LA-CEAL CONNECT for Obesity

(CONNECT Trial)

Recruiting at 17 trial locations

Overseen By Erin Peacock, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tulane University

Disqualifiers: Recent childbirth, Pregnancy, Weight-loss program, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 months

522 Participants Needed

Trial Summary

What is the purpose of this 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 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

Research Team

Marie Krousel-Wood, MD, MSPH

Principal Investigator

Tulane University

Eligibility Criteria

This trial is for adults living with obesity in low-income and underserved communities in Louisiana. Participants should be interested in weight loss and willing to use digital technologies for self-monitoring, attend group meetings, and visit the clinic for study measurements.

Inclusion Criteria

Weighing less than 400 pounds

Receiving care from or willing to register at a participating FQHC clinic

Able to complete the study within the next year (e.g., not planning to move from the area within study period)

Exclusion Criteria

I have a condition that worsens with exercise or weight loss.

Currently participating in a weight-loss program

Being an employee or a family member of an employee of any participating FQHC

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants visit the clinic site for baseline clinical and survey measurements

1 week

1 visit (in-person)

Treatment

Participants receive the LA-CEAL CONNECT multilevel weight loss intervention or enhanced usual care

6 months

2 visits (in-person) at 6 and 12 months

Follow-up

Participants are monitored for weight loss sustainability and changes in health metrics

6 months

1 visit (in-person) at 12 months

Treatment Details

Interventions

• LA-CEAL CONNECT

Trial Overview The LA-CEAL CONNECT intervention includes health coaching, self-monitoring of weight and physical activity, community resource engagement, and tailored educational materials. It's being compared to enhanced usual care to see if it leads to better outcomes like weight loss and improved health measures over 6 to 12 months.

Participant Groups

Group I: LA-CEAL CONNECT Intervention Experimental Treatment 6 Interventions

Participants will receive: 1) culturally tailored and health literacy-appropriate educational materials about weight loss and obesity, 2) health coaching from community health workers over 6 months, and 3) digital weight scale and fitness tracker (e.g., Fitbit). Communities will receive support to conduct Community Asset Mapping and design and implement Community Action Projects to promote health resources in their community. FQHC clinic providers will receive: 1) education on guideline-based obesity management, 2) toolkit with resources for obesity management.

Group II: Enhanced Usual Care Active Control 2 Interventions

Participants will receive culturally tailored and health literacy-appropriate educational materials about weight loss and obesity. FQHC clinic providers will receive education on obesity management.

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+