Clinical trial NCT05393232: Groceries for Black Residents of Boston to Stop Hypertension Among Adults With Treated Hypertension
Official title: Effects of DASH Groceries on Blood Pressure in Black Residents of Urban Food Deserts With Treated Hypertension
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: hypertension
blood pressure
nutrition
diet
DASH
sodium
trial
dietitian
cholesterol
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-05-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individual level, parallel, randomized trial
Primary purpose: TREATMENT

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 area urban food deserts.

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 diet is a proven strategy for lowering blood pressure in Black adults, diet disparities are increasing in urban food deserts due to poor access and the high costs of healthy foods. Our proposed clinical trial will randomize 150 Black adults, who are actively treated for hypertension and reside in Boston area urban food deserts to either:

1. 12 weeks of dietitian-assisted, DASH grocery delivery via an online, virtual grocery store at an amount sufficient to replace all Calorie needs of each participant, allowing for some sharing with family members

   or
2. Self-directed shopping with a monthly stipend over a 3-month period

After the 12-week intervention phase, participants will undergo a 9-month observation phase. At 3-months after the intervention is complete the investigators will repeat in-person study assessments and perform qualitative interviews in a subset of the population to determine barriers and facilitators to intermediate-term maintenance of the intervention. At 9-months after the intervention, participants will participate in a phone visit designed to assess longer-term maintenance of the intervention.

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

Primary outcomes:
measure: Seated, office-based, systolic blood pressure (intervention phase)
timeFrame: Measured 3 months after randomization
Secondary outcomes:
measure: Seated, office-based, systolic blood pressure (observation phase)
timeFrame: Measured 6 months after randomization
measure: Seated, office-based, diastolic blood pressure (intervention & observation phases)
timeFrame: Measured 3 and 6 months after randomization
measure: Ambulatory blood pressure monitoring: wake-time systolic and diastolic blood pressure (intervention & observation phases)
timeFrame: Measured 3 and 6 months after randomization
measure: Body Mass Index (BMI) (intervention & observation phases)
timeFrame: Measured 3 and 6 months after randomization
measure: 24-hour urine potassium (intervention & observation phases)
timeFrame: Measured 3 and 6 months after randomization
measure: 24-hour urine sodium (intervention & observation phases)
timeFrame: Measured 3 and 6 months after randomization
measure: Hemoglobin A1c (intervention & observation phases)
timeFrame: Measured 3 and 6 months after randomization
measure: Lipids (intervention & observation phases)
timeFrame: Measured 3 and 6 months after randomization
measure: Serum potassium (intervention & observation phases)
timeFrame: Measured 3 and 6 months after randomization
measure: Serum creatinine (intervention & observation phases)
timeFrame: Measured 3 and 6 months after randomization
measure: Daily intake of fat, fruits, and vegetables (intervention & observation phases)
timeFrame: Measured 3, 6, and 12 months after randomization
measure: 24-hour dietary recall (intervention & observation phases)
timeFrame: Measured 3 and 6 months after randomization
Other outcomes:
measure: Qualitative Interviews
timeFrame: 6 months after randomization
measure: Short Form 12 Item Health Survey (SF-12)
timeFrame: Measured 3, 6, and 12 months after randomization
measure: Grocery shopping and dining habits
timeFrame: Measured 3, 6, and 12 months after randomization
measure: Perceived Stress Scale 4 (PSS-4)
timeFrame: Measured 3, 6, and 12 months after randomization
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center - Clinical Research Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Stephen P Juraschek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: