PRALIMAP-CINeCO: Comparison of Health E-coaching Versus Referral to the Usual Care System (PRALIMAPCINeCO)

Randomized Controlled Trial PRALIMAP-CINeCO: Comparison of Health E-coaching Versus Referral to the Usual Care System for Overweight and Obese Young Adults

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. Determine the acceptability of health e-coaching: acceptability of new technologies (container), acceptability of personalized health e-coaching (content).
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. 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. 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. 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. 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).

Study Overview

• Status: Recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Other: Health e-coaching

• Study Type: Interventional
• Enrollment (Estimated): 384
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yacoubou OMOROU; Phone Number: 0383859303; Email: Y.OMOROU@chru-nancy.fr
• Study Contact Backup: Name: Mélanie BEGUINET; Phone Number: 0383851997; Email: dripromoteur@chru-nancy.fr

Study Locations

• France
  • Nancy, France, 54000
    • Recruiting
    • CHRU de Nancy
    • Contact: Yacoubou OMOROU; Phone Number: 0383859303; Email: Y.OMOROU@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Among the young adults who agreed to participate in follow-up visit (T3) in the PRALIMAP-CINeCO trial (Part 1), the inclusion criteria for the inclusion criteria for the proposed research are as follows:

• 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

Among the students who agreed to participate, through the Student Health Service of the University of Lorraine, the inclusion criteria for the proposed research are as follows:

• 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
• Reside in France
• Be of legal age (18 years or older)
• Be a student at the Université de Lorraine

Exclusion Criteria:

If the follow-up visit n°3 (T3) during the PRALIMAP-CINeCO trial (1st part) or the inclusion visit (T0 for University of Lorraine students), was completed, the non-inclusion criteria for the referral of young adults young adults (health e-coaching/current care) are as follows:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group: health e-coaching; 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; Management of overweight / obesity
No Intervention: Control group: Usual Care System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Self Efficacy Diet	TESQ-E (Self-Efficacy Diet Questionnaire)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of satisfaction	Satisfaction questionnaire	Study completion, an average of 1 year
Change of the level of quality of Life	Questionnaire EQ-5D-5L	Before and after intervention, an average of 1 year
Change of the Knowledge on nutrition and physical activity	Questionnaire of knowledge on nutrition and physical activity	Before and after intervention, an average of 1 year

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Collaborators: University of Lorraine; Cnam-ISTNA

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Estimated): January 9, 2025
• Study Completion (Estimated): January 9, 2025

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 30, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: young adults; E-coaching; Usual Care System
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: 2021PI178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No