CHW Nutrition Support for Type 2 Diabetes
(INTEGRATE-CHW Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This study tests whether adding CHW support to usual nutrition care helps adults with type 2 diabetes, hypertension, or chronic kidney disease manage their diet and health. At Caridad Center, a free clinic in Palm Beach County, Florida, usual care includes medical nutrition therapy from a registered dietitian and medically tailored groceries. Many patients find it hard to keep up dietary changes because of limited nutrition knowledge, cooking skills, food costs, and cultural fit.
Two hundred adults will be randomly assigned to usual care or usual care plus INTEGRATE-CHW, a 12-week program of six sessions with a trained CHW. In each session the participant selects one or two goals from the dietitian's plan and builds an action plan with the CHW. The dietitian remains responsible for the nutrition plan. The study will compare nutrition self-efficacy, nutrition literacy, diet quality, food security, and clinical measures between groups at baseline and Week 12. It will also evaluate how well the program fits into routine clinic care.
Who Is on the Research Team?
Janet Diaz Martinez
Principal Investigator
Florida International University
Are You a Good Fit for This Trial?
This trial is for adults with type 2 diabetes, high blood pressure, or chronic kidney disease who get care at Caridad Center in Palm Beach County, Florida. Participants should be able to take part in nutrition sessions and follow a diet plan.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- INTEGRATE-CHW
Trial Overview
The study compares usual nutrition care (dietitian support and tailored groceries) versus the same care plus extra help from a trained community health worker over 12 weeks. Participants are randomly assigned to one of these two groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Usual care plus a 12-week CHW-delivered, nutrition-focused self-management support program: six sessions of approximately 60 minutes at Weeks 1, 3, 5, 7, 9, and 11, delivered in person or virtually by participant preference, and a Week 12 wrap-up aligned with the routine dietitian visit and laboratory review.
Caridad Center standard care: individualized medical nutrition therapy from a registered dietitian approximately every three months and medically tailored groceries or meal boxes biweekly for 12 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Florida International University
Lead Sponsor
United States Department of Agriculture (USDA)
Collaborator
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