NCT04941651 Efficacy of Telenutrition for the Treatment of Overweight Patients With Obesity and/or High Cardiometabolic Risk
| NCT ID | NCT04941651 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Overweight and Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 346 participants |
| Start Date | 2024-01-02 |
| Primary Completion | 2025-11-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 346 participants in total. It began in 2024-01-02 with a primary completion date of 2025-11-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Excessive alcohol consumption \> 30 g / day -Pregnant or breastfeeding woman * symptomatic cardiovascular disease : angina, lower extremity arterial occlusive disease, stroke or myocardial infarction dating of less than 6 months. * Uncontrolled psychiatric illness * Patients receiving or about to receive during the study period a systemic or local treatment susceptible to interfere with the evaluation of the primary criteria (corticosteroids, antipsychotics, tricyclic antidepressants) except if these treatments have been stable for at least 6 months without a plan to modify the dose during the 12 months of the study * Adhering to a prescribed diet for weight loss, in the past 3 months * Person with a severe eating disorder: bulimia, binge eating disorder according to DSM-V criteria - Presence of celiac disease, Crohn's disease or other metabolic disorder or condition affecting nutritional needs such as allergies or food intolerances (except partial lactose intolerance) * Anticipated difficulties in following the patient * Lack of social coverage in France * Lack of written or electronic informed consent
Contact & Investigator
Marylou Para, MD, PhD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT04941651 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Overweight and Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04941651 currently recruiting?
Yes, NCT04941651 is actively recruiting participants. Contact the research team at marylou.para@aphp.fr for enrollment information.
Where is the NCT04941651 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04941651 clinical trial?
NCT04941651 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Marylou Para, MD, PhD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 346 participants.
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