NCT00814554

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,458

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 25, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 30, 2010

Status Verified

March 1, 2010

Enrollment Period

3.3 years

First QC Date

December 23, 2008

Last Update Submit

June 29, 2010

Conditions

Keywords

obesitynutritioncluster randomized trialhigh schoolprimary prevention

Outcome Measures

Primary Outcomes (1)

  • Overweight and obesity according to IOTF references

    0-1-2 years

Secondary Outcomes (1)

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

    0-1-2 years

Study Arms (8)

control

NO INTERVENTION

no intervention was carried out in high school

Educational strategy

EXPERIMENTAL

Educational strategy was carried out in high school.

Behavioral: Educational strategy

Screening strategy

EXPERIMENTAL

Screening strategy was carried out in high school.

Behavioral: Screening strategy

Environmental strategy

EXPERIMENTAL

Environmental strategy was carried out in high school.

Other: Environmental strategy

Educational and Screening strategies

EXPERIMENTAL

Educational strategy and Screening strategy were carried out in high school

Behavioral: Educational strategyBehavioral: Screening strategy

Screening and Environmental strategies

EXPERIMENTAL

Screening strategy and Environmental strategy were carried out in high school

Behavioral: Screening strategyOther: Environmental strategy

Educational and Environmental strategies

EXPERIMENTAL

Educational strategy and Environmental strategy were carried out in high school

Behavioral: Educational strategyOther: Environmental strategy

the three strategies

EXPERIMENTAL

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

Behavioral: Educational strategyBehavioral: Screening strategyOther: Environmental strategy

Interventions

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).

Also known as: Axe 1
Educational and Environmental strategiesEducational and Screening strategiesEducational strategythe three strategies

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.

Also known as: Axe 2
Educational and Screening strategiesScreening and Environmental strategiesScreening strategythe three strategies

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.

Also known as: Axe 3
Educational and Environmental strategiesEnvironmental strategyScreening and Environmental strategiesthe three strategies

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nancy-University

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (6)

  • 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.

MeSH Terms

Conditions

Body WeightObesity

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Serge Briançon, Pr

    Public Health School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 23, 2008

First Posted

December 25, 2008

Study Start

September 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

June 30, 2010

Record last verified: 2010-03

Locations