Groceries for Residents of Southeastern USA to Stop Hypertension

NCT06891911 | Recruiting

• 2 other identifiers: 2025P000102GRT67144
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Elevated Blood Pressure; Cardiovascular Diseases; Dietary Intervention

Keywords

Hypertension; Dash Diet; Low Sodium; Diet; Nutrition; Clinical trial; Dietitian

Outcome Measures

Primary Outcomes (1)

• Self-measured systolic blood pressure

  This entails 4 measurements, 2 in the morning and 2 in the evening, over a 7 day period (at least 3 concurrent days is acceptable for analysis).

  Measured before and after the 4-week intervention

Secondary Outcomes (8)

• Self-measured diastolic blood pressure

  Measured before and after the 4-week intervention

• Seated systolic and diastolic blood pressure (technician-measured)

  Measured before and after the 4-week intervention

• Body Mass Index (BMI)

  Height is measured before the intervention. Weight is measured before and after the 4-week intervention.

• 24-hour dietary recall

  Measured before and after the 4-week intervention

• Spot urine sodium/potassium ratio

  Measured before and after the 4-week intervention

Other Outcomes (2)

• General Health Status

  Measured before and after the 4-week intervention

• Financial strain

  Measured before and after the 4-week intervention

Study Arms (2)

Dietitian-Assisted DASH Groceries

EXPERIMENTAL

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.

Behavioral: Dietitian-Assisted DASH groceries

Self-directed shopping

ACTIVE COMPARATOR

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

Behavioral: Self-directed shopping

Interventions

Dietitian-Assisted DASH groceries 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.

Dietitian-Assisted DASH Groceries

Self-directed shopping 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.

Self-directed shopping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Resting systolic blood pressure of 120 to \<160 mm Hg and diastolic blood pressure \<110 mm Hg
• Resident of Florida, Georgia, and Tennessee
• 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
• Have access to refrigeration, cooking appliances, and Wi-Fi/cellular service
• Have access to mobile device or computer to be able to conduct grocery orders via video conference and send/receive text messages
• Willing and able to complete required measurement procedures
• Able to provide consent for the study
• 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

You may not qualify if:

• Serum potassium ≥5.0 mmol/L or \<3.5 mmol/L
• Estimated glomerular filtration rate (eGFR) \<30 mL/min per 1.73 m\^2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
• Hemoglobin A1c ≥6.5%
• 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:
• GLP-1 and dual GLP-1/GIP receptor agonists
• Anti-hypertension medications
• Sodium-glucose co-transporter 2 (SGLT2) inhibitors
• Glucose lowering medications
• Use of any of the following medications:
• Potassium supplement, except if part of a multivitamin
• Warfarin (Coumadin)
• Chronic oral corticosteroid (intermittent use is okay)
• Weight loss medications (non-GLP-1 receptor agonists)
• Sulfonylurea or any insulin use
• Any medication not compatible with participation as determined by the investigators

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• American Heart Association: collaborator
• University of Vermont: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Central Study Contacts

Stephen P. Juraschek, MD, PhD

CONTACT

6177541416; sjurasch@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The interventionists are masked to study outcomes. The participants and dietitian interventionists are masked to study outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Individual, parallel, randomized control

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 24, 2025
• Study Start: October 14, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)