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 @ 1:55 PM
Ignite Modification Date:
2025-12-24 @ 1:55 PM
NCT ID:
NCT01203995
Eligibility Criteria:
Inclusion Criteria:
1. Aged 40 to 64 years.
2. One or more CHC visits in the past 12 months.
3. Body-mass index of ≥30 and \<50.
4. English speaking.
5. Access to telephone.
6. A permanent address.
7. Willingness to be randomized.
8. Willingness to have computer installed in home.
Exclusion Criteria:
1. Any serious medical condition likely to hinder accurate weight measurement, or for which weight loss is contraindicated or could cause weight loss (e.g., cancer).
2. Current diagnosis of psychosis or bipolar disorder.
3. Unstable or recent onset of cardiovascular disease within 6 months or presence of congestive heart failure
4. Illness that might be associated with weight change, such as asthma (because of treatment with corticosteroids), psychosis
5. Use of medications that might cause weight gain such as hypoglycemic oral medicines or insulin, anti-depressants, and weight loss medications.
6. Unwilling or unable to provide informed consent.
7. Receiving disability insurance.
8. Pregnant or nursing in past 6 months, or plans to become pregnant within 12 months.
9. Enrolled in a weight loss program or study or member of household enrolled in study.
10. Residence outside of Marion County, Indiana.
11. Residence relocation plans within 12 months.
12. Planned or prior bariatric surgery.
13. Substance abuse.
14. History of treatment for eating disorder.
15. Unstable weight with loss or gain of ≥ 5% in last 3 months.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01203995
Study Brief:
Protocol Section:
NCT01203995