- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00814554
Effectiveness Evaluation of Three Strategies of Promotion of Healthy Dietary and Physical Activity Behaviours to Prevent Weight Excess Among Teenagers (PRALIMAP)
29. juni 2010 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
5458
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Vandoeuvre les nancy, Frankrig, 54500
- Nancy-University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Being student in the included public high school in Region of Lorraine (East of France) whatever the age
Exclusion Criteria:
- None
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: control
no intervention was carried out in high school
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|
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Eksperimentel: Educational strategy
Educational strategy was 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).
Andre navne:
|
|
Eksperimentel: 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.
Andre navne:
|
|
Eksperimentel: 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.
Andre navne:
|
|
Eksperimentel: 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).
Andre navne:
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.
Andre navne:
|
|
Eksperimentel: 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.
Andre navne:
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.
Andre navne:
|
|
Eksperimentel: 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).
Andre navne:
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.
Andre navne:
|
|
Eksperimentel: 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).
Andre navne:
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.
Andre navne:
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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Overweight and obesity according to IOTF references
Tidsramme: 0-1-2 years
|
0-1-2 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Knowledge, attitude and behaviors toward nutrition (food and physical activity)
Tidsramme: 0-1-2 years
|
0-1-2 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Serge Briançon, Pr, Public Health School
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2006
Primær færdiggørelse (Faktiske)
1. december 2009
Studieafslutning (Faktiske)
1. december 2009
Datoer for studieregistrering
Først indsendt
23. december 2008
Først indsendt, der opfyldte QC-kriterier
24. december 2008
Først opslået (Skøn)
25. december 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
30. juni 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. juni 2010
Sidst verificeret
1. marts 2010
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- pralimap-0610
- CNIL-906312
- CCTIRS-06.376
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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