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Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.
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.
  • Behavioral: Health Literacy and Culturally Tailored Materials
    Participants will receive health literacy-appropriate written information on community resources and weight management
  • 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.

Recruiting Locations

NOELA Community Health Center
New Orleans, Louisiana 70129
Contact:
Laura Perry
504-988-8906
Lperry5@tulane.edu

More Details

Status
Recruiting
Sponsor
Tulane University

Study Contact

Laura Perry, PhD
504-988-8906
Lperry5@tulane.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.