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Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health

Key facts

Where
Boynton Beach, United StatesSee the site

Where in United States

  • Caridad Center, Inc.Boynton Beach, United StatesNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Florida International University
Trial code
NCT07918508
Record updated
5 November 2026
Original description
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.Read full original descriptionShow less

Integrating Tailored Medical Nutrition Therapy and Community Health Worker Support to Advance Cardio-Kidney-Metabolic Health

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.

Inclusion: Adults aged 18 years or older receiving care at Caridad Center; Documented diagnosis of type 2 diabetes (HbA1c ≥ 6.5%), hypertension (systolic blood pressure ≥ 130 mmHg), or chronic kidney disease Stages 1-4 (eGFR 15-59 mL/min/1.73 m² regardless of albuminuria, or eGFR ≥ 15 mL/min/1.73 m² with albuminuria ≥ 30 mg/g); Eligible for medical nutrition therapy and medically tailored groceries through -Caridad Center; Able to provide informed consent in English or Spanish.

Exclusion: Cognitive impairment precluding participation; Dialysis or advanced kidney failure (CKD Stage 5; eGFR < 15 mL/min/1.73 m²); Pregnancy; Plans to relocate during the 12-week intervention.

ClinicalTrials.gov NCT07918508