ADAPT-Altering Diet for African American Populations to Treat Hypertension

This study is currently recruiting participants.

Verified by University of Alabama at Birmingham, February 2008

Sponsors and Collaborators:	University of Alabama at Birmingham National Institutes of Health (NIH) National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00621569

Purpose

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).

Condition	Intervention	Phase
Hypertension	Behavioral: Dietary Approaches to Stop Hypertension-The DASH diet Behavioral: Intervention with no dietary component - information regarding useful life skills	Phase I

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment
Official Title:	A Culturally Appropriate Intervention in Hypertensive African-Americans Based on the DASH Diet—The ADAPT Hypertension Study = Altering Diet for African American Populations to Treat Hypertension

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

Change in blood pressure with dietary intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	141
Study Start Date:	January 2005
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Group intervention with no dietary focus	Behavioral: Intervention with no dietary component - information regarding useful life skills Participants receive information regarding useful life skills in a group setting
2: Experimental DASH diet intervention	Behavioral: Dietary Approaches to Stop Hypertension-The DASH diet 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).

Eligibility

Ages Eligible for Study:	25 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621569

Contacts

Contact: Catherine C Bethea, MA	205-975-4907	ccbethea@uab.edu
Contact: Tiffany L Cox	205-996-5032	mistlc@uab.edu

Locations

United States, Alabama
University of Alabama at Birmingham Department of Nutrition Sciences	Recruiting
Birmingham, Alabama, United States, 35294-3360
Contact: Jamy Ard, MD 205-996-2181 ardj@uab.edu

Sponsors and Collaborators

University of Alabama at Birmingham

National Institutes of Health (NIH)

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Jamy D Ard, MD

University of Alabama at Birmingham

More Information

Responsible Party:	University of Alabama at Birmingham ( Jamy D. Ard, MD )
Study ID Numbers:	F0408110045, U01 HL079171
Study First Received:	February 12, 2008
Last Updated:	February 21, 2008
ClinicalTrials.gov Identifier:	NCT00621569
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:

Blood Pressure
Dash Diet

Study placed in the following topic categories:

Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009