Hypertension Clinical Trial
— GoFreshOfficial title:
Effects of DASH Groceries on Blood Pressure in Black Residents of Urban Food Deserts Without Treated Hypertension
GoFresh is a randomized trial, testing the effects of a home-delivered DASH-patterned grocery intervention on blood pressure in Black adults, residing in Boston area urban food deserts.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | September 30, 2025 |
Est. primary completion date | March 31, 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 - 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: - 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: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center - Clinical Research Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center | American Heart Association |
United States,
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 |
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