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:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT04044794
Eligibility Criteria:
Inclusion Criteria:
* Age 19-65 years
* Body mass index (BMI) 30 - 50 kg/m2
* Receives care at one of the participating primary care clinics
* Resides in one location at least 5 days each week
* Possesses a smartphone with data plan
* Wi-Fi or Bluetooth internet connection in home
Exclusion Criteria:
* Pregnancy or anticipating pregnancy during study duration. This is a weight loss study and weight gain/loss due to pregnancy and/or delivery would confound study results. Additionally, weight loss is not recommended for pregnant women.
* Unwilling or unable to do any of the following: give informed consent, accept random assignment, attend five measurement assessments
* Likely to relocate and no longer be seen at UAB primary care in the next 2 years
* Weight loss ≥5% of body weight in past 6 months (other than postpartum)
* Weight \>180 kg (396lbs) due to the limitation of the scale being used.
* Current participation in another weight loss study
* Bariatric surgery or revision in the past two years
* Prescription weight loss medications within the past 6 months
* Another household member already participating in the study
* Potential participants living farther than 50 miles driving distance from UAB will be excluded from the study. It is expected that those living farther away will be more difficult to retain as study participants.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
65 Years
Study:
NCT04044794
Study Brief:
Protocol Section:
NCT04044794