Recruiting

Obesity InterventionCollaborative Multi-level Obesity Intervention Engaging Communities Trial

Sponsor:

Tulane University

Code:

NCT06835686

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Health Literacy and Culturally Tailored Materials

Community-Engaged Health Coaching and Navigation

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

Community Asset Mapping (CAM)

Primary Care Provider Training

Study Details

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

Conditions

Obesity

Study ID

NCT06835686

Start date

Mar 14, 2025

Status verified date

Aug, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

being 18 to 75 years of age
living with obesity, defined as a BMI between 30 and 50 kg/m2 for non-Asian identifying participants and BMI between 27.5 and 50 kg/m2 for Asian-identifying participants
weighing less than 400 pounds
receiving care from or willing to register at a participating FQHC clinic
able to understand and speak English
able to complete the study within the next year (e.g., not planning to move from the area within study period)

Exclusion Criteria:

having given birth within the past year, pregnant or planning to become pregnant during study period (within 1 year)
currently participating in a weight-loss program
having lost more than 10 pounds in the last 6 months
being an employee or a family member of an employee of any participating FQHC
having a disease that can interfere with or be aggravated by exercise or weight loss

Study Design

Enrollment

522 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LA-CEAL CONNECT Intervention

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.

active comparator: Enhanced Usual Care

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.

Interventions

Health Literacy and Culturally Tailored Materials

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

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.

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.

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.

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.

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.

Primary outcome measure

Between-group difference in % weight change [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Laura Perry, PhD

Obesity InterventionCollaborative Multi-level Obesity Intervention Engaging Communities Trial

Study Details

Eligibility Criteria

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

More Information