GoFresh is a randomized trial, testing the effects of a home-delivered DASH-patterned grocery intervention on blood pressure in Black adults, residing in Boston area urban food deserts.
Hypertension affects over half of Black adults in the United States - more than any other group - and diet is a principal determinant of disparities in hypertension among Black adults. While the DASH diet is a proven strategy for lowering blood pressure in Black adults, diet disparities are increasing in urban food deserts due to poor access and the high costs of healthy foods. This clinical trial will randomize 150 Black adults residing in Boston area urban food deserts to either: 1. 12 weeks of dietitian-assisted, DASH grocery delivery via an online, virtual grocery store at an amount sufficient to replace all Calorie needs of each participant, allowing for some sharing with family members or 2. Self-directed shopping with a monthly stipend over a 3-month period After the 12-week intervention phase, participants will undergo a 9-month observation phase. At 3-months after the intervention is complete the investigators will repeat in-person study assessments and perform qualitative interviews in a subset of the population to determine barriers and facilitators to intermediate-term maintenance of the intervention. At 9-months after the intervention, participants will participate in a phone visit designed to assess longer-term maintenance of the intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
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, 12-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. Observation Phase: For months 4-12 of the study, participants will be asked to continue following a DASH grocery shopping pattern without the provision of weekly groceries.
Intervention Phase: Participants will receive some basic information on healthy eating and a monthly stipend at 4, 8, and 12-weeks of the intervention. Observation Phase: For months 4-12 of the study, participants will be asked to follow their typical shopping pattern without the provision of a monthly stipend.
Beth Israel Deaconess Medical Center - Clinical Research Center
Boston, Massachusetts, United States
Seated, office-based, systolic blood pressure (intervention phase)
In-person, measured with an automated oscillometric device that will perform 3 measurements.
Time frame: Measured 3 months after randomization
Seated, office-based, systolic blood pressure (observation phase)
In-person, measured with an automated oscillometric device that will perform 3 measurements.
Time frame: Measured 6 months after randomization
Seated, office-based, diastolic blood pressure (intervention & observation phases)
In-person, measured with an automated oscillometric device that will perform 3 measurements.
Time frame: Measured 3 and 6 months after randomization
Ambulatory blood pressure monitoring: wake-time systolic and diastolic blood pressure (intervention & observation phases)
Ambulatory blood pressure monitoring with a mobile blood pressure device that will measure blood pressure over a 24-hour period.
Time frame: Measured 3 and 6 months after randomization
Body Mass Index (BMI) (intervention & observation phases)
In-person, measurement based on height and weight. Height is measured via a stadiometer and weight is measured via calibrated scale.
Time frame: Measured 3 and 6 months after randomization
24-hour urine potassium (intervention & observation phases)
Collected at home after a clinic void over a 24-hour period
Time frame: Measured 3 and 6 months after randomization
24-hour urine sodium (intervention & observation phases)
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Collected at home after a clinic void over a 24-hour period
Time frame: Measured 3 and 6 months after randomization
Hemoglobin A1c (intervention & observation phases)
In-person blood collection; measure of glycemia over the preceding 3 months
Time frame: Measured 3 and 6 months after randomization
Lipids (intervention & observation phases)
Measured in fasted serum specimens collected during phlebotomy. Includes total cholesterol, high density lipoprotein cholesterol, derived low density lipoprotein cholesterol, and triglycerides
Time frame: Measured 3 and 6 months after randomization
Serum potassium (intervention & observation phases)
Measured in blood as part of a basic metabolic panel
Time frame: Measured 3 and 6 months after randomization
Serum creatinine (intervention & observation phases)
Measured in blood as part of a basic metabolic panel
Time frame: Measured 3 and 6 months after randomization
Daily intake of fat, fruits, and vegetables (intervention & observation phases)
Assessed via questionnaire in-person and via phone call; assessed via a validated food screener (Block et al; PMID: 10788730).
Time frame: Measured 3, 6, and 12 months after randomization
24-hour dietary recall (intervention & observation phases)
Assessed via questionnaire in-person using the Automated Self-Administered 24-Hour Dietary Recall (ASA24)
Time frame: Measured 3 and 6 months after randomization