Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial
ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTulane University
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Health Literacy and Culturally Tailored Materials
- Community-Engaged Health Coaching and Navigation
- Self-Monitoring and Remote Patient Monitoring of weight and physical activity
- Community Asset Mapping (CAM)
- Primary Care Provider Training
- Obesity Toolkit for Primary Care Providers
Treatment groups
522 Participants
are divided into 2 treatment groupsSponsors and collaborators
Tulane University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov