Status:
COMPLETED
Healthy Me: A Program for Older Women
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Obesity
Eligibility:
FEMALE
55-99 years
Phase:
NA
Brief Summary
The first phase of the study is a feasibility survey of eligible participants, completed prior to initiating the intervention. The intervention consists of a 6-month 1:1 randomized trial with a waitli...
Detailed Description
Older African American (AA) women have the highest prevalence of both obesity and frailty. In academic, expert-led interventions, obese, frail, older individuals both lost weight and improved their ph...
Eligibility Criteria
Inclusion
- African American women aged ≥55
- BMI ≥27 kg/m2
- Stable body weight (± 2 kg for 6 months prior to study)
- Sedentary (not exercising more than 1 hour per week)
- Must have a primary care provider and provide contact information
- Conditional
- Participants with type 2 diabetes on insulin or sulfonylureas will be allowed to participate in the study only if their providers agree to manage the changing medications requirements associated with possible weight loss by signing a "Permission to Participate" form. It is important to include patients with type 2 diabetes on insulin and sulfonylureas because these participants can benefit greatly from weight loss.
Exclusion
- Type 2 diabetes on insulin or sulfonylureas without provider approval
- current cancer diagnosis
- Provider did not approve participation
- use of medications thought to effect metabolism, body weight, energy expenditure, or appetite
- major psychiatric disorder
- current moderate to severe symptoms of depression
- dementia
- neurological conditions causing functional limitations
- unstable medical illness such as unstable angina, recent MI, or congestive heart failure class III-IV
- terminal medical conditions
- Currently enrolled in a weight loss program
Key Trial Info
Start Date :
May 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2025
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT03843190
Start Date
May 17 2023
End Date
January 17 2025
Last Update
January 28 2025
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27707