Groceries for Black Residents of Boston to Stop Hypertension Among Adults With Treated Hypertension

NCT ID: NCT05393232

Last Updated: 2025-10-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-13
• Study Completion Date: 2025-11-30

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dietitian-Assisted DASH groceries

Participants will order groceries sufficient to meet their caloric needs each week for 12 weeks with the assistance of a dietitian/nutrition interventionist. Groceries will be delivered to participants' homes or picked up at a convenient location. The dietitian/nutrition interventionist will provide brief educational content at the time of food delivery. Orders will be placed via phone or through virtual counseling sessions. During the remainder of the study (months 4-12), participants will be asked to apply what they learned without the provision of groceries.

Group Type: EXPERIMENTAL

Dietitian-Assisted DASH groceries

Intervention Type: BEHAVIORAL

The DASH ("Dietary Approaches to Stop Hypertension"), is a healthy dietary pattern that lowers blood pressure without reducing weight. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages.

Intervention Phase:

This intervention is a weekly, 12-week DASH dietary intervention. A dietitian will assist participants in ordering groceries in a pattern consistent with the DASH diet to be delivered to their homes. The quantity of groceries will be based on participant Calorie needs and family size.

Observation Phase:

For months 4-12 of the study, participants will be asked to continue following a DASH grocery shopping pattern without the provision of weekly groceries.

Self-directed shopping (referent assignment)

Participants will receive a monthly stipend over a 3 month period and some basic information about healthy eating. The stipend is not restricted to foods. During the remainder of the study (months 4-12), participants will be asked to continue their typical shopping without the provision of the monthly stipend.

Group Type: ACTIVE_COMPARATOR

Self-directed shopping

Intervention Type: BEHAVIORAL

Intervention Phase:

Participants will receive some basic information on healthy eating and a monthly stipend at 4, 8, and 12-weeks of the intervention.

Observation Phase:

For months 4-12 of the study, participants will be asked to follow their typical shopping pattern without the provision of a monthly stipend.

Interventions

Dietitian-Assisted DASH groceries

The DASH ("Dietary Approaches to Stop Hypertension"), is a healthy dietary pattern that lowers blood pressure without reducing weight. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages.

Intervention Phase:

This intervention is a weekly, 12-week DASH dietary intervention. A dietitian will assist participants in ordering groceries in a pattern consistent with the DASH diet to be delivered to their homes. The quantity of groceries will be based on participant Calorie needs and family size.

Observation Phase:

For months 4-12 of the study, participants will be asked to continue following a DASH grocery shopping pattern without the provision of weekly groceries.

Intervention Type: BEHAVIORAL

Self-directed shopping

Intervention Phase:

Participants will receive some basic information on healthy eating and a monthly stipend at 4, 8, and 12-weeks of the intervention.

Observation Phase:

For months 4-12 of the study, participants will be asked to follow their typical shopping pattern without the provision of a monthly stipend.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Stephen Juraschek

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen P Juraschek, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center - Clinical Research Center

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://gofreshstudy.org

Main trial website (shared with the GoFresh Trial)

Other Identifiers

R01MD016068

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022P000221

Identifier Type: -

Identifier Source: org_study_id