Effects of DASH Groceries on Blood Pressure in Black Residents of Urban Food Deserts Without Treated Hypertension
Phase: NA
Conditions: Elevated Blood Pressure, Hypertension
Sponsor: Beth Israel Deaconess Medical Center

 
 
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Effects of DASH Groceries on Blood 
Pressure in Black Residents of Urban Food 
Deserts Without Treated Hypertension 
 
 
Short Title: Groceries for Black Residents of 
Boston to Stop Hypertension  
 
 
PROTOCOL Version 1.7 
 
 
MAR 25, 2025 
 
 
 
 

 
 
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SUMMARY OF PROTOCOL VERSIONS AND CHANGES 
Version 1.0 
 Original version submitted to the Beth Israel Deaconess Medical Center 
Institutional Review Board on September 21, 2021. 
Version 1.1 
 Version 1.1 submitted to the Beth Israel Deaconess Medical Center Institutional 
Review Board on May 31, 2022. 
Version 1.2 
 Version 1.2 submitted to the Beth Israel Deaconess Medical Center Institutional 
Review Board on September 22, 2022. 
Version 1.3 
 Version 1.3 submitted to the Beth Israel Deaconess Medical Center Institutional 
Review Board on December 13, 2022.   
Version 1.4 
 Version 1.4 submitted to the Beth Israel Deaconess Medical Center Institutional 
Review Board on December 28, 2022.   
Version 1.5 
 Version 1.5 submitted to the Beth Israel Deaconess Medical Center Institutional 
Review Board on March 28, 2023. 
 
Version 1.6 
 Version 1.6 submitted to the Beth Israel Deaconess Medical Center Institutional 
Review Board on November 1, 2023. 
 
 
 
 

 
 
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GoFresh Protocol Table of Contents 
1. ABSTRACT ............................................................................................................................................ 5 
2. SPECIFIC AIMS ..................................................................................................................................... 5 
3. BACKGROUND ..................................................................................................................................... 6 
4. OVERVIEW OF DESIGN ..................................................................................................................... 8 
6. RECRUITMENT ................................................................................................................................... 12 
BIDMC Clinical Research Center ...................................................................................................... 12 
Recruitment strategies ........................................................................................................................ 12 
Data collection contact schedule ....................................................................................................... 15 
8. QUALITY ASSURANCE AND QUALITY CONTROL ................................................................... 21 
9. QUALITATIVE INTERVIEWS ............................................................................................................ 22 
10. RANDOMIZATION AND MASKING .............................................................................................. 23 
11. INTERVENTIONS ............................................................................................................................. 24 
Distribution and adherence ................................................................................................................ 24 
12. SAFETY .............................................................................................................................................. 28 
Potential Risks ...................................................................................................................................... 29 
Risks related to breaches of confidentiality ..................................................................................... 29 
13. ANALYSIS .......................................................................................................................................... 32 
Power and sample size ....................................................................................................................... 32 
Missing data .......................................................................................................................................... 33 
Trial-wide data release ........................................................................................................................ 34 
16. TIMELINE ........................................................................................................................................... 35 
17. REFERENCES ................................................................................................................................... 37 
 
 
 
 

 
 
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LIST OF ABBREVIATIONS / GLOSSARY 
ABPM  
Ambulatory Blood Pressure Monitoring 
AOBP  
Automated Office Blood Pressure 
BIDMC 
Beth Israel Deaconess Medical Center 
BMI   
Body Mass Index 
BP 
 
Blood Pressure 
CAB     
Community Advisory Board 
CRC  
Clinical Research Center (at BIDMC) 
CVD  
Cardiovascular disease 
DASH  
Dietary Approaches to Stop Hypertension 
DIGO  
Diet Gout Trial 
DBP  
Diastolic Blood Pressure 
DSMB  
Data Safety and Monitoring Board  
GTE  
Getting to Equity 
FV (1-3) 
Follow-up Visit 
GOFRESH Groceries for Black Residents of Boston to Stop Hypertension Trial 
GO 
 
Grocery ordering calls 
HIPAA 
Health Insurance Portability and Accountability Act 
HR 
 
Heart rate 
HTN  
Hypertension  
NIHMD 
National Institute of Minority Health and Health Disparities 
IRB 
 
Institutional Review Board 
OH 
 
Orthostatic Hypotension 
PS 
 
Pre-Screening Visit 
PRISM 
Practical Robust Implementation Sustainability Model 
RE-AIM 
Reach, Effectiveness, Adoption, Implementation, Maintenance 
[Implementation Framework] 
RESTORE 
Addressing Social Determinants to Prevent Hypertension Network 
RZ 
 
Randomization Visit 
SDOH  
Social Determinants of Health 
SNAP  
Supplemental Nutritional Assistance Program 
SBP 
 
Systolic Blood Pressure 
SV (a & b) 
Screening Visit 
USDA  
US Department of Agriculture  
 
 

 
 
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1. ABSTRACT 
 
Over 103 million adults in the US have hypertension (HTN)1 a major contributor to coronary heart 
disease and early death.2 The rising prevalence in HTN is driven by increased consumption of 
high sodium, processed foods,3 which is particularly rampant among low-income urban 
communities that are disproportionately Black.4 Diet is the most substantial determinant of rising 
racial disparities in HTN risk,4,5 highlighting a critical need for innovative solutions to overcome 
barriers to healthy eating among Black adults in the US. Our proposal tests a dietitian-assisted, 
technology-based DASH grocery intervention to improve access to and consumption of a DASH 
eating plan among Black adults in the Boston area urban food deserts. The intervention will 
provide (1) three months of DASH-patterned groceries, (2) basic and scalable online skills in 
DASH grocery shopping using a web-based home-delivery platform and training in food storage 
and preparation, and (3) information on local venues (co-ops, stores, and food pantries) where 
participants can source healthy foods long-term at lower cost. This study will establish the 
effectiveness of home-delivered DASH groceries sufficient to meet dietary needs to reduce blood 
pressure (BP) and improve cardiovascular risk factors. Moreover, we will identify facilitators and 
barriers to maintenance of DASH adherence and home meal preparation.    
 
2. SPECIFIC AIMS 
 
Aim 1: Determine the effectiveness of dietitian-assisted, virtually ordered, home-delivered 
DASH groceries on systolic blood pressure (SBP) among Black adults with elevated blood 
pressure (BP) or untreated stage 1 or 2 hypertension. H1.1 DASH groceries will lower SBP 
(primary outcome) compared to self-directed grocery shopping after 3 months and effects will be 
maintained at 6 months post-randomization.  
 
Aim 2: Determine the immediate and sustained effects of dietitian-assisted grocery 
shopping on families’ adoption of the DASH eating plan and frequency of home-prepared 
meals versus out-of-home dining, 3-, 6-, and 12-months post-randomization. H2.1 DASH 
groceries will ↑ DASH adherence (self-report, ↓urine sodium & ↑ potassium) and H2.2 ↑ home-
prepared meals and ↓ out-of-home dining (self-report, quantified using the SHoPPER 
questionnaire).  
 
Aim 3: Evaluate the reach, maintenance, and cost-effectiveness of the intervention up to 
12 months post-randomization using a RE-AIM framework and mixed methods. H3.1: 
Reach, quantified during our recruitment campaign, will be high. H3.2: A 3-month, dietitian 

 
 
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assisted program will be cost-effective compared to self-directed grocery shopping at 1 year. 
H3.3: Identifying barriers and facilitators in qualitative interviews will enhance scalability. 
 
3. BACKGROUND 
 
The DASH eating plan is a balanced eating plan rich in fruit, vegetables, low-fat dairy, and 
lean meats that is reduced in red meat, sweets, and sugary beverages.6,7 A reduced sodium, 
DASH eating plan has been demonstrated in randomized trials to lower BP8  within four weeks9 
and is endorsed by the American Heart Association (AHA).10 Notably, the recipes in the original 
DASH trials were modeled after traditional American meals, dietary habits, and foods, using a 
one-size-fits-all approach,6,7 but implementation in a diverse range of urban cultural and ethnic 
groups has been limited.  
 
