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

Overweight and Obesity Clinical Trial

— PRALIMAPCINeCO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05386017
• Other study ID #: 2020PI261
• Status: Recruiting
• Start date: December 13, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: Central Hospital, Nancy, France
• Contact: Yacoubou OMOROU
• Phone: 0383859303
• Email: Y.OMOROU[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Beforehand, an information letter will be sent to the young adults included in PRALIMAP-INÈS at the postal and e-mail addresses initially provided. The objective is to present the study and to inform about the upcoming solicitation by the project team.

The young adults are contacted by a member trained in the project and the telephone call. This person will contact the young adults by phone to: follow up on the information letter, present the study to the young adult, verify the contact information from the T0, propose to fill out the questionnaire (T3) and propose to participate in a follow-up visit. The follow-up visit will take place in a medical center near the young adult's current place of residence, work or study. This visit will include a questionnaire as well as anthropometric measurements.

In addition to the data previously collected during follow-up visit 3, approximately 60 young adults will participate in a qualitative interview conducted by a sociologist. The goal is to gain a deeper understanding of the trajectories of young adults with respect to The objective is to gain a deeper understanding of the trajectories of young adults with respect to the social aspects that may affect health behavior. Dimensions such as educational and professional backgrounds, family and social networks, living conditions social networks, living conditions, etc. will be explored in detail.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 852
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• As part of the cohort follow-up, there are no non-inclusion criteria.

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Other:
• Anthropometric measurements and sociodemographic and health data collection
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

Locations

Country	Name	City	State
France	CHRU de Nancy	Nancy

Sponsors (3)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Cnam-ISTNA, University of Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Eating habits	Diet, tobacco and alcohol consumption (food frequency questionnaire (FNORS, 2009))	Between visit of inclusion in PRALIMAP-INÉS trials (Time 0) and 7 years after the inclusion in PRALIMAP-INÉS trials (Time 3)
Secondary	Physical activity	Physical activity and sedentary behaviour (GPAQ) (Rivière et al., 2018)	Between visit of inclusion in PRALIMAP-INÉS trials (Time 0) and 7 years after the inclusion in PRALIMAP-INÉS trials (Time 3)
Secondary	Anxiety, depression	Anxiety and depression (HAD) (Zigmond and Snaith, 1983)	Between visit of inclusion in PRALIMAP-INÉS trials (Time 0) and 7 years after the inclusion in PRALIMAP-INÉS trials (Time 3)
Secondary	Level of quality of life	Quality of life (SF12) (Gandek et al., 1998)	Between visit of inclusion in PRALIMAP-INÉS trials (Time 0) and 7 years after the inclusion in PRALIMAP-INÉS trials (Time 3)
Secondary	Educational/professional trajectories	Social statut (Family Affluence Scale [FAS] (Hartley et al., 2016))	Between visit of inclusion in PRALIMAP-INÉS trials (Time 0) and 7 years after the inclusion in PRALIMAP-INÉS trials (Time 3)
Secondary	Economic	Income	Between visit of inclusion in PRALIMAP-INÉS trials (Time 0) and 7 years after the inclusion in PRALIMAP-INÉS trials (Time 3)
Secondary	Eating disorders	- Eating disorders (EAT-26) (Garner and Garfinkel, 1979): dieting, bulimia and food preoccupation and oral control	Between visit of inclusion in PRALIMAP-INÉS trials (Time 0) and 7 years after the inclusion in PRALIMAP-INÉS trials (Time 3)