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

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 Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Intervention with no dietary component - information regarding useful life skills; Behavioral: Dietary Approaches to Stop Hypertension-The DASH diet

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.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-3360
      • University of Alabama at Birmingham Department of Nutrition Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in blood pressure with dietary intervention	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in weight	6 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)

Publications and helpful links

Helpful Links

• Alabama Collaboration for Cardiovascular Equality (ACCE) is an initiative under the leadership of Drs. Catarina Kiefe and Sandral Hullett and is comprised of STORIES (NCT00101491), led by Dr. Thomas Houston, and ADAPT (NCT00621569), led by Dr. Jamy Ard

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (ACTUAL): July 1, 2008
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: February 12, 2008
• First Submitted That Met QC Criteria: February 21, 2008
• First Posted (ESTIMATE): February 22, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): March 18, 2013
• Last Update Submitted That Met QC Criteria: March 15, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Blood Pressure; Dash Diet
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: F0408110045; U01HL079171 (NIH)