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 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT03823469
Eligibility Criteria:
Inclusion Criteria:
* Stable oral medications for the past 3 months (or with type 2 diabetes mellitus who are well controlled (Hga1C\<7.5) and on stable oral medications for the past 6 months
* Body mass index (BMI) equal or greater than 27.5 Kg/m2 and equal or lower than 35 Kg/m2.
* Subjects who will agree to be randomized to either one of the 2 study arms
* Accessible by phone, and able to watch online videos.
* English (Spaulding) or Hebrew (Sheba) speaking subjects
* At least self-report one visit with a physician or dietitian in the last 12 months.
Exclusion Criteria:
* Pregnant or nursing women within the past 6 months
* Weight loss medications (e.g., topiramate, buproprion, orlistat) within the past 6 months or medications likely to cause weight gain or prevent weight loss (e.g., corticosteroids, lithium, olanzapine, risperidone, clozapine
* Either type 1 or 2 diabetes who are on insulin
* Uncontrolled hypothyroidism or hyperthyroidism
* Serious medical conditions likely to hinder accurate measurement of weight, or for which weight loss is contraindicated, or which would cause weight loss (e.g., end stage renal disease on dialysis, cancer diagnosis or treatment within 2 years)
* Unstable angina or with myocardial infarction, stroke or atherosclerotic cardiovascular disease procedure within 6 months prior to screening
* Self-reported average consumption of \> 14 alcoholic drink per week
* Prior or planned bariatric surgery
* Unintentional weight loss within 6 months of enrollment (≥ 5% of body weight), or Intentional weight loss within 6 months (≥ 5% of body weight)
* Subjects following specific dietetic recommendations (e.g., celiac sprue, cystic fibrosis)
* Subjects with eating disorders, or any psychiatric hospitalization in last year prior to screening.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
70 Years
Study:
NCT03823469
Study Brief:
Protocol Section:
NCT03823469