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ADAPT-Altering Diet for African American Populations to Treat Hypertension

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00621569
First received: February 12, 2008
Last updated: March 15, 2013
Last verified: March 2013
History of Changes

February 12, 2008
March 15, 2013
January 2005
July 2008   (final data collection date for primary outcome measure)
Change in blood pressure with dietary intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00621569 on ClinicalTrials.gov Archive Site
Change in weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
ADAPT-Altering Diet for African American Populations to Treat Hypertension
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

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).

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Hypertension
  • 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).
  • Behavioral: Intervention with no dietary component - information regarding useful life skills
    Participants receive information regarding useful life skills in a group setting
  • Active Comparator: 1
    Group intervention with no dietary focus
    Intervention: Behavioral: Intervention with no dietary component - information regarding useful life skills
  • Experimental: 2
    DASH diet intervention
    Intervention: Behavioral: Dietary Approaches to Stop Hypertension-The DASH diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
December 2011
July 2008   (final data collection date for primary outcome measure)

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
Both
25 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00621569
F0408110045, U01HL079171
No
Jamy Ard, MD, University of Alabama at Birmingham
University of Alabama at Birmingham
  • National Institutes of Health (NIH)
  • National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Jamy D Ard, MD University of Alabama at Birmingham
Principal Investigator: Catarina Kiefe, MD, PhD University of Alabama at Birmingham
University of Alabama at Birmingham
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP