Overweight Management and Social Inequalities

NCT01688453 | Completed DMC

• 1 other identifier: C11-46
• Study Type: interventional
• Target: 1,689
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The prevalence of overweight and obesity continues to increase in socially less advantaged populations but is stabilizing even is decreasing in socially more advantaged populations. The PRALIMAP trial highlighted the effectiveness of structured screening and care management in decreasing the prevalence of overweight and obesity in high school adolescents over 2 years. The PRALIMAP-INES trial aims to investigate whether a strengthened care management (CM) for socially less advantaged adolescents in school in the short and long term has an equivalent effect as a standard-CM on decreasing the prevalence of overweight and obesity among socially advantaged adolescents. Intervention: PRALIMAP-INÉS is a mixed prospective and multicenter trial of 1,250 overweight and obese adolescents aged 13 to 18 years who are attending grade 9 and 10 in the 35 state-run schools of the Vosges department (northeastern France) for the academic years 2012-2013 2013-2014 and 2014-2015. Overweight adolescents (including obese) classified as advantaged are allocated to the standard-CM and those less advantaged are randomized to standard CM or strengthened-CM. The standard-CM consists of 5 collective sessions of 2 hr each performed in high school and supervised by a healthcare mobile team specialised in overweight and obesity care management for adolescents. The strengthened-CM consists of 5 collective sessions with the same standard operating procedure as the standard-CM with supplementary interventions between each session: strengthened solicitation with the adolescent and the family, peer-led educational sessions, motivational interviews, financial support for physical activity practice, cooking classes and multidisciplinary consultation meetings. Data on sociodemographics, anthropometrics, physical activity and mental health are collected at 3 visits: at the entry to grade 9 or 10 (before the intervention=T0), at the end of grade 9 or 10 (at the end of the intervention=T1) and at the end of grade 11 (1 year after the intervention=T2). Process evaluation data are also collected during the trial. Expected results: To confirm the effectiveness of overweight CM for adolescents in a school setting and to highlight or not the effectiveness of specific strengthened interventions adapted for socially less advantaged adolescents to maintain social equality in access to overweight care.

Conditions

Overweight

Keywords

overweight/obesity; adolescence; care management

Outcome Measures

Primary Outcomes (3)

• Change in Body Mass Index from to baseline to 1 and 2 years

  BMI is measured at baseline(on grade 10 entry) and after 1 and 2 follow up years(at the end of grades 10 and 11).

  0-1-2 years

• Change in overweight and obesity status according to IOTF norms

  overweight and obesity status is calculated from BMI at each measurement time according to the IOTF norms for age and sex

  up to 2 years

• Change in BMI Z score from baseline to one and two years

  BMI Z score is calculated from BMI at each time measurement using WHO reference and SAS macro

  up to 2 years

Secondary Outcomes (3)

• Change in waist circumference

  2 years

• change in eating attitude score from baseline to 1 and 2 years

  up to 2 years

• Change in anxiety and depression scores from baseline to 1 and 2 years

  up to 2 years

Other Outcomes (1)

• Change in Nutritional behavior from baseline to 1 and 2 years

  up to 2 years

Study Arms (3)

Group 1:

ACTIVE COMPARATOR

Socially advantaged overweight or obese adolescents are allocated to the standard care management.

Behavioral: Standard care management

Group 2

EXPERIMENTAL

Socially less advantaged overweight or obese adolescents are allocated to the standard care management.

Behavioral: Standard care management

Group 3

EXPERIMENTAL

Socially less advantaged overweight or obese adolescents are allocated to the strengthened care management.

Behavioral: The strengthened care management

Interventions

The strengthened care management BEHAVIORAL

The strengthened care management is the addition of the standard care management and of additional interventions. The standard-care management program consists of 5 collective sessions of 2 hr each about nutritional practices (food and physical activity) and on changes of nutritional behaviours. The sessions are organized in high schools by the healthcare team in collaboration with pediatricians, dietitians and the Sickness Insurance Primary Fund. The additional interventions are strengthened solicitation and accompaniment, peer-led education, motivational interview, financial support for physical activity practice, cooking classes and meetings of multidisciplinary consultation.