Over the past 20 years, the average consumption of fruits and vegetables has remained 
between 1-2 servings/day,4  much lower than the 7-9 servings/day recommended in the DASH 
eating plan.8 While improvements in diet have been observed among higher income groups, the 
average number of servings of fruit and vegetables among the 42 million recipients of US food 
stamps (SNAP or Supplemental Nutrition Assistance Program) has stagnated at 1.3 
servings/day.4 Lower diet quality is even more prevalent among Black versus White adults in 
urban areas.11 The lower diet quality among Black adults is related to food insecurity, the inability 
to afford enough food for a healthy lifestyle,12 and is experienced by 21% of Black (vs 16% of 
Hispanic and 8% of White) households.13 Several national studies have found strong 
associations between food insecurity and higher BP,14 worsening disparities in the prevalence of 
cardiometabolic diseases.15  
Distance, cost, and cultural acceptability perpetuate dietary health disparities.16 Education 
is necessary but not sufficient to address disparities in healthy eating because of barriers to 
accessing healthy foods related to pervasive social determinants of health (SDOH). First, many 
Black adults live in urban food deserts, defined as communities characterized by lower income 
and a low concentration of local healthy grocery stores, such that fresh produce cannot be 
accessed without a car or public transportation.17,18 Second, DASH-like diets are costly,19 and 
price prevents their consumption among adults with low incomes and on food assistance,20 
perpetuating the experience of food insecurity. Finally, urban settings contain rich cultural and 
ethnic diversity with diverse eating patterns that may not align with the published DASH meals,21 
despite attempts to translate to additional cultural groups.22 
Virtual grocery delivery is a promising innovation to mitigate the barriers outlined above. 
Prior studies showed that home delivery of DASH meals improved health.23,24 However, these 
studies relied on predetermined and fixed meals, which have limited generalizability to diverse 

 
 
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groups and dietary preferences. In contrast, groceries can be prepared, adapted, or tailored to 
meet each person’s taste, enabling adults to customize healthy eating to their own family 
traditions, a feature highlighted by some groups as essential for improved acceptability of DASH 
foods.25 The sustainability of this strategy is supported by the US Department of Agriculture 
(USDA), which launched a SNAP virtual purchasing pilot, to add online grocery vendors to their 
ecommerce platform, which has seen widespread expansion during the COVID-19 epidemic.26 
The USDA also recently launched a “Food Box” program to provide fresh produce, dairy, and 
meat groceries to families affected by COVID-19.27                
A growing number of food policy experts have advocated for grocery subsidies,28 with 
some recommending that SNAP be restricted to fruits and vegetables alone as a means of 
addressing health disparities.29,30 However, there is limited evidence that the mere provision of 
healthy groceries would affect long-term change in dietary intake. In contrast, the 5+ Nuts and 
Beans trial demonstrated that dietitian-assisted grocery shopping, even when limited to the 
SNAP allotment of $30/week, increased the number of fruit and vegetable servings consumed by 
urban-dwelling Black adults.31 In a subsequent trial, we showed that dietitian-assisted DASH 
grocery shopping of $105/week with Amazon Fresh (the Diet Gout [DIGO] trial) lowered urine 
sodium excretion over a 4-week period.32 These two trials suggest that the provision of groceries 
coupled with mild skill acquisition does improve consumption of the DASH eating plan. 
There is a critical need for a rigorous trial that demonstrates clinical effectiveness. While 
prior work demonstrated the ability of dietitian-assisted, DASH grocery interventions for changing 
behavior, neither study significantly affected clinical outcomes like BP or LDL-cholesterol.31,33 
Comparison of our two trials suggests that further replacement of participants’ diets with study 
foods will achieve greater behavioral and clinical effects.  
Translation and sustainability of the proposed intervention require a patient-centered focus 
that addresses SDoH. Even though the proposed intervention will improve access to healthy 
foods via grocery delivery, other contextual factors such as family dynamics, SDoH (e.g., food 
insecurity, lack of transportation), community norms and resources, culture, and even local or 
state level policies related to nutrition may affect continued consumption of the DASH eating 
plan. Using qualitative methods, we will evaluate the facilitators and barriers to sustaining the 
DASH eating plan among Black adults with elevated BP or HTN living in food deserts and the 
failure or success of the intervention from the participants’ perspective.  
Findings from the proposed study will provide the evidence needed for policy makers to 
evaluate the long-term impact of addressing the adoption of the DASH eating plan in low-income 
populations. As more states and the USDA consider using SNAP benefits to purchase online 
groceries, our proposal has the potential to change national SNAP policies to sponsor a DASH-
patterned grocery program if the intervention is effective and can be implemented at an 
affordable cost.29 
 
 

 
 
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4. OVERVIEW OF DESIGN 
 
This project is guided by the National Institute of Minority Health and Health Disparities (NIMHD) 
health equity research framework while its evaluation will be guided by the RE-AIM 
implementation framework.34,35 Specifically, the NIMHD framework will be used to evaluate the 
impact of a multilevel intervention (dietitian-assisted, technology-based DASH groceries) to 
improve access to and consumption of a DASH eating plan by Black adults in Boston area food 
deserts (Figure 1). We will use RE-AIM to evaluate the reach, adoption, maintenance, and cost-
effectiveness of the intervention to inform broader scalability (see section 7 for details related to 
the implementation aims). 
 
Using a Hybrid Type I effectiveness-implementation design, we will randomly assign at least 176 
Black adults with elevated BP or untreated stage 1 or 2 HTN to one of two 3-month lifestyle 
interventions: (1) Dietitian-assisted, virtually-ordered, home-delivered groceries consistent with 
the DASH eating plan or (2) Self-directed grocery shopping. The study has an intervention phase 
and a post-intervention maintenance phase. During the intervention phase, we will perform a 
randomized controlled trial with two parallel arms (Figure 2).  

 
 
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Aim 1 focuses on outcomes measured at the beginning and end of the intervention phase (3-
months post-randomization) and 6-months post-randomization during the post-intervention 
maintenance period. The primary outcome is office systolic BP (SBP). Secondary outcomes are 
office DBP, wake-time 26-hour SBP and diastolic BP (DBP), high-density lipoprotein cholesterol, 
low-density lipoprotein cholesterol, triglycerides, and hemoglobin A1c. Aim 2 focuses on 
determining the effect of the intervention on DASH adherence (adoption), incorporating 
qualitative interviews with self-reported adherence data and 24-hour urine electrolytes at 3- and 
6-months post-randomization. We also determine meal preparation and dining practices at 3-, 6-, 
and 12-months post-randomization. Aim 3 will evaluate the reach, maintenance, and 
implementation (cost-effectiveness) of the intervention over the entire 12-month study using a 
RE-AIM framework. 
 
5. STUDY POPULATION AND ELIGIBILITY 
 
Eligibility criteria are summarized below. This trial focuses on hypertension in the setting of no 
active hypertension medication use. We will include families with less than or equal to 6 adults 
(including the index person) at dinner time to allow for sharing (a child less than 18 is counted as 
half an adult), while maintaining adequate food for the study participant. 
 
Inclusion criteria 
 
 Age 18 to 100 years 
 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 based on the cumulative average across three pre-randomization visits 
 Residence in communities identified by the Massachusetts Department of Public Health 
as Suffolk County (Boston area) food deserts: Brighton, Chelsea, Dorchester, Hyde Park, 

 
 
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Mattapan, Revere, Roxbury, Winthrop, or East Boston, Malden, Jamaica Plain, 
Roslindale, and Everett.   
 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 criteria 
 
Laboratory Exclusions: 
 Serum potassium ≥5.0 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% 
 
Medication Exclusions: 
 Any use 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: 
o Sodium-glucose co-transporter 2 (SGLT2) inhibitors 
o Stimulants 
o Inhaled or oral medications for asthma or chronic obstructive pulmonary disease 
(COPD) 
o Hormone replacement therapy or thyroid hormone 
o Weight-increasing psychotropic agents, including antipsychotic agents, lithium, and 
mirtazapine 
 Use of any of the following medications: 
o Potassium supplement, except if part of a multivitamin 
o Warfarin (Coumadin) 
o Chronic oral corticosteroid (intermittent use is okay) 
o 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 
 
 

 
 
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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 a 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 (a child less than 18 is counted as half an 
adult) 
 Investigator discretion  
*Extreme food insecurity is based on responding with “Often True” to both questions on the 
hunger vital sign questionnaire, i.e., “Within the past 3 months we worried whether our food 

 
 
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would run out before we got money to buy more” and “Within the past 3 months the food we 
bought just didn’t last and we didn’t have money to get more”, in addition to answering  “Yes” to 
this confirmatory question, within the past 3 months, have you involuntarily gone an entire day 
without eating? “36 
6. RECRUITMENT 
 
BIDMC Clinical Research Center 
The trial study assessments will be conducted at the BIDMC Clinical Research Center (CRC), 
Bowdoin Street Health Center, or at a clinical office where the PI and his team currently practice 
within the greater BIDMC health network, as approved by our IRB in Boston, Massachusetts. 
The Clinical Research Center is a research facility within BIDMC that maintains contiguous 
space for inpatient, outpatient, and administrative activities. The outpatient area consists of 12 
rooms with 2 of these equipped with beds and private bathrooms. The unit staff includes nurses, 
patient care technicians, dietitians, dietary support staff, a laboratory assistant, and a practice 
coordinator. The unit is open for patient activity 24 hours per day, 7 days per week. In addition, 
the Sample Processing Laboratory Service processes samples for analysis at various 
laboratories, including Quest Diagnostics. Samples are stored at room temperature or in a 
monitored and alarmed refrigerator, ‐20 C freezer short-term or ‐80 C freezer for long-term 
storage. 
Recruitment strategies 
We will implement a variety of strategies to achieve our recruitment target, i.e., at least 176 
participants. Our experience is that multiple strategies work synergistically to promote study 
name-brand recognition to enhance recruitment. We will employ the following approaches: 
(1) Website with information on the trial and GoFresh team members, as well as embedded 
Qualtrics survey form for sign up. The website is accessibility optimized. All sign-up responses 
are captured in Qualtrics and subsequently uploaded to the centralized study recruitment 
database.  
(2) Flyers placed in the clinic waiting areas and flyer boards in the zip codes of interest with 
phone number, website, and QR code as contact options.  
(3) Direct mail We will use two direct mailing strategies for recruitment: 1) Obtaining a list of 
BIDMC patients who meet basic eligibility criteria (race, eligible zip code, and age) through the 
BIDMC Insight Core. 2) Purchasing an external mailing list of Boston residents meeting the same 
basic eligibility criteria. Individuals identified through these methods will receive a study brochure 
with business reply mail, along with information on how to contact the study team via phone, 
web, or email. 

 
 
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(4) Primary care physicians that identify their patients as eligible for the study. We will advertise 
the study at faculty meetings and provide flyers and brochures to all primary care doctors. 
In addition, we will work with our community advisory team to identify supplementary methods to 
identify patients living in minoritized communities. These are likely to include: 
(5) Community outreach to faith-based organizations in our target communities. We have 
contacted primarily Black/African American based churches within the ZIP codes of interest as 
well as reached out to Community Advisory Board (CAB) members who have connections to 
faith-based Boston area communities. We plan to have church and clinic tabling events. 
(6) Traditional media venues we will place advertisements through the Massachusetts Bay 
Transit Authority to purchase public service advertising on local bus and subway routes. MBTA 
also offers geofencing, which is an emerging digital strategy to target residents in specific zip 
codes. We will also advertise through periodical companies and via Radio programs. 
(7) Online advertising primarily using Facebook and Instagram, two social media sites with high 
numbers of users. Advertising will be done through the overarching Meta for Business platform 
and will be based out of a Facebook page using the GoFresh study information. Advertisements 
will adhere to language requirements regarding advertising to specific demographics, namely 
avoiding specifically referencing personal attributes of ad viewers as specified in Facebook’s 
advertising policies.  
(8) Clinic Recruitment we will have a recruitment table at the Bowdoin Street Clinic. We will 
complete the prescreening form with interested participants and perform field-based blood 
pressure screenings.  
(9) MyChart Recruitment we will leverage BIDMC’s MyChart patient portal to reach potentially 
eligible participants efficiently. Eligible patients will be identified through the Slicer Dicer function 
on EPIC based on the study’s inclusion/exclusion criteria. These patients will receive a secure 
MyChart message that includes a brief study overview and an option to express interest directly 
through the portal. The study team will follow up with interested patients to provide additional 
information and help answer any questions. MyChart messaging will be sent in waves to monitor 
engagement and response rates. 
 
Community Advisory Board (CAB) 
The BIDMC CAB is a community-academic partnership comprised of community leaders, 
patients, clinicians, and advocates in the Boston area. The members of the CAB are volunteers 
from the community who will meet virtually on a regular basis, on average quarterly to biannually 
to provide community input on the research process. Volunteers for the CAB are recruited from 

 
 
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diverse backgrounds (race, ethnicity, gender, professional, etc.) to afford a range of unique 
perspectives. 
Function of the CAB 
The members of the CAB will receive regular updates about the study and advise the research 
team on a variety of study-related items including the study design, recruitment, consent, 
retention, educational material development, and dissemination efforts prior to and throughout 
implementation. The CAB members will contribute their personal and professional experience to 
the research project. The CAB will be guided by an agreement that will be generated, agreed 
upon, and signed by all the CAB members. This agreement includes the membership terms, 
meeting attendance requirements, roles, and responsibilities. Members of the CAB are expected 
to participate extensively in the research process so they can adequately address issues that 
community dialogue can receive appropriate attention. Members of the CAB are compensated 
for their time for each meeting attended.  
Recruitment for the CAB 
Recruitment for the CAB is ongoing and new members will be added as attrition occurs. The 
CAB members will continue to be recruited through word of mouth, recommendations from 
community leaders, members, advocates, other CAB members, and BILH/BIDMC staff. The 
study team will provide CAB members with the background and an orientation for the study, new 
CAB members will be provided similar orientation prior to their first meeting. 
 
Recruitment of female or Black adults  
We will recruit at least 176 participants, anticipating a potential 15% attrition rate. We will aim to 
recruit a population that is ~50% female and 100% Black. In order to achieve this goal, we will be 
tracking our recruitment goals on a weekly basis and making sure we are careful with our 
enrolment diversity in terms of biological sex.   
 
7. DATA COLLECTION AND MEASUREMENTS 
Measurement Schedule 
 
 
 
 
 
 
 
 
Visit 
PS 
SVa 
& 
SVb 
RI 
RZ 
GO 
FV1a 
& 
FV1b 
FV2a 
& 
FV2b 
FV
3 
Study Phase (PR = Pre-Intervention; I = Intervention; PO = Post-
Intervention) 
PR 
PR 
PR 
PR 
I 
I 
PO 
PO 
Type (C = Clinic; T = Telephone) 
 
C 
C/
T 
C 
T 
C 
C 
T 

 
 
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Months(s) 
-
1.5 
-1 
-1 
0 
0-3 
3 
6 
12 
Verbal Consent  
X 
 
 
 
 
 
 
 
Prescreening Questionnaire (PQ) 
X 
 
 
 
 
 
 
 
Informed Consent  
 
X 
 
 
 
 
 
 
Contact Information (CI) 
 
X 
 
 
 
 
 
 
Demographics Form (DEMO) 
 
X 
 
 
 
 
 
 
Medical History Questionnaire (MHQ) 
 
X 
 
 
 
 
 
 
The eHealth Literacy Scale (eHEALS) 
 
X 
 
 
 
 
 
 
Accountable Health Communities Health-Related Social Needs 
Screening Tool (AHC) 
 
X 
 
 
 
 
 
 
Hunger Vital Sign Questionnaire (HVS) 
 
X 
 
 
 
X 
X 
X 
Run-In Visit (Grocery Delivery Practice) (RI) 
 
 
X 
 
 
 
 
 
Randomization Eligibility Form (REF) 
 
 
 
X 
 
 
 
 
Randomization Assignment & Instructions (RA) 
 
 
 
X 
 
 
 
 
Medication Reconciliation (MRX) 
 
X 
 
X 
 
X 
X 
X 
Mifflin St Jeor/Physical Activity Energy Estimator 
 
X 
 
X 
 
 
 
 
International Physical Activity Questionnaire Short Form (IPAQ-
SF) 
 
X 
 
X 
 
 
 
 
Block Screeners (Fruit/Vegetables, Fat, & Sodium) 
 
X 
 
 
 
X 
X 
X 
SHoPPER (meal preparation and behaviors) Questionnaire 
 
X 
 
 
 
X 
X 
X 
Dietary Information Questionnaire (DIQ) 
 
X 
 
 
 
 
 
 
Diet Symptoms Form (DS) 
 
X 
 
 
 
X 
X 
X 
Height Measurement (BMI) 
 
X 
 
 
 
 
 
 
Weight Measurement (BMI) 
 
X 
 
 
 
X 
X 
 
26-Hour Blood Pressure Monitoring (ABPM) 
 
X 
 
 
 
X 
X 
 
Omron HEM-907XL BP measurement 
 
X 
 
X 
 
X 
X 
 
Fasting phlebotomy (LAB) 
 
X 
 
 
 
X 
X 
 
24-Hour Urine Collection (Na, K, Cr, Albuminuria, Ca, Mg) & Spot 
Urine (UC) 
 
X 
 
 
 
X 
X 
 
24-Hour Recall (NUT) 
 
X 
 
 
 
X 
X 
 
Perceived Stress Scale 4 (PSS-4) 
 
X 
 
 
 
X 
X 
X 
Krieger Discrimination Questionnaire (KD) 
 
X 
 
 
 
 
 
 
Pre-Post Intervention Knowledge Assessment Form (KNOW)  
 
 
 
X 
 
X 
 
 
Qualitative Interview (QI) 
 
 
 
 
 
X 
 
 
Short Form Health Survey (SF-12) 
 
X 
 
 
 
X 
X 
X 
Close Out Questionnaire (CO) 
 
 
 
 
 
 
 
X 
Intervention group only: Grocery Orders, Intervention 
Understanding (IU) 
 
 
 
 
X 
 
 
 
Intervention group only: Diet Palatability 
 
 
 
 
X 
 
 
 
 
Data collection contact schedule 
Eligibility, baseline, and follow-up data will be collected online, by phone, through mailings, and 
at in-person visits. In-person data collection visits will primarily be conducted at the Clinical 
Research Center at BIDMC. Participants will be offered a stipend to help with transportation to 
and from in-person visits. In general, we will try to be as flexible as possible to meet the needs of 
our participants. For example, we will schedule in-person visits at times that are most feasible for 

 
 
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our participants. See Table above for an overview of proposed data collection items by visit. The 
data collection points for participant-level data are as follows: 
Pre-Screening Visit (PS) – A brief telephone interview for interested adults focused on trial 
eligibility. Ineligible participants will be thanked and provided with an explanation of the 
reason for ineligibility.   
Screening Visits (SVa & SVb) – A series of 2 in-person visits performed at the CRC or Bowdoin 
Street Health Center to determine eligibility, describe the trial plan, and obtain written 
informed consent (SVa). Participants will be screened for health-related social needs 
including food insecurity modified to reflect the last 3 months. Participants will be asked for 
demographic information, an expanded medical history, contact information, health 
communities questionnaire, baseline fruit and vegetable consumption,9 and estimated resting 
metabolic rate (Mifflin St Jeor/International physical activity questionnaire).37 We also will 
administer the SHoPPER questionnaire on shopping habits, food preparation, and dining 
behaviors.38,39 Participants also will be asked to rate the baseline presence of symptoms 
related to the DASH eating plan (e.g. bloating, etc.) adapted from the DASH-Sodium trial.12 
Participants will subsequently undergo physical measures (height, weight, office BP), 
phlebotomy, and will return home with equipment for 26-hour BP monitoring and 24-hour 
urine collection (dropped off at the CRC 1-2 days later; during the SVb visit). SVb will also 
include questionnaires to assess perceived health, stress, and discrimination. SVb will also 
include a 24-hour recall that coincides with the 24-hour urine timeline. To facilitate high 
through-put and accessible screening, SVa may be split into a “mini” visit focused on the 
demographic and contact information, the food insecurity screening instrument, and the first 
set of blood pressure measurements. Eligible participants at the “mini” are invited back to 
complete the remaining components of SVa. 
Run In Visit (RI) – The purpose of this visit will be to determine safe and secure delivery of food 
items from Amazon Fresh or Instacart to participants’ homes. After SVb, there will be a form 
completed by a Registered Dietitian that identifies a perishable “practice” food item that the 
participant would like to receive, as well as their address for delivery. A follow-up telephone 
call will take place after delivery to confirm that the item was received. This call will be used 
to identify any barriers to food delivery prior to randomization. In the event groceries cannot 
reach participants’ homes, the dietitian will work with participants to identify a more 
accessible pick-up location in the participants’ community (e.g., a library with a refrigerator). 
Transportation support will be provided for grocery pick-up on an as needed basis. 
Randomization Visit (RZ) – Eligible adults will undergo the randomization visit within 60 days of 
screening. This visit includes repeat blood pressure and weight assessments. Once 
randomized, participants will receive instructions related to their assignment.  

 
 
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Grocery Ordering Calls (GO) – Participants assigned the intervention will order groceries 
weekly with our study dietitian, who will use examples from the participants’ experience the 
preceding week to reinforce strategies to promote healthy eating. Participants will also be 
asked about last week’s consumption patterns, which will be estimated using a weekly food 
use worksheet.   
Follow-up Visit 1 (FV1a & FV1b) – This includes 2 in-person assessments that will be 
performed at the CRC or Bowdoin Street Health Center, 3 months post-randomization. FV1a 
includes a food insecurity screener, assessment of current medications, a rapid food 
frequency questionnaire, the SHoPPER questionnaire (on shopping habits, meal preparation, 
and dining behaviors), and a dietary symptom questionnaire. In addition, we will measure 
weight, perform phlebotomy, and perform an office BP measurement. Participants will be 
provided with a 26-hour ambulatory BP monitor and a 24-hour urine collection kit (to be 
dropped off at the CRC 1-2 days later at FV1b). FV1b will include a participant self-reported 
health form (short form health survey), a 26-hour ambulatory BP monitor and 24-urine 
collection form drop off forms, a perceived stress questionnaire, a post intervention 
knowledge assessment questionnaire, an office BP measurement, as well as repeat weight 
measurement. Those who do the DASH grocery intervention will be asked about diet 
compliance and palatability. FV1b will also include a 24-hour recall that coincides with the 
24-hour urine timeline. 
Follow-up Visit 2 (FV2a & FV2b) – This includes 2 in-person assessments that will be 
performed at the CRC or Bowdoin Street Health Center, 5-6-months post-randomization 
(equivalent to 2-3 months after the intervention). FV2a includes a food insecurity screener, 
assessment of current medications, a rapid food frequency questionnaire, the SHoPPER 
questionnaire, and a dietary symptom questionnaire. We also will measure weight and BP 
and perform phlebotomy. Participants will be fitted with a 26-hour ambulatory BP monitor and 
24-hour urine collection kit (dropped off at the CRC 1-2 days later at FV2b). FV2b will also 
include a 24-hour recall that coincides with the 24-hour urine timeline, perceived stress scale 
questionnaire,41 and short-form health survey42. In addition, 45 participants (35 from the 
DASH group and 10 from the self-directed group) will be randomly selected to participate in 
comprehensive qualitative interviews to characterize facilitators and barriers to DASH 
adoption (“Post-Intervention Maintenance Phase Qualitative Interviews”). The total number 
may be reduced or increased based on theme saturation (see Qualitative Interviews section 
below). 
Follow-up Visit 3 (FV3) – Twelve months post-randomization (~6 months after FV2), all 
participants will undergo a telephone visit. This includes a food insecurity screener, 
assessment of medications, a rapid food frequency questionnaire, the SHoPPER 
questionnaire,38,39 a perceived stress survey, a short form health survey, and a dietary 
symptom questionnaire. They will also complete a close out questionnaire reflecting on their 

 
 
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time in the program and have the option to fill out a participant testimonial for more detailed 
feedback.  
  
Adherence 
General Adherence 
To ensure that participants do not miss any of their study visits, we will send reminder calls or text 
messages based on the participants' preferred method of contact. We will also mail reminder/thank 
you letters in between FV1b-FV2a and FV2b-FV3.  
 
Blood Pressure Adherence  
We will use the OMRON HEM-907XL device and follow a standard blood pressure measurement 
protocol (see section on Blood Pressure measurement below); participants will be asked to sit and 
rest in the appropriate position for five minutes prior to taking their blood pressure measurements. 
The study staff will all undergo training and certification prior to blood pressure measurement. 
Recertification will occur on an annual basis.     
 
ABPM Adherence 
The participant will be given an activity log with the ABPM monitor to ensure accurate 
documentation of the sleep and wake hours, while wearing the ABPM. To ensure adherence using 
the ABPM monitor we will complete the log with the participant in-person during the SVb, FV1b, 
and FV2b visits. We will also give participants an ABPM Survey to complete after their 26-hour 
monitoring period. This instrument will be reviewed by staff for completeness at SVb, FV1b, and 
FV2b.  
 
Lab tests/phlebotomy Adherence 
We will send out reminder calls, or messages based on the participants’ preferred method of 
contact as a reminder for phlebotomy visits (SVa, FV1a, FV2a) and to bring in their urine jug (SVb, 
FV1b, FV2b).    
Primary outcome variable. 
The primary outcome (Aim 1) is mean SBP via automated office BP (AOBP). Secondary 
outcomes (Aim 1) include DBP (AOBP), wake-time 26-hour SBP and DBP, BMI, lipids, and 
hemoglobin A1c. Other outcomes (Aim 2), include the self-reported fruits and vegetables intake 
(servings/day), 24-hour urine sodium and potassium (our intervention is low in sodium and high 
in potassium), and family shopping, preparation, and dining habits (SHoPPER questionnaire).38,39  
A. Primary Effectiveness Endpoint (Aim 1): Office-based automated SBP will be measured during 
all in-person visits using an OMRON HEM907-XL, a validated oscillometric device.43 BP will be 
measured by trained and certified staff, using an appropriately sized cuff. Three measurements 
(separated by 60 seconds) will be obtained at each visit, using participants’ non-dominant arm 
after 5 minutes of quiet, seated rest with a supported back.44 Baseline BP will be averaged 

 
 
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across SVa, SVb, and RZ visits. Follow-up BP will be measured at FV1a & FV1b and FV2a & 
FV2b (3- and 6-months post-randomization, respectively).45 
Secondary outcome variables.  
1. Office-based automated DBP will be measured concurrent with SBP described above. 
2. Awake-time 26-hour SBP and DBP: A Spacelabs 90227 device will be used to perform 26-
hr ambulatory BP monitoring (ABPM). This Spacelabs device has been validated in multiple 
adult populations.46 Awake-time will be defined by a participant log. The ABPM device will 
measure BP every 20 minutes over a 26-hour period, except between 1 to 5 am where 
measurements are performed every 30 minutes. We will also characterize sleep-time and 
26-hour BP as well as nocturnal BP and dipping status (wake-to-sleep ratio, relevant for 
CVD risk).47  
3. BMI is based on height and weight. Height will be measured with a stadiometer at SVa and 
weight will be measured via a calibrated scale at SVa, SVb, RZ, FV1a, FV1b, FV2a, and 
FV2b.  
4. Fasted biomarkers measured by Quest diagnostics (Secaucus, New Jersey) at SVa, FV1a, 
and FV2a. These include lipids (total cholesterol, high density lipoprotein cholesterol, 
derived low density lipoprotein cholesterol, and triglycerides), hemoglobin A1c, and serum 
creatinine and potassium. Additional specimens for ancillaries will be stored in a 
biorepository. 
 
Secondary Adoption Endpoints: Behaviors (Specific Aim 2)  
1. Fruit and vegetable servings and dietary fat intake: Assessed via 5-minute, validated food 
screeners (SV, FV1-3).48 
2. 24-hour urine potassium and sodium will be collected at home after a clinic void (SVa, FV1a, 
FV2a and returned 1-2 days later at the (SVb, FV1b, FV2b) as objective measures of 
compliance.  
3. Food shopping, meal preparation, and dining behaviors and habits will be assessed via the 
interviewer-administered SHoPPER questionnaire38,39 at the (SVa, RZ, FV1a, FV2a, FV3), 
which has been adapted for this study. A 24-hour recall will also be conducted by a certified 
study staff member at visits SVb, FV1b, and FV2b, using the Automated Self-Administered 
24-Hour (ASA24®) Dietary Assessment Tool. 
1. Other Measures (Questionnaires): The Accountable Health Communities Health Related 
Social Needs Screening Tool41 will be interviewer-administered at SVa to examine the 
prevalence of health-related social needs among participants at baseline. The Perceived 

 
 
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Stress Scale41 will be administered at SVb, FV1b, FV2b, FV3 to assess the participant’s 
feelings on stress. In addition, all participants will complete the 2-item Hunger Vital Sign,49,50 
a food insecurity screener, at SVa, FV1a, FV2a, and FV3. The IPAQ51 will be used at SVa 
and RZ with the Mifflin-St. Jeor estimator (along with age, sex, and BMI) to estimate resting 
metabolic rate (average across visits) to determine the amount of groceries. A Diet Symptoms 
Questionnaire adapted from the DASH-Sodium trial will be administered at SVa, FV1a, FV2a, 
and FV3 to document any dietary reactions, including light-headedness, bloating, headaches, 
or fatigue. Medication lists will be assessed via pill bottle evaluation at SVa and updated 
throughout the study (RZ, FV1a, FV2a, and FV3). We will closely monitor for the addition of 
anti-HTN medications between visits. Grocery order sheets from the intervention phase will 
be used to compare the micronutrient profile of the intervention, using ESHA software (Salem, 
OR) and for exploratory stratified analyses based on the distribution of specific food items or 
micronutrients (e.g., potassium).  
RE-AIM Secondary Endpoints: Reach & Implementation (Specific Aim 3) 
1. Reach: We will track referrals, participation rates, and recruitment yields as in prior work.52,53  
2. Implementation: The SF-12 will assess global health-related quality of life at SVb, FV1b, 
FV2b, and FV3.  A standard intervention costing instrument will gather costs of groceries and 
dietitian salary and effort gathered over study phases through structured interviews of staff, 
financial records, and direct observation. Beyond these instruments we will also track process 
information (e.g., Run-in Visit results), that can be used to access scalability. 

 
 
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8. QUALITY ASSURANCE AND QUALITY CONTROL 
 
The investigative team understands the critical importance of collecting complete, high-quality 
data and developing procedures to accomplish this important objective.  Core activities include: 
 Standardization - maintaining common study documents (protocol, MOP, case report 
forms) with special efforts to minimize version control issues. 
 Training – developing training procedures led by experienced investigators and senior 
staff, developing and implementing certification procedures and performance metrics, and 
conducting annual training.  
 Robust data systems – implementing a web-based data entry system with duplicate data 
entry; using off-site data storage with automated back-up systems; programming data 
queries to check logic and consistency of data between forms over time; implementing 
replicate programing for major papers. 
 Study visits – conducting study visits has an important role in promoting best practices, 
identifying operational problems not evident in trial reports, and maintaining a culture that 
promotes high quality. 
 Performance monitoring with feedback – tracking enrollment and follow-up 
(observed/expected, overall); monitoring missed visits and rescheduling another visit 
within 1 week; data completeness; protocol deviations; and data entry errors (by staff 
review); distributing feedback through routine trial monitoring reports. These reports, 
together with constructive feedback, have an important role in identifying and resolving 
issues expeditiously.    
 

 
 
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9. QUALITATIVE INTERVIEWS  
A random subset of participants from the intervention arm (N = 35; including participants who 
discontinued the intervention early) and the self-directed arm (N = 10) will be invited to participate 
in semi-structured qualitative telephone interviews to understand the acceptability of the 
intervention as well as facilitators and barriers to maintaining the DASH eating plan. This number 
of interviews is aligned with qualitative data collection standards for reaching saturation of 
information;54 however, we will conduct additional interviews if new themes continue to emerge. 
Similarly, we will conduct fewer interviews if saturation is achieved prior to the planned 45 
interviews. 
 
Participant interviews will last 45-60 minutes, and a $25 incentive will be offered for participation. 
Participants will be reminded of the possibility of being selected for an interview at FV2a and will 
be informed of their selection at FV2b. Participants can choose to conduct the interview at the 
time of FV2b or can schedule the interview for a more convenient time. All interviews will be 
audio recorded and the audio recordings will be transcribed via an outside transcription service 
(transcripts will exclude any identifying information).  
 
Interview guides were developed for both participants and dietitian coaches with Getting to 
Equity (GTE)55 and the Practical, Robust Implementation Sustainability Model (PRISM)56 
frameworks. Both emphasize the “people perspective” and the interplay of person, environment, 
and other contexts. We will apply a health equity lens to understand: (a) the ways adhering to the 
DASH eating plan are relevant and important to the population, (b) if home-delivered groceries 
are an effective and appropriate mechanism to address access and consumption barriers, and 
(c) what are the other multi-level contextual factors that may facilitate or impede adherence. 
These qualitative data will be combined with the Health-Related Social Needs Screening Tool, 2-
item Hunger Vital Sign,57,58 and the SHoPPER questionnaire38,39 to identify contextual facilitators 
and barriers.  
 

 
 
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10. RANDOMIZATION AND MASKING  
After screening, consenting participants will be 1:1 randomized to the DASH grocery or self-
directed arm using web-based, password-protected, randomization software following a 
permuted block scheme (sizes of 2, 4, or 6). Participants and staff directly administering the 
intervention will be informed of randomization assignments, but they will be masked to study 
results until after the study is complete. Meanwhile, staff who perform clinic assessments and the 
study investigators will be masked to randomization assignments.  
The randomization schemes will be generated by the Beth Israel Deaconess Medical Center 
biostatistician using permuted block methods. Randomly-varying block sizes of 2, 4 and 6 will be 
used. Randomization will be stratified by baseline systolic blood pressure: 120-139 mm Hg or 
140-<150 mm Hg (stage II hypertension) in order to ensure balanced treatment assignments in 
each BP group.59 Details of the block sizes will be concealed from study staff and investigators 
and generated prior to the study and added to the data management system/REDCap for digital 
randomization. Randomization tables will be uploaded to REDCap corresponding to the two BP 
strata. A designated staff member that is unblinded (most commonly our dietitian interventionist) 
will randomize participants by clicking on a digital randomization button in REDCap after 
informed consent, confirmation of eligibility, reviewing details of the intervention, and signing an 
intervention understanding form. This will be performed in a private location in the clinical 
research center away from other study staff. Once the assignment is revealed in REDCap, this 
information will be shared with the study dietitian, who will provide instructions pertinent for each 
intervention phase. Intervention assignment will not be shared with research coordinator or 
assistants performing data assessments or with study investigators. Other members of the study 
team will not be able to access this assignment information in REDCap. Study personnel and 
investigators will not be unmasked until follow-up and all data collection are completed.   

 
 
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11. INTERVENTIONS 
 
Distribution and adherence  
Overview:   Participants will be assigned to one of two 3-month interventions: (1) dietitian-
assisted, DASH-patterned, home-delivered groceries ordered weekly through Amazon Fresh or 
Instacart over 12 weeks or (2) self-directed grocery shopping (monthly stipend and DASH eating 
plan brochure) over 3 months (referent). All participants will receive materials for addressing food 
insecurity, a set of measuring cups and spoons, a digital food thermometer, and page one of 
NHLBI’s “Your Guide to Lowering Your Blood Pressure with DASH.”18,60  
 
Self-Directed Shopping: These participants receive an unrestricted stipend of $500/month (at 4, 
8, and 12 weeks). There will be a call with the dietitian at week 8 to establish contact, check on 
the payments, and schedule FV1.  
Dietitian-Assisted DASH Grocery Intervention: Participants randomized to the DASH grocery 
intervention will participate in weekly calls with the study dietitian. These calls will serve three 
purposes: (1) order groceries for the week, (2) assess compliance from the prior week’s order, 
and (3) allow for education on fundamentals of healthy grocery shopping, meal storage, 
preparation, and in-home eating (Table 3). 
 
