Phase
Condition
Williams Syndrome
Stress
Circulation Disorders
Treatment
Dietitian-Assisted DASH groceries
Self-directed shopping
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 6 adults at dinner time (children are considered to be half an adult)
Investigator discretion
Study Design
Study Description
Connect with a study center
Beth Israel Deaconess Medical Center - Clinical Research Center
Boston, Massachusetts 02215
United StatesSite Not Available
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