ADAPT-Altering Diet for African American Populations to Treat Hypertension

Not Applicable

Completed

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

• Registration Number: NCT00621569
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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).

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 Timeline

• Study Start: 2005-01
• Study First Submitted: 2008-02-12
• Study First Submitted QC: 2008-02-21
• Study First Posted: 2008-02-22
• Primary Completion: 2008-07
• Study Completion: 2011-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-15
• Last Update Posted: 2013-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Intervention with no dietary component - information regarding useful life skills	Group intervention with no dietary focus
2	Dietary Approaches to Stop Hypertension-The DASH diet	DASH diet intervention

Primary Outcome Measures

Name	Time	Method
Change in blood pressure with dietary intervention	6 months

Secondary Outcome Measures

Name	Time	Method
Change in weight	6 months

Trial Locations

Locations (1)

University of Alabama at Birmingham Department of Nutrition Sciences; 🇺🇸 Birmingham, Alabama, United States