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 @ 10:49 PM
Ignite Modification Date:
2025-12-24 @ 10:49 PM
NCT ID:
NCT01452269
Eligibility Criteria:
Inclusion Criteria:
* Deaf men and women ages 40-70 years who use sign language and live in the Rochester Metropolitan Statistical Area (MSA), have a body mass index (BMI) of 25-45
* Permission to participate from a primary healthcare provider if: 1) self-reported diagnosis of a recent cardiovascular disease event (heart attack or stroke in past 6 months), and 2) self-reported heart condition, chest pain, dizziness, or other reason not to participate in physical activity 3) self-reported weight loss surgery in the past two years
* Must be willing to follow a healthy dietary pattern and to abstain from using weight loss medications during the study
* Must be willing and able to attend group sessions and to participate in data collection requirements
Exclusion Criteria:
* Participants who had a cardiovascular disease event in the past 6 months who did not obtain medical clearance from their provider
* Participants who had self-reported heart condition, chest pain, dizziness, or other reason not to participate in physical activity who did not obtain medical clearance from their provider
* Participants who had weight loss surgery in the past two years and who did not obtain medical clearance from their provider
* Pregnancy, breastfeeding, or planning a pregnancy during the study period (each of which will be determined by subject self-report through an in-person interview with a research team member)
* Those people who are unable or unwilling to provide written, informed consent
* Those people who are unable to see and interact with computer-based questionnaires and educational interventions
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT01452269
Study Brief:
Protocol Section:
NCT01452269