Project Summary
PCORI has identified obesity as an important research topic. Patients, primary care clinicians, and others want to learn: Which treatment options achieve the best weight-loss outcomes for adults, especially those in minority racial/ethnic groups, individuals with low socioeconomic status, and residents of rural areas? To help answer this question, PCORI launched a funding initiative in 2014 on Obesity Treatment Options Set in Primary Care for Underserved Populations: Pragmatic Clinical Trials to Evaluate Real-World Comparative Effectiveness. This research project is one of the studies PCORI awarded as part of this program.
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?
According to the Centers for Disease Control and Prevention, more than 35 percent of US adults have obesity. Obesity increases the risk of type 2 diabetes, heart disease, stroke, gallbladder disease, respiratory problems, and several cancers. Obesity also contributes to poor quality of life. People with low incomes or people who live in areas with few resources are at increased risk of developing obesity. Forty-two percent of African Americans in Louisiana have obesity. Overall, the state ranks first in obesity in the United States. The research team wants to compare two ways of providing health care to reduce obesity in Louisiana, especially among African Americans and people with low incomes.
Who can this research help?
Results from this study can help health clinic directors and primary care doctors choose ways to treat obesity.
What is the research team doing?
Researchers are working with 18 primary care clinics in Louisiana that serve people with low incomes and have a patient population with a high percentage of African Americans. At each clinic, about 44 patients with obesity are taking part in the study, for a total of about 800 people.
The research team is assigning clinics by chance to one of two groups. One group of clinics is caring for people enrolled in the study in the same way that they usually care for patients. Patients in this group also get newsletters about sleep, stopping smoking, and other health topics. The second group of clinics provides lifestyle counseling to patients in the study. Lifestyle counseling includes frequent in-person meetings with a trained health coach.
The research team is measuring patients’ body weight at the beginning of the study and every six months for two years. The team also measures changes in blood pressure, waist size, blood sugar, physical ability, mood, quality of life, and other outcomes. The team is working with patients, clinic staff members, and community groups to make sure that the lifestyle counseling respects patients’ cultures. The intervention is being delivered in a culturally appropriate manner.
Research methods at a glance
| Design Element | Description |
|---|---|
| Design | Cluster-randomized controlled trial |
| Population | Adults ages 20-75 or older who are obese (body mass index between 30 and 50 kg/m2) |
| Interventions/ Comparators |
|
| Outcomes |
Primary: changes in body weight Secondary: changes in waist circumference, blood pressure, fasting glucose, fasting lipids, patient-reported outcomes |
 |
2-year follow-up for primary outcome |
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