HypertensioniTHRIVENCT07075588
Integrating Free-choice Marketplace, dieTitian coacHing, cultuRally Tailored messagIng to improVE Blood Pressure
A study testing iTHRIVE intervention and Active comparator in people with Hypertension and Hypertension Complicated With Type 2 Diabetes, run by Johns Hopkins University at 3 sites in United States.
Trial summary
iTHRIVE intervention is a 2-arm randomized controlled trial testing the effects of digital FARMacy, personalized dietitian coaching with produce prescriptions, and home blood pressure measurement in 100 hypertensive adults living in high food priority areas in counties in Maryland. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Hypertension Complicated With Type 2 Diabetes
- What is being tested?
- iTHRIVE intervention and Active comparator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Jun 2026to 20 Mar 2028
- 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21-70 years
- Self-identify as Black/African American or Hispanic/Latino
- Have Stage 2 CKM defined as:
- Systolic BP ≥130mmHg (measured at screening) AND at least one of:
- Hypertension (ICD-10: I10-I16)
- Prediabetes (HbA1c 5.7-6.4%) or Type 2 Diabetes (HbA1c ≥6.5%)
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- Stage 3 chronic kidney disease (CKD) (eGFR 30-59 mL/min/1.73m²)
- Live in census tracts identified by the Montgomery/ Prince George's/Baltimore City County Departments of Planning as HFPA:
- Healthy Food Availability Index score is low (0-9.5),
- Median household income ≤185% of Federal Poverty Level
- 30% of households have no vehicle,
- Distance to supermarket >1/4 mile. 5. Have refrigeration, food preparation appliances (microwave, stove), and cell phones for the App
Who cannot join
- Age <21 years
- Diagnosis of end-stage renal disease (ESRD), dialysis
- Serious medical condition that either limits life expectancy or requires active management (e.g., cancer)
- Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence
- Active alcohol or substance use disorder (i.e., not sober/abstinent for ≥ 30 days)
- Patients with cognitive impairment or other condition preventing their participation in the intervention
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- Pregnant, breastfeeding, or planning pregnancy
- Current participation in a care management program related to health conditions (e.g., weight reduction, smoking cessation) or another clinical trial that could interfere with the study protocol
- Planning to move out of the geographic area in 12 months
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Johns Hopkins Community Physicians
Baltimore, Maryland, 21205
Margaret Utibe, 410-873-7993, thrive-fim@jh.edu
- Not yet recruiting
Johns Hopkins School of Nursing
Baltimore, Maryland, 21205
Mojisola Olusola-Bello, MD, MPH, 240-540-4934, molusol1@jh.edu
- Not yet recruiting
Holy Cross Hospital
Gaithersburg, Maryland, 20876
Tosin Tomiwa, 410-873-7993, thrive-fim@jh.edu
Erix Rivera
About this study
iTHRIVE intervention is a 2-arm randomized controlled trial testing the effects of digital FARMacy, personalized dietitian coaching with produce prescriptions, and home blood pressure measurement in 100 hypertensive adults living in high food priority areas in counties in Maryland.
Read the detailed description
Cardiovascular-kidney-metabolic (CKM) syndrome is a devastating public health crisis that affects nearly 90% of US adults. CKM accounts for >30% of all US deaths and >5 million hospitalizations annually and imposes an annual economic burden of ≥$1 trillion, with a disproportionate impact on Black, Hispanic adults. Inequitable access to care, high-quality food, culturally tailored dietitian support, and living in "food deserts" (also known as Healthy Food Priority Areas (HFPAs) exacerbate CKM disparities. Innovative approaches are urgently needed to sustainably improve food access and CKM health of Black and Hispanic adults.
More than three times as many Black adults (31%) in Baltimore City live in HFPAs compared to White adults (9%). About 45% of households in Montgomery County earn less than the self-sufficiency standard, 64% of Supplemental Nutrition Assistance Program (SNAP)-eligible adults are unenrolled, the highest rate in MD. In 2022, 48% of Prince George's County residents lived in HFPAs. Reasons for these disparities are complex and comprise factors at the individual, provider, community, and systemic levels.
Evidence-based interventions that improve CKM health include personalized dietitian coaching, home blood pressure monitoring (HBPM), and culturally tailored messages. Digital interventions could improve access to dietitians and fruits/vegetables (f/v) through digital "FARMacy" (akin to a virtual farmers market). Implementation strategies for the delivery of these digital interventions are critical gaps, and clinic integration remains unclear. Digital FARMacy platforms offer potential for increased reach and engagement-relative effectiveness and implementation approach have not been explored.
