Diet Intervention for Hypertension: Adaptation and Dissemination to Native Communities (NOSH)
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|ClinicalTrials.gov Identifier: NCT02796313|
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : October 8, 2019
We will conduct a randomized trial to test our DASH (Dietary Approaches to Stop Hypertension) based intervention in 400 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 3 urban sites: two in Washington and one in Oklahoma.
In addition, we will conduct a pilot study after the 8 week intervention concludes to test whether providing 6 additional week of dietitian support (without the grocery supplement) can help improve blood pressure over the long term.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Behavioral: DASH Groceries + Weekly Sessions Behavioral: Groceries + Brochure||Not Applicable|
For Goal 1, all participants complete 4 data collection visits at the clinic (in person screening visit, 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 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.
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.
The pilot study will provide preliminary evidence for natural attenuation of BP, and will evaluate the added benefit of the additional telephone support that can be used to inform design of future studies.
Beginning in Year 3, 100 intervention group participants (50 at each site) who attend the Week 8 follow up research visit and who successfully completed 5 of the 8 weekly phone calls will be randomized to:
- Pilot Control group -no additional support, weekly BP measurements only
- Pilot Intervention group - 6 extra weeks of 20-minute phone consultations with the dietitian (enhanced intervention)
We will also recruit 100 control group participants (50 at each site) to the pilot study, who will be automatically assigned to receive no additional support while providing weekly BP measurements.
The enhanced intervention consultations will provide support for maintaining a low-sodium DASH lifestyle after the weekly grocery credit ends. We will contact pilot study participants by telephone 6 and 9 months after baseline and talk them through accessing BP readings from their home BP monitor.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Diet Intervention for Hypertension: Adaptation and Dissemination to Native Communities|
|Actual Study Start Date :||November 17, 2017|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||June 2020|
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 $30 credit for groceries.
Behavioral: DASH Groceries + Weekly Sessions
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 $30 credit for groceries.
Behavioral: Groceries + Brochure
Control group participants will receive a printed brochure about the health benefits of a low-salt diet. They will place an unrestricted $30 grocery order for 8 weeks.
- Improved blood pressure [ Time Frame: 12 weeks ]Systolic blood pressure measurements collected throughout the study.
- Improved urinary sodium/potassium levels [ Time Frame: 12 weeks ]Measured by 24 hour urine samples collected at 3 time points.
- Improved BMI [ Time Frame: 12 weeks ]Measured by weight and height. Waist circumference will also be measured.
- Improved blood lipids [ Time Frame: 12 weeks ]Measured by cholesterol panel at 3 time points
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796313
|Contact: Dedra Buchwaldfirstname.lastname@example.org|
|United States, Oklahoma|
|Chickasaw Nation Health Clinic||Recruiting|
|Purcell, Oklahoma, United States, 73080|
|Contact: Melanie Todd|
|United States, Washington|
|Seattle Indian Health Board||Recruiting|
|Seattle, Washington, United States, 98144|
|Contact: Erin Prasad|
|Spokane, Washington, United States, 99201|
|Contact: Candy Jackson|
|Principal Investigator:||Dedra Buchwald||Washington State University|