ADAPT-Altering Diet for African American Populations to Treat Hypertension

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Dietary Approaches to Stop Hypertension-The DASH diet
* Behavioral: Intervention with no dietary component - information regarding useful life skills


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Group intervention with no dietary focus | Behavioral: Intervention with no dietary component - information regarding useful life skills<br>* Participants receive information regarding useful life skills in a group setting<br>|
| Experimental: 2<br>DASH diet intervention | Behavioral: Dietary Approaches to Stop Hypertension-The DASH diet<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Pressure, Dash Diet