NCT03843190Completed
Healthy Me: A Program for Older Women
Changes in Weight and Physical Function for Older African American Women in a National, Nonprofit, Community-Based, Peer-Led, Weight Loss Program
Source: ClinicalTrials.gov · Last updated 20 May 2026
Brief summary (registry, in English)
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 waitlist control that recruits 120 older AA women. The rationale for these aims is that the successful completion is expected to provide evidence that a community-based, peer-led weight loss program with a national infrastructure can help a vulnerable, underserved population lose weight and improve their physical function. For older, obese, frail individuals, this could improve their CVD risk factors, quality of life, enhance their health; reduce their healthcare utilization, illness, and disability; and decrease their adverse geriatric outcomes. After completing these aims, the investigators expect that they will have proven that the community-based, peer-led weight loss program can improve both weight and physical function among older, obese AA women. This also could help other demographic groups with obesity and poor physical function. Eventually, it could help older adults maintain their health and independence in the community
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 116 (actual)
- First submitted
- 29 Jan 2019
- Start date
- 17 May 2023
- Primary completion date
- 17 Jan 2025
- Lead sponsor
- Duke University
- Diseases
- Obesity
- NCT number
- NCT03843190
What you commit to
- Study type: Interventional
- Participants enrolled: 116
- From 17 May 2023 to the primary completion date, 17 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- use of medications thought to effect metabolism, body weight, energy expenditure, or appetite
Other illness
- Type 2 diabetes on insulin or sulfonylureas without provider approval
- current cancer diagnosis
- major psychiatric disorder
- 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
Other
- Provider did not approve participation
- current moderate to severe symptoms of depression
- Currently enrolled in a weight loss program
Who the study is looking for
- 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 Inclusion Criteria:
- 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.
Age in the registry: 55 years to 99 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.