Groceries for High Blood Pressure

(GoFreshSE Trial)

Overseen By Stephen P. Juraschek, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Potassium supplements, Warfarin, Insulin, others

Disqualifiers: Cardiovascular disease, Cancer, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a dietitian-assisted grocery delivery program can help lower high blood pressure in adults. One group will receive home-delivered groceries tailored to their dietary needs, guided by a dietitian, while another group will shop for themselves using a stipend and basic healthy eating tips. The trial seeks participants in Florida, Georgia, and Tennessee who have high blood pressure and can commit to eating only the provided groceries for four weeks. Participants must have access to refrigeration, cooking appliances, and the internet to participate fully. As an unphased study, this trial offers a unique opportunity to contribute to innovative dietary research that could improve heart health.

Will I have to stop taking my current medications?

The trial requires that you do not have unstable doses of certain medications, like anti-hypertension drugs, in the 6 months before starting. You also cannot use specific medications like potassium supplements (unless in a multivitamin) or warfarin. It's best to discuss your current medications with the study team to see if they are compatible.

What prior data suggests that this grocery intervention is safe for adults with high blood pressure?

Research has shown that the Dietitian-Assisted DASH groceries are safe and easy to use. Studies have found that this program, which delivers groceries to the home and includes guidance from a dietitian, successfully lowers blood pressure without major side effects. Participants in similar studies have reported improved blood pressure levels, indicating that this method is both effective and safe. No significant negative effects have been reported, making this a promising way to manage high blood pressure through diet. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Dietitian-Assisted DASH Groceries because it offers a personalized and convenient approach to managing high blood pressure through diet. Unlike traditional treatments that rely on medications or broad dietary guidelines, this method provides tailored grocery plans with the help of a dietitian, ensuring that participants receive the right nutrients directly to their homes. This hands-on, educational approach could empower individuals to make healthier food choices, potentially leading to better blood pressure management with fewer side effects compared to medication-based treatments.

What evidence suggests that the Dietitian-Assisted DASH groceries might be an effective treatment for high blood pressure?

Research has shown that the DASH diet, which stands for Dietary Approaches to Stop Hypertension, can help lower blood pressure. Studies have found that people who follow the DASH diet and reduce salt intake experience significant improvements in blood pressure. In this trial, participants in the Dietitian-Assisted DASH Groceries arm will receive groceries and advice from a dietitian. Previous studies suggest this approach can lead to better results than shopping independently. The dietitian assists in selecting foods that fit the DASH plan, which is crucial for managing high blood pressure. These findings suggest that a structured grocery plan like this could effectively lower blood pressure. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults in Florida, Georgia, and Tennessee with high blood pressure who can get home-delivered groceries and are willing to eat only these foods for 4 weeks. They must have internet access, a mobile device or computer, and be able to do video calls and texts. Participants need a stable blood pressure range (systolic 120-<160 mm Hg, diastolic <110 mm Hg) and access to emergency healthcare.

Inclusion Criteria

I can order groceries online and text.

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

I can access a primary care team or emergency services for follow-up if needed during the study.

Exclusion Criteria

Serum potassium ≥5.0 mmol/L or <3.5 mmol/L

Hemoglobin A1c ≥6.5%

My medication doses for diabetes or blood pressure are not changing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either dietitian-assisted, DASH-patterned, home-delivered groceries or a stipend for self-directed grocery shopping over 4 weeks

4 weeks

Weekly virtual counseling sessions for dietitian-assisted group

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dietitian-Assisted DASH groceries

Trial Overview

GoFreshSE is examining if getting dietitian-assisted DASH-patterned groceries delivered at home helps lower blood pressure in adults with hypertension. It's a randomized control trial where some people will shop on their own while others receive specialized grocery assistance.

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 4 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.

Group II: Self-directed shopping Active Control 1 Intervention

Participants will receive a stipend and some basic information about healthy eating. The stipend is not restricted to foods.

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

University of Vermont

Collaborator

Trials

283

Recruited

3,747,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

The DASH eating plan is beneficial for people with diabetes, as it not only helps control blood pressure but also improves insulin resistance and reduces high cholesterol levels.

This diet encourages a variety of healthy foods, making it suitable for the whole family and effective in managing weight and obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DASH Eating Plan: An Eating Pattern for Diabetes Management. Campbell, AP.[2020]

The HF-DASH diet, which substitutes full-fat for low-fat dairy and reduces sugar intake, effectively lowers blood pressure similarly to the standard DASH diet while also reducing triglycerides and VLDL particle concentrations.

