HypertensionGoFreshSENCT06891911
Groceries for Residents of Southeastern USA to Stop Hypertension
A study testing Dietitian-Assisted DASH groceries and Self-directed shopping in people with Hypertension and Elevated Blood Pressure, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
GoFreshSE is a randomized control trial, testing the effects of a home-delivered, dietitian-assisted, DASH-patterned grocery intervention on blood pressure in adults with high blood pressure in Florida, Georgia, and Tennessee. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Elevated Blood Pressure, Cardiovascular Diseases
- What is being tested?
- Dietitian-Assisted DASH groceries and Self-directed shopping
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Resting systolic blood pressure of 120 to <160 mm Hg and diastolic blood pressure <110 mm Hg
- Resident of Florida, Georgia, and Tennessee
- Able to receive home-delivered groceries or pick them up at a convenient location and willing to eat only the groceries provided over a 4-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 and send/receive text messages
- Willing and able to complete required measurement procedures
- Able to provide consent for the study
- Has access to a primary care team, urgent care center, or emergency room the study team can refer to for follow up care if warranted during the study
Who cannot join
- Laboratory Exclusions:
- Serum potassium ≥5.4 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 (i.e. a change in the 6 months prior to screening or randomization or planning to start within study period) of the following:
Show all 39Show fewer
- GLP-1 and dual GLP-1/GIP receptor agonists
- Anti-hypertension medications
- Sodium-glucose co-transporter 2 (SGLT2) inhibitors
- Glucose lowering medications
- 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 (non-GLP-1 receptor agonists)
- Sulfonylurea or any insulin use
- Any medication not compatible with participation as determined by the investigators
- Physical Exclusions:
- Systolic blood pressure: <120 or ≥160 mm Hg or diastolic blood pressure ≥110 mm Hg
- Arm circumference >52 cm (or the upper limit of the validated BP device)
- Medical History Exclusions:
- Self-reported weight loss or gain of 15 pounds during prior 2 months
- 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)
- Gastrointestinal surgery or history that affects nutrition absorption or requires a specific diet that will deter DASH diet adherence
- Pregnancy or lactation or planned pregnancy during the study period
- Any emergency department (ED) visit for asthma or chronic obstructive pulmonary disease (COPD) in the last 6 months
- Hypoglycemia hospitalization in the last 12 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 outside of eligible states prior to the end of the study
- Families with more than 6 adults at dinner time (children count as half an adult)
- Investigator discretion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Kayla M Ferro, MPH, RD, 6179037509, kferro@bidmc.harvard.edu
Marian Sarpong (Budu), MD, MPH, 617-935-0980, mbudu@bidmc.harvard.edu
About this study
GoFreshSE is a randomized control trial, testing the effects of a home-delivered, dietitian-assisted, DASH-patterned grocery intervention on blood pressure in adults with high blood pressure in Florida, Georgia, and Tennessee.
Read the detailed description
Hypertension (HTN) affects half of US adults and is one of the most important modifiable risk factors for cardiovascular disease (CVD) and death.
The DASH diet is a proven strategy for lowering blood pressure in adults. Our proposed clinical trial will evaluate the effectiveness of a scalable solution: home-delivered, low-sodium groceries aligned with the DASH dietary pattern and ordered with dietitian assistance via a virtual supermarket, in reducing blood pressure.
Participants will be assigned to one of two 1-month long interventions: (1) dietitian-assisted, DASH-patterned, home-delivered groceries ordered weekly through Amazon Fresh (or Whole Foods) over 4 weeks or (2) self-directed grocery shopping (monthly stipend and DASH diet brochure) (referent).
- Being tested
- Dietitian-Assisted DASH groceries, Self-directed shopping
- Keywords
- Hypertension, Dash Diet, Low Sodium, Diet, Nutrition, Clinical trial, Dietitian
- Medical subject headings
- Hypertension, Cardiovascular Diseases
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, 4-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.
Self-directed shoppingBehavioural
Intervention Phase:
Participants will receive some basic information on healthy eating and a stipend during the 4-week intervention period. They are permitted to use the stipend however they choose and will not be asked about how they spent these funds.
| Study group | Role | What they receive |
|---|---|---|
| Dietitian-Assisted DASH Groceries | Experimental | Participants will order groceries sufficient to meet their caloric needs each week for 4 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. Receives: Behavioral: Dietitian-Assisted DASH groceries |
| Self-directed shopping | Active comparator | Participants will receive a stipend and some basic information about healthy eating. The stipend is not restricted to foods. Receives: Behavioral: Self-directed shopping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-measured systolic blood pressure
This entails 4 measurements, 2 in the morning and 2 in the evening, over a 7 day period (at least 3 concurrent days is acceptable for analysis).
Measured: Measured before and after the 4-week intervention
Secondary outcomes (8)
Self-measured diastolic blood pressure
This entails 4 measurements, 2 in the morning and 2 in the evening, over a 7 day period (at least 3 concurrent days is acceptable for analysis).
Measured: Measured before and after the 4-week intervention
Seated systolic and diastolic blood pressure (technician-measured)
Seated systolic and diastolic blood pressure measured by a technician in participants' homes, using the office blood pressure device.
