Online nutritional coaching for overweight patients with obesity and high cardiometabolic risk
Efficacy of Telenutrition (OBE-COACH) for the Treatment of Overweight Patients With Obesity and/or High Cardiometabolic Risk
NA · Assistance Publique - Hôpitaux de Paris · NCT04941651
This study tests whether an online nutritional coaching program can help overweight people with obesity and high heart health risks lose weight and improve their health compared to a regular e-learning program.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 346 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Paris) |
| Trial ID | NCT04941651 on ClinicalTrials.gov |
What this trial studies
The OBE-COACH program is an automated online nutritional coaching service designed to improve lifestyle habits in overweight patients with obesity and/or high cardiometabolic risk. Participants will be enrolled in a controlled study where one group receives access to the OBE-COACH program, while the control group utilizes an e-learning program without the interactive coaching. The study will assess participants at baseline, 6 months, and 12 months to evaluate the program's effectiveness in promoting weight loss and improving health outcomes. The program aims to enhance long-term adherence to dietary and physical activity recommendations.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18 to 75 with obesity or overweight and at least one cardiometabolic risk factor.
Not a fit: Patients with uncontrolled psychiatric illnesses or recent cardiovascular events may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve weight management and reduce cardiometabolic risks for patients.
How similar studies have performed: Previous studies have shown success with similar online nutritional coaching approaches, indicating potential for this enhanced program.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Hôpital La Pitié Salpêtrière — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Marylou Para, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Marylou Para, PHU
- Email: marylou.para@aphp.fr
- Phone: 01 40 25 84 50
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Overweight and Obesity, Overweight patients, Obesity, Cardiometabolic risk, telenutrition, online nutritional coaching service