Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00498459
Status:
COMPLETED
Last Update Posted:
2018-03-07
First Post:
2007-07-09
Brief Title:
Intervention Centered on Adolescents Physical Activity and Sedentary Behavior ICAPS
Sponsor:
Louis Pasteur University Strasbourg
Organization:
Louis Pasteur University Strasbourg
Study Overview
Official Title:
Intervention Centered on Adolescents Physical Activity and Sedentary Behavior ICAPS
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICAPS
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 eg 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 interventions 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
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 eg 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 interventions 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None