Measured: Measured before and after the 4-week intervention
Body Mass Index (BMI)
At home measurement based on height and weight measured by a technician via a stadiometer and scale.
Measured: Height is measured before the intervention. Weight is measured before and after the 4-week intervention.
24-hour dietary recall
Assessed via self-administered questionnaire using the Automated Self-Administered 24-Hour Dietary Recall (ASA24).
Measured: Measured before and after the 4-week intervention
Spot urine sodium/potassium ratio
Measured in urine collected at the participants' homes.
Measured: Measured before and after the 4-week intervention
Lipids
Measured in fasted serum specimens collected during phlebotomy. Includes total cholesterol, high density lipoprotein cholesterol, derived low density lipoprotein cholesterol, and triglycerides
Measured: Measured before and after the 4-week intervention
Fasting glucose
Measured in blood as part of a basic metabolic panel
Measured: Measured before and after the 4-week intervention
Serum potassium
Measured in blood as part of a basic metabolic panel
Measured: Measured before and after the 4-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start14 Oct 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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, parallel, randomized control
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, University of Vermont
- Responsible party
- Principal investigator, Stephen Juraschek, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891911
- Sponsor's protocol ID
- 2025P000102
- Other IDs
- GRT67144
- Acronym
- GoFreshSE
- Status last verified
- Oct 2025
- First submitted
- 18 Mar 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Groceries for Residents of Southeastern USA to Stop Hypertension
- ClinicalTrials.gov ID
- NCT06891911
- Acronym / sponsor ID
- GoFreshSE / 2025P000102
- Keywords
- Hypertension, Dash Diet, Low Sodium, Diet, Nutrition, Clinical trial, Dietitian
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- American Heart Association, University of Vermont
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
GoFreshSE is a randomized control trial, testing the effects of a home-delivered, dietitian-assisted, DASH-patterned grocery intervention on blood pressure in adults with high blood pressure in Florida, Georgia, and Tennessee.
Detailed description
Hypertension (HTN) affects half of US adults and is one of the most important modifiable risk factors for cardiovascular disease (CVD) and death.
The DASH diet is a proven strategy for lowering blood pressure in adults. Our proposed clinical trial will evaluate the effectiveness of a scalable solution: home-delivered, low-sodium groceries aligned with the DASH dietary pattern and ordered with dietitian assistance via a virtual supermarket, in reducing blood pressure.
Participants will be assigned to one of two 1-month long interventions: (1) dietitian-assisted, DASH-patterned, home-delivered groceries ordered weekly through Amazon Fresh (or Whole Foods) over 4 weeks or (2) self-directed grocery shopping (monthly stipend and DASH diet brochure) (referent).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Individual, parallel, randomized control
| Arm | Type | Receives |
|---|---|---|
| Dietitian-Assisted DASH Groceries | Experimental | Behavioral: Dietitian-Assisted DASH groceriesParticipants will order groceries sufficient to meet their caloric needs each week for 4 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. |
| Self-directed shopping | Active comparator | Behavioral: Self-directed shoppingParticipants will receive a stipend and some basic information about healthy eating. The stipend is not restricted to foods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Resting systolic blood pressure of 120 to <160 mm Hg and diastolic blood pressure <110 mm Hg
- Resident of Florida, Georgia, and Tennessee
- Able to receive home-delivered groceries or pick them up at a convenient location and willing to eat only the groceries provided over a 4-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 and send/receive text messages
Key exclusion criteria (39 listed)
- Laboratory Exclusions:
- Serum potassium ≥5.4 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietitian-Assisted DASH groceriesThe 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, 4-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. | Behavioural | Dietitian-Assisted DASH Groceries |
| Self-directed shoppingIntervention Phase: Participants will receive some basic information on healthy eating and a stipend during the 4-week intervention period. They are permitted to use the stipend however they choose and will not be asked about how they spent these funds. | Behavioural | Self-directed shopping |
Primary outcome
Self-measured systolic blood pressure
Time frame: Measured before and after the 4-week intervention
This entails 4 measurements, 2 in the morning and 2 in the evening, over a 7 day period (at least 3 concurrent days is acceptable for analysis).
8 secondary outcomes
Self-measured diastolic blood pressure
Time frame: Measured before and after the 4-week intervention
Seated systolic and diastolic blood pressure (technician-measured)
Time frame: Measured before and after the 4-week intervention
Body Mass Index (BMI)
Time frame: Height is measured before the intervention. Weight is measured before and after the 4-week intervention.
24-hour dietary recall
Time frame: Measured before and after the 4-week intervention
Spot urine sodium/potassium ratio
Time frame: Measured before and after the 4-week intervention
Lipids
Time frame: Measured before and after the 4-week intervention
Fasting glucose
Time frame: Measured before and after the 4-week intervention
Serum potassium
Time frame: Measured before and after the 4-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietitian-Assisted DASH groceries and Self-directed shopping in people with Hypertension and Elevated Blood Pressure, 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 8 inclusion and 39 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: looking for participants now, as of the sponsor's last update on 19 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen P. Juraschek, MD, PhD (6177541416, sjurasch@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-measured systolic blood pressure (time frame: Measured before and after the 4-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2026.