Groceries for Residents of Southeastern USA to Stop Hypertension

NCT ID: NCT06891911

Last Updated: 2025-10-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-14
• Study Completion Date: 2026-06-30

Brief Summary

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.

Detailed Description

Hypertension (HTN) affects half of US adults and is one of the most important modifiable risk factors for cardiovascular disease (CVD) and death.

The DASH diet is a proven strategy for lowering blood pressure in adults. Our proposed clinical trial will evaluate the effectiveness of a scalable solution: home-delivered, low-sodium groceries aligned with the DASH dietary pattern and ordered with dietitian assistance via a virtual supermarket, in reducing blood pressure.

Participants will be assigned to one of two 1-month long interventions: (1) dietitian-assisted, DASH-patterned, home-delivered groceries ordered weekly through Amazon Fresh (or Whole Foods) over 4 weeks or (2) self-directed grocery shopping (monthly stipend and DASH diet brochure) (referent).

Conditions

Hypertension; Elevated Blood Pressure; Cardiovascular Diseases; Dietary Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dietitian-Assisted DASH Groceries

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 Type: EXPERIMENTAL

Dietitian-Assisted DASH groceries

Intervention Type: BEHAVIORAL

The DASH ("Dietary Approaches to Stop Hypertension"), is a healthy dietary pattern that lowers blood pressure without reducing weight. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages.

Intervention Phase:

This intervention is a weekly, 4-week DASH dietary intervention. A dietitian will assist participants in ordering groceries in a pattern consistent with the DASH diet to be delivered to their homes. The quantity of groceries will be based on participant Calorie needs and family size.

Self-directed shopping

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

Group Type: ACTIVE_COMPARATOR

Self-directed shopping

Intervention Type: BEHAVIORAL

Intervention Phase:

Participants will receive some basic information on healthy eating and a stipend during the 4-week intervention period. They are permitted to use the stipend however they choose and will not be asked about how they spent these funds.

Interventions

Dietitian-Assisted DASH groceries

The DASH ("Dietary Approaches to Stop Hypertension"), is a healthy dietary pattern that lowers blood pressure without reducing weight. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages.

Intervention Phase:

This intervention is a weekly, 4-week DASH dietary intervention. A dietitian will assist participants in ordering groceries in a pattern consistent with the DASH diet to be delivered to their homes. The quantity of groceries will be based on participant Calorie needs and family size.

Intervention Type: BEHAVIORAL

Self-directed shopping

Intervention Phase:

Participants will receive some basic information on healthy eating and a stipend during the 4-week intervention period. They are permitted to use the stipend however they choose and will not be asked about how they spent these funds.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Stephen Juraschek

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stephen P. Juraschek, MD, PhD

Role: CONTACT

sjurasch@bidmc.harvard.edu

6177541416

Facility Contacts

Kayla M Ferro, MPH, RD

Role: primary

kferro@bidmc.harvard.edu

6179037509

Emily Aidoo, MD, MPH

Role: backup

eaidoo@bidmc.harvard.edu

617-754-1438

Other Identifiers

GRT67144

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2025P000102

Identifier Type: -

Identifier Source: org_study_id