Project Summary  

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

One out of every three adults in the United States has obesity. Among black women, the number is one in two. Obesity can lead to serious health problems such as high blood pressure, diabetes, and heart disease. Losing weight can help reduce the risk for health problems and improve quality of life. But most people who lose weight gain it back.

In this study, the research team is looking at a culturally sensitive treatment program and a standard program to see which works better to help black women lose weight and keep it off.

Who can this research help?

Health clinics can use results from this study when considering treatment programs to offer for black women with obesity. Black women with obesity and their doctors can consider the findings when choosing an obesity treatment program.

What is the research team doing?

This study is taking place at 20 health clinics in the Jacksonville area in Florida. The research team is recruiting 680 black women aged 21 years or older with obesity. For six months, all patients take part in a culturally sensitive weight loss program called Health Smart for Weight Loss. In this program, community health workers, or CHWs, work with healthcare providers to help patients lose weight. CHWs get training to teach people about health and link people with health and social services in their community.

After patients complete the Health Smart for Weight Loss program, the research team assigns patients by chance to one of two treatment programs:

• A patient-centered, culturally sensitive, weight loss maintenance program: Doctors talk with patients about preventing weight gain and setting weight loss goals in ways that take into account their cultures and values.
• A standard behavioral weight loss maintenance program: Doctors talk with patients about preventing weight gain without focusing on patients’ cultures and values.

Patients in both of these programs meet with their doctors every three months for one year.

The research team is weighing patients at the start of the study and again after 6 and 18 months to track patients’ weight loss and whether they keep weight off over time. CHWs and clinicians fill out surveys at the start of the study and again six months later. The surveys ask how well CHWs and clinicians work with each other in caring for patients in the weight loss programs.

Patients, clinicians, policy makers, insurers, community advocates, and other groups are working with the research team to plan and carry out the study.

Research methods at a glance

Design Elements	Description
Design	Randomized controlled trial
Population	680 black women ages 21 years and older who have a BMI between 30–50 kg/m2
Interventions/ Comparators	Health-Smart for Weight Loss program plus a patient-centered, culturally sensitive weight loss maintenance program, which includes a weight loss program with CHWs for 6 months, followed by 3 meetings for 1 year with doctors trained to talk with patients about preventing weight gain in culturally sensitive ways Health-Smart for Weight Loss program plus a standard behavioral weight loss maintenance program, which includes a weight loss program with CHWs for 6 months, followed by 3 meetings for 1 year with doctors trained to talk to their patients about preventing weight gain, without focusing on cultural sensitivity
Outcomes	Primary: weight loss, weight loss maintenance Secondary: level of CHW integration in participating primary care clinics
Timeframe	18-month follow-up for primary outcomes

Project Details

Principal Investigator

Carolyn M. Tucker, PhD

Project Status

In progress; Recruiting

Project Title

Culturally Sensitive, Primary Care Clinic-Based Interventions by Community Health Workers and Trained Physicians to Promote and Sustain Weight Loss among Black Women Patients with Obesity

Board Approval Date

September 2017

Project End Date

July 2022

Organization

University of Florida

Year Awarded

2017

State

Florida

Project Type

Research Project

Health Conditions  

Multiple/Comorbid Chronic Conditions

Nutritional and Metabolic Disorders

Obesity

Intervention Strategies

Behavioral Interventions
Care Coordination
Other Health Services Interventions
Technology Interventions
Training and Education Interventions

Populations

Racial/Ethnic Minorities
Low Income
Women
Individuals with Multiple Chronic/co-morbid Conditions

Funding Announcement

Addressing Disparities

Project Budget

$2,099,918

Study Registration Information

HSRP20181367

NCT03418701