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Behavioral Intervention

Weight Loss Program for Obesity

N/A

Waitlist Available

Led By Nia S Mitchell, MD

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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Weight change

Secondary study objectives

Physical Function as measured by 30-second chair stands

Physical Function as measured by 6-minute walk test

Physical Function as measured by 8-ft up and go

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Waitlist controlExperimental Treatment2 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 Treatment1 Intervention

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

0 / 7Eligibility criteria met