Produce Prescription for High Blood Pressure

Not yet recruiting at 2 trial locations
MK
CM
Overseen ByCherese M Kwan
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Hawaii
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a produce prescription program can help Native Hawaiian and Pacific Islander adults in Hawaii manage high blood pressure. Participants receive $100 monthly to buy fruits and vegetables and may also receive one-on-one support from Community Health Workers to address challenges like transportation or cooking skills. The goal is to determine if this additional support improves blood pressure and overall health. Suitable candidates for this trial include adults with high blood pressure who are patients of the participating health centers and face difficulties affording healthy food. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance community health and access to nutritious food.

Do I need to stop my current medications for this 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?

Previous studies have shown that treatments involving Community Health Workers (CHWs) are safe and well-tolerated for managing high blood pressure. Research indicates that these programs effectively lower blood pressure without significant side effects. For example, one study found that systolic blood pressure dropped by 14.5 mmHg over 18 months with CHW assistance, demonstrating this method's safety and effectiveness. Other studies also show that CHWs can help improve patients' blood pressure over time, with no major safety concerns reported. This suggests that support from CHWs in the produce prescription program is likely safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about the Produce Prescription for high blood pressure because it offers a fresh approach by focusing on dietary changes rather than medication. Unlike standard treatments that typically rely on antihypertensive drugs like ACE inhibitors or beta-blockers, this program encourages patients to incorporate more fruits and vegetables into their diets. The unique aspect of this trial is its use of community health workers to provide personalized support and guidance, helping participants navigate and maintain a healthier lifestyle. This focus on diet and community support could lead to sustainable long-term health benefits, making it a promising alternative for managing high blood pressure.

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

Research has shown that Community Health Workers (CHWs) in health programs can significantly aid in managing high blood pressure. One study found that individuals supported by CHWs experienced an average reduction of 6.6 points in their systolic blood pressure. Another study revealed that those with CHW support achieved better blood pressure control than those without it. In this trial, one group will receive a Produce Prescription program along with one-on-one Community Health Worker navigation sessions, while another group will receive only the Produce Prescription program. These findings suggest that the additional support from CHWs, as provided in one of the trial arms, could improve health outcomes for individuals with high blood pressure.13678

Are You a Good Fit for This Trial?

This trial is for Native Hawaiian and Pacific Islander adults in Hawaii, age 20 or older, who are patients at certain health centers. Participants must have high blood pressure (over 130 mmHg) diagnosed by a doctor and currently struggle to afford enough healthy food.

Inclusion Criteria

* patient of the participating health center clinic
I am 20 years old or older.
I have high blood pressure diagnosed by my doctor, with readings over 130 mmHg.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive $100 in vouchers every month for 12 months to redeem for fruits and vegetables, with Group 1 receiving additional support from a Community Health Worker every two months.

12 months
5 visits (in-person) at start, 3, 6, 9, and 12 months

Follow-up

Participants are monitored for changes in blood pressure, fruit and vegetable consumption, and food insecurity status after the treatment phase.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Community Health Worker navigated Produce Prescription
  • Produce Prescription Only

Trial Overview

The study compares two groups: both get $100/month in vouchers or produce boxes for fruits and vegetables for one year. One group also gets regular support from a community health worker to help with challenges like using the vouchers; the other does not receive this extra support.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Community Health Worker Navigated Produce Prescription (Intervention Arm)Experimental Treatment1 Intervention
Group II: Produce Prescription Only (Control Arm)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Hawaii

Lead Sponsor

Trials
122
Recruited
55,200+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials
473
Recruited
1,374,000+

Citations

Produce Prescription for High Blood Pressure

The study has two main goals: (1) to implement a produce prescription program and see if adding personal support from Community Health Workers ( ...

Community Health Workers as Allies in Hypertension Self ...

Fewer than half (47.8%) of CHWs agreed or strongly agreed that their “patients are able to follow their high blood pressure medicine ...

Approaches and outcomes of community health worker's ...

Summarised outcomes of individual studies showed CHW enhanced the control and management of hypertension. Further studies are needed to indicate the impact and ...

Task-sharing with community health workers to treat ... - PMC

One of these studies showed a statistically significant, net mean reduction in SBP of 14.5 mmHg at 18 months [34], suggesting that drug treatment by CHWs has a ...

Community Health Workers as Key Allies in the Global ...

After 6 months at trial completion, BP control was superior in the CHW intervention (68.2%, n=154) compared with control (41.6%, n=137) group (P ...

Outcomes of the Pharmacist and Community Health Worker ...

This study demonstrates that the pharmacist-CHW heart healthy clinic model effectively improves patients' blood pressure over time, regardless ...

Community Health Worker-led Hypertension Management

This study is to determine if hypertension management by community health workers (CHW) supported by a mobile health application and remote physician ...

Community Health Worker Hypertension Survey Findings, ...

About what percentage of your clients take prescribed medication for high blood pressure? 29.0%. 0.0%. 71.1%. Yes. No. Don't know/Not sure. 0%. 10%. 20%. 30%.