While both the DASH and HF-DASH diets lowered blood pressure, only the standard DASH diet significantly reduced LDL cholesterol and other harmful lipoproteins compared to a control diet, suggesting that the HF-DASH diet may be a safer alternative without compromising blood pressure benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the DASH (Dietary Approaches to Stop Hypertension) diet and a higher-fat DASH diet on blood pressure and lipids and lipoproteins: a randomized controlled trial. Chiu, S., Bergeron, N., Williams, PT., et al.[2023]

The DASH dietary pattern is linked to a significant reduction in the incidence of cardiovascular disease (CVD) by 20%, coronary heart disease by 21%, stroke by 19%, and diabetes by 18%, based on a review of 15 studies involving over 942,000 participants.

In controlled trials, the DASH diet led to notable improvements in blood pressure, with a decrease in systolic blood pressure by 5.2 mmHg and diastolic blood pressure by 2.6 mmHg, along with reductions in total cholesterol, LDL cholesterol, HbA1c, fasting insulin, and body weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DASH Dietary Pattern and Cardiometabolic Outcomes: An Umbrella Review of Systematic Reviews and Meta-Analyses. Chiavaroli, L., Viguiliouk, E., Nishi, SK., et al.[2020]

In a study of 412 adults with pre- or stage 1 hypertension, combining a low sodium diet with the DASH diet resulted in significant reductions in systolic blood pressure (SBP), especially in individuals with higher baseline SBP levels (≥150 mm Hg), where reductions reached up to -20.8 mm Hg.

Reducing sodium intake alone also lowered SBP across all baseline levels, indicating that both dietary interventions are effective in managing blood pressure, with the most pronounced effects observed in those with higher initial blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Sodium Reduction and the DASH Diet in Relation to Baseline Blood Pressure. Juraschek, SP., Miller, ER., Weaver, CM., 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 Satter House Trial of Reduced Sodium Meals (SOTRUE) showed that a low sodium meal plan for 14 days in older adults led to a reduction in seated systolic blood pressure (SBP) from 123 to 112 mmHg, indicating potential benefits for blood pressure management.

While the low sodium diet did lower SBP by 4.8 mmHg compared to a typical sodium diet, the results were not statistically significant, suggesting that further research with a larger sample size and longer duration is necessary to confirm the efficacy and safety of low sodium meals in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of a Low Sodium Meal Plan on Blood Pressure in Older Adults: The SOTRUE Randomized Feasibility Trial. Juraschek, SP., Millar, CL., Foley, A., et al.[2021]

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, 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 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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06891911

Study Details | NCT06891911 | Groceries for Residents of ...

GoFreshSE is a randomized control trial, testing the effects of a home-delivered, dietitian-assisted, DASH-patterned grocery intervention on blood pressure in ...

2.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/37/NCT05121337/Prot_000.pdf

Effects of DASH Groceries on Blood Pressure in Black ...

1 DASH groceries will lower SBP. (primary outcome) compared to self-directed grocery shopping after 3 months and effects will be maintained at 6 ...

3.

nhlbi.nih.gov

nhlbi.nih.gov/files/docs/public/heart/new_dash.pdf

Your Guide to Lowering Your Blood Pressure with DASH

Results showed that reducing dietary sodium lowered blood pressure for both eating plans. At each sodium level, blood pressure was lower on the DASH eating ...

4.

statnews.com

statnews.com/2025/11/10/aha-food-as-medicine-lowered-blood-pressure/

At AHA meeting, CRISPR data gleamed but 'food as medicine ...

After 12 weeks, the people who got both groceries and support saw their blood pressure improve more than the people in the group with just the ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11004932/

Rationale and Design of the Groceries for Black Residents ...

GoFresh is testing whether online, dietitian-assisted, home-delivered, DASH-patterned groceries lowers BP among Black adults with elevated BP.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41206973/

DASH-Patterned Groceries and Effects on Blood Pressure

Conclusions and relevance: In this study, a program of home-delivered, DASH-style groceries plus dietitian counseling decreased BP and LDL ...

7.

newsroom.heart.org

newsroom.heart.org/news/for-black-adults-in-food-deserts-food-delivery-dietary-guidance-reduced-blood-pressure

For Black adults in food deserts, food delivery & dietary ...

The systolic blood pressure levels among people in the DASH group decreased by an average of 5.7 mm Hg, compared to an average decrease of 2.2 ...