MedTrace Logo

Healthy Me: A Program for Older Women

NCT03843190 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2026-05-20

Study results available
· View outcomes & findings →

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

Interventions

BEHAVIORAL

Take of Pounds Sensibly (TOPS)

Dietitian-facilitated classes

OTHER

Waitlist Control

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

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Nia S Mitchell, MD, MPH · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-17
Primary Completion
2025-01-17
Completion
2025-01-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03843190 on ClinicalTrials.gov