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

Primary Purpose

Body Weight, Nutrition Processes, Prevention

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Educational strategy
Screening strategy
Environmental strategy
Sponsored by
University of Nancy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Body Weight focused on measuring obesity, nutrition, cluster randomized trial, high school, primary prevention

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • Nancy-University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

control

Educational strategy

Screening strategy

Environmental strategy

Educational and Screening strategies

Screening and Environmental strategies

Educational and Environmental strategies

the three strategies

Arm Description

no intervention was carried out in high school

Educational strategy was carried out in high school.

Screening strategy was carried out in high school.

Environmental strategy was carried out in high school.

Educational strategy and Screening strategy were carried out in high school

Screening strategy and Environmental strategy were carried out in high school

Educational strategy and Environmental strategy were carried out in high school

Educational strategy, Screening strategy and Environmental strategy were carried out in high school.

Outcomes

Primary Outcome Measures

Overweight and obesity according to IOTF references

Secondary Outcome Measures

Knowledge, attitude and behaviors toward nutrition (food and physical activity)

Full Information

First Posted
December 23, 2008
Last Updated
June 29, 2010
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
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1. Study Identification

Unique Protocol Identification Number
NCT00814554
Brief Title
Effectiveness Evaluation of Three Strategies of Promotion of Healthy Dietary and Physical Activity Behaviours to Prevent Weight Excess Among Teenagers
Acronym
PRALIMAP
Official Title
PRALIMAP: Effectiveness Evaluation of Three Strategies of Prevention of Overweight and Obesity in Adolescents; a Cluster Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight, Nutrition Processes, Prevention
Keywords
obesity, nutrition, cluster randomized trial, high school, primary prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5458 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Description
no intervention was carried out in high school
Arm Title
Educational strategy
Arm Type
Experimental
Arm Description
Educational strategy was carried out in high school.
Arm Title
Screening strategy
Arm Type
Experimental
Arm Description
Screening strategy was carried out in high school.
Arm Title
Environmental strategy
Arm Type
Experimental
Arm Description
Environmental strategy was carried out in high school.
Arm Title
Educational and Screening strategies
Arm Type
Experimental
Arm Description
Educational strategy and Screening strategy were carried out in high school
Arm Title
Screening and Environmental strategies
Arm Type
Experimental
Arm Description
Screening strategy and Environmental strategy were carried out in high school
Arm Title
Educational and Environmental strategies
Arm Type
Experimental
Arm Description
Educational strategy and Environmental strategy were carried out in high school
Arm Title
the three strategies
Arm Type
Experimental
Arm Description
Educational strategy, Screening strategy and Environmental strategy were carried out in high school.
Intervention Type
Behavioral
Intervention Name(s)
Educational strategy
Other Intervention Name(s)
Axe 1
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Screening strategy
Other Intervention Name(s)
Axe 2
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Environmental strategy
Other Intervention Name(s)
Axe 3
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overweight and obesity according to IOTF references
Time Frame
0-1-2 years
Secondary Outcome Measure Information:
Title
Knowledge, attitude and behaviors toward nutrition (food and physical activity)
Time Frame
0-1-2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being student in the included public high school in Region of Lorraine (East of France) whatever the age Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serge Briançon, Pr
Organizational Affiliation
Public Health School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nancy-University
City
Vandoeuvre les nancy
ZIP/Postal Code
54500
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
36100207
Citation
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.
Results Reference
derived
PubMed Identifier
28178972
Citation
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.
Results Reference
derived
PubMed Identifier
25393601
Citation
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.
Results Reference
derived
PubMed Identifier
23253647
Citation
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.
Results Reference
derived
PubMed Identifier
22992391
Citation
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.
Results Reference
derived
PubMed Identifier
21134278
Citation
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.
Results Reference
derived

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

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