Actively Recruiting
Groceries for Residents of Southeastern USA to Stop Hypertension
Led by Beth Israel Deaconess Medical Center · Updated on 2025-10-28
150
Participants Needed
1
Research Sites
32 weeks
Total Duration
On this page
Sponsors
B
Beth Israel Deaconess Medical Center
Lead Sponsor
A
American Heart Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Groceries for Residents of Southeastern USA to Stop Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Resting systolic blood pressure of 120 to less than 160 mm Hg and diastolic blood pressure less than 110 mm Hg
- Resident of Florida, Georgia, or Tennessee
- Able to receive home-delivered groceries or pick them up at a convenient location
- Willing to eat only the provided groceries during the 4-week study period
- Have access to refrigeration, cooking appliances, and Wi-Fi or cellular service
- Have access to a mobile device or computer to order groceries via video conference and send/receive text messages
- Willing and able to complete required measurement procedures
- Able to provide consent to participate
- Have access to a primary care team, urgent care center, or emergency room for follow-up care if needed during the study
You will not qualify if you...
- Serum potassium level 5.0 mmol/L or higher, or less than 3.5 mmol/L
- Estimated glomerular filtration rate (eGFR) less than 30 mL/min per 1.73 m2
- Hemoglobin A1c level 6.5% or higher
- Unstable doses of GLP-1 or dual GLP-1/GIP receptor agonists within 6 months prior or planning to start during the study
- Unstable doses of anti-hypertension medications within 6 months prior or planning to start during the study
- Unstable doses of SGLT2 inhibitors within 6 months prior or planning to start during the study
- Unstable doses of glucose lowering medications within 6 months prior or planning to start during the study
- Use of potassium supplements (unless part of a multivitamin), warfarin (Coumadin), chronic oral corticosteroids (intermittent use allowed), weight loss medications (non-GLP-1), sulfonylurea, or insulin
- Any medication deemed incompatible by investigators
- Systolic blood pressure less than 120 or 160 mm Hg or higher, or diastolic blood pressure 110 mm Hg or higher
- Arm circumference greater than 52 cm (or above the validated blood pressure device limit)
- Weight loss or gain of 15 pounds in the past 2 months
- Active cardiovascular disease or event in past 6 months, including certain surgeries, heart attack, stroke, or heart failure requiring hospitalization
- Cancer diagnosis or treatment in past 2 years (exceptions for certain localized cancers)
- Gastrointestinal surgery or conditions affecting nutrition absorption or diet adherence
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Emergency visits for asthma or COPD in past 6 months
- Hospitalization for hypoglycemia in past 12 months
- Any serious illness or condition incompatible with participation
- Significant food allergies, preferences, intolerances, or dietary needs affecting diet adherence
- Drinking more than 14 alcoholic drinks per week or more than 6 drinks on any occasion per week
- Active substance use disorder interfering with participation
- Extreme food insecurity
- Participation in or planning to start a weight loss program
- Current participation in another clinical trial that may interfere
- Planning to move outside eligible states before study ends
- Families with more than 6 adults at dinner time (children count as half an adult)
- Any other exclusions as determined by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
S
Stephen P. Juraschek, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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