N/A
N=116
Healthy Me: A Program for Older Women
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03843190 ↗Enrolled (actual)
116
Serious AEs
4.3%
Results posted
May 2026
Primary outcome: Primary: Weight Change — -2.50; -0.51 percentage of body weight — p=0.008
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Take of Pounds Sensibly (TOPS) (Behavioral); Waitlist Control (Other)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- Female
- Sponsor
- Duke University
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Change |
-2.50; -0.51 | 0.008 sig |
| SECONDARY Systolic Blood Pressure (BP) |
137.60; 135.86; 132.15; 130.9; 132.86; 132.10 | 0.9357 |
| SECONDARY Diastolic Blood Pressure (BP) |
78.16; 78.33; 75.32; 76.38; 76.20; 78.20 | 0.7513 |
| SECONDARY Waist Circumference (WC) |
109.90; 111.87; 107.10; 111.71; 107.44; 111.22 | 0.3805 |
| SECONDARY Hemoglobin A1c (HA1c) |
6.28; 6.16; 6.21; 5.98; 6.20; 6.00 | 0.8424 |
| SECONDARY HDL (High-Density Lipoprotein) Cholesterol |
63.47; 64.20; 61.71; 64.03; 63.77; 61.26 | 0.2093 |
| SECONDARY LDL (Low-Density Lipoprotein) Cholesterol, Calculated |
103.15; 108.56; 108.29; 103.49; 104.38; 98.46 | 0.0055 sig |
| SECONDARY LDL (Low-Density Lipoprotein) Cholesterol, Direct |
105.04; 109.89; 106.03; 102.67; 104.51; 97.77 | 0.0079 sig |
| SECONDARY Triglycerides |
113.11; 138.14; 106.86; 110.69; 99.05; 108.62 | 0.8071 |
| SECONDARY Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - General Health |
72.50; 73.39; 75.99; 71.89; 72.71; 69.76 | 0.4928 |
| SECONDARY Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Physical Functioning |
71.29; 74.46; 73.46; 75.05; 70.65; 72.44 | 0.9301 |
| SECONDARY Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Role Functioning/Physical |
72.84; 72.77; 73.72; 72.30; 76.83; 71.34 | 0.3854 |
| SECONDARY Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Role Functioning/Emotional |
81.03; 83.93; 80.34; 77.48; 80.49; 80.49 | 0.4742 |
| SECONDARY Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Energy/Fatigue |
64.57; 65.18; 63.46; 62.97; 68.41; 65.24 | 0.361 |
| SECONDARY Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Emotional Well-being |
85.66; 84.21; 83.49; 81.73; 82.34; 83.61 | 0.2902 |
| SECONDARY Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Social Functioning |
80.39; 86.16; 80.45; 81.08; 83.84; 81.10 | 0.2324 |
| SECONDARY Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Pain |
66.34; 71.83; 73.65; 68.92; 71.83; 66.89 | 0.0883 |
| SECONDARY Healthcare Utilization as Measured by Number of Primary Care Visits |
1.02; 0.98; 3.98; 3.46; 3.12; 2.98 | — |
| SECONDARY Healthcare Utilization as Measured by Number of Participants With Emergency Department Visits |
2; 1; 0; 1; 2; 4 | — |
| SECONDARY Healthcare Utilization as Measured by Number of Participants With Hospitalizations |
1; 1; 2; 1; 1; 2 | — |
| SECONDARY Physical Function as Measured by Short Physical Performance Battery (SPPB) |
9.81; 9.86; 10.36; 9.95; 9.95; 10.10 | 0.9592 |
| SECONDARY Physical Function as Measured by 8-ft Up and Go |
7.80; 8.47; 8.29; 7.41; 7.73; 8.11 | 0.6597 |
| SECONDARY Physical Function as Measured by Isometric Hand Grip, Right Hand |
24.52; 26.69; 27.10; 28.82; 27.28; 26.96 | 0.4086 |
| SECONDARY Physical Function as Measured by Isometric Hand Grip, Left Hand |
24.00; 26.90; 27.03; 28.26; 26.70; 28.57 | 0.6097 |
| SECONDARY Physical Function as Measured by 30 Second Chair Stands |
11.58; 11.04; 10.84; 11.86; 11.41; 12.11 | 0.9807 |
| SECONDARY Physical Function as Measured by 6 Minute Walk Test |
454.83; 442.83; 458.87; 464.90; 478.74; 479.88 | 0.6332 |
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 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
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03843190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.