- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02796313
Diet Intervention for Hypertension: Adaptation and Dissemination to Native Communities (NOSH)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All participants complete 3 data collection visits following an over-the-phone eligibility screening call (baseline, week 8, and week 12). Participants will be randomized into either the control group or the intervention group at the baseline visit.
All participants will receive 8 weekly credits for groceries and will be given equipment for monitoring their BP at home. Study staff will help participants place their grocery orders each week, and will collect readings from the home BP monitoring equipment at the same time. This data will be used to understand whether the intervention is effective for controlling BP.
All participants will be encouraged to maintain their regular levels of physical activity and receive treatment as usual from their healthcare providers.
The control group participants will receive an American Heart Association printed brochure about the health benefits of a low-salt diet. All foods will be available to purchase, including those that do not meet the DASH diet guidelines.
The intervention group participants will receive 1 hour of nutritional counseling over the phone and a personalized prescription for the low-salt DASH diet based on estimated calorie needs at baseline, followed by weekly 20-minute phone calls in weeks 1-8 to provide extra support.
The intervention group's food choices will be limited to fresh produce and a pre-determined list of other foods included in the DASH diet. During weekly phone calls, the dietitian will use a structured phone curriculum to discuss in more detail a different component of the DASH diet, followed by goal setting related to that component. Through small goal setting each week, participants will receive ongoing support to improve full adherence to the DASH diet by the end of week 8.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dedra Buchwald
- Phone Number: 2067088622
- Email: dedra.buchwald@wsu.edu
Study Locations
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Oklahoma
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Purcell, Oklahoma, United States, 73080
- Chickasaw Nation Health Clinic
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South Dakota
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Rapid City, South Dakota, United States, 57702
- Avera Research Institute
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Washington
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Seattle, Washington, United States, 98144
- Seattle Indian Health Board
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Spokane, Washington, United States, 99201
- NATIVE Project
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
Participants in the intervention group will receive tailored advice on adopting a low-sodium DASH diet, comprising nutritional education and ongoing guidance for purchasing heart-healthy foods, plus a weekly $35 credit for groceries.
|
Intervention group participants will receive 1 hour of in-person nutritional counseling and a personalized prescription for the low-salt DASH diet based on estimated calorie needs at baseline, followed by weekly 20-minute phone calls in weeks 1-8 to provide extra support.
|
Active Comparator: Control Group
Participants in the control group will receive printed educational materials with general information about low-salt diets plus a weekly $35 credit for groceries.
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Control group participants will receive a printed brochure about the health benefits of a low-salt diet.
They will place an unrestricted $35 grocery order for 8 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improved blood pressure
Time Frame: 12 weeks
|
Systolic blood pressure measurements collected throughout the study.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improved urinary sodium/potassium levels
Time Frame: 12 weeks
|
Measured by 24 hour urine samples collected at 3 time points.
|
12 weeks
|
Improved BMI
Time Frame: 12 weeks
|
Measured by weight and height.
Waist circumference will also be measured.
|
12 weeks
|
Improved blood lipids
Time Frame: 12 weeks
|
Measured by cholesterol panel at 3 time points
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dedra Buchwald, Washington State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01HL126578 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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