Hypertension (HTN)INTEGRATE-CHWNCT07918508
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
A study testing INTEGRATE-CHW in people with Hypertension (HTN) and CKD - Chronic Kidney Disease, run by Florida International University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension (HTN), CKD - Chronic Kidney Disease, Cardio-Renal Syndrome
- What is being tested?
- INTEGRATE-CHW
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2027to 14 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- Dialysis or advanced kidney failure (CKD Stage 5; eGFR < 15 mL/min/1.73 m²)
- Pregnancy
- Cognitive impairment precluding participation
- Plans to relocate during the 12-week intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Integrating Tailored Medical Nutrition Therapy and Community Health Worker Support to Advance Cardio-Kidney-Metabolic Health
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.
Read the detailed description
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).
- Conditions
- Hypertension (HTN), CKD - Chronic Kidney Disease, Cardio-Renal Syndrome, Food Insecurity, Type 2 Diabetes
- Being tested
- INTEGRATE-CHW, Usual Care
- Keywords
- Medical Nutrition Therapy, Community Health Workers, Self-Management Support, Nutrition Self-Efficacy, Nutrition Literacy, Diet Quality, Medically Tailored Groceries, Pragmatic Trial
- Medical subject headings
- Hypertension, Renal Insufficiency, Chronic, Cardio-Renal Syndrome, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTEGRATE-CHWBehavioural
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.
Usual CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| INTEGRATE-CHW | Experimental | 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. Receives: Behavioral: INTEGRATE-CHW |
| Usual Care | Active comparator | 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. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 12
Secondary outcomes (8)
Change From Baseline in USDA Six-Item Food Security Module Score at Week 12
USDA six-item food security module.
Measured: Baseline and Week 12
Change From Baseline in HbA1c (%) at Week 12
Glycated hemoglobin (%), extracted from the electronic medical record.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 12
Change From Baseline in Lipid Profile at Week 12
Lipid profile, extracted from the electronic medical record.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start15 Jul 2027 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion14 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic, individually randomized two-arm trial (1:1) comparing usual care with usual care plus CHW-facilitated nutrition self-management support.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Dr. Janet Diaz Martinez, Florida International University
- Investigators
- Janet Diaz Martinez, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918508
- Sponsor's protocol ID
- IRB-26-0430
- Other IDs
- 2027-68015-47755
- Acronym
- INTEGRATE-CHW
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Tailored Medical Nutrition Therapy and Community Health Worker Support to Advance Cardio-Kidney-Metabolic Health
- ClinicalTrials.gov ID
- NCT07918508
- Acronym / sponsor ID
- INTEGRATE-CHW / IRB-26-0430
- Conditions
- Hypertension (HTN), CKD - Chronic Kidney Disease, Cardio-Renal Syndrome, Food Insecurity, Type 2 Diabetes
- Keywords
- Medical Nutrition Therapy, Community Health Workers, Self-Management Support, Nutrition Self-Efficacy, Nutrition Literacy, Diet Quality, Medically Tailored Groceries, Pragmatic Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- 15 Jul 2027 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 14 Jan 2030 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic, individually randomized two-arm trial (1:1) comparing usual care with usual care plus CHW-facilitated nutrition self-management support.
| Arm | Type | Receives |
|---|---|---|
| INTEGRATE-CHW | Experimental | Behavioral: INTEGRATE-CHWUsual 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 Care | Active comparator | Behavioral: Usual CareCaridad 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Dialysis or advanced kidney failure (CKD Stage 5; eGFR < 15 mL/min/1.73 m²)
- Pregnancy
- Cognitive impairment precluding participation
- Plans to relocate during the 12-week intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INTEGRATE-CHWTrained 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. | Behavioural | INTEGRATE-CHW |
| Usual CareIndividualized 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. | Behavioural | Usual Care |
Primary outcome
Change From Baseline in Nutrition Self-Efficacy Scale Score at Week 12
Time frame: Baseline and 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.
Change From Baseline in Short Food Literacy Questionnaire (SFLQ) Score at Week 12
Time frame: Baseline and 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.
Change From Baseline in Healthy Eating Index-2020 (HEI-2020) Total Score at Week 12
Time frame: Baseline and Week 12
Healthy Eating Index-2020 (HEI-2020) total score, derived from two 24-hour dietary recalls.
8 secondary outcomes
Change From Baseline in USDA Six-Item Food Security Module Score at Week 12
Time frame: Baseline and Week 12
Change From Baseline in HbA1c (%) at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Systolic Blood Pressure (mmHg) at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Diastolic Blood Pressure (mmHg) at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Body Mass Index (kg/m²) at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Lipid Profile at Week 12
Time frame: Baseline and Week 12
Change From Baseline in eGFR (mL/min/1.73 m²) at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Urinary Albumin-to-Creatinine Ratio (mg/g) at Week 12
Time frame: Baseline and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janet Diaz Martinez principal investigator
Florida International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTEGRATE-CHW in people with Hypertension (HTN) and CKD - Chronic Kidney Disease, run by Florida International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jordan Program coordinator (305-348-4720, joquinta@fiu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Nutrition Self-Efficacy Scale Score at Week 12 (time frame: Baseline and Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.