Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial

Not Applicable

Recruiting

• Conditions: Obesity

• Registration Number: NCT06835686
• Lead Sponsor: Tulane University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-12
• Study First Submitted QC: 2025-02-18
• Study First Posted: 2025-02-19
• Status Verified: 2025-03
• Study Start: 2025-03-14
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19
• Primary Completion: 2028-03-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 522

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Between-group difference in % weight change	6 months	Trained personnel will measure weight at all visits using a digital weight scale. For weight, measurement will be performed twice, with a third measurement if the first 2 measurements deviate more than 0.1 kg. An average of the two closest measurements will be used for analyses.

Secondary Outcome Measures

Name	Time	Method
Between-group difference in change in waist circumference	6 months	Trained personnel will measure waist circumference at all study visits using a non-elastic tape measure placed on the skin in a horizontal plane around the abdomen at the level of the iliac crest. The measurement will be performed twice, with a third measurement if the first 2 measurements deviate more than 0.5 cm; average of the two closest measurements will be used for analyses.
Between-group difference in change in blood pressure	6 months	Systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be measured at every study visit using an oscillometric Omron Professional Intellisense Blood Pressure Monitor HEM-907XL and following the American Heart Association (AHA) protocol.
Between-group difference in change in dietary intake	6 months	Diet will be self-reported at every study visit using a diet screener that has been developed by the study investigators and used in past studies. The screener will assess frequency of consumption of selected food and drinks over the past month - including fruits and vegetables, high-fat foods, and alcoholic beverages.
Between-group difference in change in physical activity	6 months	Physical activity will be self-reported at every study visit using the 7-item international physical activity questionnaire - short form (IPAQ-SF). This tool records the time spent at 4 different activity levels (vigorous, moderate, walking, sitting) according to 7-day recall. Scores are computed by calculating total minutes/week or total MET-minutes/week spent in the following activity levels: vigorous, moderate, walking, sitting. A total physical activity score is computed by summing the values for vigorous, moderate, and walking domains. The minimum score is 0 (no activity), with higher scores indicating more physical activity. The categorical physical activity level (low, moderate, and high) will be calculated using cut points recommended by the authors. Continuous activity score may be used as a more sensitive measure of participant physical activity change.
Between-group difference in change in quality of life	6 months	Quality of life will be self-reported at every study visit using the 10-item Patient Reported Outcomes Measurement Information System (PROMIS) Global Health measure. Raw scores for Global Physical Health and Global Mental health will be computed, ranging from 4 to 20. Per PROMIS scoring guidelines, raw scores will be transformed to a T-score metric, with higher scores representing better health on each domain.

Trial Locations

Locations (18)

InclusivCare - Avondale Clinic; 🇺🇸 Avondale, Louisiana, United States

CommuniHealth Services - Bastrop Clinic; 🇺🇸 Bastrop, Louisiana, United States

CareSouth Medical and Dental - Baton Rouge Clinic; 🇺🇸 Baton Rouge, Louisiana, United States

Teche Action Clinic - Franklin; 🇺🇸 Franklin, Louisiana, United States

Southeast Community Health Systems - Greensburg Clinic; 🇺🇸 Greensburg, Louisiana, United States

Teche Action Clinic - Houma; 🇺🇸 Houma, Louisiana, United States

Southeast Community Health Systems - Independence Clinic; 🇺🇸 Independence, Louisiana, United States

InclusivCare - Kenner Clinic; 🇺🇸 Kenner, Louisiana, United States

RKM Primary Care - Loranger Clinic; 🇺🇸 Loranger, Louisiana, United States

InclusivCare - Marrero; 🇺🇸 Marrero, Louisiana, United States

David Raines Community Health Center - Minden Clinic; 🇺🇸 Minden, Louisiana, United States

Teche Action Clinic - Morgan City; 🇺🇸 Morgan City, Louisiana, United States

NOELA Community Health Center; 🇺🇸 New Orleans, Louisiana, United States

Teche Action Clinic - South Pierre Part; 🇺🇸 Pierre Part, Louisiana, United States

CareSouth Medical and Dental - Plaquemine Clinic; 🇺🇸 Plaquemine, Louisiana, United States

David Raines Community Health Center - Shreveport Clinic; 🇺🇸 Shreveport, Louisiana, United States

RKM Primary Care - Springfield Clinic; 🇺🇸 Springfield, Louisiana, United States

CommuniHealth Services - West Monroe Clinic; 🇺🇸 West Monroe, Louisiana, United States