An interventional study of DASH Groceries + Weekly Sessions and Groceries + Brochure in Hypertension, sponsored by Washington State University. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-02.
Sponsored by Washington State University · Not applicable, Interventional, and Treatment
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.
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 315 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Washington State University is the lead sponsor of 82 studies on the registry; 16 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants must:
Exclusion Criteria:
People are ineligible if they:
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.
Behavioral: DASH Groceries + Weekly Sessions
Participants in the control group will receive printed educational materials with general information about low-salt diets plus a weekly $35 credit for groceries.
Behavioral: Groceries + Brochure
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.
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.
Improved blood pressure
Systolic blood pressure measurements collected throughout the study.
Time frame: 12 weeks
Improved urinary sodium/potassium levels
Measured by 24 hour urine samples collected at 3 time points.
Time frame: 12 weeks
Improved BMI
Measured by weight and height. Waist circumference will also be measured.
Time frame: 12 weeks
Improved blood lipids
Measured by cholesterol panel at 3 time points
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Washington State University