Effectiveness Evaluation of Three Strategies of Promotion of Healthy Dietary and Physical Activity Behaviours to Prevent Weight Excess Among Teenagers (PRALIMAP)
29 de junio de 2010 actualizado por: 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.
Descripción general del estudio
Estado
Estado
Terminado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
Inscripción
5458
Fase
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
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Vandoeuvre les nancy, Francia, 54500
- Nancy-University
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Being student in the included public high school in Region of Lorraine (East of France) whatever the age
Exclusion Criteria:
- None
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
8
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Sin intervención: control
no intervention was carried out in high school
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Experimental: 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).
Otros nombres:
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Experimental: Screening strategy
Screening strategy was carried out in high school.
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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.
Otros nombres:
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Experimental: Environmental strategy
Environmental strategy was carried out in high school.
|
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.
Otros nombres:
|
|
Experimental: 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).
Otros nombres:
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.
Otros nombres:
|
|
Experimental: 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.
Otros nombres:
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.
Otros nombres:
|
|
Experimental: 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).
Otros nombres:
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.
Otros nombres:
|
|
Experimental: 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).
Otros nombres:
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.
Otros nombres:
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Overweight and obesity according to IOTF references
Periodo de tiempo: 0-1-2 years
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0-1-2 years
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Knowledge, attitude and behaviors toward nutrition (food and physical activity)
Periodo de tiempo: 0-1-2 years
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0-1-2 years
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Serge Briançon, Pr, Public Health School
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
Inicio del estudio
1 de septiembre de 2006
Finalización primaria (Actual)
Finalización primaria
1 de diciembre de 2009
Finalización del estudio (Actual)
Finalización del estudio
1 de diciembre de 2009
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
23 de diciembre de 2008
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
24 de diciembre de 2008
Publicado por primera vez (Estimar)
Publicado por primera vez
25 de diciembre de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización publicada
30 de junio de 2010
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
29 de junio de 2010
Última verificación
Última verificación
1 de marzo de 2010
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- pralimap-0610
- CNIL-906312
- CCTIRS-06.376
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .