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

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: Waitlist Control; Behavioral: Take of Pounds Sensibly (TOPS)

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 physical function. However, because of high personnel costs and nonexistent nationwide infrastructure, large-scale implementation of these interventions is impractical. The long-term goals are to eliminate the health disparities of obesity and frailty in older AA women. This proposal's overall objective is to determine the effects of a low-cost, community-based, peer-led weight loss program with a national infrastructure on obesity, physical function, and healthcare utilization in older AA women. To treat obesity and frailty in older AA women, it is critical to test a weight loss intervention that 1) has preliminary evidence of benefit; 2) is acceptable to older AA women; 3) is affordable; and 4) can be broadly disseminated. Take Off Pounds Sensibly (TOPS) is a national, nonprofit, community-based, peer-led weight loss program that meets these criteria. First, the applicant's retrospective database analyses of TOPS showed two important results: 1) Participants who renew their annual membership lose and maintain significant weight loss (SWL) for up to 7 years; and 2) Compared to their younger counterparts, older women are more likely to achieve SWL. Second, the applicant started three TOPS chapters for older AA women in a successful pilot study. Though the study ended in 2012, one of the chapters is still active almost 6 years later. Third, TOPS is affordable; it only costs $120 annually. Finally, TOPS has a nationwide infrastructure with chapters in all 50 states. Since obese, frail, older individuals in academic, expert-led weight loss interventions can improve their physical function, the central hypothesis is that a low cost, community-based, peer-led weight loss program with a national infrastructure can provide SWL, improved physical function, and lower healthcare utilization for AA women, an underserved, vulnerable population. The rationale for the proposed research is that TOPS and academic, expert-led weight loss interventions share components critical to successful weight loss; therefore, TOPS can deliver similar outcomes. The central hypothesis will be tested by pursuing the following aims in obese, frail, older AA women: Determine the effect of TOPS on 1) weight change and cardiovascular disease risk factors; 2) physical function and quality of life; and 3) healthcare utilization. This project is innovative because it uses a "community to academia" approach to treat the health disparities; our study population focuses on older AA women with decreased physical function; our outcomes focus on weight, physical function, and healthcare utilization; and our unique study settings. The proposed research is significant because determining the real-world effectiveness of the TOPS program and its impact on weight, physical function, and healthcare utilization in AA women can have a widespread impact on the older population at large. Thus, it has the potential to reduce adverse geriatric outcomes among all older individuals.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27707
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Take Off Pounds Sensibly (TOPS); This group will receive TOPS intervention at the start of the study.	Behavioral: Take of Pounds Sensibly (TOPS); Dietitian-facilitated classes
Other: Waitlist control; This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.	Other: Waitlist Control; At end of study, offered peer-led classes to attend.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Change	Percent of body weight change over 6 months	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure (BP)	A measure of cardiovascular disease (CVD) risk.	Baseline, 3 months, 6 months
Diastolic Blood Pressure (BP)	A measure of cardiovascular disease (CVD) risk.	Baseline, 3 months, 6 months
Waist Circumference (WC)	A measure of cardiovascular disease (CVD) risk.	Baseline, 3 months, 6 months
Hemoglobin A1c (HA1c)	Percentage of hemoglobin that is coated with glucose. A measure of cardiovascular disease (CVD) risk.	Baseline, 3 months, 6 months
HDL (High-Density Lipoprotein) Cholesterol	A measure of cardiovascular disease (CVD) risk.	Baseline, 3 months, 6 months
LDL (Low-Density Lipoprotein) Cholesterol, Calculated	A measure of cardiovascular disease (CVD) risk.	Baseline, 3 months, 6 months
LDL (Low-Density Lipoprotein) Cholesterol, Direct	A measure of cardiovascular disease (CVD) risk.	Baseline, 3 months, 6 months
Triglycerides	A measure of cardiovascular disease (CVD) risk.	Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - General Health	The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Physical Functioning	The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Role Functioning/Physical	The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Role Functioning/Emotional	The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Energy/Fatigue	The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Emotional Well-being	The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Social Functioning	The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Pain	The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	Baseline, 3 months, 6 months
Healthcare Utilization as Measured by Number of Primary Care Visits	Number of primary care visits reported by participant in last month (baseline) or since last study visit (3 and 6 months).	Baseline, 3 months, 6 months
Healthcare Utilization as Measured by Number of Participants With Emergency Department Visits	Number of participants reporting emergency department visit(s) in last month (baseline) or since last study visit (3 and 6 months).	Baseline, 3 months, 6 months
Healthcare Utilization as Measured by Number of Participants With Hospitalizations	Number of participants reporting hospitalization(s) in last month (baseline) or since last study visit (3 and 6 months).	Baseline, 3 months, 6 months
Physical Function as Measured by Short Physical Performance Battery (SPPB)	The Short Physical Performance Battery (SPPB) is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults. Scores range from zero to 12 possible points. Lower scores are associated with lower function.	Baseline, 3 months, 6 months
Physical Function as Measured by 8-ft Up and Go	The 8-foot up-and-go test is a timed test that measures balance, agility, and speed while walking or moving. Higher times are associated with worse physical function.	Baseline, 3 months, 6 months
Physical Function as Measured by Isometric Hand Grip, Right Hand	Decreased grip strength is a predictor of adverse outcomes in older adults.	Baseline, 3 months, 6 months
Physical Function as Measured by Isometric Hand Grip, Left Hand	Decreased grip strength is a predictor of adverse outcomes in older adults.	Baseline, 3 months, 6 months
Physical Function as Measured by 30 Second Chair Stands	Counts the number of times a participant goes from sitting to standing in 30 seconds. Tests leg strength and endurance. Higher number associated with higher leg strength and endurance.	Baseline, 3 months, 6 months
Physical Function as Measured by 6 Minute Walk Test	Measures distance walked in 6 minutes and assesses aerobic capacity and endurance. Higher number indicates higher aerobic capacity and endurance.	Baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Nia S Mitchell, MD, MPH, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2023
• Primary Completion (Actual): January 17, 2025
• Study Completion (Actual): January 17, 2025

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: weight loss; physical function; african american women
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Weight Loss
• Other Study ID Numbers: Pro00100588; R01AG058725 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No