Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial
NCT ID: NCT06835686
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
522 participants
INTERVENTIONAL
2025-03-14
2028-03-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
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.
Health Literacy and Culturally Tailored Materials
Participants will receive health literacy-appropriate written information on community resources and weight management
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Tulane University
OTHER
Responsible Party
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Principal Investigators
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Marie Krousel-Wood, MD, MSPH
Role: PRINCIPAL_INVESTIGATOR
Tulane University
Locations
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InclusivCare - Avondale Clinic
Avondale, Louisiana, United States
CommuniHealth Services - Bastrop Clinic
Bastrop, Louisiana, United States
CareSouth Medical and Dental - Baton Rouge Clinic
Baton Rouge, Louisiana, United States
Teche Action Clinic - Franklin
Franklin, Louisiana, United States
Southeast Community Health Systems - Greensburg Clinic
Greensburg, Louisiana, United States
Teche Action Clinic - Houma
Houma, Louisiana, United States
Southeast Community Health Systems - Independence Clinic
Independence, Louisiana, United States
InclusivCare - Kenner Clinic
Kenner, Louisiana, United States
RKM Primary Care - Loranger Clinic
Loranger, Louisiana, United States
InclusivCare - Marrero
Marrero, Louisiana, United States
David Raines Community Health Center - Minden Clinic
Minden, Louisiana, United States
Teche Action Clinic - Morgan City
Morgan City, Louisiana, United States
NOELA Community Health Center
New Orleans, Louisiana, United States
Teche Action Clinic - South Pierre Part
Pierre Part, Louisiana, United States
CareSouth Medical and Dental - Plaquemine Clinic
Plaquemine, Louisiana, United States
David Raines Community Health Center - Shreveport Clinic
Shreveport, Louisiana, United States
RKM Primary Care - Springfield Clinic
Springfield, Louisiana, United States
CommuniHealth Services - West Monroe Clinic
West Monroe, Louisiana, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-822
Identifier Type: -
Identifier Source: org_study_id
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