Status:
ACTIVE_NOT_RECRUITING
Groceries for Black Residents of Boston to Stop Hypertension Among Adults With Treated Hypertension
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
National Institute on Minority Health and Health Disparities (NIMHD)
Conditions:
Hypertension
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
GoFreshRx is a randomized trial, testing the effects of a home-delivered DASH-patterned grocery intervention on blood pressure in Black adults actively treated for hypertension, residing in Boston are...
Detailed Description
Hypertension affects over half of Black adults in the United States - more than any other group - and diet is a principal determinant of disparities in hypertension among Black adults. While the DASH ...
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
- 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
Exclusion
Key Trial Info
Start Date :
October 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05393232
Start Date
October 13 2022
End Date
November 1 2025
Last Update
October 28 2025
Active Locations (1)
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1
Beth Israel Deaconess Medical Center - Clinical Research Center
Boston, Massachusetts, United States, 02215