Effectiveness Evaluation of Three Strategies of Promotion of Healthy Dietary and Physical Activity Behaviours to Prevent Weight Excess Among Teenagers (PRALIMAP)
29 juin 2010 mis à jour par: University of Nancy
PRALIMAP: Effectiveness Evaluation of Three Strategies of Prevention of Overweight and Obesity in Adolescents; a Cluster Randomised Controlled Trial
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
5458
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Vandoeuvre les nancy, France, 54500
- Nancy-University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Being student in the included public high school in Region of Lorraine (East of France) whatever the age
Exclusion Criteria:
- None
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: control
no intervention was carried out in high school
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Expérimental: Educational strategy
Educational strategy was carried out in high school.
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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).
Autres noms:
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Expérimental: Screening strategy
Screening strategy was carried out in high school.
|
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.
Autres noms:
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Expérimental: Environmental strategy
Environmental strategy was carried out in high school.
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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.
Autres noms:
|
|
Expérimental: Educational and Screening strategies
Educational strategy and Screening strategy were carried out in high school
|
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).
Autres noms:
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.
Autres noms:
|
|
Expérimental: Screening and Environmental strategies
Screening strategy and Environmental strategy were carried out in high school
|
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.
Autres noms:
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.
Autres noms:
|
|
Expérimental: Educational and Environmental strategies
Educational strategy and Environmental strategy were carried out in high school
|
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).
Autres noms:
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.
Autres noms:
|
|
Expérimental: the three strategies
Educational strategy, Screening strategy and Environmental strategy were carried out in high school.
|
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).
Autres noms:
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.
Autres noms:
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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Overweight and obesity according to IOTF references
Délai: 0-1-2 years
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0-1-2 years
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Knowledge, attitude and behaviors toward nutrition (food and physical activity)
Délai: 0-1-2 years
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0-1-2 years
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Serge Briançon, Pr, Public Health School
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Manneville F, Briancon S, Legrand K, Langlois J, Lecomte E, Omorou AY, Guillemin F. Physical Activity and Eating Behavior Inequalities Mediating the Effects of Socioeconomic Status and Sex on Adolescent Quality of Life: Insights of the PRALIMAP Trial. J Phys Act Health. 2022 Sep 13;19(10):648-657. doi: 10.1123/jpah.2022-0093. Print 2022 Oct 1.
- Langlois J, Omorou AY, Vuillemin A, Briancon S, Lecomte E; PRALIMAP Trial Group. Association of socioeconomic, school-related and family factors and physical activity and sedentary behaviour among adolescents: multilevel analysis of the PRALIMAP trial inclusion data. BMC Public Health. 2017 Feb 8;17(1):175. doi: 10.1186/s12889-017-4070-9.
- Omorou AY, Langlois J, Lecomte E, Vuillemin A, Briancon S; PRALIMAP Trial Group. Adolescents' Physical Activity and Sedentary Behavior: A Pathway in Reducing Overweight and Obesity. The PRALIMAP 2-Year Cluster Randomized Controlled Trial. J Phys Act Health. 2015 May;12(5):628-35. doi: 10.1123/jpah.2014-0035. Epub 2014 Nov 13.
- Bonsergent E, Agrinier N, Thilly N, Tessier S, Legrand K, Lecomte E, Aptel E, Hercberg S, Collin JF, Briancon S; PRALIMAP Trial Group. Overweight and obesity prevention for adolescents: a cluster randomized controlled trial in a school setting. Am J Prev Med. 2013 Jan;44(1):30-9. doi: 10.1016/j.amepre.2012.09.055.
- Legrand K, Bonsergent E, Latarche C, Empereur F, Collin JF, Lecomte E, Aptel E, Thilly N, Briancon S. Intervention dose estimation in health promotion programmes: a framework and a tool. Application to the diet and physical activity promotion PRALIMAP trial. BMC Med Res Methodol. 2012 Sep 19;12:146. doi: 10.1186/1471-2288-12-146.
- Briancon S, Bonsergent E, Agrinier N, Tessier S, Legrand K, Lecomte E, Aptel E, Hercberg S, Collin JF; PRALIMAP Trial Group. PRALIMAP: study protocol for a high school-based, factorial cluster randomised interventional trial of three overweight and obesity prevention strategies. Trials. 2010 Dec 6;11:119. doi: 10.1186/1745-6215-11-119.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2006
Achèvement primaire (Réel)
1 décembre 2009
Achèvement de l'étude (Réel)
1 décembre 2009
Dates d'inscription aux études
Première soumission
23 décembre 2008
Première soumission répondant aux critères de contrôle qualité
24 décembre 2008
Première publication (Estimation)
25 décembre 2008
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
30 juin 2010
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 juin 2010
Dernière vérification
1 mars 2010
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- pralimap-0610
- CNIL-906312
- CCTIRS-06.376
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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