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| ID | Type | Description | Link |
|---|---|---|---|
| GRT67144 | Other Grant/Funding Number | American Heart Association |
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
| University of Vermont | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Self-directed shopping | Active Comparator | Participants will receive a stipend and some basic information about healthy eating. The stipend is not restricted to foods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietitian-Assisted DASH groceries | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 before and after the 4-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 before and after the 4-week intervention |
| Seated systolic and diastolic blood pressure (technician-measured) |
| Measure | Description | Time Frame |
|---|---|---|
| General Health Status | Single General Health Status Question: "Would you say that in general your health is excellent, very good, good, fair, or poor?" | Measured before and after the 4-week intervention |
| Financial strain |
Inclusion Criteria:
Exclusion Criteria:
A. Laboratory Exclusions:
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:
Use of any of the following medications:
Any medication not compatible with participation as determined by the investigators
C. Physical Exclusions:
D. Medical History Exclusions:
E. Lifestyle and Other Exclusions:
F. Investigator discretion
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephen P. Juraschek, MD, PhD | Contact | 6177541416 | sjurasch@bidmc.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
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Individual, parallel, randomized control
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The interventionists are masked to study outcomes. The participants and dietitian interventionists are masked to study outcomes.
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| Self-directed shopping | Behavioral | 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. |
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Seated systolic and diastolic blood pressure measured by a technician in participants' homes, using the office blood pressure device. |
| 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. | 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 before and after the 4-week intervention |
| Spot urine sodium/potassium ratio | Measured in urine collected at the participants' homes. | 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 before and after the 4-week intervention |
| Fasting glucose | Measured in blood as part of a basic metabolic panel | Measured before and after the 4-week intervention |
| Serum potassium | Measured in blood as part of a basic metabolic panel | Measured before and after the 4-week intervention |
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
| Measured before and after the 4-week intervention |