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Completed

NCT Number: NCT02796313

Diet Intervention for Hypertension: Adaptation and Dissemination to Native Communities

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chickasaw Nation Health Clinic, Purcell, Oklahoma, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DASH Groceries + Weekly Sessions

Behavioral

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.

Groceries + Brochure

Behavioral

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.

Primary outcomes

  1. Improved blood pressure

    Time frame: 12 weeks

    Systolic blood pressure measurements collected throughout the study.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Washington State University

Other

Collaborators

  • Oklahoma State University

Registry information

Acronym: NOSH

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Jun 10, 2016
Registry last updated
Oct 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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