The investigators propose to test the effects of iTHRIVE using a randomized controlled trial among 100 adult participants living in HFPAs in MD counties with uncontrolled BP defined as systolic blood pressure (SBP) ≥130 milimiters of mercury (mmHg) and diabetes or moderate risk chronic renal disease. Participants will be randomized to either iTHRIVE (digital FARMacy, personalized dietitian coaching with produce prescription [PRx], and HBPM) or enhanced usual care (EUC, general dietary advice, standard food bags). The investigators will assess the effectiveness of iTHRIVE in improving systolic blood pressure at 6 months and evaluate the reach, adoption, implementation, maintenance, and budget impact of iTHRIVE
- Being tested
- iTHRIVE intervention, Active comparator
- Keywords
- Digital Farmacy, DASH Diet, Personalized dietitian coaching
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTHRIVE interventionBehavioural
Integration of three traditionally siloed components:
- Digitally enabled food access
- Personalized nutrition support
- Clinical care-rision of home blood pressure device with app
Active comparatorBehavioural
Active comparator arm will receive enhanced usual care that consists of:
- Standard produce bag
- Home blood pressure Device without app
- General dietary advice
| Study group | Role | What they receive |
|---|---|---|
| iTHRIVE intervention arm | Experimental | iTHRIVE intervention will include access to a digital produce prescription platform, virtual dietitian coaching, a Home blood pressure monitor with App integration, and produce Receives: Behavioral: iTHRIVE intervention |
| Comparator Arm | Active comparator | The active comparator arm will receive enhanced usual care, standard produce bags, general dietary advice, and a home blood pressure monitor Receives: Behavioral: Active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure (mmHg)
Systolic blood pressure measured in millimeters of mercury (mmHg) by the home blood pressure device and in the electronic medical record (EMR)
Measured: Baseline, 3, 6 and 12 months
Secondary outcomes (6)
Hemoglobin A1c (percent)
Hemoglobin A1c
Measured: Baseline, 3, and 6 months
Weight in pounds
Weight will be measured in pounds
Measured: Baseline, 3, 6, and 12 months
Change in Dietary Patterns assessed by 24 hour dietary recall
Change in Dietary Approaches to Stop Hypertension (DASH) adherence scores are summarized from 24-hour dietary recall administered by the investigator. Score range 0-9, higher scores indicate better adherence.
Measured: Baseline and 6 months
Cost effectiveness
Intervention cost/person will be estimated based on the total cost of the intervention and the estimated cost of treatment
Measured: Baseline and 12 weeks
Cultural appropriateness and acceptability assessed by Cultural Sensitivity Assessment Tool
Self-reported acceptance of Data Apps using Cultural Sensitivity Assessment Tool ( CSAT) with a score range of 1 to 4. A score of 2.5 is the cut-off score for acceptability
Measured: Baseline, 6 and 12 months
Height in inches
Height will be measured in inches
Measured: Baseline, 3,6 and 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start25 Jun 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion20 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Oluwabunmi Ogungbe, PhD, MPH, RN, Principal investigator, Johns Hopkins School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075588
- Sponsor's protocol ID
- IRB00457380
- Other IDs
- 25CDA1453103
- Acronym
- iTHRIVE
- Status last verified
- Jun 2026
- First submitted
- 17 Jul 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Free-choice Marketplace, dieTitian coacHing, cultuRally Tailored messagIng to improVE Blood Pressure
- ClinicalTrials.gov ID
- NCT07075588
- Acronym / sponsor ID
- iTHRIVE / IRB00457380
- Keywords
- Digital Farmacy, DASH Diet, Personalized dietitian coaching
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- American Heart Association, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 25 Jun 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 20 Mar 2028 (estimated)
- First posted
- 20 Jul 2025 (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.
iTHRIVE intervention is a 2-arm randomized controlled trial testing the effects of digital FARMacy, personalized dietitian coaching with produce prescriptions, and home blood pressure measurement in 100 hypertensive adults living in high food priority areas in counties in Maryland.
Detailed description
Cardiovascular-kidney-metabolic (CKM) syndrome is a devastating public health crisis that affects nearly 90% of US adults. CKM accounts for >30% of all US deaths and >5 million hospitalizations annually and imposes an annual economic burden of ≥$1 trillion, with a disproportionate impact on Black, Hispanic adults. Inequitable access to care, high-quality food, culturally tailored dietitian support, and living in "food deserts" (also known as Healthy Food Priority Areas (HFPAs) exacerbate CKM disparities. Innovative approaches are urgently needed to sustainably improve food access and CKM health of Black and Hispanic adults.