Group 3

Standard care management BEHAVIORAL

The standard-care management program consists of 5 collective sessions of 2 hr each about nutritional practices (food and physical activity) and on changes of nutritional behaviours. The sessions are organized in high schools by the healthcare team in collaboration with pediatricians, dietitians and the Sickness Insurance Primary Fund.

Group 1:; Group 2

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Attending grade 9 or 10 in one of the 35 state-run school of the Vosges department and be in a general, technological or vocational course,
• Aged ≤ 18 years old,
• not giving written refusal to participate in the trial,
• able to complete a questionnaire,
• overweight or obese according to the IOTF criteria (for BMI) and the McCarthy criteria (for waist circumference) and/or have a high eating disorder score, and/or express the need for management of excess weight,
• agree to an overweight and obesity care management program.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

School

Nancy, Vosges, France

Location

Related Publications (7)

• Saez L, Langlois J, Legrand K, Quinet MH, Lecomte E, Omorou AY, Briancon S; PRALIMAP-INES Trial Group. Reach and Acceptability of a Mobile Reminder Strategy and Facebook Group Intervention for Weight Management in Less Advantaged Adolescents: Insights From the PRALIMAP-INES Trial. JMIR Mhealth Uhealth. 2018 May 18;6(5):e110. doi: 10.2196/mhealth.7657.

  PMID: 29776897 RESULT

• Saez L, Legrand K, Alleyrat C, Ramisasoa S, Langlois J, Muller L, Omorou AY, De Lavenne R, Kivits J, Lecomte E, Briancon S; PRALIMAP-INES Trial Group. Using facilitator-receiver peer dyads matched according to socioeconomic status to promote behaviour change in overweight adolescents: a feasibility study. BMJ Open. 2018 Jun 22;8(6):e019731. doi: 10.1136/bmjopen-2017-019731.

  PMID: 29934380 RESULT

• Legrand K, Lecomte E, Langlois J, Muller L, Saez L, Quinet MH, Bohme P, Spitz E, Omorou AY, Briancon S; PRALIMAP-INES trial group. Reducing social inequalities in access to overweight and obesity care management for adolescents: The PRALIMAP-INES trial protocol and inclusion data analysis. Contemp Clin Trials Commun. 2017 Jun 16;7:141-157. doi: 10.1016/j.conctc.2017.05.010. eCollection 2017 Sep.

  PMID: 29696179 RESULT

• Manneville F, Omorou AY, Legrand K, Lecomte E, Rydberg JA, Briancon S, Guillemin F; PRALIMAP Trial Group. Sociodemographic and psychological characteristics associated with discrepancy between body satisfaction and weight change among adolescents. Prev Med. 2021 Sep;150:106668. doi: 10.1016/j.ypmed.2021.106668. Epub 2021 Jun 1.

  PMID: 34087324 RESULT

• Omorou AY, Manneville F, Langlois J, Legrand K, Bohme P, Muller L, Guillemin F, Briancon S, Lecomte E; PRALIMAP-INES Trial Group. Physical activity rather than sedentary behaviour is socially determined in French adolescents with overweight and obesity. Prev Med. 2020 May;134:106043. doi: 10.1016/j.ypmed.2020.106043. Epub 2020 Feb 22.

  PMID: 32097754 RESULT

• Dakin M, Manneville F, Langlois J, Briancon S, Lecomte E, Spitz E, Legrand K, Bohme P, Guillemin F, Omorou A. Role of dietary intake and physical activity in reducing weight social inequalities among adolescents: an application of G-formula to PRALIMAP-INES trial. Br J Nutr. 2024 Jul 28;132(2):182-191. doi: 10.1017/S0007114524001090. Epub 2024 May 27.

  PMID: 38800976 DERIVED

• Julia C, Omorou A, Lecomte E, Langlois J, Touvier M, Hercberg S, Briancon S, Kesse-Guyot E, Guillemin F; PRALIMAP-INES Trial Group. Behavioural risk patterns in adolescents with excess weight participating in the PRALIMAP-INES trial. Public Health Nutr. 2023 Jan;26(1):96-105. doi: 10.1017/S136898002200057X. Epub 2022 Mar 11.

  PMID: 35272723 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Serge Briançon, Pr

  University of Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2012
• First Posted: September 19, 2012
• Study Start: April 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 10, 2025

Record last verified: 2021-08

Locations

FR (1)