Clinical trial NCT06835686: Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial
Official title: LA-CEAL CONNECT: Louisiana Community Engagement Alliance (LA-CEAL) Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial (CONNECT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-02-19
Enrollment: 522
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Between-group difference in % weight change
timeFrame: 6 months
Secondary outcomes:
measure: Between-group difference in change in waist circumference
timeFrame: 6 months
measure: Between-group difference in change in blood pressure
timeFrame: 6 months
measure: Between-group difference in change in dietary intake
timeFrame: 6 months
measure: Between-group difference in change in physical activity
timeFrame: 6 months
measure: Between-group difference in change in quality of life
timeFrame: 6 months
Other outcomes:
measure: Between-group difference in % weight change
timeFrame: 12 months
measure: Between-group difference in change in waist circumference
timeFrame: 12 months
measure: Between-group difference in change in blood pressure
timeFrame: 12 months
measure: Between-group difference in change in dietary intake
timeFrame: 12 months
measure: Between-group difference in change in physical activity
timeFrame: 12 months
measure: Between-group difference in change in quality of life
timeFrame: 12 months
measure: Between-group difference in fidelity
timeFrame: 6 months
Locations:
city: Avondale
country: United States
facility: InclusivCare - Avondale Clinic
state: Louisiana
city: Bastrop
country: United States
facility: CommuniHealth Services - Bastrop Clinic
state: Louisiana
city: Baton Rouge
country: United States
facility: CareSouth Medical and Dental - Baton Rouge Clinic
state: Louisiana
city: Franklin
country: United States
facility: Teche Action Clinic - Franklin
state: Louisiana
city: Greensburg
country: United States
facility: Southeast Community Health Systems - Greensburg Clinic
state: Louisiana
city: Houma
country: United States
facility: Teche Action Clinic - Houma
state: Louisiana
city: Independence
country: United States
facility: Southeast Community Health Systems - Independence Clinic
state: Louisiana
city: Kenner
country: United States
facility: InclusivCare - Kenner Clinic
state: Louisiana
city: Loranger
country: United States
facility: RKM Primary Care - Loranger Clinic
state: Louisiana
city: Marrero
country: United States
facility: InclusivCare - Marrero
state: Louisiana
city: Minden
country: United States
facility: David Raines Community Health Center - Minden Clinic
state: Louisiana
city: Morgan City
country: United States
facility: Teche Action Clinic - Morgan City
state: Louisiana
city: New Orleans
country: United States
facility: NOELA Community Health Center
state: Louisiana
city: Pierre Part
country: United States
facility: Teche Action Clinic - South Pierre Part
state: Louisiana
city: Plaquemine
country: United States
facility: CareSouth Medical and Dental - Plaquemine Clinic
state: Louisiana
city: Shreveport
country: United States
facility: David Raines Community Health Center - Shreveport Clinic
state: Louisiana
city: Springfield
country: United States
facility: RKM Primary Care - Springfield Clinic
state: Louisiana
city: West Monroe
country: United States
facility: CommuniHealth Services - West Monroe Clinic
state: Louisiana
Study officials:
affiliation: Tulane University
name: Marie Krousel-Wood, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: