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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 : March 12, 2019
Sponsor:
Collaborator:
Oklahoma State University
Information provided by (Responsible Party):
Dedra Buchwald, Washington State University

Brief Summary:

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

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diet Intervention for Hypertension: Adaptation and Dissemination to Native Communities
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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 $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.




Primary Outcome Measures :
  1. Improved blood pressure [ Time Frame: 12 weeks ]
    Systolic blood pressure measurements collected throughout the study.


Secondary Outcome Measures :
  1. Improved urinary sodium/potassium levels [ Time Frame: 12 weeks ]
    Measured by 24 hour urine samples collected at 3 time points.

  2. Improved BMI [ Time Frame: 12 weeks ]
    Measured by weight and height. Waist circumference will also be measured.

  3. Improved blood lipids [ Time Frame: 12 weeks ]
    Measured by cholesterol panel at 3 time points



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 in-person screening visit;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796313


Contacts
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Contact: Dedra Buchwald 2067088622 dedra.buchwald@wsu.edu

Locations
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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         
NATIVE Project Recruiting
Spokane, Washington, United States, 99201
Contact: Candy Jackson         
Sponsors and Collaborators
Washington State University
Oklahoma State University
Investigators
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Principal Investigator: Dedra Buchwald Washington State University

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Responsible Party: Dedra Buchwald, Professor, Washington State University
ClinicalTrials.gov Identifier: NCT02796313     History of Changes
Other Study ID Numbers: 1R01HL126578 ( U.S. NIH Grant/Contract )
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases