RECRUITING

Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2025-03-14
Study Completion:2028-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06835686

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * being 18 to 75 years of age
  2. * 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
  3. * weighing less than 400 pounds
  4. * receiving care from or willing to register at a participating FQHC clinic
  5. * able to understand and speak English
  6. * able to complete the study within the next year (e.g., not planning to move from the area within study period)
  1. * having given birth within the past year, pregnant or planning to become pregnant during study period (within 1 year)
  2. * currently participating in a weight-loss program
  3. * having lost more than 10 pounds in the last 6 months
  4. * being an employee or a family member of an employee of any participating FQHC
  5. * having a disease that can interfere with or be aggravated by exercise or weight loss

Contacts and Locations

Study Contact

Laura Perry, PhD
CONTACT
504-988-8906
Lperry5@tulane.edu
Erin Peacock, PhD, MPH
CONTACT
504-988-1075
epeacoc@tulane.edu

Principal Investigator

Marie Krousel-Wood, MD, MSPH
PRINCIPAL_INVESTIGATOR
Tulane University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Tulane University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-14
Study Completion Date2028-03-31

Study Record Updates

Study Start Date2025-03-14
Study Completion Date2028-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity