Grocery Delivery Intervention for High Blood Pressure (GoFreshRx Trial)
Recruiting in Palo Alto (17 mi)
Overseen ByStephen P Juraschek, MD, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Beth Israel Deaconess Medical Center
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests if delivering healthy groceries can help lower blood pressure in Black adults living in areas with limited healthy food options.
Will I have to stop taking my current medications?
The trial requires that you stay on stable doses of your current hypertension medications. If your medication doses have been unstable in the last 6 months, you may not be eligible to participate.
What data supports the effectiveness of the treatment Dietitian-Assisted DASH groceries, DASH Diet, Dietary Approaches to Stop Hypertension, DASH Eating Plan, Self-directed shopping for high blood pressure?
Research shows that the DASH diet, which focuses on eating fruits, vegetables, and low-fat dairy while reducing fats and sweets, can significantly lower blood pressure. This diet is recommended for managing high blood pressure, and having a dietitian assist with grocery choices can help people stick to the diet more effectively.
12345Is the DASH diet safe for humans?
The DASH diet, which is rich in fruits, vegetables, and low-fat dairy, is generally safe for most people and can help lower blood pressure. However, people with certain conditions like chronic kidney or liver disease should be cautious and may need to adjust the diet.
23467How is the Dietitian-Assisted DASH groceries treatment different from other treatments for high blood pressure?
This treatment is unique because it involves delivering groceries that align with the DASH diet, which is rich in fruits, vegetables, and low-fat dairy, directly to patients, making it easier for them to follow a heart-healthy eating plan. Unlike medications, this approach focuses on dietary changes to naturally lower blood pressure.
23489Eligibility Criteria
This trial is for Black adults in Boston with treated high blood pressure, living in food deserts. Participants must be stable on hypertension meds, able to get and cook home-delivered groceries, and have internet access. Excluded are those with severe kidney issues, recent significant weight changes, diabetes, certain serious illnesses or conditions including active cardiovascular disease.Inclusion Criteria
I can get groceries delivered or pick them up and will only eat these for 12 weeks.
I have been on stable blood pressure medication for the last 6 months.
Exclusion Criteria
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
Participant Groups
The GoFreshRx trial is examining if a DASH-patterned grocery delivery service can lower blood pressure among Black adults being treated for hypertension. It's a randomized study where some will receive dietitian-assisted shopping while others shop themselves.
2Treatment groups
Experimental Treatment
Active Control
Group I: Dietitian-Assisted DASH groceriesExperimental Treatment1 Intervention
Participants will order groceries sufficient to meet their caloric needs each week for 12 weeks with the assistance of a dietitian/nutrition interventionist. Groceries will be delivered to participants' homes or picked up at a convenient location. The dietitian/nutrition interventionist will provide brief educational content at the time of food delivery. Orders will be placed via phone or through virtual counseling sessions. During the remainder of the study (months 4-12), participants will be asked to apply what they learned without the provision of groceries.
Group II: Self-directed shopping (referent assignment)Active Control1 Intervention
Participants will receive a monthly stipend over a 3 month period and some basic information about healthy eating. The stipend is not restricted to foods. During the remainder of the study (months 4-12), participants will be asked to continue their typical shopping without the provision of the monthly stipend.
Dietitian-Assisted DASH groceries is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as DASH Diet for:
- Hypertension
- High Blood Pressure
🇨🇦 Approved in Canada as DASH Diet for:
- Hypertension
- High Blood Pressure
🇪🇺 Approved in European Union as DASH Diet for:
- Hypertension
- High Blood Pressure
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Beth Israel Deaconess Medical Center - Clinical Research CenterBoston, MA
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Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)Collaborator
References
Determinants and consequences of adherence to the dietary approaches to stop hypertension diet in African-American and white adults with high blood pressure: results from the ENCORE trial. [2022]Although the Dietary Approaches to Stop Hypertension (DASH) diet is an accepted nonpharmacologic treatment for hypertension, little is known about what patient characteristics affect dietary adherence and what level of adherence is needed to reduce blood pressure (BP).
Dietary Approaches to Stop Hypertension (DASH) in clinical practice: a primary care experience. [2020]The Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure placed increased emphasis on lifestyle modification for the prevention and management of hypertension. The Dietary Approaches to Stop Hypertension (DASH) diet, rich in fruits, vegetables, nuts, and low-fat dairy foods, with reduced saturated and total fats, was found in clinical trials to lower blood pressure substantially and significantly. The DASH diet appears appropriate for use in the primary care setting, although it is unknown whether results will mirror those found in clinical trial.
