Skip to main content
← All trials
Hypertension (HTN)Nutrition and dietBehavioralHeart and circulationKidney and urinaryMetabolicBehavioral

What this study is

Simplified from ClinicalTrials.gov

Testing a 12-week program with a community health worker (INTEGRATE-CHW) to help manage diet and health in adults 18 and older with type 2 diabetes, high blood pressure, or chronic kidney disease at Caridad Center, a free clinic in Palm Beach County, Florida. It is added to usual nutrition care from a dietitian.

Read the original summary from ClinicalTrials.gov

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.

What's being tested

  • INTEGRATE-CHW

    Intervention · BEHAVIORAL

    Trained CHWs deliver culturally tailored sessions using FlipChart visuals, pictorial goal cards, and recipe swaps. The curriculum covers diet and CKM links and home blood pressure and glucose monitoring (Session 1), diabetes (Session 2), hypertension (Session 3), CKD (Session 4), cardiometabolic integration (Session 5), and maintenance (Session 6). Participants select one to two goals from their dietitian's plan and build confidence-rated action plans. CHWs reinforce, but do not modify, dietitian guidance. Between sessions, CHWs provide reminder and follow-up contact by telephone or text message. Participants enter home blood pressure and glucose readings and goals into REDCap directly or with CHW assistance.

  • Usual Care

    Intervention · BEHAVIORAL

    Individualized medical nutrition therapy from a registered dietitian following the Academy of Nutrition and Dietetics' Nutrition Care Process, plus biweekly medically tailored groceries or meal boxes for 12 weeks.

Study details

Official title
Integrating Tailored Medical Nutrition Therapy and Community Health Worker Support to Advance Cardio-Kidney-Metabolic Health
Sponsor
Florida International University
Conditions
Hypertension (HTN) · CKD - Chronic Kidney Disease · Cardio-Renal Syndrome · Food Insecurity · Type 2 Diabetes
Enrolling
200 people
Starts
2027-07-15
Est. completion
2030-01-14
Design
Single-blind, randomized, parallel groups
Record
View on ClinicalTrials.gov ↗