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Sponsors and Collaborators: |
University of Alabama at Birmingham National Institutes of Health (NIH) National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00621569 |
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 |
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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 |
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 |
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1: Active Comparator
Group intervention with no dietary focus
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Behavioral: Intervention with no dietary component - information regarding useful life skills
Participants receive information regarding useful life skills in a group setting
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2: Experimental
DASH diet intervention
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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).
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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.
Ages Eligible for Study: | 25 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama at Birmingham Department of Nutrition Sciences | |
Birmingham, Alabama, United States, 35294-3360 |
Principal Investigator: | Jamy D Ard, MD | University of Alabama at Birmingham |
Principal Investigator: | Catarina Kiefe, MD, PhD | University of Alabama at Birmingham |
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 |
Blood Pressure Dash Diet |
Vascular Diseases Hypertension |
Vascular Diseases Cardiovascular Diseases Hypertension |