Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension
Sponsored by Beth Israel Deaconess Medical Center
About this trial
Last updated 3 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started 3 years ago
What is this trial about?
What are the Participation Requirements?
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
- 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:
- Any use 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 5 adults at dinner time (children are considered to be half an
adult)
- Investigator discretion