NCT07918508Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Integrating Tailored Medical Nutrition Therapy and Community Health Worker Support to Advance Cardio-Kidney-Metabolic Health
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 26 Oct 2026
- Start date
- 15 Jul 2027
- Primary completion date
- 30 Apr 2029
- Lead sponsor
- Florida International University
- NCT number
- NCT07918508
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 15 Jul 2027 to the primary completion date, 30 Apr 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cognitive impairment precluding participation
Lab values
- Dialysis or advanced kidney failure (CKD Stage 5; eGFR \< 15 mL/min/1.73 m²)
Other
- Pregnancy
- Plans to relocate during the 12-week intervention
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Caridad Center, Inc. Coordinator of this site? Confirm its status | Boynton Beach | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.