Effectiveness Evaluation of Three Strategies of Promotion of Healthy Dietary and Physical Activity Behaviours to Prevent Weight Excess Among Teenagers

Body Weight Clinical Trial

— PRALIMAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00814554
• Other study ID #: pralimap-0610
• Secondary ID: CNIL-906312CCTIR
• Status: Completed
• Phase: N/A
• First received: December 23, 2008
• Last updated: June 29, 2010
• Start date: September 2006
• Est. completion date: December 2009

Study information

• Verified date: March 2010
• Source: University of Nancy
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life SciencesFrance: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5458
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Body Weight
• Nutrition Processes
• Prevention

Intervention

Behavioral:
• Educational strategy
1.Educational strategy. The strategy is to implement health promotion actions aiming at developing personal skills to adopt healthy behaviors in the field of nutrition and physical activity in conformity with up-to-date recommendations and references. Each adolescent will be provided with about 50 education hours distributed in individual and collective activities in school (15 hours), interventions during courses (20 hours), and outdoors activities (15 hours).
• Screening strategy
2. Screening strategy. Screening includes measurement of BMI and plotting the growing chart with adolescents, measurement of eating troubles. Screening will be performed by the school medical and nurse team. At risk subjects will be defined according to precise criteria and will be referred to the GP and to obesity networks developed by Health Insurance system where they are provided with specific activities with dieticians, physical activity teachers and psychologists. Subjects with psychological difficulties will be referred for psychological care.

Other:
• Environmental strategy
3. Environmental strategy. The strategy is to develop in schools favorable and supportive environments for healthy behaviors targeting the collective catering and physical activity offer and the establishment policy. Especially actions aim at increase fruits and vegetables availability, water consumption, physical activity inside the schools.

Locations

Country	Name	City	State
France	Nancy-University	Vandoeuvre les nancy

Sponsors (4)

Lead Sponsor	Collaborator
University of Nancy	Local school office of the academy of Nancy-Metz, National conservatory of arts and crafts (CNAM), Regional institute for health education (IRES)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overweight and obesity according to IOTF references		0-1-2 years	No
Secondary	Knowledge, attitude and behaviors toward nutrition (food and physical activity)		0-1-2 years	No

External Links

•   web site where any people can find information on pralimap study.