Groceries for Residents of Southeastern USA to Stop Hypertension

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Mar 18, 2025

Keywords

ClinConnect Summary

The Groceries for Residents of Southeastern USA to Stop Hypertension trial, also known as GoFreshSE, is a study aimed at helping adults in Florida, Georgia, and Tennessee lower their high blood pressure through a special grocery program. Participants will receive healthy groceries delivered to their homes, along with support from a dietitian to help them eat according to the DASH diet, which is designed to reduce blood pressure. The study is looking for adults aged 65 to 74 who have a specific range of blood pressure and can commit to using only the provided groceries for four weeks.

To be eligible, participants must have a resting blood pressure between 120 and 159 mm Hg and should be able to receive the groceries at home. They also need to have access to a refrigerator and a way to communicate online, like a computer or smartphone. During the study, participants will be asked to complete some measurements and follow the grocery plan while having access to their healthcare providers if needed. This trial is a great opportunity to explore how diet can play a role in managing blood pressure, and it’s important for potential participants to know that certain health conditions and medication use may affect their eligibility for the study.

Gender

ALL

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