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

Trial Summary

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 data supports the effectiveness of the treatment Dietitian-Assisted DASH groceries for high blood pressure?

Research shows that the DASH diet, which focuses on fruits, vegetables, and low-fat foods, is effective in lowering blood pressure. Dietitians can help people adopt this diet by providing guidance and support, making it easier to stick to the healthy eating plan. ^{1 2 3 4 5}

Is the DASH diet safe for people with high blood pressure?

The DASH diet, which is rich in fruits, vegetables, and low-fat dairy, is generally safe for most people and can be used alongside medications and other lifestyle changes. However, people with certain conditions like chronic kidney or liver disease should be cautious and may need to adjust the diet. ^{2 3 6 7 8}

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

The Dietitian-Assisted DASH groceries treatment is unique because it involves a diet rich in fruits, vegetables, and low-fat dairy, which has been shown to significantly lower blood pressure. Unlike medications, this approach focuses on dietary changes and is supported by evidence that it can also improve cholesterol levels and insulin resistance, making it a holistic option for managing high blood pressure. ^{9 10 11 12 13}

What is the purpose of this trial?

GoFreshSE is a randomized control trial, testing the effects of a home-delivered, dietitian-assisted, DASH-patterned grocery intervention on blood pressure in adults with high blood pressure in Florida, Georgia, and Tennessee.

Eligibility Criteria

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 get groceries delivered or pick them up and will eat only these for 4 weeks.

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

I can order groceries online and text.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

References

1. 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]

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

A multilevel assessment of barriers to adoption of Dietary Approaches to Stop Hypertension (DASH) among African Americans of low socioeconomic status. [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

Association between adherence to the Dietary Approaches to Stop Hypertension diet with food security and weight status in adult women. [2019]

4. 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]

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

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

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

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

Implementing DASH-Aligned Meals and Self-Measured Blood Pressure to Reduce Hypertension at Senior Centers: A RE-AIM Analysis. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of a Low Sodium Meal Plan on Blood Pressure in Older Adults: The SOTRUE Randomized Feasibility Trial. [2021]

9. United States 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. [2023]

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

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

11. Switzerland pubmed.ncbi.nlm.nih.gov

DASH Dietary Pattern and Cardiometabolic Outcomes: An Umbrella Review of Systematic Reviews and Meta-Analyses. [2020]

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

Effects of Sodium Reduction and the DASH Diet in Relation to Baseline Blood Pressure. [2022]

13. England pubmed.ncbi.nlm.nih.gov

The role of Dietary Approaches to Stop Hypertension (DASH) diet food groups in blood pressure in type 2 diabetes. [2016]