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

60 Participants Needed

Trial Summary

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 data supports the effectiveness of the THRIVE Intervention treatment for high blood pressure?

Research shows that educational programs and lifestyle interventions, like those in the THRIVE Intervention, can help people manage high blood pressure by improving diet, increasing physical activity, and enhancing self-management skills. These approaches have been shown to reduce blood pressure and improve health outcomes, especially in high-risk communities. ^{1 2 3 4 5}

How does the THRIVE Intervention treatment for high blood pressure differ from other treatments?

The THRIVE Intervention is unique because it focuses on community-based empowerment and education, particularly targeting racial/ethnic minority populations. It involves screening, education, and providing resources like blood pressure monitors and information on local health centers, which is different from standard medical treatments that primarily rely on medication. ^{1 5 6 7 8}

What is the purpose of this trial?

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 60 Black adults with hypertension.

Research Team

Oluwabunmi Ogungbe, PhD, MPH, RN

Principal Investigator

JHU School Of Nursing

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Lifestyle educational program strongly increases compliance to nonpharmacologic intervention in hypertensive patients: a 2-year follow-up study. [2021]

2. Jamaica pubmed.ncbi.nlm.nih.gov

Six-month hypertension intervention study. One year follow-up. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Nurse-led interventions in the interim: waiting on universal health coverage. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Preliminary description of the feasibility of using peer leaders to encourage hypertension self-management. [2010]

5. United States 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. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Empowerment-based nutrition interventions on blood pressure: a randomized comparative effectiveness trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of comprehensive lifestyle modification on diet, weight, physical fitness, and blood pressure control: 18-month results of a randomized trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

An approach to primary preventive treatment for children with high blood pressure in a total community. [2019]