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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

2021P000825

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18 to 100 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 3 years ago

What is this trial about?

GoFresh is a randomized trial, testing the effects of a home-delivered DASH-patterned grocery intervention on blood pressure in Black adults, residing in Boston area urban food deserts.

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

Locations

Location

Status

Recruiting