NCT00621569

Brief Summary

The purpose of the study is to develop a culturally appropriate DASH intervention and test the effectiveness of the intervention lower blood pressure in a group of African American participants at risk for developing hypertension (pre-hypertension) and those with mild hypertension (stage I).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable hypertension

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

January 1, 2005

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 18, 2013

Status Verified

March 1, 2013

Enrollment Period

3.5 years

First QC Date

February 12, 2008

Last Update Submit

March 15, 2013

Conditions

Hypertension

Keywords

Blood PressureDash Diet

Outcome Measures

Primary Outcomes (1)

  • Change in blood pressure with dietary intervention

    6 months

Secondary Outcomes (1)

  • Change in weight

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Group intervention with no dietary focus

Behavioral: Intervention with no dietary component - information regarding useful life skills

2

EXPERIMENTAL

DASH diet intervention

Behavioral: Dietary Approaches to Stop Hypertension-The DASH diet

Interventions

Dietary Approaches to Stop Hypertension-The DASH dietBEHAVIORAL

The purpose of this study is to create a culturally appropriate diet to test the effectiveness of the intervention to lower blood pressure in a grou pof African American individuals at risk for developing hypertension (pre-hypertension) and those with mild hypertension (stage I).

2
Intervention with no dietary component - information regarding useful life skillsBEHAVIORAL

Participants receive information regarding useful life skills in a group setting

1

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Baseline SBP 120-159 mmHg and DBP 80-95 mmHg
  • Age 25 or older as of the initial screening visit
  • Willing and able to participate fully in all aspects of the intervention
  • Not on rigid diet
  • Provide informed consent
  • BMI 18.5-45 kg/m2

You may not qualify if:

  • Regular use of anti-hypertensive drugs or other drugs that raise or lower BP (any in previous three months)
  • Current use of insulin or oral hypoglycemic agents
  • Use of oral corticosteroids \>5 days/month on average
  • Current use of medications for treatment of psychosis or manic-depressive illness
  • Use of oral breathing medications other than inhalers \> 5 days/month on average
  • Use of weight-loss medications in previous 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham Department of Nutrition Sciences

Birmingham, Alabama, 35294-3360, United States

Location

Related Links

MeSH Terms

Conditions

Hypertension

Interventions

Methods

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Jamy D Ard, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

  • Catarina Kiefe, MD, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 12, 2008

First Posted

February 22, 2008

Study Start

January 1, 2005

Primary Completion

July 1, 2008

Study Completion

December 1, 2011

Last Updated

March 18, 2013

Record last verified: 2013-03

Locations

US(1)