Groceries for Residents of Southeastern USA to Stop Hypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeth Israel Deaconess Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Serum potassium ≥5.4 mmol/L or <3.5 mmol/L
Estimated glomerular filtration rate (eGFR) <30 mL/min per 1.73 m² by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
Hemoglobin A1c ≥6.5%
GLP-1 and dual GLP-1/GIP receptor agonists
Trial design
Design model
Parallel
Treatments tested in this trial
Dietitian-Assisted DASH groceries
BehavioralThe 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 shopping
BehavioralIntervention 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Dietitian-Assisted DASH GroceriesExperimental treatment 1 intervention
Group B: Self-directed shoppingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Measured before and after the 4-week interventionSecondary outcomes
1
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).
Time frame
Measured before and after the 4-week intervention2
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.
Time frame
Measured before and after the 4-week intervention3
Body Mass Index (BMI)
At home measurement based on height and weight measured by a technician via a stadiometer and scale.
Time frame
Height is measured before the intervention. Weight is measured before and after the 4-week intervention.4
24-hour dietary recall
Assessed via self-administered questionnaire using the Automated Self-Administered 24-Hour Dietary Recall (ASA24).
Time frame
Measured before and after the 4-week interventionOther outcomes
1
General Health Status
Single General Health Status Question: "Would you say that in general your health is excellent, very good, good, fair, or poor?"
Time frame
Measured before and after the 4-week intervention2
Financial strain
We will ask the following questions: How often does this describe you? I don't have money to pay my bills (including food, housing, medical care or heating). Never / Rarely / Sometimes / Often / Always
Time frame
Measured before and after the 4-week interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beth Israel Deaconess Medical Center
Lead sponsor
American Heart Association
Collaborator
University of Vermont
Collaborator
Source ClinicalTrials.gov