Weight Loss Program for Obesity
What You Need to Know Before You Apply
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
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Feasibility Survey
A feasibility survey of eligible participants is completed prior to initiating the intervention
Treatment
Participants receive the TOPS intervention or are placed in a waitlist control group for 6 months
Follow-up
Participants are monitored for weight change, physical function, and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Take of Pounds Sensibly (TOPS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
National Institute on Aging (NIA)
Collaborator