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

Primary Purpose

Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Health e-coaching
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Overweight and Obesity focused on measuring E-coaching, Usual Care System, young adults

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Exclusion Criteria:

If the follow-up visit n°3 (T3) during the PRALIMAP-CINeCO trial (1st part) 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

Sites / Locations

  • CHRU de NancyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group: health e-coaching

Control group: Usual Care System

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
Change of the eating behaviors
Diet, tobacco and alcohol consumption (food frequency questionnaire)
Change of the physical activity practices
Physical activity and sedentary behaviour (GPAQ)
Change of the Self-regulatory skills
Adaptation strategy (BriefCOPE)
Change of the Self Efficacy Diet
TESQ-E (Self-Efficacy Diet Questionnaire)

Secondary Outcome Measures

Level of satisfaction
Satisfaction questionnaire
Change of the level of quality of Life
Questionnaire EQ-5D-5L
Change of the Knowledge on nutrition and physical activity
Questionnaire of knowledge on nutrition and physical activity

Full Information

First Posted
May 3, 2022
Last Updated
October 3, 2023
Sponsor
Central Hospital, Nancy, France
Collaborators
University of Lorraine, Cnam-ISTNA
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1. Study Identification

Unique Protocol Identification Number
NCT05399407
Brief Title
PRALIMAP-CINeCO: Comparison of Health E-coaching Versus Referral to the Usual Care System
Acronym
PRALIMAPCINeCO
Official Title
Randomized Controlled Trial PRALIMAP-CINeCO: Comparison of Health E-coaching Versus Referral to the Usual Care System for Overweight and Obese Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
January 9, 2025 (Anticipated)
Study Completion Date
January 9, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France
Collaborators
University of Lorraine, Cnam-ISTNA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
E-coaching, Usual Care System, young adults

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental group: health e-coaching Control group: standard care
Masking
None (Open Label)
Allocation
Randomized
Enrollment
384 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group: health e-coaching
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group: Usual Care System
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Health e-coaching
Intervention Description
Management of overweight / obesity
Primary Outcome Measure Information:
Title
Evolution of the corpulence determined from the body mass index [BMI]
Description
Body Mass Index (BMI) indicates the ratio between your weight and your height in meters squared (kg/m^2)
Time Frame
Before and after intervention, an average of 1 year
Title
Change of the eating behaviors
Description
Diet, tobacco and alcohol consumption (food frequency questionnaire)
Time Frame
Before and after intervention, an average of 1 year
Title
Change of the physical activity practices
Description
Physical activity and sedentary behaviour (GPAQ)
Time Frame
Before and after intervention, an average of 1 year
Title
Change of the Self-regulatory skills
Description
Adaptation strategy (BriefCOPE)
Time Frame
Before and after intervention, an average of 1 year
Title
Change of the Self Efficacy Diet
Description
TESQ-E (Self-Efficacy Diet Questionnaire)
Time Frame
Before and after intervention, an average of 1 year
Secondary Outcome Measure Information:
Title
Level of satisfaction
Description
Satisfaction questionnaire
Time Frame
Study completion, an average of 1 year
Title
Change of the level of quality of Life
Description
Questionnaire EQ-5D-5L
Time Frame
Before and after intervention, an average of 1 year
Title
Change of the Knowledge on nutrition and physical activity
Description
Questionnaire of knowledge on nutrition and physical activity
Time Frame
Before and after intervention, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yacoubou OMOROU
Phone
0383859303
Email
Y.OMOROU@chru-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Mélanie BEGUINET
Phone
0383851997
Email
dripromoteur@chru-nancy.fr
Facility Information:
Facility Name
CHRU de Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yacoubou OMOROU
Phone
0383859303
Email
Y.OMOROU@chru-nancy.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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