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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT00896194
Eligibility Criteria:
Inclusion Criteria:
* age 18 years or older
* BMI \> 27 and \< 43
* willing to be randomized to one of the two treatment conditions
* successful completion of screening requiring 5-day recording of food intake in a paper diary
* have at least two risk factors for coronary heart disease, e.g., overweight or obese, hypertension, dyslipidemia, positive family history (first degree relative)
NOTE: Although residing in Western Pennsylvania is not an explicit eligibility criterion, participants are asked to travel to the University of Pittsburgh frequently (weekly for the first month)
Exclusion Criteria:
* presence of a current serious illness or unstable condition requiring physician-supervised diet and exercise (e.g., diabetes, recent acute myocardial infarction) for which physician supervision of diet and physical activity prescription is needed
* physical limitations precluding ability to engage in physical activity at moderate intensity
* pregnancy or intention to become pregnant in the next 18 months
* current treatment for a psychological disorder
* reported alcohol intake \> 4 drinks/day
* previous participation in a formal weight loss program within the past 5 years, e.g., Weight Watchers or a research program, or current use of weight loss medication
* planned extended vacations, absences, or relocation within the next 18 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00896194
Study Brief:
Protocol Section:
NCT00896194