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 @ 12:20 PM
Ignite Modification Date:
2025-12-24 @ 12:20 PM
NCT ID:
NCT05625061
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) of 25 - 45 kg/m\^2 at baseline
* English-speaking, reading, and writing
* Own a smartphone with a data and text messaging plan
Exclusion Criteria:
* Type 1 diabetes or currently receiving medical treatment for Type 2 diabetes
* Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q; items 1-4).
* Other health problems which may influence the ability to walk for physical activity or be associated with unintentional weight change, including cancer treatment within the past 5 years or tuberculosis
* Lost 10 lbs. or more of body weight (and kept it off) in the last 6 months
* Past diagnosis of or receiving treatment for a clinically diagnosed eating disorder (anorexia nervosa or bulimia nervosa)
* Current symptoms of alcohol or substance dependence
* Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
* Untreated thyroid disease or any changes (type or dose) in thyroid medication in last 6 months
* Hospitalization for depression or other psychiatric disorder within the past 12 months
* History of psychotic disorder or bipolar disorder
* Currently participating in a weight loss, nutrition, or physical activity study or program or other study that would interfere with this study
* Currently using prescription medications with known effects on appetite or weight (e.g., oral steroids, weight loss medications), with the exception of individuals on a stable dose of Selective Serotonin Reuptake Inhibitors (SSRIs) for 3 months)
* Previous surgical procedure for weight loss or planned weight loss surgery in the next year
* Another member of the household is a participant or staff member on this trial
* Reason to suspect that the participant would not adhere to the study intervention
* Reside outside of the United States
* Have participated in another study conducted by the UNC Weight Research Program within the past 12 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
39 Years
Study:
NCT05625061
Study Brief:
Protocol Section:
NCT05625061