ADAPT-Altering Diet for African American Populations to Treat Hypertension
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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 |
- Change in blood pressure with dietary intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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 |
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| United States, Alabama | |
| University of Alabama at Birmingham Department of Nutrition Sciences | |
| Birmingham, Alabama, United States, 35294-3360 | |
| 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 June 18, 2013