NCT00498459

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
954

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2007

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

3.8 years

First QC Date

July 9, 2007

Last Update Submit

March 5, 2018

Conditions

Keywords

Physical activityRandomised trialPreventionAdolescentsObesityCardiovascular risk factors

Outcome Measures

Primary Outcomes (1)

  • body-mass index

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

Secondary Outcomes (4)

  • fat mass (impedancemetry)

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

  • physical activity (MOSPA)

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

  • Attitudes and motivation toward physical activity

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

  • clinical and biological cardiovascular risk factors

    at the end of the second, and fourth school years of intervention

Study Arms (2)

ICAPS

EXPERIMENTAL

Promotion Physical Activity

Behavioral: Physical activity

Control

NO INTERVENTION

No specific physical activity promotion Ususal school program

Interventions

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

ICAPS

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louis Pasteur University of Strasbourg

Strasbourg, 67200, France

Location

MeSH Terms

Conditions

Motor ActivityOverweightCardiovascular DiseasesObesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Chantal Simon, PhD, MD

    Louis Pasteur University of Strasbourg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 9, 2007

First Posted

July 10, 2007

Study Start

September 1, 2002

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

March 7, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations