Diet Intervention for Hypertension: Adaptation and Dissemination to Native Communities
NOSH
1 other identifier
interventional
315
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hypertension
Started Nov 2017
Longer than P75 for not_applicable hypertension
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2016
CompletedFirst Posted
Study publicly available on registry
June 10, 2016
CompletedStudy Start
First participant enrolled
November 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 4, 2023
CompletedOctober 2, 2023
September 1, 2023
5.3 years
June 7, 2016
September 29, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Improved blood pressure
Systolic blood pressure measurements collected throughout the study.
12 weeks
Secondary Outcomes (3)
Improved urinary sodium/potassium levels
12 weeks
Improved BMI
12 weeks
Improved blood lipids
12 weeks
Study Arms (2)
Intervention Group
EXPERIMENTALParticipants 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.
Control Group
ACTIVE COMPARATORParticipants in the control group will receive printed educational materials with general information about low-salt diets plus a weekly $35 credit for groceries.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Washington State Universitylead
- Oklahoma State Universitycollaborator
Study Sites (4)
Chickasaw Nation Health Clinic
Purcell, Oklahoma, 73080, United States
Avera Research Institute
Rapid City, South Dakota, 57702, United States
Seattle Indian Health Board
Seattle, Washington, 98144, United States
NATIVE Project
Spokane, Washington, 99201, United States
Related Publications (1)
Sinclair K, Nguyen CJ, Wetherill MS, Nelson K, Jackson AM, Taniguchi T, Jernigan VBB, Buchwald D. Native opportunities to stop hypertension: study protocol for a randomized controlled trial among urban American Indian and Alaska Native adults with hypertension. Front Public Health. 2023 Jun 2;11:1117824. doi: 10.3389/fpubh.2023.1117824. eCollection 2023.
PMID: 37333529DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dedra Buchwald
Washington State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 7, 2016
First Posted
June 10, 2016
Study Start
November 17, 2017
Primary Completion
March 4, 2023
Study Completion
March 4, 2023
Last Updated
October 2, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share