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NCT04941651: TOOLBAR

Efficacy of Telenutrition for the Treatment of Overweight Patients With Obesity and/or High Cardiometabolic Risk

Recruiting now NA Last updated 24 May 2024
What this trial tests

NA trial testing OBE-COACH program in Overweight and Obesity in 346 participants. Currently enrolling.

Timeline
2 January 2024
Primary endpoint
15 November 2025
15 November 2026

Quick facts

Lead sponsorAssistance Publique - Hôpitaux de Paris
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment346
Start date2 January 2024
Primary completion15 November 2025
Estimated completion15 November 2026
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 18 to 75, any sex, with Overweight and Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Overweight and Obesity

Currently open trials in the same condition.

Other Assistance Publique - Hôpitaux de Paris trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04941651.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing