Groceries for Black Residents of Boston to Stop Hypertension Among Adults With Treated Hypertension

Hypertension Clinical Trial

— GoFreshRx  

Official title:

Effects of DASH Groceries on Blood Pressure in Black Residents of Urban Food Deserts With Treated Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05393232
• Other study ID #: 2022P000221
• Secondary ID: R01MD016068
• Status: Recruiting
• Phase: N/A
• Start date: October 13, 2022
• Est. completion date: October 2025

Study information

• Verified date: November 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: Stephen P Juraschek, MD, PhD
• Phone: 617-754-1416
• Email: sjurasch[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

INCLUSION:

• Self-reported/self-identified as Black or African American

• Resting systolic blood pressure of 120 to <150 mm Hg and diastolic blood pressure <100 mm Hg

• Active treatment with medications intended for hypertension treatment within the last 6 months at stable doses

• Residence in communities identified as Boston area food deserts: Brighton, Chelsea, Dorchester, East Boston, Everett, Hyde Park, Jamaica Plain, Malden, Mattapan, Revere, Roslindale, Roxbury, or Winthrop

• Able to receive home-delivered groceries or pick them up at a convenient location and willing to eat only the groceries provided over a 12-week period

• Have access to refrigeration, cooking appliances, and Wi-Fi/cellular service

• Have access to mobile device or computer to be able to conduct grocery orders via video conference or by phone

• Willing and able to complete required measurement procedures

EXCLUSION:

Laboratory Exclusions:

• Serum potassium =5.0 mmol/L or <3.5 mmol/L

• Estimated glomerular filtration rate (eGFR) <30 mL/min per 1.73 m^2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation

• Hemoglobin A1c =6.5%

Medication Exclusions:

• Unstable doses of medications that lower blood pressure or medications intended for hypertension treatment (including antihypertensives taken for non-hypertension purposes) within the last 6 months

• Unstable doses (i.e. a change in the 2 months prior to screening or randomization) of the following:

• Sodium-glucose co-transporter 2 (SGLT2) inhibitors

• Stimulants

• Inhaled or oral medications for asthma or chronic obstructive pulmonary disease (COPD)

• Hormone replacement therapy or thyroid hormone

• Weight-increasing psychotropic agents, including antipsychotic agents, lithium, and mirtazapine

• Use of any of the following medications:

• Potassium supplement, except if part of a multivitamin

• Warfarin (Coumadin)

• Chronic oral corticosteroid (intermittent use is okay)

• Weight loss medications (including GLP-1 receptor agonists)

• Unwillingness to keep same dose of vitamin, mineral, and botanical supplements

• Any medication not compatible with participation as determined by the investigators

Physical Exclusions:

• Systolic blood pressure =150 mm Hg or diastolic blood pressure =100 mm Hg

• Body weight >420 pounds

• Arm circumference >50cm

• Weight loss or gain of >5.0% of body weight during prior 2 months

Medical History Exclusions:

• Type 1 or Type 2 Diabetes defined as a hemoglobin A1c =6.5% or diabetes treatment

• 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

• 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)

• Active inflammatory bowel disease, bowel resection, malabsorptive syndrome, pancreatitis (episode within past year), or history of bariatric surgery

• Pregnancy or lactation or planned pregnancy

• Any emergency department (ED) visit for asthma or chronic obstructive pulmonary disease (COPD) in the last 6 months

• Any other serious illness or condition not compatible with participation as determined by the investigators

Lifestyle and Other Exclusions:

• Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence

• Consumption of more than 14 alcoholic drinks per week or consumption of more than 6 drinks on one or more occasion per week

• Active substance use disorder that would interfere with participation

• Extreme food insecurity

• Participation in or planning to start weight loss program

• Current participation in another clinical trial that could interfere with the study protocol

• Anticipated change in residence prior to the end of the study

• Families with more than 6 adults at dinner time (children are considered to be half an adult)

• Investigator discretion

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Dietitian-Assisted DASH groceries
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.
• Self-directed shopping
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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center - Clinical Research Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative Interviews	The investigators will perform qualitative interviews in a subpopulation of both study assignments to assess for barriers and facilitators related to long-term maintenance of the intervention.	6 months after randomization
Other	Short Form 12 Item Health Survey (SF-12)	Assessment of global health-related quality of life	Measured 3, 6, and 12 months after randomization
Other	Grocery shopping and dining habits	This is a modified version of the interviewer-administered SHoPPER (Study of Household Purchasing Patterns, Eating, and Recreation) instrument (French et al; PMID: 30808311) with some modifications to assess grocery shopping, meal preparation, and dining behaviors and habits.	Measured 3, 6, and 12 months after randomization
Other	Perceived Stress Scale 4 (PSS-4)	An instrument used to assess participants' feelings about stress	Measured 3, 6, and 12 months after randomization
Primary	Seated, office-based, systolic blood pressure (intervention phase)	In-person, measured with an automated oscillometric device that will perform 3 measurements.	Measured 3 months after randomization
Secondary	Seated, office-based, systolic blood pressure (observation phase)	In-person, measured with an automated oscillometric device that will perform 3 measurements.	Measured 6 months after randomization
Secondary	Seated, office-based, diastolic blood pressure (intervention & observation phases)	In-person, measured with an automated oscillometric device that will perform 3 measurements.	Measured 3 and 6 months after randomization
Secondary	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.	Measured 3 and 6 months after randomization
Secondary	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.	Measured 3 and 6 months after randomization
Secondary	24-hour urine potassium (intervention & observation phases)	Collected at home after a clinic void over a 24-hour period	Measured 3 and 6 months after randomization
Secondary	24-hour urine sodium (intervention & observation phases)	Collected at home after a clinic void over a 24-hour period	Measured 3 and 6 months after randomization
Secondary	Hemoglobin A1c (intervention & observation phases)	In-person blood collection; measure of glycemia over the preceding 3 months	Measured 3 and 6 months after randomization
Secondary	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	Measured 3 and 6 months after randomization
Secondary	Serum potassium (intervention & observation phases)	Measured in blood as part of a basic metabolic panel	Measured 3 and 6 months after randomization
Secondary	Serum creatinine (intervention & observation phases)	Measured in blood as part of a basic metabolic panel	Measured 3 and 6 months after randomization
Secondary	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).	Measured 3, 6, and 12 months after randomization
Secondary	24-hour dietary recall (intervention & observation phases)	Assessed via questionnaire in-person using the Automated Self-Administered 24-Hour Dietary Recall (ASA24)	Measured 3 and 6 months after randomization

External Links

•   Main trial website (shared with the GoFresh Trial)