Supporting cardiovascular risk reduction in overweight and obese hypertensive patients through DASH diet and lifestyle education by primary care nurse practitioners. [2021]To describe an intervention among overweight and obese hypertensive patients, encouraging Dietary Approaches to Stop Hypertension (DASH) diet and lifestyle changes, designed and led by a primary care nurse practitioner (NP).
Compliance with the Dietary Approaches to Stop Hypertension (DASH) diet: a systematic review. [2023]The Dietary Approaches to Stop Hypertension (DASH) diet has been recognized as effective to lower blood pressure in feeding trials, but compliance with the diet must be persistent to maximize health benefits in clinical practice. This paper reports a systematic review of the latest evidence on the method to assess DASH compliance and the corresponding patients' compliance in interventional settings.
Translating the Dietary Approaches to Stop Hypertension diet from research to practice: dietary and behavior change techniques. DASH Collaborative Research Group. [2019]The Dietary Approaches to Stop Hypertension (DASH) clinical trial demonstrated that a diet that emphasizes fruits, vegetables, and low-fat dairy products, includes whole grains, nuts, fish, and poultry, and is reduced in fats, red meats, sweets, and sugar-containing beverages can be highly effective in lowering blood pressure. The National High Blood Pressure Education Program now suggests the DASH diet for preventing and managing hypertension. For persons modifying their diets, the DASH diet offers varied choices. However, simultaneously modifying several dimensions of a diet can be challenging, even for knowledgeable and motivated persons. Persons who are uncertain about modifying their diet may become overwhelmed by the needed dietary changes. Dietitians and other health care practitioners can help patients adopt the DASH diet by exploring possible ambivalence, increasing motivation, and strengthening commitment to change; encouraging patients to select dietary modifications that will fit their lifestyle; and, finally, offering information about how to change their eating behavior. In this article, we offer dietary advice and counseling suggestions for tailoring interventions to match patients' readiness for adopting the DASH diet.
The Dietary Approaches to Stop Hypertension (DASH) eating pattern in special populations. [2021]The Dietary Approaches to Stop Hypertension (DASH) trial showed that a diet rich in fruits, vegetables, low-fat dairy products with reduced total and saturated fat, cholesterol, and sugar-sweetened products effectively lowers blood pressure in individuals with prehypertension and stage I hypertension. Limited evidence is available on the safety and efficacy of the DASH eating pattern in special patient populations that were excluded from the trial. Caution should be exercised before initiating the DASH diet in patients with chronic kidney disease, chronic liver disease, and those who are prescribed renin-angiotensin-aldosterone system antagonist, but these conditions are not strict contraindications to DASH. Modifications to the DASH diet may be necessary to facilitate its use in patients with chronic heart failure, uncontrolled diabetes mellitus type II, lactose intolerance, and celiac disease. In general, the DASH diet can be adopted by most patient populations and initiated simultaneously with medication therapy and other lifestyle interventions.
Psychometric Validation of a Brief Self-report Measure of Diet Quality: The DASH-Q. [2018]The Dietary Approaches to Stop Hypertension (DASH) diet is recommended for primary and secondary prevention of cardiovascular chronic diseases. This study describes the development, internal consistency, and validation (predictive and convergent) of a population-based, self-report measure (the DASH Quality [DASH-Q]) to assess adherence to the DASH diet among adults.
Dietary Approaches to Stop Hypertension (DASH) intervention reduces blood pressure among hypertensive African American patients in a neighborhood health care center. [2022]The purpose of this study was to pilot-test DASH-Dinner with Your Nutritionist, a university-neighborhood health care center intervention to promote the Dietary Approaches to Stop Hypertension (DASH) diet. Study participants were low-income African American adults (N = 82) with poorly controlled blood pressure. Six groups, each consisting of 12 to 15 participants taking antihypertensive medications, met for 1 to 2 hours per week for 8 weeks. The intervention followed constructs of Social Cognitive Theory and featured dinners based on the DASH diet plan. Blood pressure was significantly lowered (P
The Association between DASH Diet Adherence and Cardiovascular Risk Factors. [2023]The dietary approaches to stop hypertension (DASH) encourages high fruit, vegetable, and lean protein consumption and low salt, red meat, and fat intake to prevent or treat hypertension. However, besides hypertension, adherence to this diet has been shown to decrease other cardiovascular risk factors.