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 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT05213520
Eligibility Criteria:
Inclusion Criteria:
1. Age: 18 -25 years
2. Enrolled as full-time college students
3. Have a BMI ≥ 30
4. Willing and able to give informed consent
5. Willing to follow either dietary intervention assigned to them upon randomization.
6. Able to come in for all assessment visits.
Exclusion Criteria:
1. Participants who are currently diagnosed with diabetes mellitus, cardiovascular disease, liver or kidney disease, cancer
2. Current severe psychiatric illnesses (e.g. psychosis, schizophrenia, bipolar disorders, depression
3. Current suicidal ideation, and recent or past suicide attempts
4. History of psychiatric hospitalization (past year).
5. History of diagnosed eating disorders such as bulimia nervosa, anorexia nervosa and severe binge eating disorder.
6. History of diagnosed substance abuse or alcohol abuse.
7. Currently on any weight loss diet.
8. Having lost in the past 3 months 10% or more of body weight.
9. Unwilling or unable to give informed consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
25 Years
Study:
NCT05213520
Study Brief:
Protocol Section:
NCT05213520