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Behavioral Intervention

Weight Loss Program for Obesity

N/A
Waitlist Available
Led By Nia S Mitchell, MD, MPH
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
decreased physical function (i.e., those who score between 4 and 10 [out of 12] on the Short Physical Performance Battery [SPPB])
African American women aged ≥55
Must not have
Type 2 diabetes on insulin or sulfonylureas without provider approval
Neurological conditions causing functional limitations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Summary

This trial is testing a weight loss program for obese, older African American women to see if it helps them lose weight and improve their physical function. The goal is to see if this program could eventually help other groups of people with obesity maintain their health and independence.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this is not a drug trial but rather a lifestyle intervention focusing on weight loss and improved physical activity, typical side effects associated with medications are not expected. However, participants may experience changes related to diet adjustment and increased physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My physical function is limited, scoring 4-10 on a specific test.
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I am an African American woman aged 55 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have type 2 diabetes and take insulin or sulfonylureas without my doctor's approval.
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I have a neurological condition that limits my daily activities.
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I am experiencing moderate to severe depression symptoms.
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I do not have severe heart problems like recent heart attacks or advanced heart failure.
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I am currently diagnosed with cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Weight change
Secondary outcome measures
Cardiovascular Disease (CVD) risk factors as measured by Blood pressure (BP)
Cardiovascular Disease (CVD) risk factors as measured by Hemoglobin A1c (HA1c)
Cardiovascular Disease (CVD) risk factors as measured by Lipids
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Waitlist controlExperimental Treatment1 Intervention
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 Treatment1 Intervention
This group will receive TOPS intervention at the start of the study.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,394 Previous Clinical Trials
3,059,366 Total Patients Enrolled
82 Trials studying Obesity
31,548 Patients Enrolled for Obesity
National Institute on Aging (NIA)NIH
1,704 Previous Clinical Trials
28,033,137 Total Patients Enrolled
44 Trials studying Obesity
12,838 Patients Enrolled for Obesity
Nia S Mitchell, MD, MPHPrincipal InvestigatorDuke University
1 Previous Clinical Trials
26 Total Patients Enrolled
1 Trials studying Obesity
26 Patients Enrolled for Obesity

Media Library

Take of Pounds Sensibly (TOPS) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03843190 — N/A
Obesity Research Study Groups: Take Off Pounds Sensibly (TOPS), Waitlist control
Obesity Clinical Trial 2023: Take of Pounds Sensibly (TOPS) Highlights & Side Effects. Trial Name: NCT03843190 — N/A
Take of Pounds Sensibly (TOPS) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03843190 — N/A
~40 spots leftby Mar 2025