ADAPT-Altering Diet for African American Populations to Treat Hypertension

This study has been completed.
Sponsor:
Collaborators:
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
  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: 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 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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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:
No publications provided

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
Study First Received: February 12, 2008
Last Updated: March 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Blood Pressure
Dash Diet

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014