Table 3: Curriculum 
Module 1: Principles of DASH 
Module 2: Food storage to reduce waste 
Module 3: Sodium and potassium: What do they mean for your health? 
Module 4: Quick food safety tips 
Module 5: Enhance your favorite meal and explore something new 
Module 6: Understanding nutrition labels 
Module 7: Strategies to increase fruits and vegetables servings  
Module 8: Quick and healthy meal prep 
Module 9: DASH at Home 
Module 10: DASH at restaurants and special events/holidays 
Module 11: Smart Shopping 
Module 12: Recap and DASH principles 
 
Participants will also be provided instructions on how to receive food deliveries, food storage 
strategies to avoid spoiling, meal preparation tips, and example recipes that incorporate cultural 
foods and dishes. We will also prepare 24 instructional cooking videos (10-15-minute duration) 

 
 
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based on recipes derived from various heritage diets. The dietitian will specifically address 
documented concerns about distrust of online grocery shopping among minoritized groups.13-16 
The first grocery ordering session will last 60-90 minutes to review principles, place initial orders, 
and review instructions. Based on prior experience, subsequent sessions, conducted over the 
phone, last about 30 minutes as participants standardize their orders and become familiar with 
the intervention. Follow-up calls will increasingly focus on each participant’s experience with 
groceries the prior week, how to optimize food storage and preparation, and exploration of new 
healthy food items.  
The allocation of groceries, like DASH, is designed to be isocaloric (i.e., weight neutral). Calorie 
needs will be estimated using the Mifflin-St. Jeor estimator based on age, sex, body mass index 
(BMI), and self-reported physical activity (based on the IPAQ instrument),51 a validated predictor 
of resting metabolic rate.10 The intervention will target a quantity of foods that meet a participant’s 
Calorie needs in addition to up to five additional adults at dinner. The calorie replacements will be 
categorized based on number of food servings. Groceries will be ordered weekly with the 
assistance of our study dietitian through Amazon Fresh or Instacart in fixed proportions of grains, 
vegetables, fruits, low-fat/fat-free dairy, lean meat (fish/poultry), and nuts/beans/legumes to 
achieve a low sodium (<2,300 mg/d) and high potassium diet modeled after DASH. For example, 
servings for an adult consuming 14,000 Calories/week (i.e., 2,000 Calories/day) will be sent: 49 
servings of grains, 35 servings of vegetables, 35 servings of fruits, 21 servings of fat-free/low-fat 
dairy, <42 servings of lean meats, and 4-5 servings of nuts, seeds, and legumes,60 14 servings of 
healthy fats and oil. See Table 4.1 number of food servings by calorie level. Table 4.2 outlines 
number of food servings by Calorie level for additional adults at dinner time. 
 
Table 4.1: DASH Eating Plan—Number of Food Servings by Weekly Calorie Level  
Food Group  
8400 
kcal  
9800 
kcal  
11200 
kcal  
12600 
kcal  
14000 
kcal  
16000  
kcal  
18200 
kcal  
21700 
kcal  
Grains  
28-35  
35-42  
42  
42  
42-56  
56-70  
70-77  
84-91  
Vegetables  
21-28  
21-28  
21-28  
28-35  
28-35  
30-37  
35-42  
42  
Fruits  
21-28  
21-28  
21-28  
28-35  
28-35  
30-37  
35-42  
42  
Fat-free or low-fat 
dairy products  
14-21  
14-21  
14-21  
14-21  
14-21  
21  
21  
21-28  
Lean meats, poultry, 
and fish  
21 or 
less  
21-28 or 
less  
21-28 or 
less  
42 or 
less  
42 or 
less  
42 or 
less  
42 or 
less  
42-63 or 
less  
Nuts, seeds, legumes  3 per 
week  
3 per 
week  
3-4 per 
week  
4 per 
week  
4-5 per 
week  
6 per 
week  
7 per 
week  
7 per 
week  
Fats and oils  
7  
7  
14  
14-21  
14-21  
21  
21  
28  
Adapted from NHLBI’s DASH Eating Plan. https://www.nhlbi.nih.gov/education/dash/following-dash  
 
 
Table 4.2. Number of Food Servings by Calorie Level to be Increased by the Addition of 
Adults at Dinner Time 
Food Group 
800 
kcal 
(+1 
adult) 
1600 kcal (+2 
adults) 
2400 
kcal 
(+3 
adults) 
3,200 kcal (+4 4,000 kcal (+5 

 
 
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adults) 
adults) 
Grains 
3 servings/day 
6 servings/day 
9-10 
servings/day 
12-13 
servings/day 
15-16 
servings/day 
Fruit 
2 servings/day 
4 servings/day 
4-5 servings/day 
6-7 
servings/day 
8-9 
servings/day 
Vegetable 
2 servings/day 
4 servings/day 
4-5 servings/day 
6-7 
servings/day 
8-9 
servings/day 
Fat-free or low-
fat dairy  
1-2 servings/day 2-3 servings/day 3 servings/day 
4 
servings/day 
5 
servings/day 
Lean 
meats, 
poultry, 
and 
fish 
1-2 oz/day, or 
less 
3-4 oz/day, or 
less 
6 oz/day, or less 
8 oz/day or 
less 
9-10 oz/day or 
less 
Nuts, 
seeds, 
legumes 
1-2 servings per 
order 
3-4 
per 
week 
order 
1 serving/order 
1-2 
servings/order 
1.5-2 
servings/order 
Fats or oils 
1 
serving 
per 
day 
2 servings per 
day 
3 servings per 
day 
 
 
Adapted from NHLBI DASH Eating Plan—Number of Food Servings by Calorie Level. Note that children 
under age 18 years count as 0.5 adults. 
Sodium, potassium, and saturated fat are the primary nutrient focuses for GoFresh, (Table 5) 
modelled after the DASH eating plan.6,7,61 Orders will be placed to comply with both absolute 
milligrams of sodium and potassium per day. Grocery orders will also be required to achieve 
sodium and potassium density targets adjusted to match participants’ caloric intake. 
Table 5. Daily Nutrient Targets 
Daily Nutrient Targets 
GoFresh Plan 
Sodium (mg/day) 
≤2300 
Potassium (mg/day) 
≥4700 
Saturated fat  
7% of total energy 
(~15 g/day) 
Ratios 
Na/kcal 
<1.1 
K/kcal  
>2.2 
 

 
 
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Intervention Adherence Strategy: Grocery lists will include an extensive range of spices and food 
items that conform to a DASH dietary pattern (i.e., low sodium, high potassium, reduced added 
sugars, and reduced saturated fat). Participants will also be given recipes that incorporate a 
sampling of the groceries on our DASH menu to provide ways to prepare and incorporate foods 
into their daily life and that are culturally relevant to diverse Black cultural groups. At 
randomization and during GO calls, participants will be reminded not to eat fast food or at 
restaurants, which will be monitored. It is possible that participants need to supplement our 
groceries with their own (e.g., if cooking for others). However, we will ask participants to adhere 
to our groceries for their own consumption. Participants will be strongly encouraged not to eat out 
more than once a month, especially not within 2 weeks of the follow-up visit. In addition to 
grocery orders, the study dietitian will ask participants about food consumption the preceding 
week, assessing for hoarding, sharing, spoilage, and delivery concerns, as well as providing tips 
to improve adherence. 
Delivery Action Plan: 
After the grocery order is placed and delivered, participants will be asked to inform the dietitian if 
anything is missing from their order through a text, call, or email. Participants will also be asked 
to inventory any damaged or spoiled items. In addition, the dietitian will receive alerts about items 
that were not delivered or out of stock. A supplemental order will be placed using an alternative 
vendor if greater than 25% of the servings targeted within a food group are not available for 
consumption or if the dietitian feels the participant cannot reach the DASH goals without the 
missing item(s).  
Interventionist Training: The intervention will primarily be delivered by our research dietitians. All 
staff will participate in three 60-minute sessions that will consist of training in clear 
communication skills, person-centered care, impact of literacy, oral literacy load, barriers to diet 
adherence, and the teach-back method. Training will also focus on cultural competence, the role 
of social determinants of health in health disparities, and the importance of food in Black culture. 
These sessions will include didactics and role-playing exercises.  
Monitoring Adherence  
We will ask participants assigned the DASH grocery intervention to list what foods they have left 
over from the previous week’s order. This will allow the dietitian to quantify how much they 
consumed versus threw away from the previous week. They will also be asked to list consumption 
of non-protocol foods (e.g., dining out or grocery purchases beyond the study foods) and to 
characterize on a scale from 1 to 9, whether they liked the DASH eating plan. Finally, participants 
will be asked about the timeliness, accuracy, and quality (damage/spoilage) of food delivery 
throughout the intervention phase.  
 
Two forms are designed to monitor adherence in the DASH grocery intervention group, the 
Knowledge Assessment Form (KNOW) and Diet Palatability (PAL) form. The KNOW will test the 
participants’ knowledge on basic principles of the DASH Eating Plan before and after the study. 
The purpose is to assess the effectiveness of the education modules delivered by the dietitian. 

 
 
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Topics assessed are purposes of the DASH, role of sodium and potassium, compliant DASH foods, 
and high sources of sodium. PAL is meant to assess diet acceptability, implementation, and 
behavioral effects. Key information collected is how much non-study food they consumed during 
the intervention period (including reasons why), reasons why they did not finish all the study 
groceries, confidence entering the observation phase, likeliness to continue DASH when the study 
is over, and a general rating of the at-home grocery delivery service. This form also goes into 
significant detail about online grocery shopping. It assesses the likelihood of using an at-home 
grocery delivery service after the study is over, participant’s confidence in ordering groceries 
online, and if they would recommend this program to family and friends. Lastly, this form gives the 
participants an opportunity to express their feelings about the intervention as a whole and provide 
suggestions they have for improvement. 
 
All GO calls will be scheduled at the randomization visit for the same time each week to encourage 
consistent adherence. If a participant does not pick up the first time, the study dietitian will leave a 
voicemail and call back in 5 minutes. If the participant still does not pick up, the dietitian will call 
back at the end of the business day and then attempt to reach the participant’s emergency contact. 
At this point, a text message and email will be sent to the participant to give them the opportunity 
to ask for last week’s order again if they are unable to talk on the phone that week. For those 
individuals without text or email access, groceries will not be sent to the house until the dietitian is 
able to get into contact with them. If over three weeks pass by with no contact, a letter will be sent 
to the participant’s home to encourage reconnecting to the GoFresh team, as well as coming to 
the follow up visit.  
 
Extension Period 
 
An extension period is possible if a participant misses two weeks during the active 3-month 
intervention. The ultimate goal is for each participant to be active in the intervention for the two 
consecutive weeks preceding the follow-up visit. Because of this, there will be a greater emphasis 
on those who miss weeks 10-12.  If a participant misses one visit between weeks 2-10; the dietitian 
will assess the best course of action. Options include doubling up on modules that are shorter in 
time, asking the participant if they can meet for a longer period of time during one of the visits, or 
combining similar modules. If a participant misses more than one visit between weeks 2-10, the 
GoFresh team will discuss and decide if an extension period is necessary. In general, a participant 
will only be extended for two weeks (weeks 13 or 14). Any other exceptions based on extenuating 
circumstances (e.g., COVID19, institutional requirements, etc.) will be discussed with the 
investigative team 
 
If a participant states they do not want to receive groceries anymore, staff will still encourage them 
to come in for their follow up visit for a blood pressure measurement. If the participant states they 
wish to leave the study, the staff member will document this discussion and the staff will no longer 
reach out to this individual as delineated in their consent agreement.  
12. Safety  
Safety Monitoring 

 
 
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This trial has minimal risks. Nevertheless, participant safety is a priority. We will monitor safety as 
described in this section. Prior to enrollment in this study, we will screen potential participants to 
ensure it is safe for them to participate. Substantial effort has been made to identify and minimize 
potential risks where possible and to exclude participants for whom participation in this study 
might incur undue risk (see eligibility criteria for full details on exclusions). Once enrolled, if a 
participant develops an adverse event or other medical problem, the safety of continuing in the 
study will be determined by study clinicians during a weekly trial meeting.   
At the beginning of the study, we will ask participants to provide the information to their usual 
healthcare provider. If they do not have a usual healthcare provider, we will provide them with 
resources to identify one. We will provide a printed provider letter participants can give to their 
healthcare provider outlining their involvement in the study. With the participant’s permission, we 
may also contact their healthcare providers for urgent medical issues that may arise during the 
study as described in more detail below.   
 
Potential Risks 
 
Risks related to breaches of confidentiality 
 
As with any medical information, there is the risk of psychological distress if personal health 
information is not kept confidential. To minimize the risk of a breach of confidentiality, all 
researchers involved are trained in HIPAA compliance. Data will be de-identified and stored on a 
secure, password-protected server hosted by computers in locked offices that only the research 
study team can access. All paper records associated with this study will be stored in a locked file 
cabinet in a locked room. Biospecimens will be stored using de-identified labels and kept in a 
secure location within BIDMC. Data are only used in aggregate and no identifying characteristics 
of individual participants will be published. 
 
Identifying participants with food insecurity 
 
At screening visits, we will assess food insecurity. Although potential participants who are 
deemed extremely food insecure will not be eligible for participation, all participants will receive 
locally adapted information about available resources in the event they develop food insecurity 
during the study.  
 
Risks related to phlebotomy 
Blood work will be done at designated study visits. Common but less serious risks of phlebotomy 
include minor bleeding, bruising, swelling and pain at the phlebotomy site. Rare but more serious 
risks from phlebotomy include vasovagal syncope or infection. There is no alternative to 
phlebotomy for measuring serum biomarkers and all of these risks exist in the course of routine 
medical care. To minimize any additional risk, the frequency of phlebotomy is kept to a minimum 
and will be drawn by trained staff using aseptic techniques.   
 

 
 
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Risks related to dietary changes 
 
The diet intervention is patterned after standard recommendations for a healthy diet and should 
pose minimal risk for participants. Nevertheless, any dietary changes can cause some 
symptoms, and there may be a risk of a reaction to new food types. Common reactions include 
rash or hives, itching or watery eyes, wheezing or difficulty breathing, and itching and/or swelling 
of the mouth and throat. Participants might experience mild gastrointestinal discomfort related to 
a diet that has higher amounts of fiber, dairy, fresh fruits and vegetables than they usually 
consume. These symptoms are generally mild and resolve quickly.  
 
Participants will be monitored for these reactions and their grocery orders can be modified as 
needed. Severe allergies or reactions to new foods should be rare and care will be taken to avoid 
any known food allergens. Should a reaction occur, we will recommend that the participant 
avoids the food item and seeks medical care.  
 
Risks related to family members  
 
Participants assigned the dietitian-directed intervention will be provided a food safety handout for 
family members that might eat some of the groceries. This handout has information about 
allergies, food intolerance, and food recalls. 
 
Risks related to food recalls or food storage issues 
 
We will regularly monitor Amazon Fresh and Instacart for food recalls that might impact 
participants. We will notify participants of any recalled products within 2 business days of 
discovery. 
 
Identifying patients with high blood pressure (hypertension)  
  
We anticipate that the intervention will decrease participant’s BP. However, if we discover 
unusually high blood pressure at our study visits, we will implement safety procedures and BP 
thresholds that require a response.   
  
 
For an average SBP of 160-179 mm Hg or DBP of 105-109 mm Hg, we will recommend 
that the participant seek care with usual provider within 1 month and email the study clinical 
team  
 
For an average SBP ≥ 180 mm Hg or DBP ≥ 110 mm Hg, we will recommend that the 
participant seek same day care with usual provider, urgent care or a local emergency room 
and page/call the study clinical team   
  
Identifying patients with low blood pressure (hypotension)   
  
We anticipate that the intervention will decrease participants’ BP. If we discover an unusually low 
blood pressure at our study visits, we will implement safety procedures as follows:   
  

 
 
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 
For an average SBP < 90 mm Hg or DBP < 50 mm Hg with symptoms (described below), 
we will recommend the participant seek same day care with usual provider, urgent care or a 
local emergency room and page/call the study clinical team. 
 
If participants have NEW or SEVERE symptoms such as nausea, vomiting, shortness of breath, 
chest pain, headache, vision changes, lightheaded or dizziness, fainting, or loss of 
consciousness during blood pressure assessment, they will be referred for same day care with 
their usual care provider, urgent care or a local emergency room regardless of blood pressure 
level.  
 
 
Identifying patients with lab abnormalities 
 
As part of this study, we may discover lab values that are outside of the normal range. All lab 
results will be reviewed by the study team within 72 hours. Participants will be notified of lab 
results and given recommendations for follow-up care with their usual care provider.   
 
The intervention will provide groceries that are higher in potassium than a typical American diet.  
In general, in healthy individuals, a DASH-style diet should not increase potassium levels outside 
the normal range. Nevertheless, we may incidentally discover abnormal potassium levels during 
this study.  
 
Hyperkalemia is defined as a serum potassium ≥ 5.5 mEq/L. If hyperkalemia is detected in the 
absence of hemolysis, investigators will do the following:  
 
 For mild hyperkalemia with hemolysis (K = 5.5-6.4), we will recommend repeating the lab 
within 48-72 hours and contact the study clinician team 
 For mild hyperkalemia without hemolysis (K = 5.5-6.4), we will recommend repeating the 
lab same day and page/call the study clinician team 
 For severe hyperkalemia (K > 6.4), we will recommend repeating the lab same day and 
page/call the study clinician team. 
 
Adverse event surveillance and reporting procedures 
 
The office of human research protection (OHRP) defines an adverse event as “Any untoward or 
unfavorable medical occurrence in a human subject, including any abnormal sign, symptom, or 
disease, temporally associated with the subject’s participation in the research, whether or not 
considered related to the subject’s participation in the research.”  The National Institute on Aging 
defines serious adverse events as any adverse event that:   
 Results in death 
 Is life-threatening or places the participant at immediate risk of death from the event as it 
occurred  
 Requires or prolongs hospitalization 
 Causes persistent or significant disability or incapacity  

 
 
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 Results in congenital anomalies or birth defects 
 Is another condition which investigators judge to represent significant hazards  
 
Surveillance for Severe Adverse Events (SAE) and other relevant clinical events that may be 
associated with study participation will occur at in-person and telephone visits. In addition to the 
fixed time points, participants may report events in other settings, e.g., phone contacts. A study 
clinician will review completed forms, will classify the event according to several dimensions 
(expectedness, relatedness to participation in GoFresh, and type), and will take appropriate 
action. 
 
