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Elevated Blood PressureGoFreshNCT05121337

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

A study testing Dietitian-Assisted DASH groceries and Self-directed shopping in people with Elevated Blood Pressure and Hypertension, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Elevated Blood Pressure, Hypertension
What is being tested?
Dietitian-Assisted DASH groceries and Self-directed shopping
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteUnited States
Study dates
30 Sep 2022to 5 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 42Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Beth Israel Deaconess Medical Center - Clinical Research Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Effects of DASH Groceries on Blood Pressure in Black Residents of Urban Food Deserts Without Treated Hypertension

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.

Read the 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. This clinical trial will randomize 150 Black adults residing 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.

Being tested
Dietitian-Assisted DASH groceries, Self-directed shopping
Keywords
hypertension, blood pressure, nutrition, diet, DASH, sodium, trial, dietitian, cholesterol
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietitian-Assisted DASH groceriesBehavioural

    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 shoppingBehavioural

    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.

Study groups in NCT05121337
Study groupRoleWhat they receive
Dietitian-Assisted DASH groceriesExperimentalParticipants 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.
Receives: Behavioral: Dietitian-Assisted DASH groceries
Self-directed shopping (referent assignment)Active comparatorParticipants 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.
Receives: Behavioral: Self-directed shopping

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Measured 3 months after randomization

Secondary outcomes (12)

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

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

    Measured: Measured 6 months after randomization

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

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

    Measured: Measured 3 and 6 months after randomization

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

    Ambulatory blood pressure monitoring with a mobile blood pressure device that will measure blood pressure over a 24-hour period.

    Measured: Measured 3 and 6 months after randomization

  4. Body Mass Index (BMI) (intervention & observation phases)

    In-person, measurement based on height and weight. Height is measured via a stadiometer and weight is measured via calibrated scale.

    Measured: Measured 3 and 6 months after randomization

  5. 24-hour urine potassium (intervention & observation phases)

    Collected at home after a clinic void over a 24-hour period

    Measured: Measured 3 and 6 months after randomization

  6. 24-hour urine sodium (intervention & observation phases)

    Collected at home after a clinic void over a 24-hour period

    Measured: Measured 3 and 6 months after randomization

  7. Hemoglobin A1c (intervention & observation phases)

    In-person blood collection; measure of glycemia over the preceding 3 months

    Measured: Measured 3 and 6 months after randomization

  8. Lipids (intervention & observation phases)

    Measured in fasted serum specimens collected during phlebotomy. Includes total cholesterol, high density lipoprotein cholesterol, derived low density lipoprotein cholesterol, and triglycerides

    Measured: Measured 3 and 6 months after randomization

  9. Serum potassium (intervention & observation phases)

    Measured in blood as part of a basic metabolic panel

    Measured: Measured 3 and 6 months after randomization

  10. Serum creatinine (intervention & observation phases)

    Measured in blood as part of a basic metabolic panel

    Measured: Measured 3 and 6 months after randomization

  11. Daily intake of fat, fruits, and vegetables (intervention & observation phases)

    Assessed via questionnaire in-person and via phone call; assessed via a validated food screener (Block et al; PMID: 10788730).

    Measured: Measured 3, 6, and 12 months after randomization

  12. 24-hour dietary recall (intervention & observation phases)

    Assessed via questionnaire in-person using the Automated Self-Administered 24-Hour Dietary Recall (ASA24)

    Measured: Measured 3 and 6 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2021
  2. Study start30 Sep 2022
  3. Primary completion18 Jun 2025
  4. Study completion5 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Individual level, parallel, randomized trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05121337
Sponsor's protocol ID
2021P000825
Other IDs
GEMS # 42359
Acronym
GoFresh
Status last verified
Jun 2026
First submitted
25 Oct 2021
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: This project is one of five projects that form the AHA's AddREssing Social Determinants TO PRevent HypErtension (RESTORE) Network. A de-identified database will be provided for use by investigators external to BIDMC upon reasonable request.

Publications

  • 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.

    PubMed 37061794

  • Cao J, Cha J, Harry T, Plante TB, Col H, Patil D, Turkson-Ocran RN, Feng Y, Hermosilla M, Zhang M, Juraschek SP. Motivational themes in digital advertisements enhance recruitment efficiency in cardiovascular trials. Contemp Clin Trials. 2026 Jul 24;169:108413. doi: 10.1016/j.cct.2026.108413. Online ahead of print.

    PubMed 42498080

  • 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.

    PubMed 41340057

  • 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.

    PubMed 41206973

  • 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.

    PubMed 41201904

Questions about this trial

What is this clinical trial studying?

A study testing Dietitian-Assisted DASH groceries and Self-directed shopping in people with Elevated Blood Pressure and Hypertension, run by Beth Israel Deaconess Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seated, office-based, systolic blood pressure (intervention phase) (time frame: Measured 3 months after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05121337, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.

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