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

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests if delivering healthy groceries can help lower blood pressure in Black adults living in areas with limited healthy food options.

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 the DASH diet safe for humans?

The DASH diet, which is rich in fruits, vegetables, and low-fat dairy, is generally safe for most people and can help lower blood pressure. However, people with certain conditions like chronic kidney or liver disease should be cautious and may need to adjust the diet. ^{1 2 3 4 5}

How is the Dietitian-Assisted DASH groceries treatment different from other treatments for high blood pressure?

This treatment is unique because it involves delivering groceries that align with the DASH diet, which is rich in fruits, vegetables, and low-fat dairy, directly to patients, making it easier for them to follow a heart-healthy eating plan. Unlike medications, this approach focuses on dietary changes to naturally lower blood pressure. ^{1 3 4 6 7}

What data supports the effectiveness of the treatment Dietitian-Assisted DASH groceries, DASH Diet, Dietary Approaches to Stop Hypertension, DASH Eating Plan, Self-directed shopping for high blood pressure?

Research shows that the DASH diet, which focuses on eating fruits, vegetables, and low-fat dairy while reducing fats and sweets, can significantly lower blood pressure. This diet is recommended for managing high blood pressure, and having a dietitian assist with grocery choices can help people stick to the diet more effectively. ^{1 3 4 8 9}

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

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, 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]

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]

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]

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]

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-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 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]

Citations

1. United States 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. [2022]

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

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

3. United States 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. [2021]

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

Compliance with the Dietary Approaches to Stop Hypertension (DASH) diet: a systematic review. [2023]

5. United States 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. [2019]

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

The Dietary Approaches to Stop Hypertension (DASH) eating pattern in special populations. [2021]

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

Psychometric Validation of a Brief Self-report Measure of Diet Quality: The DASH-Q. [2018]

8. United States 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. [2022]

9. Iran pubmed.ncbi.nlm.nih.gov

The Association between DASH Diet Adherence and Cardiovascular Risk Factors. [2023]