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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called LA-CEAL CONNECT, designed to help people in low-income communities lose weight and improve their health. Researchers aim to determine if this program, which includes health coaching, digital tools, and community support, can help participants lose more weight and maintain it better than standard care. It also seeks to improve other health factors such as waist size, diet, physical activity, and blood pressure. The trial seeks individuals living with obesity who currently use or are willing to use certain health clinics and can commit to the study for a year. As an unphased trial, this study offers a unique opportunity to contribute to innovative health solutions in the community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the LA-CEAL CONNECT intervention is safe for participants?

Research has shown that components of the LA-CEAL CONNECT program, such as health coaching, using devices like Fitbits to track activity, and community health projects, are generally safe and well-received. These methods have been applied in other settings without major safety issues. Using digital tools to monitor weight and exercise is common and considered safe.

Participants in the LA-CEAL CONNECT program will also receive educational materials and support from community health workers. Such programs typically do not cause significant side effects. While this trial does not involve new drugs or medical devices, which are usually tested for safety, it employs strategies already proven safe in similar contexts.

If specific side effects or challenges arise, they would likely relate to individual responses to increased physical activity or dietary changes, which are generally manageable with proper guidance. Overall, the program prioritizes safety and community support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LA-CEAL CONNECT approach for obesity because it combines personalized education, community engagement, and technology in a way that's not typical of current treatments. Unlike standard care, which often focuses solely on individual interventions like medication or diet plans, this method emphasizes culturally tailored materials and health literacy. It also includes health coaching from community workers and the use of digital tools like fitness trackers, which can motivate and track progress more effectively. Additionally, by involving communities in creating health resources, it aims to foster a supportive environment that could lead to more sustainable lifestyle changes.

What evidence suggests that the LA-CEAL CONNECT intervention could be effective for obesity?

Research has shown that programs like LA-CEAL CONNECT can aid in weight loss. In this trial, participants in the LA-CEAL CONNECT Intervention arm will receive health coaching, use digital tools to track progress, and get community support, which studies have found helps people lose weight and improve their lifestyle. Participants often eat healthier, exercise more, and feel better overall. This approach also helps maintain weight loss over time. The goal is to support people in underserved communities in making lasting changes. Meanwhile, participants in the Enhanced Usual Care arm will receive culturally tailored and health literacy-appropriate educational materials about weight loss and obesity, along with education for FQHC clinic providers on obesity management. ^{1 2 3 4 6}

Who Is on the Research Team?

Marie Krousel-Wood, MD, MSPH

Principal Investigator

Tulane University

Are You a Good Fit for This Trial?

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

Having given birth within the past year, pregnant or planning to become pregnant during study period (within 1 year)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06835686

Study Details | NCT06835686 | Collaborative Multi-level ... 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 ...

2. trial.medpath.com trial.medpath.com/clinical-trial/2ee8ffe1e4bf3aa5/nct06835686-louisiana-obesity-intervention-underserved-communities

Collaborative Multi-level Obesity Intervention Engaging ... - MedPath 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 ...

3. tulane.trialstoday.org tulane.trialstoday.org/trial/NCT06835686

Tulane Research - Clinical Translational Unit Purpose. The goal of this clinical trial is to test the effectiveness of an evidence-based multi-level intervention for weight loss and the ...

4. app.trialscreen.org app.trialscreen.org/trials/collaborative-multi-level-obesity-intervention-engaging-underserved-communities-trial-nct06835686

Obesity Intervention Trial in Underserved Communities Participants in the LA-CEAL CONNECT intervention group may experience weight loss, improved diet and physical activity levels, better quality of life, and ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06835686/collaborative-multi-level-obesity-intervention-engaging-underserved-communities-trial

Collaborative Multi-level Obesity Intervention Engaging ... Will LA-CEAL CONNECT sustain weight loss at 12 months? Will LA-CEAL CONNECT improve waist circumference, diet quality, physical activity, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8411392/

Implementation of the Connect for Health pediatric weight ... The results of the obesity-related care metrics demonstrated the opportunity to improve screening and interventions in the pediatric primary care setting. The ...