LA-CEAL CONNECT: Louisiana Community Engagement Alliance (LA-CEAL) Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial (CONNECT)

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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)

Locations
United States
Louisiana
InclusivCare - Avondale Clinic
RECRUITING
Avondale
CommuniHealth Services - Bastrop Clinic
RECRUITING
Bastrop
CareSouth Medical and Dental - Baton Rouge Clinic
RECRUITING
Baton Rouge
Teche Action Clinic - Franklin
RECRUITING
Franklin
Southeast Community Health Systems - Greensburg Clinic
RECRUITING
Greensburg
Teche Action Clinic - Houma
RECRUITING
Houma
Southeast Community Health Systems - Independence Clinic
RECRUITING
Independence
InclusivCare - Kenner Clinic
RECRUITING
Kenner
RKM Primary Care - Loranger Clinic
RECRUITING
Loranger
InclusivCare - Marrero
RECRUITING
Marrero
David Raines Community Health Center - Minden Clinic
RECRUITING
Minden
Teche Action Clinic - Morgan City
RECRUITING
Morgan City
NOELA Community Health Center
RECRUITING
New Orleans
Teche Action Clinic - South Pierre Part
RECRUITING
Pierre Part
CareSouth Medical and Dental - Plaquemine Clinic
RECRUITING
Plaquemine
David Raines Community Health Center - Shreveport Clinic
RECRUITING
Shreveport
RKM Primary Care - Springfield Clinic
RECRUITING
Springfield
CommuniHealth Services - West Monroe Clinic
RECRUITING
West Monroe
Contact Information
Primary
Laura Perry, PhD
Lperry5@tulane.edu
504-988-8906
Backup
Erin Peacock, PhD, MPH
epeacoc@tulane.edu
504-988-1075
Time Frame
Start Date: 2025-03-14
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 522
Treatments
Experimental: LA-CEAL CONNECT Intervention
Participants will receive: 1) culturally tailored and health literacy-appropriate educational materials about weight loss and obesity, 2) health coaching from community health workers over 6 months, and 3) digital weight scale and fitness tracker (e.g., Fitbit).~Communities will receive support to conduct Community Asset Mapping and design and implement Community Action Projects to promote health resources in their community.~FQHC clinic providers will receive: 1) education on guideline-based obesity management, 2) toolkit with resources for obesity management.
Active_comparator: Enhanced Usual Care
Participants will receive culturally tailored and health literacy-appropriate educational materials about weight loss and obesity. FQHC clinic providers will receive education on obesity management.
Related Therapeutic Areas
Sponsors
Leads: Tulane University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov