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NCT06835686NARecruiting

Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial

Tulane University

Start Date

3/14/2025

Completion Date

3/31/2028

Summary

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

Eligibility Criteria

Age Range: 18 years to 75 years

Inclusion Criteria: * 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) Exclusion Criteria: * 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

Interventions

BEHAVIORAL

Health Literacy and Culturally Tailored Materials

BEHAVIORAL

Community-Engaged Health Coaching and Navigation

BEHAVIORAL

Self-Monitoring and Remote Patient Monitoring of weight and physical activity

OTHER

Community Asset Mapping (CAM)

OTHER

Primary Care Provider Training

OTHER

Obesity Toolkit for Primary Care Providers

Interested in This Trial?

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Conditions

Obesity

Locations

InclusivCare - Avondale Clinic

Avondale, Louisiana 70094

United States

CommuniHealth Services - Bastrop Clinic

Bastrop, Louisiana 71220

United States

CareSouth Medical and Dental - Baton Rouge Clinic

Baton Rouge, Louisiana 70806

United States

Teche Action Clinic - Franklin

Franklin, Louisiana 70538

United States

Southeast Community Health Systems - Greensburg Clinic

Greensburg, Louisiana 70441

United States

Teche Action Clinic - Houma

Houma, Louisiana 70360

United States

Southeast Community Health Systems - Independence Clinic

Independence, Louisiana 70443

United States

InclusivCare - Kenner Clinic

Kenner, Louisiana 70062

United States

RKM Primary Care - Loranger Clinic

Loranger, Louisiana 70446

United States

InclusivCare - Marrero

Marrero, Louisiana 70072

United States

David Raines Community Health Center - Minden Clinic

Minden, Louisiana 71055

United States

Teche Action Clinic - Morgan City

Morgan City, Louisiana 70380

United States

NOELA Community Health Center

New Orleans, Louisiana 70129

United States

Teche Action Clinic - South Pierre Part

Pierre Part, Louisiana 70339

United States

CareSouth Medical and Dental - Plaquemine Clinic

Plaquemine, Louisiana 70764

United States

David Raines Community Health Center - Shreveport Clinic

Shreveport, Louisiana 71107

United States

RKM Primary Care - Springfield Clinic

Springfield, Louisiana 70462

United States

CommuniHealth Services - West Monroe Clinic

West Monroe, Louisiana 71292

United States