Clinical trial NCT00621569: ADAPT-Altering Diet for African American Populations to Treat Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Blood Pressure
Dash Diet
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-02-22
Enrollment: 122
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in blood pressure with dietary intervention
timeFrame: 6 months
Secondary outcomes:
measure: Change in weight
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Department of Nutrition Sciences
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jamy D Ard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Catarina Kiefe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: