Weight Loss Program for Obesity

Overseen By Principal Investigator

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Duke University

Must not be taking: Metabolism, weight, appetite drugs

Disqualifiers: Cancer, psychiatric disorder, dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

119 Participants Needed

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feasibility Survey

A feasibility survey of eligible participants is completed prior to initiating the intervention

2 weeks

Treatment

Participants receive the TOPS intervention or are placed in a waitlist control group for 6 months

6 months

Monthly meetings

Follow-up

Participants are monitored for weight change, physical function, and quality of life

4 weeks

Treatment Details

Interventions

• Take of Pounds Sensibly (TOPS)

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+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+