Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial
CONNECT
LA-CEAL CONNECT: Louisiana Community Engagement Alliance (LA-CEAL) Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial (CONNECT)
2 other identifiers
interventional
522
1 country
18
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Mar 2025
Typical duration for not_applicable obesity
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2025
CompletedFirst Posted
Study publicly available on registry
February 19, 2025
CompletedStudy Start
First participant enrolled
March 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
May 19, 2026
May 1, 2026
3 years
January 12, 2025
May 18, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Between-group difference in % weight change
Trained personnel will measure weight at all visits using a digital weight scale. For weight, measurement will be performed twice, with a third measurement if the first 2 measurements deviate more than 0.1 kg. An average of the two closest measurements will be used for analyses.
6 months
Secondary Outcomes (5)
Between-group difference in change in waist circumference
6 months
Between-group difference in change in blood pressure
6 months
Between-group difference in change in dietary intake
6 months
Between-group difference in change in physical activity
6 months
Between-group difference in change in quality of life
6 months
Other Outcomes (7)
Between-group difference in % weight change
12 months
Between-group difference in change in waist circumference
12 months
Between-group difference in change in blood pressure
12 months
- +4 more other outcomes
Study Arms (2)
LA-CEAL CONNECT Intervention
EXPERIMENTALParticipants 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.
Enhanced Usual Care
ACTIVE COMPARATORParticipants will receive culturally tailored and health literacy-appropriate educational materials about weight loss and obesity. FQHC clinic providers will receive education on obesity management.
Interventions
Participants will receive health literacy-appropriate written information on community resources and weight management
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.
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.
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.
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.
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie Krousel-Wood, MD, MSPH
Tulane University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2025
First Posted
February 19, 2025
Study Start
March 14, 2025
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
March 31, 2028
Last Updated
May 19, 2026
Record last verified: 2026-05