Clinical trial NCT06891911: Groceries for Residents of Southeastern USA to Stop Hypertension
Official title: Groceries for Residents of Southeastern USA to Stop Hypertension
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Elevated Blood Pressure
Cardiovascular Diseases
Dietary Intervention
Keywords: Hypertension
Dash Diet
Low Sodium
Diet
Nutrition
Clinical trial
Dietitian
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: University of Vermont
First posted: 2025-03-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individual, parallel, randomized control
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

1. Resting systolic blood pressure of 120 to \<160 mm Hg and diastolic blood pressure \<110 mm Hg
2. Resident of Florida, Georgia, and Tennessee
3. 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
4. Have access to refrigeration, cooking appliances, and Wi-Fi/cellular service
5. Have access to mobile device or computer to be able to conduct grocery orders via video conference and send/receive text messages
6. Willing and able to complete required measurement procedures
7. Able to provide consent for the study
8. 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

Exclusion Criteria:

A. Laboratory Exclusions:

1. Serum potassium ≥5.0 mmol/L or \<3.5 mmol/L
2. Estimated glomerular filtration rate (eGFR) \<30 mL/min per 1.73 m\^2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
3. Hemoglobin A1c ≥6.5%

B. 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:

1. GLP-1 and dual GLP-1/GIP receptor agonists
2. Anti-hypertension medications
3. Sodium-glucose co-transporter 2 (SGLT2) inhibitors
4. Glucose lowering medications

Use of any of the following medications:

1. Potassium supplement, except if part of a multivitamin
2. Warfarin (Coumadin)
3. Chronic oral corticosteroid (intermittent use is okay)
4. Weight loss medications (non-GLP-1 receptor agonists)
5. Sulfonylurea or any insulin use

Any medication not compatible with participation as determined by the investigators

C. Physical Exclusions:

1. Systolic blood pressure: \<120 or ≥160 mm Hg or diastolic blood pressure ≥110 mm Hg
2. Arm circumference \>52 cm (or the upper limit of the validated BP device)

D. Medical History Exclusions:

1. Self-reported weight loss or gain of 15 pounds during prior 2 months
2. 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
3. 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)
4. Gastrointestinal surgery or history that affects nutrition absorption or requires a specific diet that will deter DASH diet adherence
5. Pregnancy or lactation or planned pregnancy during the study period
6. Any emergency department (ED) visit for asthma or chronic obstructive pulmonary disease (COPD) in the last 6 months
7. Hypoglycemia hospitalization in the last 12 months
8. Any other serious illness or condition not compatible with participation as determined by the investigators

E. Lifestyle and Other Exclusions:

1. Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence
2. Consumption of more than 14 alcoholic drinks per week or consumption of more than 6 drinks on one or more occasion per week
3. Active substance use disorder that would interfere with participation
4. Extreme food insecurity
5. Participation in or planning to start weight loss program
6. Current participation in another clinical trial that could interfere with the study protocol
7. Anticipated change in residence outside of eligible states prior to the end of the study
8. Families with more than 6 adults at dinner time (children count as half an adult)

F. Investigator discretion

Primary outcomes:
measure: Self-measured systolic blood pressure
timeFrame: Measured before and after the 4-week intervention
Secondary outcomes:
measure: Self-measured diastolic blood pressure
timeFrame: Measured before and after the 4-week intervention
measure: Seated systolic and diastolic blood pressure (technician-measured)
timeFrame: Measured before and after the 4-week intervention
measure: Body Mass Index (BMI)
timeFrame: Height is measured before the intervention. Weight is measured before and after the 4-week intervention.
measure: 24-hour dietary recall
timeFrame: Measured before and after the 4-week intervention
measure: Spot urine sodium/potassium ratio
timeFrame: Measured before and after the 4-week intervention
measure: Lipids
timeFrame: Measured before and after the 4-week intervention
measure: Fasting glucose
timeFrame: Measured before and after the 4-week intervention
measure: Serum potassium
timeFrame: Measured before and after the 4-week intervention
Other outcomes:
measure: General Health Status
timeFrame: Measured before and after the 4-week intervention
measure: Financial strain
timeFrame: Measured before and after the 4-week intervention
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References: