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 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 12:59 AM
NCT ID:
NCT05751993
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-55 years
2. Body Mass Index of 25-40 kg/m2
3. English-speaking and writing
4. Has a smartphone with a data and text messaging plan
Exclusion Criteria:
1. Currently participating in a weight loss, nutrition, or physical activity study or program or other study that would interfere with this study
2. 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 SSRIs for 3 months)
3. Previous surgical procedure for weight loss or planned weight loss surgery in the next year
4. Currently pregnant or planning pregnancy in the next 4 months
5. Lost 10 or more pounds and kept it off in the last 6 months
6. 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). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate
7. Pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program, diabetes treated with insulin, history of heart attack or stroke, current treatment for cancer, or inability to walk for exercise
8. Type 1 diabetes or currently receiving medical treatment for Type 2 diabetes
9. 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
10. Health or psychological diagnoses that preclude participation in a prescribed dietary and exercise program, including history of or diagnosis of schizophrenia or bipolar disorder, hospitalization for a psychiatric diagnosis in the past year, a current diagnosis of alcohol or substance abuse
11. Report a past diagnosis of or receiving treatment for a DSM-5-TR eating disorder (anorexia nervosa, bulimia nervosa, or other diagnosis)
12. Another member of the household is a participant or staff member in this trial
13. Not willing to attend one study visit
14. Not willing to wear a Fitbit every day
15. Reason to suspect that the participant would not adhere to the study intervention
16. Have participated in another study conducted by the UNC Weight Research Program within the past 12 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05751993
Study Brief:
Protocol Section:
NCT05751993