Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT05393232
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05393232
Study Brief:
Protocol Section:
NCT05393232