What side effects are associated with this type of intervention?

Common treatments for high blood pressure, such as the DASH diet, which reduces sodium intake and increases nutrients like potassium, calcium, and magnesium, can have side effects. These may include gastrointestinal issues like bloating and gas due to higher fiber intake, potential electrolyte imbalances, and initial lightheadedness or dizziness as the body adjusts to lower sodium levels. These side effects are typically mild and manageable with proper dietary planning and monitoring.

What prior FDA approvals exist?

The FDA has approved various medications for the treatment of high blood pressure, including diuretics, ACE inhibitors, angiotensin II receptor blockers (ARBs), calcium channel blockers, and beta-blockers. These medications help manage blood pressure through different mechanisms, such as reducing fluid volume, relaxing blood vessels, and decreasing heart rate. In addition to pharmacologic treatments, the DASH diet, which reduces sodium intake and increases the intake of potassium, calcium, and magnesium, has been recognized for its effectiveness in lowering blood pressure. While the FDA does not approve diets, the principles of the DASH diet are supported by clinical guidelines and research, including trials like the Home-Delivered DASH-Patterned Groceries study, which highlight the benefits of dietary interventions in managing hypertension.

What other types of research exist?

Promising alternatives to Home-Delivered DASH-Patterned Groceries for high blood pressure patients include the Mediterranean diet, which emphasizes fruits, vegetables, whole grains, nuts, and healthy fats, and low-sodium diets that focus on reducing overall sodium intake. Both dietary patterns have shown efficacy in managing blood pressure and improving cardiovascular health.

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Behavioral Intervention

Grocery Delivery Intervention for High Blood Pressure (GoFreshRx Trial)

N/A

Recruiting

Led By Stephen P Juraschek, MD, PhD

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured 3 months after randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if delivering healthy groceries can help lower blood pressure in Black adults living in areas with limited healthy food options.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves dietary changes rather than medication, typical drug side effects aren't expected. However, participants may experience changes in their health due to new eating patterns which could include digestive adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can get groceries delivered or pick them up and will only eat these for 12 weeks.

Select...

I have been on stable blood pressure medication for the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured 3 months after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured 3 months after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured 3 months after randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Seated, office-based, systolic blood pressure (intervention phase)

Secondary study objectives

24-hour dietary recall (intervention & observation phases)

24-hour urine potassium (intervention & observation phases)

24-hour urine sodium (intervention & observation phases)

+9 more

Other study objectives

Grocery shopping and dining habits

Perceived Stress Scale 4 (PSS-4)

Qualitative Interviews

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high blood pressure include dietary interventions like the DASH diet and pharmacologic treatments. The DASH diet reduces sodium intake and increases the intake of potassium, calcium, and magnesium, which help lower blood pressure by balancing sodium effects and improving vascular function. Pharmacologic treatments, such as diuretics, ACE inhibitors, and calcium channel blockers, work by reducing blood volume, relaxing blood vessels, and decreasing the heart's workload. These mechanisms are crucial for patients to understand as they highlight the importance of combining dietary and pharmacologic strategies to effectively manage high blood pressure.