Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial

Last updated: March 17, 2025
Sponsor: Tulane University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Treatment

Self-Monitoring and Remote Patient Monitoring of weight and physical activity

Obesity Toolkit for Primary Care Providers

Health Literacy and Culturally Tailored Materials

Clinical Study ID

NCT06835686
2024-822
OT2HL158287
  • Ages 18-75
  • All Genders

Study 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

Inclusion Criteria:

  • being 18 to 75 years of age

  • living with obesity, defined as a BMI between 30 and 50 kg/m2 for non-Asianidentifying participants and BMI between 27.5 and 50 kg/m2 for Asian-identifyingparticipants

  • 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 thearea within study period)

Exclusion

Exclusion Criteria:

  • having given birth within the past year, pregnant or planning to become pregnantduring 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

Study Design

Total Participants: 522
Treatment Group(s): 6
Primary Treatment: Self-Monitoring and Remote Patient Monitoring of weight and physical activity
Phase:
Study Start date:
March 14, 2025
Estimated Completion Date:
March 31, 2028

Connect with a study center

  • InclusivCare - Avondale Clinic

    Avondale, Louisiana 70094
    United States

    Active - Recruiting

  • CommuniHealth Services - Bastrop Clinic

    Bastrop, Louisiana 71220
    United States

    Active - Recruiting

  • CareSouth Medical and Dental - Baton Rouge Clinic

    Baton Rouge, Louisiana 70806
    United States

    Active - Recruiting

  • Teche Action Clinic - Franklin

    Franklin, Louisiana 70538
    United States

    Active - Recruiting

  • Southeast Community Health Systems - Greensburg Clinic

    Greensburg, Louisiana 70441
    United States

    Active - Recruiting

  • Teche Action Clinic - Houma

    Houma, Louisiana 70360
    United States

    Active - Recruiting

  • Southeast Community Health Systems - Independence Clinic

    Independence, Louisiana 70443
    United States

    Active - Recruiting

  • InclusivCare - Kenner Clinic

    Kenner, Louisiana 70062
    United States

    Active - Recruiting

  • RKM Primary Care - Loranger Clinic

    Loranger, Louisiana 70446
    United States

    Active - Recruiting

  • InclusivCare - Marrero

    Marrero, Louisiana 70072
    United States

    Active - Recruiting

  • David Raines Community Health Center - Minden Clinic

    Minden, Louisiana 71055
    United States

    Active - Recruiting

  • Teche Action Clinic - Morgan City

    Morgan City, Louisiana 70380
    United States

    Active - Recruiting

  • NOELA Community Health Center

    New Orleans, Louisiana 70129
    United States

    Active - Recruiting

  • Teche Action Clinic - South Pierre Part

    Pierre Part, Louisiana 70339
    United States

    Active - Recruiting

  • CareSouth Medical and Dental - Plaquemine Clinic

    Plaquemine, Louisiana 70764
    United States

    Active - Recruiting

  • David Raines Community Health Center - Shreveport Clinic

    Shreveport, Louisiana 71107
    United States

    Active - Recruiting

  • RKM Primary Care - Springfield Clinic

    Springfield, Louisiana 70462
    United States

    Active - Recruiting

  • CommuniHealth Services - West Monroe Clinic

    West Monroe, Louisiana 71292
    United States

    Active - Recruiting

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