Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06835686

Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial

Led by Tulane University · Updated on 2025-03-19

522

Participants Needed

18

Research Sites

159 weeks

Total Duration

On this page

Sponsors

T

Tulane University

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years
  • Living with obesity, defined as BMI 30 to 50 kg/m2 for non-Asian and 27.5 to 50 kg/m2 for Asian-identifying participants
  • Weight less than 400 pounds
  • Receiving care from or willing to register at a participating community health clinic
  • Able to understand and speak English
  • Able to complete the study within the next year without plans to move
Not Eligible

You will not qualify if you...

  • Given birth within the past year, pregnant, or planning pregnancy during study period
  • Currently in a weight-loss program
  • Lost more than 10 pounds in the last 6 months
  • Employee or family member of an employee at any participating clinic
  • Having a disease that could interfere with or be worsened by exercise or weight loss

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 18 locations

1

InclusivCare - Avondale Clinic

Avondale, Louisiana, United States, 70094

Actively Recruiting

2

CommuniHealth Services - Bastrop Clinic

Bastrop, Louisiana, United States, 71220

Actively Recruiting

3

CareSouth Medical and Dental - Baton Rouge Clinic

Baton Rouge, Louisiana, United States, 70806

Actively Recruiting

4

Teche Action Clinic - Franklin

Franklin, Louisiana, United States, 70538

Actively Recruiting

5

Southeast Community Health Systems - Greensburg Clinic

Greensburg, Louisiana, United States, 70441

Actively Recruiting

6

Teche Action Clinic - Houma

Houma, Louisiana, United States, 70360

Actively Recruiting

7

Southeast Community Health Systems - Independence Clinic

Independence, Louisiana, United States, 70443

Actively Recruiting

8

InclusivCare - Kenner Clinic

Kenner, Louisiana, United States, 70062

Actively Recruiting

9

RKM Primary Care - Loranger Clinic

Loranger, Louisiana, United States, 70446

Actively Recruiting

10

InclusivCare - Marrero

Marrero, Louisiana, United States, 70072

Actively Recruiting

11

David Raines Community Health Center - Minden Clinic

Minden, Louisiana, United States, 71055

Actively Recruiting

12

Teche Action Clinic - Morgan City

Morgan City, Louisiana, United States, 70380

Actively Recruiting

13

NOELA Community Health Center

New Orleans, Louisiana, United States, 70129

Actively Recruiting

14

Teche Action Clinic - South Pierre Part

Pierre Part, Louisiana, United States, 70339

Actively Recruiting

15

CareSouth Medical and Dental - Plaquemine Clinic

Plaquemine, Louisiana, United States, 70764

Actively Recruiting

16

David Raines Community Health Center - Shreveport Clinic

Shreveport, Louisiana, United States, 71107

Actively Recruiting

17

RKM Primary Care - Springfield Clinic

Springfield, Louisiana, United States, 70462

Actively Recruiting

18

CommuniHealth Services - West Monroe Clinic

West Monroe, Louisiana, United States, 71292

Actively Recruiting

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Research Team

L

Laura Perry, PhD

CONTACT

E

Erin Peacock, PhD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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