Diet Intervention for Hypertension: Adaptation and Dissemination to Native Communities

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-17

Study Completion Date

2023-03-04

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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 $35 credit for groceries.

Group Type EXPERIMENTAL

DASH Groceries + Weekly Sessions

Intervention Type 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.

Control Group

Participants in the control group will receive printed educational materials with general information about low-salt diets plus a weekly $35 credit for groceries.

Group Type ACTIVE_COMPARATOR

Groceries + Brochure

Intervention Type 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.

Interventions

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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.

Intervention Type 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 $35 grocery order for 8 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No