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Health worker diet support for diabetes, high blood pressure, kidney disease

Tests health worker diet coaching in diabetes, hypertension, kidney disease.

Key facts

Who runs it
Florida International University
Where
Boynton Beach, United StatesSee the site
Trial code
Registry title
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Status
Not yet recruiting
People taking part
200 people, planned
Starts
15 Jul 2027
Expected to end
14 Jan 2030
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • INTEGRATE-CHW
  • Usual Care
Record updated
5 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 2 diabetes, high blood pressure or chronic kidney disease who get care at Caridad Center. It tests added community health worker support for diet and health.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Type 2 diabetes (HbA1c ≥ 6.5% (48 mmol/mol)), or high blood pressure (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).
Earlier treatment
People must be able to get medical nutrition therapy and medically tailored groceries through Caridad Center.

Main reasons for not taking part

  • Dialysis or advanced kidney failure (CKD Stage 5; eGFR < 15 mL/min/1.73 m²)
  • Pregnancy
  • Cognitive impairment that prevents taking part
  • Plans to move away during the 12-week program
  • Cannot give informed consent in English or Spanish

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in United States

  • Caridad Center, Inc.Boynton Beach, United StatesContact: Jordan Program coordinatorNo longer taking part

About the trial

What the trial wants to find out

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

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.

The 2 groups in the trial

  • INTEGRATE-CHWTreatment being tested

    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.

  • Usual CareExisting treatment, for comparison

    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.

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?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Integrating Tailored Medical Nutrition Therapy and Community Health Worker Support to Advance Cardio-Kidney-Metabolic Health
Plain-language title
Health worker diet support for diabetes, high blood pressure, kidney diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
5 November 2026