outcome Measures

body-mass index

Secondary Outcome Measures

fat mass (impedancemetry)
physical activity (MOSPA)
Attitudes and motivation toward physical activity
clinical and biological cardiovascular risk factors

Full Information

First Posted
July 9, 2007
Last Updated
March 5, 2018
Sponsor
Louis Pasteur University, Strasbourg
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, National Nutritional Health Program, France, Minister of Youth Affairs and Sports, France
search

1. Study Identification

Unique Protocol Identification Number
NCT00498459
Brief Title
Intervention Centered on Adolescents' Physical Activity and Sedentary Behavior (ICAPS)
Acronym
ICAPS
Official Title
Intervention Centered on Adolescents' Physical Activity and Sedentary Behavior (ICAPS)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Louis Pasteur University, Strasbourg
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, National Nutritional Health Program, France, Minister of Youth Affairs and Sports, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Overweight, Cardiovascular Disease
Keywords
Physical activity, Randomised trial, Prevention, Adolescents, Obesity, Cardiovascular risk factors

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
954 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICAPS
Arm Type
Experimental
Arm Description
Promotion Physical Activity
Arm Title
Control
Arm Type
No Intervention
Arm Description
No specific physical activity promotion Ususal school program
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Intervention Description
Physical promotion according to socio-ecological model Limitation of sedentary behaviour
Primary Outcome Measure Information:
Title
body-mass index
Time Frame
at the end of the second, third and fourth school years of intervention
Secondary Outcome Measure Information:
Title
fat mass (impedancemetry)
Time Frame
at the end of the second, third and fourth school years of intervention
Title
physical activity (MOSPA)
Time Frame
at the end of the second, third and fourth school years of intervention
Title
Attitudes and motivation toward physical activity
Time Frame
at the end of the second, third and fourth school years of intervention
Title
clinical and biological cardiovascular risk factors
Time Frame
at the end of the second, and fourth school years of intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chantal Simon, PhD, MD
Organizational Affiliation
Louis Pasteur University of Strasbourg
Official's Role
Study Chair
Facility Information:
Facility Name
Louis Pasteur University of Strasbourg
City
Strasbourg
ZIP/Postal Code
67200
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs