NCT06835686 Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial
| NCT ID | NCT06835686 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tulane University |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 522 participants |
| Start Date | 2025-03-14 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 522 participants in total. It began in 2025-03-14 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Marie Krousel-Wood, MD, MSPH
PRINCIPAL INVESTIGATOR
Tulane University
Frequently Asked Questions
Who can join the NCT06835686 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06835686 currently recruiting?
Yes, NCT06835686 is actively recruiting participants. Contact the research team at Lperry5@tulane.edu for enrollment information.
Where is the NCT06835686 trial being conducted?
This trial is being conducted at Avondale, United States, Bastrop, United States, Baton Rouge, United States, Franklin, United States and 11 additional locations.
Who is sponsoring the NCT06835686 clinical trial?
NCT06835686 is sponsored by Tulane University. The principal investigator is Marie Krousel-Wood, MD, MSPH at Tulane University. The trial plans to enroll 522 participants.
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