Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial (CONNECT)

Tulane University

Status: Enrolling

Conditions: Obesity

Treatments: Other: Obesity Toolkit for Primary Care Providers; Other: Community Asset Mapping (CAM); Behavioral: Health Literacy and Culturally Tailored Materials; Behavioral: Self-Monitoring and Remote Patient Monitoring of weight and physical activity; Other: Primary Care Provider Training; Behavioral: Community-Engaged Health Coaching and Navigation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06835686

OT2HL158287 (U.S. NIH Grant/Contract)

2024-822

Details and patient eligibility

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

Enrollment: 522 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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522 participants in 2 patient groups

LA-CEAL CONNECT Intervention

Experimental group

Description:

Participants will receive: 1) culturally tailored and health literacy-appropriate educational materials about weight loss and obesity, 2) health coaching from community health workers over 6 months, and 3) digital weight scale and fitness tracker (e.g., Fitbit). Communities will receive support to conduct Community Asset Mapping and design and implement Community Action Projects to promote health resources in their community. FQHC clinic providers will receive: 1) education on guideline-based obesity management, 2) toolkit with resources for obesity management.

Treatment:

Behavioral: Community-Engaged Health Coaching and Navigation

Other: Primary Care Provider Training

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

Behavioral: Health Literacy and Culturally Tailored Materials

Other: Community Asset Mapping (CAM)

Other: Obesity Toolkit for Primary Care Providers

Enhanced Usual Care

Active Comparator group

Description:

Participants will receive culturally tailored and health literacy-appropriate educational materials about weight loss and obesity. FQHC clinic providers will receive education on obesity management.

Treatment:

Other: Primary Care Provider Training

Behavioral: Health Literacy and Culturally Tailored Materials