In view of the study population and the 1-year duration of follow-up, medical events unrelated to 
participation in GoFresh are expected to occur, including the development of cancer, heart 
disease, stroke, cognitive decline, and the development or worsening of other chronic conditions; 
increased symptoms from a chronic condition; surgeries and procedures; musculoskeletal 
problems; and accidents. 
 
All serious adverse events and all unanticipated problems will be reported individually to the IRB 
(GoFresh has a specific ad-hoc form for such reports), and these reports will be forwarded to the 
DSMB, the NIA, the Study Chair, and the Steering Committee within 3-5 working days of when 
the study team learned of the event.   
 
Other adverse events will be reported to GoFresh on a study specific ad-hoc form and we will 
complete the appropriate IRB form and report to the DSMB at the time of regular data reports.  
However, clinics will have the option of bringing any event to the immediate attention of the IRB 
(via emailing a local or non-local report form to the IRB) for review and discussion by the 
Steering Committee and for consideration of immediate reporting to the DSMB. 
 
13. ANALYSIS 
 
The trial has sufficient resources to enroll at least 176 participants who will be randomly allocated 
to 1 of 2 sequences for each of the two groups: (1) the Self-Directed group or (2) the DASH 
intervention group.  
Power and sample size 
A. Aim 1 Immediate Effects: Clinical Outcomes (Effectiveness) 
1. Primary endpoint: The proposed study is powered for office SBP. Based on the 12-week 
SBP means and variances from the DASH-Sodium trial,6 with 75 people in each arm, we 
will be able to detect a difference in SBP of -5.8 mm Hg (type 1 error of 0.05, power of 
0.85). The 12-week between-group difference in SBP in DASH-Sodium was -8.9 mm Hg.  
2. Secondary endpoints: We will have adequate power to detect small differences (i.e., 
<15%) in wake-time SBP, BMI, cholesterol, triglycerides, and hemoglobin A1c.   

 
 
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B. Aim 2 Immediate Effects: Behaviors (Adoption) 
We will be able to detect changes of 13.0% to 29.5% in self-reported fruit and vegetable intake, 
urine sodium and potassium, and home-prepared dinners per week. These differences are 
smaller in magnitude than actual differences observed in prior trials.29,30 
Analysis Plan (RE-AIM Framework)  
Reach. As in prior work, we will quantify recruitment yields and engagement.52,53 
 
Effectiveness & Adoption. The analysis will be conducted by the Statistical Core under the intent-
to-treat principle for both effectiveness and adoption endpoints. The residual distribution of all 
outcomes will be checked for normality and log-transformed where appropriate. For the Primary 
Aim, we will use generalized estimating equation (GEE) models with a treatment-by-visit 
interaction term. The visit term will be used to compare changes on office SBP between 3 
months versus baseline, 6 months versus 3 months, and 6 months versus baseline with a 
product (interaction) term to compare changes across intervention assignment (DASH vs self-
directed shopping). Models will be adjusted for ZIP code or baseline blood pressure in sensitivity 
analyses. Continuous variables will be analyzed with a Gaussian distribution, identity link, while 
dichotomous variables will be analyzed with a binomial distribution, logit link. 
 
Implementation. Quality-of-life and cost data will be used to analyze health economic data and 
budget impact, based on cost per HTN case prevented and 10-year cost per quality-adjusted life-
year gained. 
 
Maintenance. In qualitative analyses, a coding dictionary will be developed and implemented 
based on review of the transcripts’ content and interview questions. Codes will denote content of 
questions, GTE and PRISM domains/principles, and concepts naturally emerging from discussion. 
During the coding process, inter-rater reliability will be established by comparing the agreement in 
coded text with 20% of the transcripts between coders. Coding differences will be resolved through 
consensus through regular and iterative discussions. A qualitative database will be compiled, 
coded, and analyzed using qualitative software (NVivo). We will use text retrieval and grouping 
functions on specific codes and combinations of codes for a particular topic and summarize the 
issues, agreements, and disagreements in content for each item. This process will result in a list 
of themes related to intervention acceptability31 and determinants (barriers and facilitators) of 
DASH eating plan sustainability. As we summarize and interpret, we will identify findings or 
patterns among themes and will review data for statements that directly confirm or discredit our 
interpretations.62 This theme-focused analysis will provide qualitative data to be integrated with our 
quantitative findings and guide refinement of the intervention. 
 
Missing data  
Based on the existing literature, we will employ recommended strategies to address missing 
data.63,64,65,66 However, every effort will be made to collect outcome data on all participants.  
 

 
 
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14. DATA MANAGEMENT  
Data will be collected from the following main sources: 1) Data collected by trial staff on trial 
forms for later entry or directly inputted into the data management system(DMS)/REDCap; 2) 
Data from Quest laboratories electronically available for upload; 3) Data from Spacelabs 
ambulatory blood pressure monitoring devices available for direct upload; 4) Data from the 
Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool, estimating the 
nutrient content of consumed foods, and 5) Data derived from ESHA software, estimating the 
nutrient content of the intervention; 6) Data collected from self-administered forms; and 7) Data 
collected via our online Qualtrics (Seattle, Wa) screening survey or a recruitment tracking Excel 
database. The DMS will be accessible only via the secure website and only to authorized 
personnel. Data entered into the DMS will be subject to intra- and inter-item checks, such as 
range checks, logic checks, and consistency checks. Missing data items will be noted in the 
database, although certain key values (e.g., blood pressure measurement) will not be allowed to 
be marked ‘missing.’ Data entry staff will perform data entry as soon as possible after data has 
been collected (within one week). 
Recruitment data for tracking enrollment sources and goals will be managed separately in a 
secured team folder. All laptops are password protected and encrypted. 
 
Data confidentiality and integrity 
The investigative team, including staff at all levels of the study, will be trained in the importance 
of data integrity and maintaining participant confidentiality, including HIPAA (Health Insurance 
Portability and Accountability Act). All data will be stored on secure servers. All study-related 
computers will be located behind appropriate firewalls and will maintain automated virus update 
mechanisms. Printed materials will be maintained in locked rooms and file cabinets accessible 
only to the study team. All staff will sign statements attesting to their understanding of and 
willingness to abide by policies regarding confidentiality and data integrity. Annual Staff Retreats 
will be conducted for further training on the importance of data integrity.  
 
Trial-wide data release 
De-identified trial data will be shared with external investigators on an individual basis through 
contact with the trials’ principal investigator. GoFresh is part of the RESTORE network and will 
share common data elements as part of this network. 

 
 
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15. COLLABORATIONS 
GoFresh and the RESTORE Network  
GoFresh is one of five projects that make up the AddREssing Social Determinants TO PRevent 
HypErtension (RESTORE) Health Equity Research Network. RESTORE will advance the science 
of health equity to prevent hypertension (HTN) and cardiovascular disease (CVD) with projects 
focused on the translation of evidence-based interventions for HTN prevention into community-
based settings. 
The Aims of RESTORE are to: 
Aim 1. Work with Black communities to achieve health equity in prevention of HTN by mitigating 
the negative impact of social determinants of health (SDOH) on BP in Black adults.  
Aim 2. Develop and evaluate strategies for implementing evidence-based lifestyle interventions 
to prevent HTN in Black communities, thereby shifting the blood pressure (BP) distribution lower 
for the entire U.S. population. 
Aim 3. Disseminate findings to policy makers, payors, and stakeholders like state departments of 
health to ensure sustainability of HTN prevention strategies in Black communities. 
Aim 4. Train the next generation of early-career scientists in health equity and CVD research. 
As a member of RESTORE, GoFresh has adopted standardized data elements that correspond 
with other RESTORE projects to enable cross-site comparisons of the various implementation 
strategies. GoFresh will share de-identified, common data elements with the RESTORE network 
to facilitate pooled analyses and ancillary studies. 
GoFresh and GoFreshRx  
GoFresh focuses on adults without treated hypertension. In parallel we are conducting a trial 
funded by the National Institute of Minority Health and Health Disparities, using a similar 
intervention and design, focused on Black adults with treated hypertension. Instruments for both 
trials will be shared to facilitate pooled analysis of data elements.  
 
16. TIMELINE  
 
There are four main phases:  
(1) Protocol development and IRB review (year 1, quarters 1-2); (2) Intervention development 
(year 1, quarters 1-2); (3) Recruitment, randomization, and follow-up (year 1, quarter 3 to year 
4, quarter 2); (4) Data analyses and dissemination (year 3, quarter 3 to year 4, quarter 4). 
Qualitative interviews occur in years 1-3 with analysis in year 4. 
 

 
 
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Project Years 
1 
2 
3 
4 
Calendar Year 
10/2021-9/2022 
10/2022-9/2023 
10/2023-9/2024 
10/2024-9/2025 
Quarter 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
Protocol 
Development/ 
IRB Review 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Intervention 
Development 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment, 
Randomization, 
Follow-up 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data Analysis 
and 
Dissemination 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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