Efficacy of Telenutrition (OBE-COACH) for the Treatment of Overweight Patients With Obesity and/or High Cardiometabolic Risk

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The OBE-COACH program is an automated online nutritional coaching service that was evaluated in its first version (MXS-CARE program) in a clinical trial coordinated by our team, in type 2 diabetic patients with abdominal obesity. Results have confirmed the efficiency of the program to improve lifestyle habits, including the 4-month diet, and to reduce weight and HbA1c levels. Based on our experience and the scientific literature, the investigators assume that adherence to the program may diminish in the long term to the point of calling into question its efficiency. So IRIADE compagny developed an enhanced program called OBE-COACH. The OBE-COACH program has been specifically designed to facilitate long-term user adherence. The OBE-COACH program, integrates a bidirectional interactive link between the patient and an automated support system (IRIADE-MED system) associated with an inexpensive remote human support. In the TOOLBAR study, the investigators will evaluate the efficiency of the OBE-COACH solution in a population of obese patients or overweight persons with at least one cardiometabolic risk factor. A group of patients will have access to the OBE-COACH program. It will be compared to a control group which will receive an e-learning program with free access to advice sheets via the web, to a menu generator, videos and a catalog of physical activity, (resources made available by the web site www.mangerbouger.fr (public health France, ministry in charge of health) . Indeed, the investigators judged that the loss of patients during follow-up would be greater if e-learning was not offered in the control group.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Men or women 18 to 75 years

• Obesity defined by a body mass index \> 30 kg / m2 or a BMI\> 25 kg / m2 with the presence of at least one major cardiometabolic risk factors among the followings: dyslipidemia, hypertension, diabetes, prediabetes

• Stable weight in the last six months (weight variation \< 4 kg peak-to-peak)

• Access and current use of internet, possession of an email address and a smartphone.

• Understanding and reading French

• Patient not currently following a nutritional monitoring and not having planned to be engaged in a nutritional monitoring during the coming year

Locations
Other Locations
France
Hôpital La Pitié Salpêtrière
RECRUITING
Paris
Contact Information
Primary
Marylou Para, PHU
marylou.para@aphp.fr
01 40 25 84 50
Backup
Boris Hansel, MD, PhD
boris.hansel@aphp.fr
01 40 25 87 35
Time Frame
Start Date: 2024-01-02
Estimated Completion Date: 2026-11-15
Participants
Target number of participants: 346
Treatments
Experimental: OBE-COACH program
The OBE-COACH experimental group: access to the complete OBE-COACH program
Active_comparator: e-learning program
The control group: access to an e-learning program with free access via the web to advice sheets, a menu generator and a catalog of physical activity (resources made available by the site www.mangerbouger.fr ; Public Health France, Ministry of Health) and provision of connected devices (auto-tensiometer and balance).
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov