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Community weight loss program shows promise for older black women

NCT ID NCT03843190

Disease control Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a 6-month peer-led weight loss program called TOPS (Take Off Pounds Sensibly) in 116 older African American women with obesity. Participants attended dietitian-facilitated classes, while a waitlist group received the program later. The goal was to see if this community-based approach could help them lose weight and improve physical function, potentially lowering heart disease risk and boosting quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Take of Pounds Sensibly (TOPS) peer-led weight loss program
What this could lead to
If successful, this program could help older African American women lose weight and improve their physical function, reducing risks for heart disease and other obesity-related conditions.
What could go wrong
This is a small, completed feasibility study with 116 participants. Results may not apply to other groups, and weight loss programs often have mixed long-term success.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

116 people

The number who actually took part.

Started

May 2023

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 to 99 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Weight Loss

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity

Contacts and locations

Locations

  • Duke University

    Durham, North Carolina, 27707, United States

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Other studies related to the condition(s) this trial covers.