More than three times as many Black adults (31%) in Baltimore City live in HFPAs compared to White adults (9%). About 45% of households in Montgomery County earn less than the self-sufficiency standard, 64% of Supplemental Nutrition Assistance Program (SNAP)-eligible adults are unenrolled, the highest rate in MD. In 2022, 48% of Prince George's County residents lived in HFPAs. Reasons for these disparities are complex and comprise factors at the individual, provider, community, and systemic levels.
Evidence-based interventions that improve CKM health include personalized dietitian coaching, home blood pressure monitoring (HBPM), and culturally tailored messages. Digital interventions could improve access to dietitians and fruits/vegetables (f/v) through digital "FARMacy" (akin to a virtual farmers market). Implementation strategies for the delivery of these digital interventions are critical gaps, and clinic integration remains unclear. Digital FARMacy platforms offer potential for increased reach and engagement-relative effectiveness and implementation approach have not been explored.
The investigators propose to test the effects of iTHRIVE using a randomized controlled trial among 100 adult participants living in HFPAs in MD counties with uncontrolled BP defined as systolic blood pressure (SBP) ≥130 milimiters of mercury (mmHg) and diabetes or moderate risk chronic renal disease. Participants will be randomized to either iTHRIVE (digital FARMacy, personalized dietitian coaching with produce prescription [PRx], and HBPM) or enhanced usual care (EUC, general dietary advice, standard food bags). The investigators will assess the effectiveness of iTHRIVE in improving systolic blood pressure at 6 months and evaluate the reach, adoption, implementation, maintenance, and budget impact of iTHRIVE
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iTHRIVE intervention arm | Experimental | Behavioral: iTHRIVE interventioniTHRIVE intervention will include access to a digital produce prescription platform, virtual dietitian coaching, a Home blood pressure monitor with App integration, and produce |
| Comparator Arm | Active comparator | Behavioral: Active comparatorThe active comparator arm will receive enhanced usual care, standard produce bags, general dietary advice, and a home blood pressure monitor |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 21-70 years
- Self-identify as Black/African American or Hispanic/Latino
- Have Stage 2 CKM defined as:
- Systolic BP ≥130mmHg (measured at screening) AND at least one of:
- Hypertension (ICD-10: I10-I16)
Key exclusion criteria (9 listed)
- Age <21 years
- Diagnosis of end-stage renal disease (ESRD), dialysis
- Serious medical condition that either limits life expectancy or requires active management (e.g., cancer)
- Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence
- Active alcohol or substance use disorder (i.e., not sober/abstinent for ≥ 30 days)
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 |
|---|---|---|
| iTHRIVE interventionIntegration of three traditionally siloed components: 1. Digitally enabled food access 2. Personalized nutrition support 3. Clinical care-rision of home blood pressure device with app | Behavioural | iTHRIVE intervention arm |
| Active comparatorActive comparator arm will receive enhanced usual care that consists of: 1. Standard produce bag 2. Home blood pressure Device without app 3. General dietary advice | Behavioural | Comparator Arm |
Primary outcome
Systolic blood pressure (mmHg)
Time frame: Baseline, 3, 6 and 12 months
Systolic blood pressure measured in millimeters of mercury (mmHg) by the home blood pressure device and in the electronic medical record (EMR)
6 secondary outcomes
Hemoglobin A1c (percent)
Time frame: Baseline, 3, and 6 months
Weight in pounds
Time frame: Baseline, 3, 6, and 12 months
Change in Dietary Patterns assessed by 24 hour dietary recall
Time frame: Baseline and 6 months
Cost effectiveness
Time frame: Baseline and 12 weeks
Cultural appropriateness and acceptability assessed by Cultural Sensitivity Assessment Tool
Time frame: Baseline, 6 and 12 months
Height in inches
Time frame: Baseline, 3,6 and 12months
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 30 Jun 2026.
- Individual participant dataSharing planned: No
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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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.
Oluwabunmi Ogungbe, PhD, MPH, RN principal investigator
Johns Hopkins School of Nursing
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTHRIVE intervention and Active comparator in people with Hypertension and Hypertension Complicated With Type 2 Diabetes, run by Johns Hopkins University at 3 sites 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 12 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Oluwabunmi Ogungbe, PhD, MPH, RN (410-614-1519, oogungb3@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (mmHg) (time frame: Baseline, 3, 6 and 12 months). 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 30 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.