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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a community-based, peer-led weight loss program called Take Off Pounds Sensibly (TOPS) to determine its effectiveness in helping older African American women lose weight and improve physical function. Participants will be randomly assigned to either start the program immediately or join a waitlist. The trial aims to demonstrate that this approach can reduce health risks and enhance the quality of life for those who are obese and have limited physical activity. It suits African American women over 55 who have a stable weight, are not very active, and have a primary care doctor. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance community health programs.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot participate if you use medications that affect metabolism, body weight, energy expenditure, or appetite. If you have type 2 diabetes and are on insulin or sulfonylureas, your doctor must agree to manage your medications during the study.

What prior data suggests that this weight loss program is safe for older adults?

Research has shown that the "Take Off Pounds Sensibly" (TOPS) program is a well-accepted method for weight loss. One study found that participants who regularly engaged in TOPS lost between 5.9% and 7.1% of their starting weight over one to three years. This indicates that the program is both effective and manageable for long-term use.

Established in 1948, the program emphasizes education and support. Its long history and community focus suggest it is generally safe, having assisted people in losing weight for decades.

While specific safety data for this study is unavailable, the program's long-term use and continued participation by many individuals suggest that the TOPS program provides a safe and supportive way to lose weight. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Take Off Pounds Sensibly (TOPS) program for obesity because it offers a community-based, supportive approach to weight loss. Unlike traditional options like medications or surgery, TOPS focuses on behavioral changes and peer support, making it accessible and sustainable for many people. This approach emphasizes lifestyle modifications and encourages long-term success by fostering a sense of accountability and motivation within group meetings. By providing a non-invasive alternative, TOPS has the potential to empower individuals to achieve healthier weights through positive lifestyle changes.

What evidence suggests that the Take Off Pounds Sensibly (TOPS) program might be an effective treatment for obesity?

Research has shown that the "Take Off Pounds Sensibly" (TOPS) program can help people lose weight and maintain the loss. Participants in the program lost about 6% of their starting weight in the first year and maintained this weight loss for up to three years. Another study found that those who stayed in the program lost between 5.9% and 7.1% of their initial weight over one to three years. This evidence suggests that TOPS can be effective for long-term weight loss. In this trial, one group will receive the TOPS intervention at the start, while another group will serve as a waitlist control. Additionally, research on older African American women indicates that losing weight through this program can improve physical abilities. ^{1 2 6 7 8}

Who Is on the Research Team?

Nia S Mitchell, MD, MPH

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4811034/

Up to 7 Years of Sustained Weight Loss for ... The purpose of this study is to determine the long-term weight loss of participants who consecutively renew their annual membership in Take Off Pounds Sensibly ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1038/oby.2010.202

Determining the Effectiveness of Take Off Pounds Sensibly ... People who remained in the program lost ∼6% of initial weight in the first year and maintained that weight loss for up to 3 years. TOPS ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714425000096

Changes in weight and physical function for older African ... Changes in weight and physical function for older African American women in Take Off Pounds Sensibly (TOPS): Study protocol for a randomized clinical trial.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20864948/

Determining the effectiveness of Take Off Pounds Sensibly ... Individuals with consecutive renewals in TOPS lost 5.9-7.1% of their initial weight over a period of 1-3 years. People who remained in the ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03815214?term=take&viewType=Table&rank=8

NCT03815214 | Take Off Pounds After Stroke Trial (TOPS) The TOPS trial is designed as a PROBE study to test the feasibility, safety, and efficacy of a 12-week high protein, calorie restricted, partial meal ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8159888/

Commercial weight-loss programs in the management of ... This review describes the evidence for commercial programs, particularly 12-month weight loss, among individuals with obesity.

7. health.maryland.gov health.maryland.gov/carroll/Pages/TOPS.aspx

TOPS Program - Maryland Department of Health TOPS (Taking Off Pounds Sensibly) is a non-profit weight loss support organization founded in 1948. The guiding principles of TOPS are education, support and ...

8. tops.org tops.org/home

TOPS.org For 75 years, TOPS Club has helped people take off, and keep off, the weight. ... To help and support our members as they take off and keep off pounds sensibly.