An interventional study of INTEGRATE-CHW and Usual Care in Hypertension (HTN), CKD - Chronic Kidney Disease and Cardio-Renal Syndrome, sponsored by Florida International University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Florida International University · Not applicable, Interventional, and Health services research
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-management framework, and Lorig and Holman's self-management skills. Self-efficacy serves as the central behavioral mechanism of change, operationalized through confidence-based goal setting, problem solving, and action planning. Enhanced self-efficacy is expected to improve adherence to dietary goals and, in turn, clinical cardio-kidney-metabolic indicators.
Aim 1 will determine the effect of INTEGRATE-CHW on behavioral outcomes. Aim 2 will examine preliminary effects on clinical outcomes. Aim 3 will evaluate implementation using mixed methods guided by RE-AIM and Proctor's framework, including semi-structured interviews with approximately 15 intervention participants and 5 staff (CHWs, registered dietitians, and clinic leads) exploring satisfaction, perceived burden, and workflow fit.
Analyses follow the intent-to-treat principle with two-sided tests (α = 0.05) and Benjamini-Hochberg false-discovery control. Between-group differences at Week 12 are estimated with analysis of covariance adjusting for baseline values. Behavioral models adjust for age, sex, language, baseline food insecurity, and CKD status. Clinical models adjust for age, sex, CKM profile, and medication classes (SGLT2 inhibitor, GLP-1 receptor agonist, ACE inhibitor/ARB, and statin use). Linear mixed-effects models are used for sensitivity analyses. Exploratory analyses test effect modification by baseline food insecurity, nutrition literacy level, and dominant CKM condition, and test whether changes in self-efficacy, literacy, or diet quality mediate changes in clinical indicators. A total of 200 participants (100 per arm) provides at least 80% power (α = 0.05) to detect a small-to-moderate effect (Cohen's d ≈ 0.35).
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Florida International University is the lead sponsor of 104 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: INTEGRATE-CHW
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.
Behavioral: Usual Care
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.
Change From Baseline in Nutrition Self-Efficacy Scale Score at Week 12
5-item Nutrition Self-Efficacy Scale, which measures confidence in maintaining healthy eating behaviors despite common barriers. Interviewer-administered in English or Spanish.
Time frame: Baseline and Week 12
Change From Baseline in Short Food Literacy Questionnaire (SFLQ) Score at Week 12
12-item Short Food Literacy Questionnaire (SFLQ), which evaluates the ability to interpret nutrition information, read labels, and make balanced food choices. Interviewer-administered in English or Spanish.
Time frame: Baseline and Week 12
Change From Baseline in Healthy Eating Index-2020 (HEI-2020) Total Score at Week 12
Healthy Eating Index-2020 (HEI-2020) total score, derived from two 24-hour dietary recalls.
Time frame: Baseline and Week 12
Change From Baseline in USDA Six-Item Food Security Module Score at Week 12
USDA six-item food security module.
Time frame: Baseline and Week 12
Change From Baseline in HbA1c (%) at Week 12
Glycated hemoglobin (%), extracted from the electronic medical record.
Time frame: Baseline and Week 12
Change From Baseline in Systolic Blood Pressure (mmHg) at Week 12
Systolic blood pressure (mmHg), extracted from the electronic medical record.
Time frame: Baseline and Week 12
Change From Baseline in Diastolic Blood Pressure (mmHg) at Week 12
Diastolic blood pressure (mmHg), extracted from the electronic medical record.
Time frame: Baseline and Week 12
Change From Baseline in Body Mass Index (kg/m²) at Week 12
Body mass index (kg/m²), extracted from the electronic medical record.
Time frame: Baseline and Week 12
Change From Baseline in Lipid Profile at Week 12
Lipid profile, extracted from the electronic medical record.
Time frame: Baseline and Week 12
Change From Baseline in eGFR (mL/min/1.73 m²) at Week 12
eGFR (mL/min/1.73 m²), extracted from the electronic medical record.
Time frame: Baseline and Week 12
Change From Baseline in Urinary Albumin-to-Creatinine Ratio (mg/g) at Week 12
uACR (mg/g), extracted from the electronic medical record; log-transformed and reported as ratios of geometric means.
Time frame: Baseline and Week 12
Feasibility: Proportion of Eligible Patients Who Enroll and Complete Follow-up
Proportion of eligible patients who enroll and complete follow-up.
Time frame: Enrollment through Week 12 follow-up
Reach: Demographic Comparability of Enrolled Participants With the Clinic's CKM Population
Demographic comparability between enrolled participants and the clinic's CKM population.
Time frame: Enrollment period
Fidelity: Percentage of CHW Sessions Meeting All Required Elements
Percentage of CHW sessions meeting all required elements, assessed through CHW session checklists, direct observation, and periodic audio review.
Time frame: Weeks 1-12
Acceptability: Theoretical Framework of Acceptability (TFA) Survey Score
Theoretical Framework of Acceptability (TFA) survey completed by intervention participants.
Time frame: Week 12
Adoption: Proportion of RDs, CHWs, and Food Partners Delivering the Program as Intended
Proportion of participating registered dietitians, CHWs, and food partners delivering the program as intended.
Time frame: Up to 21 months (intervention delivery period)
Incremental Cost per Participant (US Dollars)
Estimated from staff time, session duration, and supply costs, with cost per unit outcome.
Time frame: 12 weeks
Plan to share: Yes — Following publication of primary findings, de-identified datasets, data dictionaries, and codebooks will be made available through FIU's secure repository. Shared files will exclude personally identifiable information and contain only derived variables.
Supporting information: Analytic code
Time frame: Following publication of primary findings; data will remain available for at least five years after project completion or publication of final results, whichever occurs later.
Access criteria: De-identified datasets, data dictionaries, codebooks, and analytic code will be available to researchers through FIU's institutional repository and, where applicable, the USDA Ag Data Commons, under FIU's Open Data Policy for research and educational re-use with attribution. Shared files will exclude personally identifiable information and contain only derived variables. Requests for restricted materials, such as qualitative transcripts, will require a data-use agreement and ethics approval.
No publications or documents are linked to this record.
Start is estimated for Jul 2027; primary completion for Apr 2029, 21 months later.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 21 months is close to that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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