RecruitingNot Applicable

Collaborative Multi-level Obesity Intervention Engaging Communities Trial

United States522 participantsStarted 2025-03-14

Plain-language 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 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 Louisiana 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 Louisiana 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

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Between-group difference in % weight change

Timeframe: 6 months

Trial details

NCT IDNCT06835686

SponsorTulane University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-31

Contact for this trial

Laura Perry, PhD

504-988-8906 Lperry5@tulane.edu

View on ClinicalTrials.gov More Obesity trials