Clinical trial NCT05386017: Post-interventional Future for Adolescents From the PRALIMAP-INÉS Trial
Official title: Post-interventional Future for Adolescents From the PRALIMAP-INÉS Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Overweight and Obesity
Keywords: teenager
impact in adulthood
management of overweight
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: University of Lorraine
name: Cnam-ISTNA
First posted: 2022-05-23
Enrollment: 852
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evolution of the corpulence determined from the body mass index [BMI].
timeFrame: Between visit of inclusion in PRALIMAP-INÉS trials (Time 0) and 7 years after the inclusion in PRALIMAP-INÉS trials (Time 3)
Secondary outcomes:
measure: Eating habits
timeFrame: Between visit of inclusion in PRALIMAP-INÉS trials (Time 0) and 7 years after the inclusion in PRALIMAP-INÉS trials (Time 3)
measure: Physical activity
timeFrame: Between visit of inclusion in PRALIMAP-INÉS trials (Time 0) and 7 years after the inclusion in PRALIMAP-INÉS trials (Time 3)
measure: Anxiety, depression
timeFrame: Between visit of inclusion in PRALIMAP-INÉS trials (Time 0) and 7 years after the inclusion in PRALIMAP-INÉS trials (Time 3)
measure: Level of quality of life
timeFrame: Between visit of inclusion in PRALIMAP-INÉS trials (Time 0) and 7 years after the inclusion in PRALIMAP-INÉS trials (Time 3)
measure: Educational/professional trajectories
timeFrame: Between visit of inclusion in PRALIMAP-INÉS trials (Time 0) and 7 years after the inclusion in PRALIMAP-INÉS trials (Time 3)
measure: Economic
timeFrame: Between visit of inclusion in PRALIMAP-INÉS trials (Time 0) and 7 years after the inclusion in PRALIMAP-INÉS trials (Time 3)
measure: Eating disorders
timeFrame: Between visit of inclusion in PRALIMAP-INÉS trials (Time 0) and 7 years after the inclusion in PRALIMAP-INÉS trials (Time 3)
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU de Nancy
Study officials:
affiliation: Central Hospital, Nancy, France
name: Yacoubou OMOROU
role: PRINCIPAL_INVESTIGATOR
References: