iTHRIVE Intervention for High Blood Pressure

(iTHRIVE Trial)

Overseen By Yvonne Commodore-Mensah, PhD, MHS, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Esrd, Cancer, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to managing high blood pressure using digital tools, personalized diet coaching, and home blood pressure monitoring (iTHRIVE intervention). Researchers aim to determine if these methods can improve health for people with hypertension, particularly those in areas with limited access to healthy food. The study includes two groups: one receiving the new digital support and another receiving standard care with some dietary advice. Suitable participants have high blood pressure, possibly diabetes or kidney disease, and live in specific areas of Maryland with limited access to supermarkets and other resources. As an unphased trial, this study presents a unique opportunity to explore innovative health solutions that could significantly enhance quality of life.

Do I have to stop taking my current medications for the iTHRIVE trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that managing blood pressure more aggressively can be safe and effective. One study found that people receiving this intense treatment experienced similar outcomes to those receiving regular care, indicating no increase in side effects compared to usual methods.

The iTHRIVE program includes digital tools and guidance from a dietitian, which are generally safe and well-tolerated. Sources report no specific harm from these components of the iTHRIVE program.

Since this trial is not in a specific phase, it may be in the early stages of testing, which could mean limited safety data. However, using tools like home blood pressure monitors and receiving dietary advice is typically safe. If there are concerns, consulting a healthcare provider can help determine if this trial is suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the iTHRIVE intervention because it offers a fresh approach to managing high blood pressure by integrating digital health tools with personalized dietary support. Unlike traditional treatments that often rely solely on medication, iTHRIVE combines access to a digital produce prescription platform, virtual dietitian coaching, and a home blood pressure monitor with app integration. This holistic approach aims to empower patients to make sustainable lifestyle changes, potentially improving blood pressure control through diet and technology, rather than relying solely on medication.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

Research shows that the iTHRIVE program, which participants in this trial may receive, might help lower blood pressure. In an earlier study, a similar program reduced the systolic blood pressure by an average of 3.5 points, a significant change. Another similar program showed a decrease of 2.5 points over 12 weeks. These results suggest that personalized diet coaching combined with home monitoring could effectively manage high blood pressure. Although all details are not yet known, early results appear promising for those seeking to control high blood pressure. ^{1 5 6 7 8}

Who Is on the Research Team?

Oluwabunmi Ogungbe, PhD, MPH, RN

Principal Investigator

Johns Hopkins School of Nursing

Are You a Good Fit for This Trial?

This trial is for Black/African American or Hispanic/Latino adults aged 21-70 living in certain Maryland areas with limited access to healthy foods. Participants must have high blood pressure, possibly alongside prediabetes, type 2 diabetes, or mild kidney disease. Exclusions include active substance abuse, significant dietary restrictions, pregnancy, other clinical trials participation, plans to move soon, cognitive impairments preventing intervention adherence and severe medical conditions.

Inclusion Criteria

Self-identify as Black/African American or Hispanic/Latino

Live in census tracts identified by the Montgomery/Prince George's/Baltimore City County Departments of Planning as HFPA with specific criteria related to Healthy Food Availability Index score, Median household income, vehicle ownership, distance to supermarket, and possession of refrigeration, food preparation appliances, and cell phones for the App

I am between 21 and 70 years old.

Exclusion Criteria

Active alcohol or substance use disorder (i.e., not sober/abstinent for ≥ 30 days)

I am under 21 years old.

I have food allergies or dietary needs that affect my diet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the iTHRIVE intervention or enhanced usual care, including digital FARMacy access, dietitian coaching, and home blood pressure monitoring

6 months

Regular virtual visits for dietitian coaching and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of blood pressure, dietary patterns, and cultural appropriateness

6 months

Follow-up assessments at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Active comparator
• iTHRIVE intervention

Trial Overview The iTHRIVE intervention tests a digital 'FARMacy', personalized dietitian coaching with produce prescriptions against an active comparator in hypertensive adults. The study aims to see if these interventions can improve blood pressure when participants are given tools like home BP monitors and live in food priority areas.

How Is the Trial Designed?

Group I: iTHRIVE intervention arm Experimental Treatment 1 Intervention

iTHRIVE intervention will include access to a digital produce prescription platform, virtual dietitian coaching, a Home blood pressure monitor with App integration, and produce

Group II: Comparator Arm Active Control 1 Intervention

The active comparator arm will receive enhanced usual care, standard produce bags, general dietary advice, and a home blood pressure monitor

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07075588

Integrating Free-choice Marketplace, dieTitian coacHing, ... The investigators will assess the effectiveness of iTHRIVE in improving systolic blood pressure at 6 months and evaluate the reach, adoption ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11971814/

results of the HALCYON randomized controlled trial - PMC The observed reduction in SBP of −3.5 mmHg is consistent with effect sizes reported in similar intervention trials and suggests a clinically ...

3. withpower.com withpower.com/trial/thrive-program-for-high-blood-pressure-7a1e7

THRIVE Program for High Blood Pressure A 12-week salt reduction program significantly lowered blood pressure in adults, with an average decrease of -2.5 mm Hg in systolic blood pressure and -2.7 mm ...

4. ahajournals.org ahajournals.org/doi/10.1161/JAHA.125.041846

Applications of Human‐Centered Design to Food Is ... ... effectiveness. Secondary clinical outcomes in the THRIVE pilot study currently involve changes in blood pressure, medication adherence ...

5. evtoday.com evtoday.com/news/sonivie-gains-ide-approval-for-thrive-pivotal-trial-of-tivus-rdn-system

SoniVie Gains IDE Approval for THRIVE Pivotal Trial of ... The responder ASBP 3-month average reduction was -16.2mmHg. No device-related adverse events were reported in the 1-month primary safety ...

6. withpower.com withpower.com/trial/phase-hypertension-10-2025-1400c

iTHRIVE Intervention for High Blood Pressure iTHRIVE intervention is a 2-arm randomized controlled trial testing the effects of digital FARMacy, personalized dietitian coaching with produce ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12327570/

Impact of Intensive Blood Pressure Control Versus Standard ... This is shown by our results, which indicate that intensive blood pressure control lowers the risk of hypertension-related complications by 20%, ...

8. nejm.org nejm.org/doi/full/10.1056/NEJMoa1611179

Effect of Intensive Blood-Pressure Treatment on Patient ... Patient-reported outcomes among participants who received intensive treatment, which targeted a systolic blood pressure of less than 120 mm Hg, were similar