ADAPT-Altering Diet for African American Populations to Treat Hypertension

NCT ID: NCT00621569

Last Updated: 2013-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2011-12-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Group intervention with no dietary focus

Group Type: ACTIVE_COMPARATOR

Intervention with no dietary component - information regarding useful life skills

Intervention Type: BEHAVIORAL

Participants receive information regarding useful life skills in a group setting

2

DASH diet intervention

Group Type: EXPERIMENTAL

Dietary Approaches to Stop Hypertension-The DASH diet

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: BEHAVIORAL

Intervention with no dietary component - information regarding useful life skills

Participants receive information regarding useful life skills in a group setting

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Jamy Ard, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jamy D Ard, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Catarina Kiefe, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham Department of Nutrition Sciences

Birmingham, Alabama, United States

Countries

United States

Related Links

http://clinicaltrials.gov/show/NCT00101491

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

Other Identifiers

U01HL079171

Identifier Type: NIH

Identifier Source: secondary_id

View Link

F0408110045

Identifier Type: -

Identifier Source: org_study_id