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ADAPT-Altering Diet for African American Populations to Treat Hypertension (ADAPT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00621569
First Posted: February 22, 2008
Last Update Posted: March 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jamy Ard, MD, University of Alabama at Birmingham
  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
Hypertension Behavioral: Dietary Approaches to Stop Hypertension-The DASH diet Behavioral: Intervention with no dietary component - information regarding useful life skills

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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:


Further study details as provided by Jamy Ard, MD, University of Alabama at Birmingham:

Primary Outcome Measures:
  • Change in blood pressure with dietary intervention [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Change in weight [ Time Frame: 6 months ]

Enrollment: 122
Study Start Date: January 2005
Study Completion Date: December 2011
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
Experimental: 2
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

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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Jamy Ard, MD, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00621569     History of Changes
Other Study ID Numbers: F0408110045
U01HL079171 ( U.S. NIH Grant/Contract )
First Submitted: February 12, 2008
First Posted: February 22, 2008
Last Update Posted: March 18, 2013
Last Verified: March 2013

Keywords provided by Jamy Ard, MD, University of Alabama at Birmingham:
Blood Pressure
Dash Diet

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases