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Behavioral Intervention

Healthy Diet for High Blood Pressure (GoFresh 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

Be older than 18 years old

Must not have

Weight loss or gain of >5.0% of body weight during prior 2 months

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured 3 months after randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a healthy diet can lower blood pressure in adults who live in areas with limited access to fresh food.

Who is the study for?

This trial is for Black adults living in certain Boston areas without treated hypertension, with systolic blood pressure between 120-149 mm Hg and diastolic below 100 mm Hg. Participants must be able to receive and consume only provided groceries for 12 weeks, have kitchen facilities, Wi-Fi/cell service, and a device for grocery orders. Exclusions include severe health conditions like diabetes or recent cardiovascular events, significant weight changes recently, extreme diets or food insecurities.

What is being tested?

The GoFresh trial is examining if home-delivered DASH-patterned groceries can lower blood pressure among Black adults in urban food deserts of Boston. It's a randomized study where some will get dietitian-assisted shopping while others will shop on their own.

What are the potential side effects?

Since the intervention involves dietary changes rather than medication, side effects may include initial discomfort adjusting to new foods or patterns of eating but are not expected to be severe.

Eligibility Criteria

Exclusion Criteria

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

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I have lost or gained more than 5% of my weight in the last 2 months.

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I have not had any major heart issues or strokes in the last 6 months.

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I have diabetes with an A1c level of 6.5% or higher, or I am on diabetes treatment.

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