Groceries for Residents of Southeastern USA to Stop Hypertension

Korábbi kezelés

• 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:
• 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
• 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
• Gastrointestinal surgery or history that affects nutrition absorption or requires a specific diet that will deter DASH diet adherence
• Anticipated change in residence outside of eligible states prior to the end of the study

Más betegség

• Anti-hypertension medications
• 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)
• Any emergency department (ED) visit for asthma or chronic obstructive pulmonary disease (COPD) in the last 6 months
• Any other serious illness or condition not compatible with participation as determined by the investigators
• Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence
• Active substance use disorder that would interfere with participation

Laborértékek

• Laboratory Exclusions:
• Serum potassium ≥5.4 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%
• 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
• Families with more than 6 adults at dinner time (children count as half an adult)

Egyéb

• GLP-1 and dual GLP-1/GIP receptor agonists
• Warfarin (Coumadin)
• 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)
• Medical History Exclusions:
• Pregnancy or lactation or planned pregnancy during the study period
• Hypoglycemia hospitalization in the last 12 months
• Lifestyle and Other Exclusions:
• Consumption of more than 14 alcoholic drinks per week or consumption of more than 6 drinks on one or more occasion per week
• Extreme food insecurity
• Participation in or planning to start weight loss program
• Current participation in another clinical trial that could interfere with the study protocol
• Investigator discretion

• 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