Effectiveness Evaluation of Three Strategies of Promotion of Healthy Dietary and Physical Activity Behaviours to Prevent Weight Excess Among Teenagers (PRALIMAP)
This study has been completed.
Sponsor:
University of Nancy
Collaborators:
National conservatory of arts and crafts (CNAM)
Regional institute for health education (IRES)
Local school office of the academy of Nancy-Metz
Information provided by:
University of Nancy
ClinicalTrials.gov Identifier:
NCT00814554
First received: December 23, 2008
Last updated: June 29, 2010
Last verified: March 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Body Weight Nutrition Processes Prevention |
Behavioral: Educational strategy Behavioral: Screening strategy Other: Environmental strategy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | PRALIMAP: Effectiveness Evaluation of Three Strategies of Prevention of Overweight and Obesity in Adolescents; a Cluster Randomised Controlled Trial |
Resource links provided by NLM:
Further study details as provided by University of Nancy:
Primary Outcome Measures:
- Overweight and obesity according to IOTF references [ Time Frame: 0-1-2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Knowledge, attitude and behaviors toward nutrition (food and physical activity) [ Time Frame: 0-1-2 years ] [ Designated as safety issue: No ]
| Enrollment: | 5458 |
| Study Start Date: | September 2006 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: control
no intervention was carried out in high school
|
|
|
Experimental: Educational strategy
Educational strategy was carried out in high school.
|
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).
Other Name: Axe 1
|
|
Experimental: Screening strategy
Screening strategy was carried out in high school.
|
Behavioral: 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 Name: Axe 2
|
|
Experimental: Environmental strategy
Environmental strategy was carried out in high school.
|
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.
Other Name: Axe 3
|
|
Experimental: Educational and Screening strategies
Educational strategy and Screening strategy were carried out in high school
|
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).
Other Name: Axe 1
Behavioral: 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 Name: Axe 2
|
|
Experimental: Screening and Environmental strategies
Screening strategy and Environmental strategy were carried out in high school
|
Behavioral: 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 Name: Axe 2
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.
Other Name: Axe 3
|
|
Experimental: Educational and Environmental strategies
Educational strategy and Environmental strategy were carried out in high school
|
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).
Other Name: Axe 1
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.
Other Name: Axe 3
|
|
Experimental: the three strategies
Educational strategy, Screening strategy and Environmental strategy were carried out in high school.
|
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).
Other Name: Axe 1
Behavioral: 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 Name: Axe 2
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.
Other Name: Axe 3
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Being student in the included public high school in Region of Lorraine (East of France) whatever the age
Exclusion Criteria:
- None
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814554
Locations
| France | |
| Nancy-University | |
| Vandoeuvre les nancy, France, 54500 | |
Sponsors and Collaborators
University of Nancy
National conservatory of arts and crafts (CNAM)
Regional institute for health education (IRES)
Local school office of the academy of Nancy-Metz
Investigators
| Principal Investigator: | Serge Briançon, Pr | Public Health School |
More Information
Additional Information:
No publications provided by University of Nancy
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Briançon Serge Pr, Public Health School - laboratory EA4003 |
| ClinicalTrials.gov Identifier: | NCT00814554 History of Changes |
| Other Study ID Numbers: | pralimap-0610, CNIL-906312, CCTIRS-06.376 |
| Study First Received: | December 23, 2008 |
| Last Updated: | June 29, 2010 |
| Health Authority: | France: National Consultative Ethics Committee for Health and Life Sciences France: French Data Protection Authority |
Keywords provided by University of Nancy:
|
obesity nutrition cluster randomized trial high school primary prevention |
Additional relevant MeSH terms:
|
Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013