Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT04941651
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04941651
Study Brief:
Protocol Section:
NCT04941651