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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT01369004
Eligibility Criteria:
Inclusion Criteria:
* Be between the ages of 18-60 years old
* Have a BMI between 25-40 kg/m\^2 and weigh no more than 310 lbs.
* Live in the Chapel Hill/Durham/Raleigh, NC area
* Be able to attend data collection visits at baseline, 3-months, and 6-months at the UNC Weight Research Program Center
* Have access to the Internet and a computer for daily tracking of weight
* Be willing to be randomized to either group
Exclusion Criteria:
* History of psychiatric diseases (bipolar disorder, schizophrenia, hospitalization for depression within the past year), drug or alcohol dependency, or uncontrolled thyroid conditions
* History of major health conditions, such as heart disease, diabetes, and past incidence of stroke, cancer diagnosis (non-skin) within the past 5 years
* No physician consent for participation if currently on blood pressure medications, have issues with dizziness, or have bone or joint issues.
* Currently pregnant, anticipating on becoming pregnant in the next 9 months, or currently breastfeeding
* History of eating disorder or currently seeking treatment for an eating disorder.
* Current participation in a structured weight loss program,or taking weight loss medications
* Current participation in a weight control study within the past 6 months
* Current participation in another research study that might affect study hypotheses
* Have lost 5% of their body weight and kept it off within the past 6 months
* History of surgery for weight loss
* Plans to be out of the area for an extensive amount of time without Internet access or move out of the area within the next 9 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01369004
Study Brief:
Protocol Section:
NCT01369004