Grocery Delivery Intervention for High Blood Pressure

(GoFreshRx Trial)

Overseen By Ruth-Alma Turkson-Ocran, PhD, FNP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Must be taking: Antihypertensives

Must not be taking: SGLT2 inhibitors, Stimulants, others

Disqualifiers: Diabetes, Cardiovascular disease, Cancer, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether home delivery of healthy groceries can lower high blood pressure in Black adults living in specific Boston neighborhoods. Participants will receive groceries aligned with a DASH diet, known to aid in blood pressure management, for 12 weeks, along with guidance from a dietitian. This trial suits individuals with high blood pressure who are taking medication and reside in a Boston area food desert. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance access to healthy foods and effectively manage blood pressure.

Will I have to stop taking my current medications?

The trial requires that you stay on stable doses of your current hypertension medications. If your medication doses have been unstable in the last 6 months, you may not be eligible to participate.

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

Research has shown that the DASH diet safely and effectively lowers blood pressure. This eating plan, rich in fruits, vegetables, and low-fat dairy, is generally easy for most people to follow. Reports of negative effects from the DASH diet are rare.

In similar studies where participants received groceries based on the DASH diet with dietitian support, no major safety issues emerged. This method, which involves grocery delivery with dietitian assistance, primarily aims to simplify healthy eating, thereby aiding in blood pressure reduction.

Overall, evidence suggests that this grocery delivery method is safe for individuals with high blood pressure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how a dietitian-assisted grocery delivery system can help manage high blood pressure, a fresh approach compared to typical medication or lifestyle advice. Unlike standard treatments that often rely on medications or generic dietary guidelines, this intervention provides personalized grocery planning and delivery with expert guidance, making it easier for participants to follow the DASH (Dietary Approaches to Stop Hypertension) diet. The hands-on support and convenience of tailored grocery delivery might encourage better adherence to a balanced diet, potentially leading to more effective blood pressure control.

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

Research shows that the DASH diet effectively lowers blood pressure. This trial will compare two approaches: Dietitian-Assisted DASH groceries and Self-directed shopping. In the Dietitian-Assisted DASH groceries arm, participants receive groceries and guidance from a dietitian to follow the DASH diet, which includes plenty of fruits, vegetables, and low-fat dairy products. Studies have proven that this diet can significantly reduce systolic blood pressure. The Self-directed shopping arm provides participants with a monthly stipend and basic healthy eating information. Research indicates that the DASH diet lowers blood pressure more effectively than regular diet changes, especially when sodium intake stays below 2400 mg per day. This method has been more successful than standard care in improving blood pressure and overall heart health. ^{1 3 4 6 7}

Who Is on the Research Team?

Stephen P Juraschek, MD, PhD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for Black adults in Boston with treated high blood pressure, living in food deserts. Participants must be stable on hypertension meds, able to get and cook home-delivered groceries, and have internet access. Excluded are those with severe kidney issues, recent significant weight changes, diabetes, certain serious illnesses or conditions including active cardiovascular disease.

Inclusion Criteria

I can get groceries delivered or pick them up and will only eat these for 12 weeks.

Have access to refrigeration, cooking appliances, and Wi-Fi/cellular service

Self-reported/self-identified as Black or African American

Exclusion Criteria

Lifestyle and Other Exclusions: Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence, Consumption of more than 14 alcoholic drinks per week or consumption of more than 6 drinks on one or more occasion per week, Active substance use disorder that would interfere with participation, Extreme food insecurity, Participation in or planning to start weight loss program, Current participation in another clinical trial that could interfere with the study protocol, Anticipated change in residence prior to the end of the study, Families with more than 6 adults at dinner time (children are considered to be half an adult), Investigator discretion

I haven't changed my blood pressure, asthma, COPD, or hormone medications in the last 6 months.

Physical Exclusions: Systolic blood pressure ≥150 mm Hg or diastolic blood pressure ≥100 mm Hg, Body weight >420 pounds, Arm circumference >50cm, Weight loss or gain of >5.0% of body weight during prior 2 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either dietitian-assisted DASH grocery delivery or a monthly stipend for self-directed shopping over a 12-week period

12 weeks

Weekly virtual or phone sessions for grocery orders

Observation

Participants are monitored for maintenance of dietary changes without the provision of groceries or stipend

9 months

In-person assessments at 3 and 9 months, phone visit at 9 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

3 months

In-person assessments and qualitative interviews

What Are the Treatments Tested in This Trial?

Interventions

• Dietitian-Assisted DASH groceries
• Self-directed shopping

Trial Overview

The GoFreshRx trial is examining if a DASH-patterned grocery delivery service can lower blood pressure among Black adults being treated for hypertension. It's a randomized study where some will receive dietitian-assisted shopping while others shop themselves.

How Is the Trial Designed?

Group I: Dietitian-Assisted DASH groceries Experimental Treatment 1 Intervention

Participants will order groceries sufficient to meet their caloric needs each week for 12 weeks with the assistance of a dietitian/nutrition interventionist. Groceries will be delivered to participants' homes or picked up at a convenient location. The dietitian/nutrition interventionist will provide brief educational content at the time of food delivery. Orders will be placed via phone or through virtual counseling sessions. During the remainder of the study (months 4-12), participants will be asked to apply what they learned without the provision of groceries.

