Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial

Recruiting now · Not applicable

Conditions studied: Obesity

In brief

The goal of this clinical trial is to test the effectiveness of an evidence-based multi-level intervention for weight loss and the feasibility, fidelity, and sustainability of implementing the intervention in low-income and underserved people living with obesity in Louisiana. The main questions it aims to answer are: * Will an evidence-based multi-level obesity intervention (called LA-CEAL CONNECT) in adults living with obesity in low-income and underserved communities achieve weight loss at 6 months compared to enhanced usual care? * Will LA-CEAL CONNECT sustain weight loss at 12 months? * Will LA-CEAL CONNECT improve waist circumference, diet quality, physical activity, quality of life, and blood pressure at 6 and 12 months? * Will LA-CEAL CONNECT be feasible to implement in adults living with obesity in low-income and underserved communities? Researchers will compare the LA-CEAL CONNECT multilevel weight loss intervention to enhanced usual care to evaluate if LA-CEAL CONNECT leads to greater weight loss and greater changes in waist circumference, diet, physical activity, quality of life, and blood pressure than enhanced usual care. Participants in both arms will: * Receive health literacy-tailored educational materials and resources for weight loss * Visit the clinic site for baseline, 6-month and 12-month study visits to collect clinical and survey measurements Participants in the CONNECT intervention arm will also: * receive health coaching * self-monitor weight and physical activity using digital technologies * attend group meetings to identify and increase utilization of community health and wellness resources

Key facts

Study ID

NCT06835686

Run by

Tulane University

People needed

522

Starts

2025-03-14

Expected to finish

2028-03-31

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• being 18 to 75 years of age
• living with obesity, defined as a BMI between 30 and 50 kg/m2 for non-Asian identifying participants and BMI between 27.5 and 50 kg/m2 for Asian-identifying participants
• weighing less than 400 pounds
• receiving care from or willing to register at a participating FQHC clinic
• able to understand and speak English
• able to complete the study within the next year (e.g., not planning to move from the area within study period)

You may not qualify if…

• having given birth within the past year, pregnant or planning to become pregnant during study period (within 1 year)
• currently participating in a weight-loss program
• having lost more than 10 pounds in the last 6 months
• being an employee or a family member of an employee of any participating FQHC
• having a disease that can interfere with or be aggravated by exercise or weight loss

Where it is running

• InclusivCare - Avondale Clinic — Avondale, Louisiana, United States (enrolling)
• CommuniHealth Services - Bastrop Clinic — Bastrop, Louisiana, United States (enrolling)
• CareSouth Medical and Dental - Baton Rouge Clinic — Baton Rouge, Louisiana, United States (enrolling)
• Teche Action Clinic - Franklin — Franklin, Louisiana, United States (enrolling)
• Southeast Community Health Systems - Greensburg Clinic — Greensburg, Louisiana, United States (enrolling)
• Teche Action Clinic - Houma — Houma, Louisiana, United States (enrolling)
• Southeast Community Health Systems - Independence Clinic — Independence, Louisiana, United States (enrolling)
• InclusivCare - Kenner Clinic — Kenner, Louisiana, United States (enrolling)
• RKM Primary Care - Loranger Clinic — Loranger, Louisiana, United States (enrolling)
• InclusivCare - Marrero — Marrero, Louisiana, United States (enrolling)
• David Raines Community Health Center - Minden Clinic — Minden, Louisiana, United States (enrolling)
• Teche Action Clinic - Morgan City — Morgan City, Louisiana, United States (enrolling)
• NOELA Community Health Center — New Orleans, Louisiana, United States (enrolling)
• Teche Action Clinic - South Pierre Part — Pierre Part, Louisiana, United States (enrolling)
• CareSouth Medical and Dental - Plaquemine Clinic — Plaquemine, Louisiana, United States (enrolling)
• David Raines Community Health Center - Shreveport Clinic — Shreveport, Louisiana, United States (enrolling)
• RKM Primary Care - Springfield Clinic — Springfield, Louisiana, United States (enrolling)
• CommuniHealth Services - West Monroe Clinic — West Monroe, Louisiana, United States (enrolling)

Full record on ClinicalTrials.gov

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