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Clinical Trials/NCT00814554
NCT00814554CompletedNot Applicable

PRALIMAP: Effectiveness Evaluation of Three Strategies of Prevention of Overweight and Obesity in Adolescents; a Cluster Randomised Controlled Trial

University of Nancy2 sites in 1 country5,458 target enrollmentStarted: September 1, 2006Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
5,458
Locations
2
Primary Endpoint
Overweight and obesity according to IOTF references

Study Overview

Brief Summary

The aim of this study is to compare the effectiveness of three public health intervention strategies to reduce weight excess and obesity prevalence among teenagers within the frame of a public health program aiming at promoting healthy eating and physical activity behaviors.

Detailed Description

A cluster randomised trial implemented in 24 high and technical schools including 20 000 fifth-former aims, on a three-year period, at evaluating the effectiveness of three strategies, combined or not, according a 2*2*2 factorial plan, concerning the promotion of healthy dietary and physical activity behaviours: to develop individual skills by individual and collective education, to propose favourable environment, to screen and care for subjects at risk of weight excess. Main outcomes are improvement of knowledge, attitudes and behaviours, mean body mass index (BMI) change, proportion of obese children according to international standards after two years of follow-up, and finally psychological and sociological factors which are facilitators or barriers to such actions. The evidence of the effectiveness of one or the other of the strategies will help to define interventions framework for medical, educative and economic sector actors.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Being student in the included public high school in Region of Lorraine (East of France) whatever the age

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Overweight and obesity according to IOTF references

Time Frame: 0-1-2 years

Secondary Outcomes

  • Knowledge, attitude and behaviors toward nutrition (food and physical activity)(0-1-2 years)

Investigators

Sponsor
University of Nancy
Sponsor Class
Other

Study Sites (2)

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