Hypertension Clinical Trial
— NOSHOfficial title:
Diet Intervention for Hypertension: Adaptation and Dissemination to Native Communities
Verified date | September 2023 |
Source | Washington State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
We will conduct a randomized trial to test our DASH (Dietary Approaches to Stop Hypertension) based intervention in 370 adult American Indians with inadequately controlled systolic blood pressure (≥130 mmHg). Over the 5 years of the project, we will recruit and randomize 200 participants from each of 4 urban sites: two in Washington, one in Oklahoma, and one in South Dakota.
Status | Completed |
Enrollment | 315 |
Est. completion date | March 4, 2023 |
Est. primary completion date | March 4, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Participants must: - be at least 18 years old; - have had diagnosed hypertension for at least 1 year; - be on a stable routine of antihypertensive medications for at least 2 months OR not currently medicated, without anticipated changes for the duration of the study; - have systolic BP = 130 mmHg at the past 2 clinic visits and at the screening call; - have access to regular medical care and permission from their primary care provider to participate (study staff obtain verbal permission before recruiting participants); - be physically and cognitively able to use the home BP monitoring device; - be willing and able to follow all other study procedures. Exclusion Criteria: People are ineligible if they: - experienced incident cardiovascular disease or stroke within the previous 6 months; - have a known diagnosis of secondary hypertension (e.g., renal artery stenosis); - have a recent history of high blood potassium due to certain medications that can raise potassium levels; - have diagnosed Stage 4 or 5 kidney disease; - are currently or planning to become pregnant during the course of the study; - are participating in another health research study involving hypertension; - are receiving treatment for cancer or another serious or terminal medical condition. |
Country | Name | City | State |
---|---|---|---|
United States | Chickasaw Nation Health Clinic | Purcell | Oklahoma |
United States | Avera Research Institute | Rapid City | South Dakota |
United States | Seattle Indian Health Board | Seattle | Washington |
United States | NATIVE Project | Spokane | Washington |
Lead Sponsor | Collaborator |
---|---|
Washington State University | Oklahoma State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improved blood pressure | Systolic blood pressure measurements collected throughout the study. | 12 weeks | |
Secondary | Improved urinary sodium/potassium levels | Measured by 24 hour urine samples collected at 3 time points. | 12 weeks | |
Secondary | Improved BMI | Measured by weight and height. Waist circumference will also be measured. | 12 weeks | |
Secondary | Improved blood lipids | Measured by cholesterol panel at 3 time points | 12 weeks |
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