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Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial
NCT06835686 · View on ClinicalTrials.gov ↗
Study 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
Conditions Studied
Interventions
- BEHAVIORAL Health Literacy and Culturally Tailored Materials
- BEHAVIORAL Community-Engaged Health Coaching and Navigation
- BEHAVIORAL Self-Monitoring and Remote Patient Monitoring of weight and physical activity
- OTHER Community Asset Mapping (CAM)
- OTHER Primary Care Provider Training
Study Locations (18)
Louisiana
- InclusivCare - Avondale Clinic — Avondale
- CommuniHealth Services - Bastrop Clinic — Bastrop
- CareSouth Medical and Dental - Baton Rouge Clinic — Baton Rouge
- Teche Action Clinic - Franklin — Franklin
- Southeast Community Health Systems - Greensburg Clinic — Greensburg
- Teche Action Clinic - Houma — Houma
- Southeast Community Health Systems - Independence Clinic — Independence
- InclusivCare - Kenner Clinic — Kenner
- RKM Primary Care - Loranger Clinic — Loranger
- InclusivCare - Marrero — Marrero
- David Raines Community Health Center - Minden Clinic — Minden
- Teche Action Clinic - Morgan City — Morgan City
- NOELA Community Health Center — New Orleans
- Teche Action Clinic - South Pierre Part — Pierre Part
- CareSouth Medical and Dental - Plaquemine Clinic — Plaquemine
- David Raines Community Health Center - Shreveport Clinic — Shreveport
- RKM Primary Care - Springfield Clinic — Springfield
- CommuniHealth Services - West Monroe Clinic — West Monroe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 522 participants |
| Start Date | 2025-03-14 |
| Est. Completion | 2028-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06835686
The ClinicalTrials.gov registry entry for NCT06835686 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 522 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tulane University, which has 89 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 5 interventions — of which Health Literacy and Culturally Tailored Materials is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06835686 reports 18 study locations spanning 1 distinct geographic area — top geographies include Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06835686 about?
NCT06835686 is a clinical study titled "Collaborative Multi-level Obesity Intervention Engaging Underserved Communities 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 a...
What is the current status of trial NCT06835686?
This trial is currently recruiting. It is a NA study. The enrollment target is 522 participants. The study started on 2025-03-14. Estimated completion is 2028-03-31.
What conditions does trial NCT06835686 study?
This clinical trial studies the following conditions: Obesity. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06835686?
The interventions under investigation include: Health Literacy and Culturally Tailored Materials (BEHAVIORAL), Community-Engaged Health Coaching and Navigation (BEHAVIORAL), Self-Monitoring and Remote Patient Monitoring of weight and physical activity (BEHAVIORAL), Community Asset Mapping (CAM) (OTHER), Primary Care Provider Training (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06835686?
This trial is sponsored by Tulane University, which has 89 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06835686 being conducted?
This trial has 18 study locations across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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