NCT01689844

Brief Summary

The Five Plus Nuts \& Beans Study is a randomized, controlled trial to compare two strategies for translating the results of the DASH (Dietary Approaches to Stop Hypertension) Study into practice for 120 African American participants who are on stable doses of antihypertensive medications. The first arm of our study offers minimal DASH-oriented dietary advice along with a food credit at a local supermarket where they make their own decision of what to eat. The second arm consists of a single one-hour session with a nutrition expert who provides choices and places an on-line order from a community grocery store (Santoni's Market) with targeted purchases of fruits, vegetables, nuts and beans. Our primary outcome is change in blood pressure at 8 weeks. Secondary outcomes are effects on glucose, uric acid, urine potassium excretion, and self-report consumption of fruits and vegetables during the same period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

1.6 years

First QC Date

April 27, 2012

Last Update Submit

August 30, 2016

Conditions

High Blood Pressure

Keywords

controlled high blood pressure

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure

    Daytime systolic blood pressure determined by OMRON 907-xl blood pressure monitoring, will be the primary outcome measurement

    8-wks follow-up

Secondary Outcomes (1)

  • Fasting glucose, lipids and uric acid; urine K and Na excretion

    8-wks follow-up

Study Arms (2)

Behavioral, DASH Plus - Dietary advice

ACTIVE COMPARATOR

This group will receive DASH diet advice and guided ordering of fruits, vegetables, nuts and beans that are high in potassium from a local supermarket.

Behavioral: DASH Plus

DASH - C

OTHER

DASH C Group will receive brief DASH diet advice and will be able to make non- guided purchases of food products from the local supermarket.

Behavioral: DASH - C

Interventions

DASH PlusBEHAVIORAL

DASH diet advice and guided shopping for high postassium foods at a local supermarket

Behavioral, DASH Plus - Dietary advice
DASH - CBEHAVIORAL

Brief DASH dietary advice, No shopping guidance at the local supermarket.

DASH - C

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • must be age 21 or older,
  • have a diagnosis of hypertension or pre-hypertension
  • under regular care with their physician, and
  • compliant with medications.
  • systolic blood pressure of 120-140 mmHg and/or
  • a diastolic blood pressure of 80-90 mmHg (average of two visits)
  • on stable doses of antihypertensive medications for a minimum of two months prior to randomization, (and for the duration of the study).
  • be able to follow all trial procedures.

You may not qualify if:

  • cardiovascular event within 6 months,
  • chronic disease that might interfere with trial participation (e.g. chronic kidney disease (estimated GFR \< 60 cc/min),
  • unwillingness or inability to adopt a DASH-like diet, and
  • consumption of more than 14 alcoholic drinks per week,
  • poorly controlled diabetes (Hemoglobin A1c \>9%),
  • use of insulin,
  • use of mineral supplements or an unwillingness to stop supplements one month prior to randomization and refrain from the supplements during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Community Physicians, East Baltimore Medical Center

Baltimore, Maryland, 21202, United States

Location

Related Publications (1)

  • Juraschek SP, White K, Tang O, Yeh HC, Cooper LA, Miller ER 3rd. Effects of a Dietary Approach to Stop Hypertension (DASH) Diet Intervention on Serum Uric Acid in African Americans With Hypertension. Arthritis Care Res (Hoboken). 2018 Oct;70(10):1509-1516. doi: 10.1002/acr.23515. Epub 2018 Aug 21.

    PMID: 29342506DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Edgar R Miller III, MD, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 27, 2012

First Posted

September 21, 2012

Study Start

April 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

August 31, 2016

Record last verified: 2016-08

Locations

US(1)