Clinical trial NCT00814554: Effectiveness Evaluation of Three Strategies of Promotion of Healthy Dietary and Physical Activity Behaviours to Prevent Weight Excess Among Teenagers
Official title: PRALIMAP: Effectiveness Evaluation of Three Strategies of Prevention of Overweight and Obesity in Adolescents; a Cluster Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight
Nutrition Processes
Prevention
Keywords: obesity
nutrition
cluster randomized trial
high school
primary prevention
Lead sponsor: University of Nancy
Sponsor class: OTHER
Collaborators: name: National conservatory of arts and crafts (CNAM)
name: Regional institute for health education (IRES)
name: Local school office of the academy of Nancy-Metz
First posted: 2008-12-25
Enrollment: 5458
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Overweight and obesity according to IOTF references
timeFrame: 0-1-2 years
Secondary outcomes:
measure: Knowledge, attitude and behaviors toward nutrition (food and physical activity)
timeFrame: 0-1-2 years
Other outcomes:
Locations:
city: Vandoeuvre les nancy
country: France
facility: Nancy-University
Study officials:
affiliation: Public Health School
name: Serge Briançon, Pr
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.