HypertensionTHRIVENCT06257550
AdapTive Personalized Dietitian coacHing, Messaging and pRoduce prescrIption to improVE Healthy Dietary Behaviors
A study testing THRIVE Intervention and Active Comparator in people with Hypertension, run by Johns Hopkins University at 1 site in United States.
Trial summary
THRIVE intervention is a 2-arm randomized pilot trial testing the feasibility and preliminary efficacy of producing prescriptions, tailored dietitian counseling with adaptive messages, and linkages to social resources among 80 Black adults with hypertension. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- THRIVE 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
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Self-identify as Black/African American
- Have diagnosed hypertension stages 1 (130-139/80-89 mm Hg) OR 2 (>140/90 mm Hg), determined via self-report and/or Electronic Medical Records (EMR)
- Live in census tracts identified by Montgomery County Department of Planning as HFPA:
- Healthy Food Availability Index score is low (0-9.5),
- Median household income ≤185% of Federal Poverty Level
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- >30% households have no vehicle, Distance to supermarket >1/4 mile.
- Participants must have refrigeration, food appliances (microwave, stove),
- Cell phone to receive messages
Who cannot join
- Age <18 years
- Type 1 or Type 2 Diabetes defined as a hemoglobin A1c ≥6.5% or diabetes treatment
- Diagnosis of end-stage renal disease (ESRD)
- Condition which interferes with outcome measurement (e.g., dialysis)
- Serious medical condition which 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
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- Patients with cognitive impairment or other condition preventing their participation in the intervention
- Current participation in a care management program related to health conditions (e.g., weight reduction, smoking cessation)
- Current participation in another clinical trial that could interfere with the study protocol
- Those planning to move out of the geographic area in 12 months
- Unwillingness to provide informed consent
- Other conditions or situations at the discretion of the Investigative team
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THRIVE: AdapTive Personalized Dietitian coacHing, Messaging and pRoduce prescrIption to improVE Healthy Dietary Behaviors
THRIVE intervention is a 2-arm randomized pilot trial testing the feasibility and preliminary efficacy of producing prescriptions, tailored dietitian counseling with adaptive messages, and linkages to social resources among 80 Black adults with hypertension.
Read the detailed description
Nearly 55% of Black adults have hypertension and uncontrolled blood pressure. Dietary Approaches to Stop Hypertension (DASH) promotes a dietary pattern rich in fruits and vegetables (fruits and vegetables), low-fat dairy, lean meats with reduced saturated fat, and sweets, which is effective in lowering blood pressure. The proposed THRIVE intervention will enroll 80 Black adults with hypertension living in Healthy Food Priority Areas (HFPAs) in a 2-arm randomized pilot study. One group will receive Produce prescriptions, personalized dietitian coaching, and adaptive bi-directional messaging; the other group will receive standard produce bags. Both groups will be linked to needed social services.
The investigators will assess changes in overall DASH adherence, acceptability, and feasibility at 3- and 6-months post-randomization. The investigators will: 1) Develop and beta test THRIVE among Black adults with hypertension living in HFPAs; 2) Test feasibility and preliminary efficacy of THRIVE at 6 \& 12 weeks; 3) Determine short-term sustainability of THRIVE at 6 months.
- Conditions
- Hypertension
- Being tested
- THRIVE Intervention, Active Comparator
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRIVE InterventionBehavioural
THRIVE Intervention includes:
- Weekly Pulse Surveys
- Adaptive culturally tailored messages
- Personalized Dietitian Coaching
- Produce Prescription "FARMacy" Mobile Market
- Linkages to Social Services
Active ComparatorBehavioural
The Active Comparator arm will receive standard produce bags through our food is medicine partner, and will receive the linkages to needed social and health resources intervention components.
| Study group | Role | What they receive |
|---|---|---|
| THRIVE Intervention Arm | Experimental | The THRIVE intervention arm will receive produce prescription, personalized dietitian coaching, adaptive bi-directional messaging; and linkages to social services. Receives: Behavioral: THRIVE Intervention |
| Comparator Arm | Active comparator | The comparator arm will receive standard produce bags; and linkages to social services. Receives: Behavioral: Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH Adherence as assessed by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)
Adherence will be assessed by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24). The scores range from 0 to 100, with higher scores reflecting greater adherence.
Measured: 0, 12 weeks and 24 weeks
Secondary outcomes (9)
Recruitment rate
Recruitment yield per time
Measured: 0, 12 weeks, 24 weeks
Cost of the intervention
Intervention cost/person will be estimated based on the cost of the intervention
Measured: 0, 12 weeks, 24 weeks
Participant Accrual
Referrals, participation rates, and recruitment yields.
Measured: 0, 12 weeks and 24 weeks
Number of referrals to health and social need resources
Social needs as assessed by the number of participants connected to health services and services for social needs.
