Groceries for Black Residents of Boston to Stop Hypertension Among Adults With Treated Hypertension

A regiszterben nem jelölt feltételek

• INCLUSION:
• Self-reported/self-identified as Black or African American
• Resting systolic blood pressure of 120 to \<150 mm Hg and diastolic blood pressure \<100 mm Hg
• Active treatment with medications intended for hypertension treatment within the last 6 months at stable doses
• Residence in communities identified as Boston area food deserts: Brighton, Chelsea, Dorchester, East Boston, Everett, Hyde Park, Jamaica Plain, Malden, Mattapan, Revere, Roslindale, Roxbury, or Winthrop
• Able to receive home-delivered groceries or pick them up at a convenient location and willing to eat only the groceries provided over a 12-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 or by phone
• Willing and able to complete required measurement procedures
  • EXCLUSION:
  • 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%
  • Medication Exclusions:
• Unstable doses of medications that lower blood pressure or medications intended for hypertension treatment (including antihypertensives taken for non-hypertension purposes) within the last 6 months
• Unstable doses (i.e. a change in the 2 months prior to screening or randomization) of the following:
  • Sodium-glucose co-transporter 2 (SGLT2) inhibitors
  • Stimulants
  • Inhaled or oral medications for asthma or chronic obstructive pulmonary disease (COPD)
  • Hormone replacement therapy or thyroid hormone
  • Weight-increasing psychotropic agents, including antipsychotic agents, lithium, and mirtazapine
• 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 (including GLP-1 receptor agonists)
• Unwillingness to keep same dose of vitamin, mineral, and botanical supplements
• Any medication not compatible with participation as determined by the investigators
  • Physical Exclusions:
• Systolic blood pressure ≥150 mm Hg or diastolic blood pressure ≥100 mm Hg
• Body weight \>420 pounds
• Arm circumference \>50cm
• Weight loss or gain of \>5.0% of body weight during prior 2 months
  • Medical History Exclusions:
• Type 1 or Type 2 Diabetes defined as a hemoglobin A1c ≥6.5% or diabetes treatment
• 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)
• Active inflammatory bowel disease, bowel resection, malabsorptive syndrome, pancreatitis (episode within past year), or history of bariatric surgery
• Pregnancy or lactation or planned pregnancy
• 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
  • Lifestyle and Other Exclusions:
• Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence
• Consumption of more than 14 alcoholic drinks per week or consumption of more than 6 drinks on one or more occasion per week
• Active substance use disorder that would interfere with participation
• 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
• Anticipated change in residence prior to the end of the study
• Families with more than 6 adults at dinner time (children are considered to be half an adult)
• Investigator discretion