Groceries for Residents of Southeastern USA to Stop Hypertension
Recruiting now · Not applicable
Conditions studied: Hypertension, Elevated Blood Pressure, Cardiovascular Diseases, Dietary Intervention
In brief
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.
Key facts
- Study ID
- NCT06891911
- Run by
- Beth Israel Deaconess Medical Center
- People needed
- 150
- Starts
- 2025-10-14
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2025-10-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
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…
- A. Laboratory Exclusions:
- 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%
- 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:
- 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
- C. Physical Exclusions:
- Systolic blood pressure: <120 or ≥160 mm Hg or diastolic blood pressure ≥110 mm Hg
- Arm circumference >52 cm (or the upper limit of the validated BP device)
- D. Medical History Exclusions:
- Self-reported weight loss or gain of 15 pounds during prior 2 months
- 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
- 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)
- Gastrointestinal surgery or history that affects nutrition absorption or requires a specific diet that will deter DASH diet adherence
Where it is running
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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