Groceries for Black Residents of Boston to Stop Hypertension Among Adults With Treated Hypertension
- Conditions
- Hypertension
- Interventions
- Behavioral: Dietitian-Assisted DASH groceriesBehavioral: Self-directed shopping
- Registration Number
- NCT05393232
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- Brief Summary
GoFreshRx is a randomized trial, testing the effects of a home-delivered DASH-patterned grocery intervention on blood pressure in Black adults actively treated for hypertension, residing in Boston area urban food deserts.
- Detailed Description
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. Our proposed clinical trial will randomize 150 Black adults, who are actively treated for hypertension and reside 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dietitian-Assisted DASH groceries Dietitian-Assisted DASH groceries Participants will order groceries sufficient to meet their caloric needs each week for 12 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. During the remainder of the study (months 4-12), participants will be asked to apply what they learned without the provision of groceries. Self-directed shopping (referent assignment) Self-directed shopping Participants will receive a monthly stipend over a 3 month period and some basic information about healthy eating. The stipend is not restricted to foods. During the remainder of the study (months 4-12), participants will be asked to continue their typical shopping without the provision of the monthly stipend.
- Primary Outcome Measures
Name Time Method Seated, office-based, systolic blood pressure (intervention phase) Measured 3 months after randomization In-person, measured with an automated oscillometric device that will perform 3 measurements.
- Secondary Outcome Measures
Name Time Method 24-hour urine potassium (intervention & observation phases) Measured 3 and 6 months after randomization Collected at home after a clinic void over a 24-hour period
Serum potassium (intervention & observation phases) Measured 3 and 6 months after randomization Measured in blood as part of a basic metabolic panel
Seated, office-based, systolic blood pressure (observation phase) Measured 6 months after randomization In-person, measured with an automated oscillometric device that will perform 3 measurements.
Seated, office-based, diastolic blood pressure (intervention & observation phases) Measured 3 and 6 months after randomization In-person, measured with an automated oscillometric device that will perform 3 measurements.
Ambulatory blood pressure monitoring: wake-time systolic and diastolic blood pressure (intervention & observation phases) Measured 3 and 6 months after randomization Ambulatory blood pressure monitoring with a mobile blood pressure device that will measure blood pressure over a 24-hour period.
Body Mass Index (BMI) (intervention & observation phases) Measured 3 and 6 months after randomization In-person, measurement based on height and weight. Height is measured via a stadiometer and weight is measured via calibrated scale.
24-hour urine sodium (intervention & observation phases) Measured 3 and 6 months after randomization Collected at home after a clinic void over a 24-hour period
Hemoglobin A1c (intervention & observation phases) Measured 3 and 6 months after randomization In-person blood collection; measure of glycemia over the preceding 3 months
Daily intake of fat, fruits, and vegetables (intervention & observation phases) Measured 3, 6, and 12 months after randomization Assessed via questionnaire in-person and via phone call; assessed via a validated food screener (Block et al; PMID: 10788730).
Lipids (intervention & observation phases) Measured 3 and 6 months after randomization Measured in fasted serum specimens collected during phlebotomy. Includes total cholesterol, high density lipoprotein cholesterol, derived low density lipoprotein cholesterol, and triglycerides
Serum creatinine (intervention & observation phases) Measured 3 and 6 months after randomization Measured in blood as part of a basic metabolic panel
24-hour dietary recall (intervention & observation phases) Measured 3 and 6 months after randomization Assessed via questionnaire in-person using the Automated Self-Administered 24-Hour Dietary Recall (ASA24)
Trial Locations
- Locations (1)
Beth Israel Deaconess Medical Center - Clinical Research Center
🇺🇸Boston, Massachusetts, United States