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NCT06835686 · ClinicalTrials.gov registry record · NA
Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial
A NA study of Obesity, sponsored by Tulane University.
- Recruiting
- Registry status
- NA
- Development phase
- 522
- Enrollment target
- 18
- Study locations
NCT06835686: Recruiting NA study of Obesity, sponsored by Tulane University.
NCT06835686 is a NA study of Obesity that is actively recruiting participants, run by Tulane University. The registered enrollment target is 522 participants, below the 818-participant average among 1,053 other Obesity trials with a reported enrollment target (36% lower). The trial reports 18 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06835686, a NA study of Obesity, is actively recruiting participants, sponsored by Tulane University.
- RECRUITING
- Registry status
- NA
- Development phase
- 522 participants
- Enrollment target
- 18
- Study locations
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
Primary Outcome
Trained personnel will measure weight at all visits using a digital weight scale. For weight, measurement will be performed twice, with a third measurement if the first 2 measurements deviate more than 0.1 kg. An average of the two closest measurements will be used for analyses.
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 |
What NCT06835686 shows while recruiting
NCT06835686 is an interventional study that assigns participants to a tested intervention. The registered 522 participants enrollment target is mid-sized for trials with a published cap, below the 818-participant average among 1,053 other Obesity trials with a reported enrollment target (36% lower).
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.
NCT06835686 lists 18 locations in 1 state (Louisiana).
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.
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).
Who is sponsoring clinical trial NCT06835686?
This trial is sponsored by Tulane University, which has 73 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06835686's enrollment target sits among peer trials
522 131st of 1053 higher than 923 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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