Home-delivered DASH groceries for Southeastern US residents to lower blood pressure

Groceries for Residents of Southeastern USA to Stop Hypertension

This project will test whether adults with high blood pressure in Florida, Georgia, and Tennessee who receive dietitian‑assisted, home‑delivered DASH groceries for 4 weeks have larger blood pressure drops than those given a shopping stipend and a DASH brochure.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beth Israel Deaconess Medical Center (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT06891911 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial will assign adults with elevated blood pressure in Florida, Georgia, and Tennessee to one of two 4‑week interventions. The intervention arm receives weekly, dietitian‑assisted, DASH‑patterned groceries delivered to the home (ordered via Amazon Fresh or Whole Foods) while the comparator arm receives a monthly grocery stipend and a DASH diet brochure for self‑directed shopping. Participants must have refrigeration, cooking facilities, internet-enabled devices, and agree to use only the provided groceries during the 4‑week period, with remote dietitian support and home blood pressure monitoring. The primary outcome is change in blood pressure over the intervention period to see if the grocery intervention leads to larger reductions than the self‑directed approach.

Who should consider this trial

Good fit: Adults with resting systolic blood pressure between 120 and <160 mm Hg (diastolic <110 mm Hg) who live in Florida, Georgia, or Tennessee, can receive home deliveries or pick-ups, have cooking and refrigeration access and internet-enabled devices, and are willing to eat only the provided groceries for 4 weeks.

Not a fit: People with very high or unstable blood pressure, significant kidney dysfunction (eGFR <30 mL/min/1.73 m2), abnormal serum potassium, no access to delivery/cooking facilities, or who are unwilling to follow only the provided foods are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could make it easier for people to follow the DASH diet, lower blood pressure, and reduce cardiovascular risk at scale.

How similar studies have performed: The DASH eating pattern has strong evidence for lowering blood pressure, but large-scale, dietitian‑assisted, home‑delivered grocery interventions are less well tested though smaller pilot programs have shown promise.

Eligibility criteria

Inclusion Criteria:

1. Resting systolic blood pressure of 120 to \<160 mm Hg and diastolic blood pressure \<110 mm Hg
2. Resident of Florida, Georgia, and Tennessee
3. Able to receive home-delivered groceries or pick them up at a convenient location and willing to eat only the groceries provided over a 4-week period
4. Have access to refrigeration, cooking appliances, and Wi-Fi/cellular service
5. Have access to mobile device or computer to be able to conduct grocery orders via video conference and send/receive text messages
6. Willing and able to complete required measurement procedures
7. Able to provide consent for the study
8. Has access to a primary care team, urgent care center, or emergency room the study team can refer to for follow up care if warranted during the study

Exclusion Criteria:

A. Laboratory Exclusions:

1. Serum potassium ≥5.0 mmol/L or \<3.5 mmol/L
2. Estimated glomerular filtration rate (eGFR) \<30 mL/min per 1.73 m\^2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
3. Hemoglobin A1c ≥6.5%

B. Medication Exclusions:

Unstable doses (i.e. a change in the 6 months prior to screening or randomization or planning to start within study period) of the following:

1. GLP-1 and dual GLP-1/GIP receptor agonists
2. Anti-hypertension medications
3. Sodium-glucose co-transporter 2 (SGLT2) inhibitors
4. Glucose lowering medications

Use of any of the following medications:

1. Potassium supplement, except if part of a multivitamin
2. Warfarin (Coumadin)
3. Chronic oral corticosteroid (intermittent use is okay)
4. Weight loss medications (non-GLP-1 receptor agonists)
5. Sulfonylurea or any insulin use

Any medication not compatible with participation as determined by the investigators

C. Physical Exclusions:

1. Systolic blood pressure: \<120 or ≥160 mm Hg or diastolic blood pressure ≥110 mm Hg
2. Arm circumference \>52 cm (or the upper limit of the validated BP device)

D. Medical History Exclusions:

1. Self-reported weight loss or gain of 15 pounds during prior 2 months
2. Active cardiovascular disease or any event in the prior 6 months, including coronary artery bypass grafting (CABG), percutaneous transluminal coronary angioplasty (PTCA), myocardial infarction (MI), cerebrovascular accident (CVA), or congestive heart failure (CHF) exacerbation requiring hospital admission
3. Cancer diagnosis or treatment in the last 2 years (non-melanoma skin cancer or localized breast or prostate or bladder cancer not requiring systemic therapy is acceptable)
4. Gastrointestinal surgery or history that affects nutrition absorption or requires a specific diet that will deter DASH diet adherence
5. Pregnancy or lactation or planned pregnancy during the study period
6. Any emergency department (ED) visit for asthma or chronic obstructive pulmonary disease (COPD) in the last 6 months
7. Hypoglycemia hospitalization in the last 12 months
8. Any other serious illness or condition not compatible with participation as determined by the investigators

E. Lifestyle and Other Exclusions:

1. Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence
2. Consumption of more than 14 alcoholic drinks per week or consumption of more than 6 drinks on one or more occasion per week
3. Active substance use disorder that would interfere with participation
4. Extreme food insecurity
5. Participation in or planning to start weight loss program
6. Current participation in another clinical trial that could interfere with the study protocol
7. Anticipated change in residence outside of eligible states prior to the end of the study
8. Families with more than 6 adults at dinner time (children count as half an adult)

F. Investigator discretion

Where this trial is running

Boston, Massachusetts

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Stephen P. Juraschek, MD, PhD

Conditions Hypertension; Elevated Blood Pressure; Cardiovascular Diseases; Dietary Intervention; Dash Diet; Low Sodium; Diet; Nutrition