Group II: Self-directed shopping (referent assignment) Active Control 1 Intervention

Participants will receive a monthly stipend over a 3 month period and some basic information about healthy eating. The stipend is not restricted to foods. During the remainder of the study (months 4-12), participants will be asked to continue their typical shopping without the provision of the monthly stipend.

Dietitian-Assisted DASH groceries is already approved in United States, Canada, European Union for the following indications:

Approved in United States as DASH Diet for:

• Hypertension
• High Blood Pressure

Approved in Canada as DASH Diet for:

• Hypertension
• High Blood Pressure

Approved in European Union as DASH Diet for:

• Hypertension
• High Blood Pressure

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

The DASH diet is effective in lowering blood pressure, but studies show that compliance with the diet is often suboptimal, especially in educational interventions compared to controlled feeding trials.

There is no consensus on the best method to assess compliance with the DASH diet, highlighting the need for more effective strategies to maintain adherence beyond just dietary counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance with the Dietary Approaches to Stop Hypertension (DASH) diet: a systematic review. Kwan, MW., Wong, MC., Wang, HH., et al.[2023]

In a study of 144 overweight or obese adults with high blood pressure, those following the DASH diet alone or with weight management experienced significant reductions in blood pressure compared to those on a usual diet, highlighting the diet's efficacy as a nonpharmacologic treatment.

Greater adherence to the DASH diet was linked to larger decreases in blood pressure, and the study found that African Americans had lower adherence rates, suggesting the need for culturally tailored dietary strategies to improve compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants and consequences of adherence to the dietary approaches to stop hypertension diet in African-American and white adults with high blood pressure: results from the ENCORE trial. Epstein, DE., Sherwood, A., Smith, PJ., et al.[2022]

The DASH diet, which emphasizes fruits, vegetables, and low-fat dairy, has been shown to effectively lower blood pressure in individuals with prehypertension and stage I hypertension, based on findings from the DASH trial.

While the DASH diet is generally safe for most patients, caution is advised for those with chronic kidney or liver diseases, and modifications may be needed for individuals with chronic heart failure, uncontrolled diabetes, lactose intolerance, or celiac disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Dietary Approaches to Stop Hypertension (DASH) eating pattern in special populations. Tyson, CC., Nwankwo, C., Lin, PH., et al.[2021]

The DASH Quality (DASH-Q) measure was developed and validated to assess adherence to the DASH diet among adults, showing good internal consistency (α = .77-.83) across two diverse samples totaling 812 participants.

The DASH-Q demonstrated strong correlations with existing nutrition scales and behaviors, indicating its effectiveness as a reliable tool for evaluating diet quality and adherence to the DASH diet, which is important for managing chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric Validation of a Brief Self-report Measure of Diet Quality: The DASH-Q. Warren-Findlow, J., Reeve, CL., Racine, EF.[2018]

The DASH diet, which emphasizes fruits, vegetables, nuts, and low-fat dairy while reducing saturated fats, led to an average reduction of 6 mmHg in systolic and 3 mmHg in diastolic blood pressure among patients, with even greater reductions in those with high blood pressure.

These significant blood pressure reductions were observed within just 2 weeks of starting the diet, indicating its potential effectiveness for managing hypertension in a primary care setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Approaches to Stop Hypertension (DASH) in clinical practice: a primary care experience. Kolasa, KM.[2020]

The DASH diet, which focuses on fruits, vegetables, low-fat dairy, whole grains, nuts, fish, and poultry while reducing fats and sugars, has been shown to effectively lower blood pressure, as demonstrated in the DASH clinical trial.

Healthcare practitioners, including dietitians, play a crucial role in helping individuals adopt the DASH diet by addressing ambivalence, enhancing motivation, and providing tailored dietary advice to fit personal lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating the Dietary Approaches to Stop Hypertension diet from research to practice: dietary and behavior change techniques. DASH Collaborative Research Group. Windhauser, MM., Ernst, DB., Karanja, NM., et al.[2019]

A study of 2,831 adults in Iran found that adherence to the DASH diet is associated with lower levels of cardiovascular risk factors, including blood pressure, fasting blood sugar, triglycerides, and cholesterol.

Specifically, individuals in the highest quintile of DASH diet adherence had a 28% lower odds of hyperglycemia, suggesting that the DASH diet may be effective in reducing the risk of diabetes and other cardiovascular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association between DASH Diet Adherence and Cardiovascular Risk Factors. Shoaibinobarian, N., Danehchin, L., Mozafarinia, M., et al.[2023]

The DASH-Dinner with Your Nutritionist intervention, involving 82 low-income African American adults over 8 weeks, effectively lowered blood pressure in participants who attended most sessions, highlighting its potential efficacy.

This program, based on the DASH diet and Social Cognitive Theory, suggests that community-based interventions can help improve blood pressure control and reduce health disparities in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Approaches to Stop Hypertension (DASH) intervention reduces blood pressure among hypertensive African American patients in a neighborhood health care center. Rankins, J., Sampson, W., Brown, B., et al.[2022]

A 2-month intervention led by a nurse practitioner for 45 overweight and obese hypertensive patients resulted in significant improvements in diet and lifestyle, as measured by standardized questionnaires.

Participants experienced an average weight loss of 3.6 pounds, indicating that the DASH diet and lifestyle changes were effective in promoting better health outcomes in this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting cardiovascular risk reduction in overweight and obese hypertensive patients through DASH diet and lifestyle education by primary care nurse practitioners. Jarl, J., Tolentino, JC., James, K., et al.[2021]

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