THRIVE Program for High Blood Pressure

(THRIVE Trial)

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

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Diabetes, End-stage renal disease, Cancer, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to manage high blood pressure in Black adults. It compares two groups: one receives personalized coaching from a dietitian, special messages, and assistance in finding social resources, while the other receives standard produce bags and resource links. This approach is part of the THRIVE Intervention, which aims to determine if these strategies improve blood pressure control. Eligible participants have high blood pressure, live in areas with limited access to healthy food, and meet other criteria such as owning a cell phone and basic kitchen appliances. As an unphased trial, this study provides a unique opportunity to explore innovative strategies for managing high blood pressure.

Will I have to stop taking my current medications?

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

What prior data suggests that the THRIVE intervention is safe for Black adults with hypertension?

Research has shown that the THRIVE treatment is generally well-tolerated. One study found that participants experienced a noticeable drop in blood pressure. Importantly, the study reported no serious side effects related to the treatment, indicating that participants did not experience significant negative reactions. Additionally, the THRIVE treatment has been tested in various situations, and the available data has revealed no safety issues. This suggests that the treatment is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the THRIVE intervention for high blood pressure because it goes beyond traditional medication by incorporating lifestyle changes and personalized support. Unlike standard care, which typically involves medication like ACE inhibitors or beta-blockers, THRIVE includes a produce prescription, personalized coaching from dietitians, and interactive messaging to help manage blood pressure through diet and lifestyle. This comprehensive approach not only addresses the symptoms but also empowers patients with tools and knowledge for long-term health improvements. Additionally, by linking participants to social services, THRIVE tackles the social determinants of health, making it a holistic approach to managing high blood pressure.

What evidence suggests that the THRIVE intervention could be effective for high blood pressure?

Research has shown that personalized advice from dietitians and access to fresh produce can help manage high blood pressure. In this trial, participants in the THRIVE Intervention Arm will receive produce prescriptions, personalized dietitian coaching, adaptive bi-directional messaging, and connections to social services. One study demonstrated that a similar 12-week program led to an average drop of 2.5 mm Hg in the top number of blood pressure readings. Another study found a noticeable decrease in blood pressure with different treatment methods, highlighting the potential of these approaches. Although one trial did not show a significant difference compared to a control group, both groups still experienced a meaningful drop in blood pressure. These findings suggest that personalized dietary changes and support may help lower blood pressure in adults with hypertension. ^{1 2 3 4 6}

Who Is on the Research Team?

Oluwabunmi Ogungbe, PhD, MPH, RN

Principal Investigator

JHU School Of Nursing

Are You a Good Fit for This Trial?

This trial is for Black adults over 18 with high blood pressure, living in low-income areas with limited access to healthy foods and supermarkets. They must have a kitchen, fridge, cell phone for messages, and diagnosed hypertension but not be severely ill or hospitalized.

Inclusion Criteria

Self-identify as Black/African American

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, >30% households have no vehicle, Distance to supermarket >1/4 mile

I have high blood pressure in the range of stage 1 or 2.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive produce prescriptions, personalized dietitian coaching, and adaptive bi-directional messaging

12 weeks

Regular visits for coaching and monitoring

Follow-up

Participants are monitored for changes in DASH adherence, blood pressure, and other health metrics

12 weeks

Follow-up assessments at 12 and 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• THRIVE Intervention

Trial Overview The THRIVE intervention tests if personalized dietitian coaching, adaptive messaging on phones, and prescriptions for fresh produce can improve diets among participants compared to usual care without these features.

How Is the Trial Designed?

Group I: THRIVE Intervention Arm Experimental Treatment 1 Intervention

The THRIVE intervention arm will receive produce prescription, personalized dietitian coaching, adaptive bi-directional messaging; and linkages to social services.

Group II: Comparator Arm Active Control 1 Intervention

The comparator arm will receive standard produce bags; and linkages to social services.

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+

Published Research Related to This Trial

A community intervention targeting hypertension in predominantly racial/ethnic minority neighborhoods led to significant blood pressure improvements, especially in individuals with severely elevated blood pressure (≥160/100 mmHg), who saw a reduction from 165.4/98.3 mmHg to 150.4/90.8 mmHg.

After 3 months, 55.2% of participants with severely elevated blood pressure achieved controlled levels, demonstrating the effectiveness of education and empowerment strategies in managing hypertension in high-risk communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Targeting of Uncontrolled Hypertension: Results of a Hypertension Screening and Education Intervention in Community Churches Serving Predominantly Racial/Ethnic Minority Populations. Prendergast, HM., Escobar-Schulz, S., Del Rios, M., et al.[2022]

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 Hg in diastolic blood pressure, particularly benefiting those with high-normal blood pressure or hypertension.

While both the salt reduction and healthy lifestyle programs improved blood pressure, the salt reduction program was more effective, highlighting the importance of dietary quality in managing hypertension, especially through adherence to the Mediterranean diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowerment-based nutrition interventions on blood pressure: a randomized comparative effectiveness trial. Moreira-Rosário, A., Ismael, S., Barreiros-Mota, I., et al.[2023]

A peer support program involving Veterans of Foreign Wars posts in Wisconsin effectively trained 27 peer leaders over 18 months to promote self-management of hypertension, with 93% of participating posts remaining active throughout the study.

The program resulted in peer leaders gaining health knowledge and confidence, which enhanced health support among veterans, highlighting the potential of community-based initiatives in improving chronic disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary description of the feasibility of using peer leaders to encourage hypertension self-management. Hayes, A., Morzinski, J., Ertl, K., et al.[2010]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7139215/

Randomized Trial of an Intervention to Improve Blood ... THRIVES intervention did not significantly reduce SBP compared to controls. However, there was similar significant decrease in mean BP in both treatment arms.

2. 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06559891

Study Details | NCT06559891 | THRIVE- THerapeutic ... THRIVE is an international, multicenter, randomized, double blind, sham-controlled study, designed to demonstrate the adjunctive effectiveness and safety of the ...

4. 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 ...

5. 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 ...

6. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.123.21725

Randomized Clinical Outcome Trials in Hypertension By showing that the risk of hypertension decreases progressively down to about 110/70 mm Hg, epidemiological data carried the message that ...