Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial

Description

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

Obesity

Study Overview

Study Details

Study overview

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

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

Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Avondale

InclusivCare - Avondale Clinic, Avondale, Louisiana, United States, 70094

Bastrop

CommuniHealth Services - Bastrop Clinic, Bastrop, Louisiana, United States, 71220

Baton Rouge

CareSouth Medical and Dental - Baton Rouge Clinic, Baton Rouge, Louisiana, United States, 70806

Franklin

Teche Action Clinic - Franklin, Franklin, Louisiana, United States, 70538

Greensburg

Southeast Community Health Systems - Greensburg Clinic, Greensburg, Louisiana, United States, 70441

Houma

Teche Action Clinic - Houma, Houma, Louisiana, United States, 70360

Independence

Southeast Community Health Systems - Independence Clinic, Independence, Louisiana, United States, 70443

Kenner

InclusivCare - Kenner Clinic, Kenner, Louisiana, United States, 70062

Loranger

RKM Primary Care - Loranger Clinic, Loranger, Louisiana, United States, 70446

Marrero

InclusivCare - Marrero, Marrero, Louisiana, United States, 70072

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Tulane University,

Marie Krousel-Wood, MD, MSPH, PRINCIPAL_INVESTIGATOR, Tulane University

Study Record Dates

2028-03-31