Florida International University
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.
Dietitian-led MNT and medically tailored food programs improve diet quality and food security during active participation, but these gains often diminish once food delivery or counseling ends. Sustaining improvement requires ongoing behavioral reinforcement and self-management support that help patients adapt nutrition guidance to their cultural and household routines. This trial tests whether CHWs embedded in the dietitian's workflow can provide that reinforcement within routine care at a safety-net clinic. The intervention is guided by Social Cognitive Theory, the Corbin and Strauss self-ma…
Inclusion Criteria: * 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 Criteria: * Dialysis or advanced kidney failure (CKD Stage 5; eGFR \< 15 mL/min/1.73 m²) *…
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.
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.