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Recruiting NCT06835686

Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial

No phase Interventional Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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).
Who it may be relevant to
Registry conditions: Obesity. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

LA-CEAL CONNECT: Louisiana Community Engagement Alliance (LA-CEAL) Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial (CONNECT)

Overview

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

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
  • 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.

Primary outcome measures

  • Between-group difference in % weight change [Time frame: 6 months]
Secondary outcome measures (5)
  • Between-group difference in change in waist circumference [Time frame: 6 months]
  • Between-group difference in change in blood pressure [Time frame: 6 months]
  • Between-group difference in change in dietary intake [Time frame: 6 months]
  • Between-group difference in change in physical activity [Time frame: 6 months]
  • Between-group difference in change in quality of life [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 18 centers
  • InclusivCare - Avondale Clinic — Avondale
  • CommuniHealth Services - Bastrop Clinic — Bastrop
  • CareSouth Medical and Dental - Baton Rouge Clinic — Baton Rouge
  • Teche Action Clinic - Franklin — Franklin
  • Southeast Community Health Systems - Greensburg Clinic — Greensburg
  • Teche Action Clinic - Houma — Houma
  • Southeast Community Health Systems - Independence Clinic — Independence
  • InclusivCare - Kenner Clinic — Kenner
  • … and 10 more centers

Identifiers

NCT: NCT06835686 · 2024-822 · OT2HL158287

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