Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension

NCT05121337 | Active Not Recruiting DMC

• 2 other identifiers: 2021P000825GEMS # 42359
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Elevated Blood Pressure; Hypertension

Keywords

hypertension; blood pressure; nutrition; diet; DASH; sodium; trial; dietitian; cholesterol

Outcome Measures

Primary Outcomes (1)

• Seated, office-based, systolic blood pressure (intervention phase)

  In-person, measured with an automated oscillometric device that will perform 3 measurements.

  Measured 3 months after randomization

Secondary Outcomes (12)

• Seated, office-based, systolic blood pressure (observation phase)

  Measured 6 months after randomization

• Seated, office-based, diastolic blood pressure (intervention & observation phases)

  Measured 3 and 6 months after randomization

• Ambulatory blood pressure monitoring: wake-time systolic and diastolic blood pressure (intervention & observation phases)

  Measured 3 and 6 months after randomization

• Body Mass Index (BMI) (intervention & observation phases)

  Measured 3 and 6 months after randomization

• 24-hour urine potassium (intervention & observation phases)

  Measured 3 and 6 months after randomization

Other Outcomes (4)

• Qualitative Interviews

  6 months after randomization

• Short Form 12 Item Health Survey (SF-12)

  Measured 3, 6, and 12 months after randomization

• Grocery shopping and dining habits

  Measured 3, 6, and 12 months after randomization

Study Arms (2)

Dietitian-Assisted DASH groceries

EXPERIMENTAL

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.

Behavioral: Dietitian-Assisted DASH groceries

Self-directed shopping (referent assignment)

ACTIVE COMPARATOR

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.

Behavioral: Self-directed shopping

Interventions

Self-directed shopping 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.

Self-directed shopping (referent assignment)

Dietitian-Assisted DASH groceries 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.

Dietitian-Assisted DASH groceries

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%
• 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)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• American Heart Association: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center - Clinical Research Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (4)

• Turkson-Ocran RN, Cluett JL, Fitzpatrick SL, Kraemer KM, McManus K, Mukamal KJ, Davis RB, Elborki M, Ferro K, Ismail N, Laura Aidoo E, Larbi Kwapong F, Castilla-Ojo N, Grobman B, Seager R, Hines AL, Miller ER, Crews DC, Juraschek SP. Rationale and Design of the Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension (GoFresh) Trial. Am J Hypertens. 2023 Apr 15;36(5):256-263. doi: 10.1093/ajh/hpad008.

  PMID: 37061794 BACKGROUND

• Ferro KM, Seager R, McManus K, Kraemer KM, Turkson-Ocran RAN, Michetti J, Allison S, Fitzpatrick S, Juraschek SP. Nutrition intervention of groceries for Black residents of Boston to stop hypertension (GoFresh) among adults with or without treated hypertension trial: rationale, design, and guiding domains. Trials. 2025 Dec 3;26(1):560. doi: 10.1186/s13063-025-09273-z.

  PMID: 41340057 DERIVED

• Juraschek SP, Col H, Ferro K, Turkson-Ocran RN, Cluett JL, Davis RB, Kraemer KM, McManus K, Mukamal KJ, Aidoo EL, Larbi Kwapong F, Budu M, Patil D, Nartey S, Michetti J, Allison S, Mate-Kole M, Cao J, Grobman B, Seager R, Hines AL, Miller ER 3rd, Crews DC, Fitzpatrick SL; GoFresh Collaborative Research Group. DASH-Patterned Groceries and Effects on Blood Pressure: The GoFresh Randomized Clinical Trial. JAMA. 2026 Jan 6;335(1):36-48. doi: 10.1001/jama.2025.21112.

  PMID: 41206973 DERIVED

• Harry T, Hussain Z, Cao J, Turkson-Ocran RN, Juraschek SP, Michos ED, Miller HN, Lahey TP, Plante TB, Feng Y. Randomized Comparison of Online Motivational Themes in Clinical Trial Recruitment. Circ Cardiovasc Qual Outcomes. 2025 Dec;18(12):e012945. doi: 10.1161/CIRCOUTCOMES.125.012945. Epub 2025 Nov 7.

  PMID: 41201904 DERIVED

Related Links

• Main trial website

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Stephen P Juraschek, MD, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will not know randomization assignment. Investigators will not know randomization assignment. Participants and the nutritionist/dietitian interventionist will need to know randomization assignment in order to carry out the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Individual level, parallel, randomized trial

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 16, 2021
• Study Start: September 30, 2022
• Primary Completion: June 18, 2025
• Study Completion: April 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6-12 months after the study is complete
• Access Criteria: Upon reasonable request to investigators.

Locations

US (1)