ADAPT-Altering Diet for African American Populations to Treat Hypertension - Full Text View

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

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

Resource links provided by NLM:

MedlinePlus related topics: Diets High Blood Pressure

U.S. FDA Resources

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).

Detailed Description:

The effectiveness of the Dietary Approaches to Stop Hypertension (DASH) diet has shown to have limited impact on blood pressure control among African Americans, which might be explained by inappropriate adaptation to African American culture and tradition. Therefore, the adequate adaptation of the DASH diet would result in blood pressure control among African-Americans. Using the nominal group technique as a part of the formative assessment, this project proposes to identify key cultural variables that impact dietary patterns for African Americans. Based on those results, a modified behavioral intervention will be developed and tested in African Americans with pre-hypertension or stage I hypertension. Primary outcomes will include change in systolic and diastolic blood pressure at six months. It is expected that this project will contribute an additional tool for physicians, patients and health care systems to improve hypertension control amongst African Americans. The specific aims for this dietary intervention are: (1) to develop a modified DASH dietary pattern that is culturally appropriate for African-Americans by using principals of formative analysis and (2) to conduct a randomized, controlled trial to determine the effectiveness of the modified DASH dietary pattern in reducing blood pressure for a cohort of African-Americans with pre-hypertension or stage I hypertension to a usual care control group.

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

Locations

United States, Alabama
University of Alabama at Birmingham Department of Nutrition Sciences
Birmingham, Alabama, United States, 35294-3360

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
Principal Investigator:	Catarina Kiefe, MD, PhD	University of Alabama at Birmingham

More Information

Additional Information:

Alabama Collaboration for Cardiovascular Equality (ACCE) is an initiative under the leadership of Drs. Catarina Kiefe and Sandral Hullett and is comprised of STORIES (NCT00101491), led by Dr. Thomas Houston, and ADAPT (NCT00621569), led by Dr. Jamy Ard This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

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 23, 2009
ClinicalTrials.gov Identifier:	NCT00621569 History of Changes
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:

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on September 04, 2009