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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00621569 |
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Date of registration:
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12/02/2008 |
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Primary sponsor: |
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Public title:
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ADAPT-Altering Diet for African American Populations to Treat Hypertension
ADAPT |
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Scientific 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 |
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Date of first enrolment:
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January 2005 |
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Target sample size:
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141 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00621569 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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United States
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Contacts
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Name:
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Catarina Kiefe, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Alabama at Birmingham |
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Name:
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Jamy D Ard, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Alabama at Birmingham |
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Key inclusion & exclusion 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
Age minimum:
25 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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Behavioral: Dietary Approaches to Stop Hypertension-The DASH diet
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Behavioral: Intervention with no dietary component - information regarding useful life skills
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Primary Outcome(s)
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Change in blood pressure with dietary intervention
[Time Frame: 6 months]
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Secondary Outcome(s)
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Change in weight
[Time Frame: 6 months]
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Secondary ID(s)
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F0408110045
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U01HL079171
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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