Weight Loss Program for Obesity

Overseen by Nia S Mitchell, MD, MPH

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Duke University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Research Team

Nia S Mitchell, MD, MPH

Principal Investigator

Duke University

Eligibility Criteria

This trial is for sedentary African American women over 55 years old with obesity (BMI ≥27 kg/m2) and decreased physical function. They must have a stable body weight and can include those with type 2 diabetes on certain medications if their doctor agrees. Exclusions apply to active cancer, certain medication use, major psychiatric disorders, severe depression, dementia, neurological issues affecting function, unstable heart conditions or terminal illnesses.

Inclusion Criteria

Sedentary (not exercising more than 1 hour per week)

I have type 2 diabetes and use insulin or sulfonylureas, and my doctor agrees to adjust my medication as needed.

Stable body weight (± 2 kg for 6 months prior to study)

Exclusion Criteria

I have type 2 diabetes and take insulin or sulfonylureas without my doctor's approval.

I have a neurological condition that limits my daily activities.

Major psychiatric disorder

Treatment Details

Interventions

• Take of Pounds Sensibly (TOPS) (Behavioral Intervention)

Trial Overview The 'Healthy Me' program tests the TOPS (Take Off Pounds Sensibly) intervention in older women to see if it helps them lose weight and improve physical function. It's a community-based peer-led program compared against a waitlist control group over six months through randomized assignment.

Participant Groups

Group I: Waitlist control Experimental Treatment 2 Interventions

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.

Group II: Take Off Pounds Sensibly (TOPS) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School