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 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT01303757
Eligibility Criteria:
Inclusion Criteria
* Aged 18 to 40 years.
* Body mass index (BMI) ≥ 27 kg/m2.
* Body weight ≤ 300 lb.
* Access to a working telephone.
* Clearance in writing from a primary care provider (i.e., physician or nurse practitioner) to rule out pre-existing medical conditions.
* Willing and able to attend group workshops (for dietary intervention) on specified evenings.
Exclusion Criteria
* Physician diagnosis of a major medical illness or eating disorder.
* Chronic use of any medication that may affect study outcomes (e.g., insulin-sensitizing agents).
* Current smoking (i.e., 1 cigarette in the past week).
* Physical, mental, or cognitive handicaps that prevent participation.
* Another member of the family (i.e., first degree relative) or household participating in the study.
* Planning to relocate from current area of residence during the proposed timeframe for study participation.
* If female, planning to become pregnant during the 18 months of the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01303757
Study Brief:
Protocol Section:
NCT01303757