Healthy Me: A Program for Older Women

NCT03843190 | Completed Results DMC

• 2 other identifiers: Pro00100588R01AG058725
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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 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

Conditions

Obesity

Keywords

weight loss; african american women; physical function

Outcome Measures

Primary Outcomes (1)

• Weight Change

  Percent of body weight change over 6 months

  Baseline to 6 months

Secondary Outcomes (25)

• Systolic Blood Pressure (BP)

  Baseline, 3 months, 6 months

• Diastolic Blood Pressure (BP)

  Baseline, 3 months, 6 months

• Waist Circumference (WC)

  Baseline, 3 months, 6 months

• Hemoglobin A1c (HA1c)

  Baseline, 3 months, 6 months

• HDL (High-Density Lipoprotein) Cholesterol

  Baseline, 3 months, 6 months

Study Arms (2)

Take Off Pounds Sensibly (TOPS)

EXPERIMENTAL

This group will receive TOPS intervention at the start of the study.

Behavioral: Take of Pounds Sensibly (TOPS)

Waitlist control

OTHER

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

Interventions

Take of Pounds Sensibly (TOPS) BEHAVIORAL

Dietitian-facilitated classes

Take Off Pounds Sensibly (TOPS)

Waitlist Control OTHER

At end of study, offered peer-led classes to attend.

Waitlist control

Eligibility Criteria

• Age: 55 Years - 99 Years
• Gender Eligibility Details: African-American women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27707, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Results Point of Contact

• Title: Nia Schwann Mitchell, MD, MPH
• Organization: Duke University

nia.s.mitchell@duke.edu

919-668-7202

Study Officials

• Nia S Mitchell, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 18, 2019
• Study Start: May 17, 2023
• Primary Completion: January 17, 2025
• Study Completion: January 17, 2025
• Last Updated: May 20, 2026
• Results First Posted: May 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)