Groceries for High Blood Pressure

(GoFreshSE Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Beth Israel Deaconess Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

GoFreshSE is a randomized control trial, testing the effects of a home-delivered, dietitian-assisted, DASH-patterned grocery intervention on blood pressure in adults with high blood pressure in Florida, Georgia, and Tennessee.

Research Team

Eligibility Criteria

This trial is for adults in Florida, Georgia, and Tennessee with high blood pressure who can get home-delivered groceries and are willing to eat only these foods for 4 weeks. They must have internet access, a mobile device or computer, and be able to do video calls and texts. Participants need a stable blood pressure range (systolic 120-<160 mm Hg, diastolic <110 mm Hg) and access to emergency healthcare.

Inclusion Criteria

I can get groceries delivered or pick them up and will eat only these for 4 weeks.

Have access to refrigeration, cooking appliances, and Wi-Fi/cellular service

I can order groceries online and text.

Exclusion Criteria

Serum potassium ≥5.0 mmol/L or <3.5 mmol/L

Hemoglobin A1c ≥6.5%

My medication doses for diabetes or blood pressure are not changing.

Treatment Details

Interventions

• Dietitian-Assisted DASH groceries (Behavioral Intervention)

Trial Overview GoFreshSE is examining if getting dietitian-assisted DASH-patterned groceries delivered at home helps lower blood pressure in adults with hypertension. It's a randomized control trial where some people will shop on their own while others receive specialized grocery assistance.

Participant Groups

Group I: Dietitian-Assisted DASH Groceries Experimental Treatment 1 Intervention

Participants will order groceries sufficient to meet their caloric needs each week for 4 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.

Group II: Self-directed shopping Active Control 1 Intervention

Participants will receive a stipend and some basic information about healthy eating. The stipend is not restricted to foods.

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Dr. Kevin Tabb

Beth Israel Deaconess Medical Center

Chief Executive Officer since 2021

MD from Hebrew University Hadassah Medical School

Dr. Chi Chang Daniel Siao

Beth Israel Deaconess Medical Center

Chief Medical Officer since 2023

MD from King George’s Medical University

University of Vermont

Collaborator

Trials

283

Recruited

3,747,000+

Dr. Dragos Banu

University of Vermont

Chief Medical Officer

MD from Saba University School of Medicine

Dr. Richard Page

University of Vermont

Chief Executive Officer since 2018

MD from Duke University

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Eduardo Sanchez

American Heart Association

Chief Medical Officer since 2013

MD from University of Texas Southwestern Medical School, MPH from UT Health Science Center at Houston, MS in Biomedical Engineering from Duke University

Katrina McGhee

American Heart Association

Chief Executive Officer since 2020

MBA from the University of Texas at Arlington