Community Asset Mapping (CAM) / Obesity / Self-Monitoring and Remote Patient Monitoring of weight and physical activity · Interventional Study

Collaborative Multi-level Obesity Intervention Engaging Communities Trial

ClinicalTrials.gov · August 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for an actively recruiting multi-level behavioral intervention trial (LA-CEAL CONNECT) designed to test weight loss effectiveness and implementation feasibility in adults with obesity in Louisiana communities. No results are reported in this record; the study compares the intervention to enhanced usual care with primary outcome assessment at 6 months and secondary assessments at 12 months.

What was studied

Interventional, Randomized, Parallel, Open label, Treatment purpose. Obesity; age from 18 Years; to 75 Years. Intervention: LA-CEAL CONNECT Intervention. Compared with: Enhanced Usual Care — Active Comparator. n = 522. 18 sites: United States.

Key findings

Safety

Registry record contains no efficacy or safety results; outcome data are not yet available.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is an active registry record for a planned interventional trial with no results reported; it describes design and enrollment targets only, making it unsuitable for evidence grading until outcome data are published.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Between-group difference in % weight change (assessed at 6 months)

DesignInterventional, Randomized, Parallel, Open label, Treatment purpose

PopulationObesity; age from 18 Years; to 75 Years

Sample size522

InterventionLA-CEAL CONNECT Intervention

ComparatorEnhanced Usual Care — Active Comparator

Setting18 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment522

Primary outcome measureBetween-group difference in % weight change at 6 months

Secondary outcome timepoint12 months

Caveats

Registry record contains no efficacy or safety results; outcome data are not yet available.
Blinding status, allocation concealment method, and outcome assessment procedures not described.
Sample size justification and assumptions about effect size not reported.
Recruitment status is 'RECRUITING' as of registry posting; completion and follow-up duration not specified.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Randomized comparison to enhanced usual care; phase and blinding status not stated.

Directness

moderate

Primary outcome is % weight change at 6 months, a direct and clinically relevant measure.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Blinding, allocation concealment, and outcome assessment methods not described in registry.

Sample adequacy

moderate

Planned enrollment 522 participants; adequacy depends on effect size hypothesis not stated.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06835686). This is a study registration, not published results. Lead sponsor: Tulane University. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 522 participants (ESTIMATED). Conditions: Obesity. 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; OTHER: Obesity Toolkit for Primary Care Providers. Primary outcome measures: Between-group difference in % weight change , 6 months. 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 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

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Community Asset Mapping (CAM)ObesitySelf-Monitoring and Remote Patient Monitoring of weight and physical activityCommunity-Engaged Health Coaching and NavigationHealth Literacy and Culturally Tailored MaterialsNCT06835686Tulane University