NCT05399407

Brief Summary

This study involves young adults from the PRALIMAP-INES trial and student volunteers from the University of Lorraine, who are overweight or obese. For young adults from the PRALIMAP-INES trial, the proposed research is a continuation of the PRALIMAP-CINeCO research (part 1). For students at the University of Lorraine, the proposed research is aimed at volunteer students who are overweight or obese, via the University of Lorraine's Student Health Service (SSE). Young adults and overweight or obese students not receiving medical care at the time of the inclusion visit (4th measurement time for PRALIMAP-INES participants and 1st time for others) will be offered the chance to take part in a randomized trial comparing the acceptability of health e-coaching versus referral to standard care. Experimental group: health e-coaching Control group: usual care system Primary objective : To determine the effectiveness of an e-health coaching intervention using new technologies that promotes changes in eating and physical activity behavior in overweight and obese young adults aged 20, an intervention targeting the development of autonomous self-regulation. Secondary objectives :

  1. 1.Determine the acceptability of health e-coaching: acceptability of new technologies (container), acceptability of personalized health e-coaching (content).
  2. 2.Determine the effectiveness of health e-coaching on the criteria of corpulence (BMI; body composition), changes in eating behaviors (TCA), emotion management skills and social interaction skills.
  3. 3.Evaluate the benefit of health e-coaching alone or combined with the previous intervention received in the PRALIMAP-INÈS trial on primary and secondary endpoints.
  4. 4.Evaluate and compare participation in a health promotion program over two life periods (adolescence and young adulthood) for young adults from the PRALIMAP-INÈS trial.
  5. 5.Evaluate the effectiveness of health e-coaching (reinforcement of autonomous self-regulation and changes in eating behaviors and physical activity practices/time spent sitting) according to the dose of intervention received by young adults (received-treatment analysis).
  6. 6.Determine the cost-efficiency and cost-utility ratios by means of a medico-economic evaluation based on the incremental cost of the e-coaching intervention in relation to the usual care offered by the health care system (ICER: Incremental Cost-Effectiveness Ratio).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
384

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

January 9, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2025

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

May 3, 2022

Last Update Submit

October 3, 2023

Conditions

Overweight and Obesity

Keywords

E-coachingUsual Care Systemyoung adults

Outcome Measures

Primary Outcomes (5)

  • 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)

    Before and after intervention, an average of 1 year

  • Change of the eating behaviors

    Diet, tobacco and alcohol consumption (food frequency questionnaire)

    Before and after intervention, an average of 1 year

  • Change of the physical activity practices

    Physical activity and sedentary behaviour (GPAQ)

    Before and after intervention, an average of 1 year

  • Change of the Self-regulatory skills

    Adaptation strategy (BriefCOPE)

    Before and after intervention, an average of 1 year

  • Change of the Self Efficacy Diet

    TESQ-E (Self-Efficacy Diet Questionnaire)

    Before and after intervention, an average of 1 year

Secondary Outcomes (3)

  • Level of satisfaction

    Study completion, an average of 1 year

  • Change of the level of quality of Life

    Before and after intervention, an average of 1 year

  • Change of the Knowledge on nutrition and physical activity

    Before and after intervention, an average of 1 year

Study Arms (2)

Experimental group: health e-coaching

EXPERIMENTAL

* Personalised and secure access to the health e-coaching platform for 12 months. * Follow-up by professionals who are specialized in the subject matter (at a distance): a psychologist, a dietician and a teacher of adapted physical activity. * Personalised activities offered to each young adult throughout their follow-up: synchronous and asynchronous activities (video, animation, quizzes, etc.), individual and collective on different themes (expression of emotions, my weight and me, eating well to start with, my image and me, making choices, my way of moving, etc.). The personalisation of the activities will be done in consultation between the professionals and the young adult according to the needs expressed and identified.

Other: Health e-coaching

Control group: Usual Care System

NO INTERVENTION

Control group : - Referral to health professionals in the health care system and, in priority, to the GP declared by the young adult. \- Transmission of the data collected during follow-up visit No. 3 / 0 (T3/T0) to the GP with relay for the implementation of a care plan.

Interventions

Health e-coachingOTHER

Management of overweight / obesity

Experimental group: health e-coaching

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Person having received complete information on the organization of the research and not and who did not object to their participation and to the use of their data to participate and to use their data
  • Have agreed to complete the pre-test questionnaire prior to/at the follow-up visit (T3)
  • Have agreed to the anthropometric measurements without invasive intervention performed at the follow-up visit (Q3)
  • Have a BMI greater than 25kg/m² (Cole et al. 2000) or a percentage of body fat mass greater than or equal to 20% for men and greater than or equal to 33% for women, depending on age and greater than or equal to 33% for women and not receiving medical medical care for this situation
  • Agree to participate in the follow-up
  • Accepting the health e-coaching/orientation to routine care
  • Affiliated to a social security system or beneficiary of such a system
  • Reside in France
  • Person having received complete information on the organization of the research and not and who did not object to their participation and to the use of their data to participate and to use their data
  • Have agreed to complete the pre-test questionnaire prior to/at the follow-up visit (T0)
  • Have agreed to the anthropometric measurements without invasive intervention performed at the follow-up visit (T0)
  • Have a BMI greater than 25kg/m² (Cole et al. 2000) or a percentage of body fat mass greater than or equal to 20% for men and greater than or equal to 33% for women, depending on age and greater than or equal to 33% for women and not receiving medical medical care for this situation
  • Agree to participate in the follow-up
  • Accepting the health e-coaching/orientation to routine care
  • Affiliated to a social security system or beneficiary of such a system
  • +3 more criteria

You may not qualify if:

  • Do not feel the need for coaching
  • Be already being treated for overweight by a health professional specializing in the treatment of specialized in the treatment of overweight and obesity or a specialized specialized medical structure/service
  • Do not agree to participate in the continuation of PRALIMAP-CINeCO
  • Major person under a legal protection measure (guardianship, curatorship, safeguard of justice)
  • Persons deprived of liberty by a judicial or administrative decision administrative decision Persons under psychiatric care in accordance with Articles L. 3212-1 and L. 3213-1 of the Public Health Code

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nancy

Nancy, 54000, France

RECRUITING

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Yacoubou OMOROU

CONTACT

0383859303Y.OMOROU@chru-nancy.fr

Mélanie BEGUINET

CONTACT

0383851997dripromoteur@chru-nancy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Experimental group: health e-coaching Control group: standard care
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 3, 2022

First Posted

June 1, 2022

Study Start

January 9, 2023

Primary Completion

January 9, 2025

Study Completion

January 9, 2025

Last Updated

October 5, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)