No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
Beth Israel Deaconess Medical Center · Other
Who this trial is looking for
This trial is looking for adults with high blood pressure living in Florida, Georgia, or Tennessee. Participants will receive groceries designed to help lower blood pressure and are required to eat only these groceries for four weeks.
Are You a Good Fit for This Trial?
You may be able to join if
I have high blood pressure
I live in Florida, Georgia, or Tennessee
I can receive groceries at home or pick them up
I have access to refrigeration and cooking appliances
I can use a device for online grocery orders
I can complete the required health measurements
I can give consent to join this study
I have a primary care team for health follow-up if needed
You may not be able to join if
I have had a recent serious medical event or surgery
I do not have stable blood pressure within the required range
I have been diagnosed with certain cancers in the last two years
I have certain kidney problems or blood test results
I have active substance use issues
I am pregnant or planning to become pregnant
I have serious dietary restrictions that would interfere
I have had significant weight change in the last two months
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 ov…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.