NCT05399407

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 384 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
OTHER	Health e-coaching	Management of overweight / obesity

Timeline

• Start date: 2023-01-09
• Primary completion: 2025-01-09
• Completion: 2025-01-09
• First posted: 2022-06-01
• Last updated: 2023-10-05

Locations

1 site across 1 country: France