ADAPT-Altering Diet for African American Populations to Treat Hypertension

Brief Summary

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”

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).

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
  • Study Primary Completion Date: July 2008

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • 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

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
    • Group intervention with no dietary focus
  • Experimental: 2
    • DASH diet intervention

Outcome Measures for this Clinical Trial

Primary Measures

  • Change in blood pressure with dietary intervention
    • Time Frame: 6 months
      Safety Issue?: No

Secondary Measures

  • Change in weight
    • Time Frame: 6 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 25 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

  • Lead Sponsor
    • University of Alabama at Birmingham
  • Collaborator
    • National Institutes of Health (NIH)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jamy Ard, MD, Associate Professor – University of Alabama at Birmingham
  • Overall Official(s)
    • Jamy D Ard, MD, Principal Investigator, University of Alabama at Birmingham
    • Catarina Kiefe, MD, PhD, Principal Investigator, University of Alabama at Birmingham

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00621569