Post-interventional Future for Adolescents From the PRALIMAP-INÉS Trial

NCT05386017 | Unknown

• 1 other identifier: 2020PI261
• Study Type: observational
• Target: 852
• Locations: 1 country
• Sites: 1

Brief Summary

The research focuses on a follow-up measure of participants in the PRALIMAP-INÈS cohort (NCT01688453 - Legrand et al. 2017). PRALIMAP-INÈS was conducted between 2012 and 2015 with the objective of showing that adapted overweight support for less advantaged adolescents has an effect equivalent to standard support for advantaged adolescents in the short term. This trial included 3 measurement times: T0 (before intervention), T1 (after intervention, at the end of the school year), T2 (after intervention) and of the school year), T2 (one year later). The proposed research is a continuation of PRALIMAP-INÈS with the addition of a 4th measurement time (T3) to study the trajectories of the intervention. (T3) to study the long-term social, economic, educational and health trajectories (in particular weight) of weight) of adolescents who have become young adults.

Conditions

Overweight and Obesity

Keywords

teenager; impact in adulthood; management of overweight

Outcome Measures

Primary Outcomes (1)

• Evolution of the corpulence determined from the body mass index [BMI].

  Body Mass Index (BMI) indicates the ratio between your weight and your height in meters squared (kg/m\^2).

  Between visit of inclusion in PRALIMAP-INÉS trials (Time 0) and 7 years after the inclusion in PRALIMAP-INÉS trials (Time 3)

Secondary Outcomes (7)

• Eating habits

  Between visit of inclusion in PRALIMAP-INÉS trials (Time 0) and 7 years after the inclusion in PRALIMAP-INÉS trials (Time 3)

• Physical activity

  Between visit of inclusion in PRALIMAP-INÉS trials (Time 0) and 7 years after the inclusion in PRALIMAP-INÉS trials (Time 3)

• Anxiety, depression

  Between visit of inclusion in PRALIMAP-INÉS trials (Time 0) and 7 years after the inclusion in PRALIMAP-INÉS trials (Time 3)

• Level of quality of life

  Between visit of inclusion in PRALIMAP-INÉS trials (Time 0) and 7 years after the inclusion in PRALIMAP-INÉS trials (Time 3)

• Educational/professional trajectories

  Between visit of inclusion in PRALIMAP-INÉS trials (Time 0) and 7 years after the inclusion in PRALIMAP-INÉS trials (Time 3)

Study Arms (1)

Young adults who were included in the PRALIMAPINES trial as adolescents

The population is all young adults who were included in the PRALIMAPINES trial as adolescents (n=1419); we estimated 852 young adults participated in the follow-up visit (T3). This visit was proposed to investigate long-term social, economic, educational/professional and health (in particular weight) trajectories in adolescents in the PRALIMAP-INÈS intervention

Other: Anthropometric measurements and sociodemographic and health data collection

Interventions

Anthropometric measurements and sociodemographic and health data collection OTHER

Anthropometric measurements : weight, height, abdominal circumference, abdominal circumference, percentage of fat mass, percentage of lean body mass, and estimated visceral fat level, visceral fat. Sociodemographic and health data collection : Collect over a 7-year period changes in physical activity practices, eating habits and behaviours and the motivations for these changes or the initiatives to change the weight, Perceived stress and control, Life courses, events and impact perception Status, level of education, social background, place of residence, relationship with family Diet, tobacco and alcohol consumptions Physical activity behaviour and barriers, sedentary behaviour, quality of life perceived, exploring possible behavioural eating disorders, anxiety, depression

Young adults who were included in the PRALIMAPINES trial as adolescents

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adolescents included for PRALIMAP-INÈS will be asked to participate in this study (n=1419). Among the 1419 included PRALIMAP-INÈS participants, we estimate that 40% of 1419 will not contribute: 10% unknown address, 15% unsuccessfully contacted, and 15% refusal to participate. Estimating precisely the number of young adults who cannot be located will be difficult, because the cohort attrition rates are variable. However, the partnership with the regional education authority facilitated the follow-up and acquiring telephone details for young people who were mostly equipped with mobile phones when they were included in the PRALIMAP-INÈS trial and the implementation of young ambassadors will also be an opportunity for follow-up.

You may qualify if:

• As part of the cohort follow-up, all young adults who participated in the PRALIMAP-INÈS trial will be contacted again. Each young adult: Was enrolled in 3rd or 2nd grade in 2012, 2013 or 2014 in the participating schools in the PRALIMAP-INÈS program (T3: over 18 years old). years old)
• Participated in the PRALIMAP-INÈS trial, and thus was considered eligible for this trial trial (with a BMI above the IOTF threshold (Cole et al. 2000) of reduced overweight of 1 kg/m² for age and sex and/or an abdominal circumference greater than the McCarthy McCarthy cut-offs for age and sex (McCarthy, Jarrett, and Crawley 2001) and having received a medical interview)
• Is enrolled in or receiving social security benefits

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• University of Lorraine: collaborator
• Cnam-ISTNA: collaborator

Study Sites (1)

CHRU de Nancy

Nancy, 54000, France

RECRUITING

Related Publications (1)

• Legrand K, Manneville F, Langlois J, Bohme P, Dosda A, Beguinet M, Briancon S, Spitz E, Lecomte E, Omorou AY. Ten-year postintervention follow-up of adolescents participating in the management of overweight and social inequalities (PRALIMAP-INES intervention): the PRALIMAP-CINeCO survey protocol. BMJ Open. 2024 Sep 12;14(9):e083090. doi: 10.1136/bmjopen-2023-083090.

  PMID: 39266314 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

• Yacoubou OMOROU

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yacoubou OMOROU

CONTACT

0383859303; Y.OMOROU@chru-nancy.fr

Mélanie BEGUINET

CONTACT

0383851997; dripromoteur@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 23, 2022
• Study Start: December 13, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)