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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05399407
Acronym
PRALIMAPCINeCO
Enrollment
384
Registered
2022-06-01
Start date
2023-01-09
Completion date
2025-01-09
Last updated
2023-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Keywords

E-coaching, Usual Care System, young adults

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. 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).

Interventions

OTHERHealth e-coaching

Management of overweight / obesity

Sponsors

University of Lorraine
CollaboratorOTHER
Cnam-ISTNA
CollaboratorUNKNOWN
Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Experimental group: health e-coaching Control group: standard care

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of the Self Efficacy DietBefore and after intervention, an average of 1 yearTESQ-E (Self-Efficacy Diet Questionnaire)
Change of the eating behaviorsBefore and after intervention, an average of 1 yearDiet, tobacco and alcohol consumption (food frequency questionnaire)
Change of the physical activity practicesBefore and after intervention, an average of 1 yearPhysical activity and sedentary behaviour (GPAQ)
Change of the Self-regulatory skillsBefore and after intervention, an average of 1 yearAdaptation strategy (BriefCOPE)
Evolution of the corpulence determined from the body mass index [BMI]Before and after intervention, an average of 1 yearBody Mass Index (BMI) indicates the ratio between your weight and your height in meters squared (kg/m\^2)

Secondary

MeasureTime frameDescription
Change of the level of quality of LifeBefore and after intervention, an average of 1 yearQuestionnaire EQ-5D-5L
Change of the Knowledge on nutrition and physical activityBefore and after intervention, an average of 1 yearQuestionnaire of knowledge on nutrition and physical activity
Level of satisfactionStudy completion, an average of 1 yearSatisfaction questionnaire

Countries

France

Contacts

Primary ContactYacoubou OMOROU
Y.OMOROU@chru-nancy.fr0383859303
Backup ContactMélanie BEGUINET
dripromoteur@chru-nancy.fr0383851997

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026