Actively Recruiting
Efficacy of Telenutrition for the Treatment of Overweight Patients With Obesity and/or High Cardiometabolic Risk
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-05-24
346
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Telenutrition for the Treatment of Overweight Patients With Obesity and/or High Cardiometabolic Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women 18 to 75 years
- Obesity defined by a body mass index > 30 kg/m2 or a BMI > 25 kg/m2 with at least one major cardiometabolic risk factor such as dyslipidemia, hypertension, diabetes, or prediabetes
- Stable weight in the last six months with weight variation less than 4 kg peak-to-peak
- Access to and current use of the internet, possession of an email address and a smartphone
- Ability to understand and read French
- Not currently undergoing nutritional monitoring and no plans to start nutritional monitoring during the coming year
You will not qualify if you...
- Excessive alcohol consumption over 30 g per day
- Pregnant or breastfeeding women
- Symptomatic cardiovascular disease such as angina, lower extremity arterial occlusive disease, stroke, or myocardial infarction within the last 6 months
- Uncontrolled psychiatric illness
- Receiving or planning to receive treatments that could interfere with study evaluation (like corticosteroids, antipsychotics, tricyclic antidepressants) unless stable for at least 6 months with no planned dose changes during the study
- Following a prescribed diet for weight loss in the past 3 months
- Severe eating disorders such as bulimia or binge eating disorder
- Presence of celiac disease, Crohn's disease, or other metabolic or nutritional disorders including allergies or food intolerances (except partial lactose intolerance)
- Anticipated difficulties in following the study protocol
- Lack of social coverage in France
- Lack of written or electronic informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hôpital La Pitié Salpêtrière
Paris, France, 75013
Actively Recruiting
Research Team
M
Marylou Para, PHU
CONTACT
B
Boris Hansel, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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