Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial

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

• Obesity

Interventions

BEHAVIORAL

Health Literacy and Culturally Tailored Materials

Participants will receive health literacy-appropriate written information on community resources and weight management

BEHAVIORAL

Community-Engaged Health Coaching and Navigation

Participants will receive virtual coaching sessions over a 6-month period from trained Community Health Workers (CHWs). Coaching will include culturally competent information and strategies for weight management, and linking participants to community wellness resources identified in Community Asset Mapping (see below). Coaches will also remotely monitor patients' weight loss and physical activity via online portals to provide patients with tailored support during coaching sessions.

BEHAVIORAL

Self-Monitoring and Remote Patient Monitoring of weight and physical activity

Participants will self-monitor weight and physical activity during the 6-month health coaching protocol using a cellular-connected digital weight scale and a Bluetooth-connected wrist-worn fitness tracking device (e.g., Fitbit). Participants will be instructed to weigh themselves and wear a fitness tracker (e.g., Fitbit) daily. Health coaches will remotely monitor weight and physical activity data logged by these devices to incorporate into health coaching sessions.

OTHER

Community Asset Mapping (CAM)

The CHW from each intervention community clinic will convene a team of community members, including but not limited to CONNECT participants, that will meet regularly to identify and describe community assets that enable, support, and promote healthy lifestyles related to weight loss and management (e.g., healthy eating and physical activity resources). Community teams will be supported to design and implement Community Action Projects to promote the utilization of community resources identified in the map.

OTHER

Primary Care Provider Training

Education sessions will be provided to FQHC providers. The training curriculum is designed to increase healthcare providers' knowledge of evidence-based and guideline-concordant obesity management strategies in primary care settings.

OTHER

Obesity Toolkit for Primary Care Providers

We will provide FQHC providers with a toolkit containing additional obesity management resources and information and the community resource guides given to participants to support obesity management.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Tulane University

  lead OTHER

Principal Investigators

• Marie Krousel-Wood, MD, MSPH · Tulane University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-14

Primary Completion

2028-03-31

Completion

2028-03-31

Countries

• United States

Study Locations