Loading
Life sciences · Interventional Study
ClinicalTrials.gov · November 5, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Interventional Study.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07918508). This is a study registration, not published results. Lead sponsor: Florida International University. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 200 participants (ESTIMATED). Conditions: Hypertension (HTN), CKD - Chronic Kidney Disease, Cardio-Renal Syndrome, Food Insecurity, Type 2 Diabetes. Interventions: BEHAVIORAL: INTEGRATE-CHW; BEHAVIORAL: Usual Care. Primary outcome measures: Change From Baseline in Nutrition Self-Efficacy Scale Score at Week 12 , Baseline and Week 12; Change From Baseline in Short Food Literacy Questionnaire (SFLQ) Score at Week 12 , Baseline and Week 12; Change From Baseline in Healthy Eating Index-2020 (HEI-2020) Total Score at Week 12 , Baseline and Week 12. Brief summary: 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.