Measured: 0, 12 weeks and 24 weeks
Systolic Blood pressure
Blood pressure measured in millimeters of mercury (mmHg)
Measured: 0, 12 and 24 weeks
Diastolic Blood pressure
Blood pressure measured in millimeters of mercury (mmHg)
Measured: 0, 12 and 24 weeks
Hemoglobin A1c
Hemoglobin A1c (percent)
Measured: 0, 12 and 24 weeks
Height in inches
Height will be measured
Measured: 0, 12 and 24 weeks
Weight in pounds
Weight will be measured
Measured: 0, 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start10 Jun 2024
- Primary completion20 Oct 2025
- Study completion31 Oct 2025
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Oluwabunmi Ogungbe, PhD, MPH, RN, Principal investigator, JHU School Of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257550
- Sponsor's protocol ID
- IRB00427492
- Other IDs
- 24FIM1264121
- Acronym
- THRIVE
- Status last verified
- Nov 2025
- First submitted
- 5 Feb 2024
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THRIVE: AdapTive Personalized Dietitian coacHing, Messaging and pRoduce prescrIption to improVE Healthy Dietary Behaviors
- ClinicalTrials.gov ID
- NCT06257550
- Acronym / sponsor ID
- THRIVE / IRB00427492
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 14 Feb 2024 (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.
THRIVE intervention is a 2-arm randomized pilot trial testing the feasibility and preliminary efficacy of producing prescriptions, tailored dietitian counseling with adaptive messages, and linkages to social resources among 80 Black adults with hypertension.
Detailed description
Nearly 55% of Black adults have hypertension and uncontrolled blood pressure. Dietary Approaches to Stop Hypertension (DASH) promotes a dietary pattern rich in fruits and vegetables (fruits and vegetables), low-fat dairy, lean meats with reduced saturated fat, and sweets, which is effective in lowering blood pressure. The proposed THRIVE intervention will enroll 80 Black adults with hypertension living in Healthy Food Priority Areas (HFPAs) in a 2-arm randomized pilot study. One group will receive Produce prescriptions, personalized dietitian coaching, and adaptive bi-directional messaging; the other group will receive standard produce bags. Both groups will be linked to needed social services.
The investigators will assess changes in overall DASH adherence, acceptability, and feasibility at 3- and 6-months post-randomization. The investigators will: 1) Develop and beta test THRIVE among Black adults with hypertension living in HFPAs; 2) Test feasibility and preliminary efficacy of THRIVE at 6 \& 12 weeks; 3) Determine short-term sustainability of THRIVE at 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THRIVE Intervention Arm | Experimental | Behavioral: THRIVE InterventionThe THRIVE intervention arm will receive produce prescription, personalized dietitian coaching, adaptive bi-directional messaging; and linkages to social services. |
| Comparator Arm | Active comparator | Behavioral: Active ComparatorThe comparator arm will receive standard produce bags; and linkages to social services. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years or older
- Self-identify as Black/African American
- Have diagnosed hypertension stages 1 (130-139/80-89 mm Hg) OR 2 (>140/90 mm Hg), determined via self-report and/or Electronic Medical Records (EMR)
- Live in census tracts identified by Montgomery County Department of Planning as HFPA:
- Participants must have refrigeration, food appliances (microwave, stove),
Key exclusion criteria (12 listed)
- Age <18 years
- Type 1 or Type 2 Diabetes defined as a hemoglobin A1c ≥6.5% or diabetes treatment
- Diagnosis of end-stage renal disease (ESRD)
- Condition which interferes with outcome measurement (e.g., dialysis)
- Serious medical condition which either limits life expectancy or requires active management (e.g. cancer)
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 |
|---|---|---|
| THRIVE InterventionTHRIVE Intervention includes: 1. Weekly Pulse Surveys 2. Adaptive culturally tailored messages 3. Personalized Dietitian Coaching 4. Produce Prescription "FARMacy" Mobile Market 5. Linkages to Social Services | Behavioural | THRIVE Intervention Arm |
| Active ComparatorThe Active Comparator arm will receive standard produce bags through our food is medicine partner, and will receive the linkages to needed social and health resources intervention components. | Behavioural | Comparator Arm |
Primary outcome
DASH Adherence as assessed by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)
Time frame: 0, 12 weeks and 24 weeks
Adherence will be assessed by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24). The scores range from 0 to 100, with higher scores reflecting greater adherence.
9 secondary outcomes
Recruitment rate
Time frame: 0, 12 weeks, 24 weeks
Cost of the intervention
Time frame: 0, 12 weeks, 24 weeks
Participant Accrual
Time frame: 0, 12 weeks and 24 weeks
Number of referrals to health and social need resources
Time frame: 0, 12 weeks and 24 weeks
Systolic Blood pressure
Time frame: 0, 12 and 24 weeks
Diastolic Blood pressure
Time frame: 0, 12 and 24 weeks
Hemoglobin A1c
Time frame: 0, 12 and 24 weeks
Height in inches
Time frame: 0, 12 and 24 weeks
Weight in pounds
Time frame: 0, 12 weeks and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
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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. This study is not recruiting at the moment.
Oluwabunmi Ogungbe, PhD, MPH, RN principal investigator
JHU School Of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THRIVE Intervention and Active Comparator in people with Hypertension, run by Johns Hopkins 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 9 inclusion and 12 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: finished, as of the sponsor's last update on 5 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DASH Adherence as assessed by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) (time frame: 0, 12 weeks and 24 weeks). 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 2025.