← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured 3 months after randomization

Awards & highlights

GoFreshRx Trial Summary

This trial is testing whether a home-delivered grocery intervention can lower blood pressure in Black adults with hypertension who live in urban food deserts.

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.Check my eligibility

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.See study design

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.

GoFreshRx Trial 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.

GoFreshRx Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

24-hour dietary recall (intervention & observation phases)

24-hour urine potassium (intervention & observation phases)

24-hour urine sodium (intervention & observation phases)

+9 more

Other outcome measures

Grocery shopping and dining habits

Perceived Stress Scale 4 (PSS-4)

Qualitative Interviews

+1 more

GoFreshRx 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor

837 Previous Clinical Trials

13,010,122 Total Patients Enrolled

National Institute on Minority Health and Health Disparities (NIMHD)NIH

383 Previous Clinical Trials

1,216,209 Total Patients Enrolled

Stephen P Juraschek, MD, PhDPrincipal InvestigatorBeth Israel Deaconess Medical Center

1 Previous Clinical Trials

150 Total Patients Enrolled

Media Library

Dietitian-Assisted DASH groceries (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05393232 — N/A

High Blood Pressure Research Study Groups: Dietitian-Assisted DASH groceries, Self-directed shopping (referent assignment)

High Blood Pressure Clinical Trial 2023: Dietitian-Assisted DASH groceries Highlights & Side Effects. Trial Name: NCT05393232 — N/A

Dietitian-Assisted DASH groceries (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05393232 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being taken on for this research project?

"Affirmative. According to data on clinicaltrials.gov, this experiment is presently recruiting participants who meet certain criteria. It was initially posted August 15th 2022 and modified most recently on the 11th of that month. 150 patients will be sought from a single centre for the study's duration."

Answered by AI

Does this experimental research accept volunteers aged 55 or above?

"This clinical trial is accepting patients between the ages of 18 and 100, although there are more specific studies available for those outside this age range. 54 trials exist to treat minors while 661 focus on adults over 65 years old."

Answered by AI

How many participants have been accepted into this research program?

"Affirmative. Records accessible on clinicaltrials.gov show that from August 15th 2022, this medical trial is actively in search of participants. Approximately 150 patients need to be sourced from 1 site."

Answered by AI

What is the eligibility criteria for joining this medical study?

"This medical trial seeks 150 hypertensive individuals aged 18 to 100. Notably, they must have systolic blood pressure ranging from 120-150mm Hg and diastolic blood pressure of under 100 mmHg, along with other conditions such as a CKD-EPI equation eGFR below 30 ml/min per 1.73 m^2 and self-identify as Black or African American. Furthermore, participants should possess access to refrigeration, cooking appliances and WiFi/cellular service and be willing to receive home delivered groceries over a 12 week period for the duration of study. Lastly serum potassium levels need to be ≥"

Answered by AI

Who else is applying?

What site did they apply to?

Beth Israel Deaconess Medical Center - Clinical Research Center

What portion of applicants met pre-screening criteria?

Did not meet criteria

Why did patients apply to this trial?

I have tried multiple different medical ways to treat my issues and am open to trying a diet change to see how this will help alleviate my ongoing needs.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

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

Stephen Juraschek 2022. "Groceries for Black Residents of Boston to Stop Hypertension Among Adults With Treated Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05393232.

All > Blood Pressure > Cholesterol