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Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial
Sponsor: Tulane University
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
Official title: LA-CEAL CONNECT: Louisiana Community Engagement Alliance (LA-CEAL) Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial (CONNECT)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
522
Start Date
2025-03-14
Completion Date
2028-03-31
Last Updated
2025-03-19
Healthy Volunteers
No
Conditions
Interventions
Health Literacy and Culturally Tailored Materials
Participants will receive health literacy-appropriate written information on community resources and weight management
Community-Engaged Health Coaching and Navigation
Participants will receive virtual coaching sessions over a 6-month period from trained Community Health Workers (CHWs). Coaching will include culturally competent information and strategies for weight management, and linking participants to community wellness resources identified in Community Asset Mapping (see below). Coaches will also remotely monitor patients' weight loss and physical activity via online portals to provide patients with tailored support during coaching sessions.
Self-Monitoring and Remote Patient Monitoring of weight and physical activity
Participants will self-monitor weight and physical activity during the 6-month health coaching protocol using a cellular-connected digital weight scale and a Bluetooth-connected wrist-worn fitness tracking device (e.g., Fitbit). Participants will be instructed to weigh themselves and wear a fitness tracker (e.g., Fitbit) daily. Health coaches will remotely monitor weight and physical activity data logged by these devices to incorporate into health coaching sessions.
Community Asset Mapping (CAM)
The CHW from each intervention community clinic will convene a team of community members, including but not limited to CONNECT participants, that will meet regularly to identify and describe community assets that enable, support, and promote healthy lifestyles related to weight loss and management (e.g., healthy eating and physical activity resources). Community teams will be supported to design and implement Community Action Projects to promote the utilization of community resources identified in the map.
Primary Care Provider Training
Education sessions will be provided to FQHC providers. The training curriculum is designed to increase healthcare providers' knowledge of evidence-based and guideline-concordant obesity management strategies in primary care settings.
Obesity Toolkit for Primary Care Providers
We will provide FQHC providers with a toolkit containing additional obesity management resources and information and the community resource guides given to participants to support obesity management.
Locations (18)
InclusivCare - Avondale Clinic
Avondale, Louisiana, United States
CommuniHealth Services - Bastrop Clinic
Bastrop, Louisiana, United States
CareSouth Medical and Dental - Baton Rouge Clinic
Baton Rouge, Louisiana, United States
Teche Action Clinic - Franklin
Franklin, Louisiana, United States
Southeast Community Health Systems - Greensburg Clinic
Greensburg, Louisiana, United States
Teche Action Clinic - Houma
Houma, Louisiana, United States
Southeast Community Health Systems - Independence Clinic
Independence, Louisiana, United States
InclusivCare - Kenner Clinic
Kenner, Louisiana, United States
RKM Primary Care - Loranger Clinic
Loranger, Louisiana, United States
InclusivCare - Marrero
Marrero, Louisiana, United States
David Raines Community Health Center - Minden Clinic
Minden, Louisiana, United States
Teche Action Clinic - Morgan City
Morgan City, Louisiana, United States
NOELA Community Health Center
New Orleans, Louisiana, United States
Teche Action Clinic - South Pierre Part
Pierre Part, Louisiana, United States
CareSouth Medical and Dental - Plaquemine Clinic
Plaquemine, Louisiana, United States
David Raines Community Health Center - Shreveport Clinic
Shreveport, Louisiana, United States
RKM Primary Care - Springfield Clinic
Springfield, Louisiana, United States
CommuniHealth Services - West Monroe Clinic
West Monroe, Louisiana, United States