Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02796313
Other study ID # 1R01HL126578
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 17, 2017
Est. completion date March 4, 2023

Study information

Verified date September 2023
Source Washington State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 315
Est. completion date March 4, 2023
Est. primary completion date March 4, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Chickasaw Nation Health Clinic Purcell Oklahoma
United States Avera Research Institute Rapid City South Dakota
United States Seattle Indian Health Board Seattle Washington
United States NATIVE Project Spokane Washington

Sponsors (2)

Lead Sponsor Collaborator
Washington State University Oklahoma State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improved blood pressure Systolic blood pressure measurements collected throughout the study. 12 weeks
Secondary Improved urinary sodium/potassium levels Measured by 24 hour urine samples collected at 3 time points. 12 weeks
Secondary Improved BMI Measured by weight and height. Waist circumference will also be measured. 12 weeks
Secondary Improved blood lipids Measured by cholesterol panel at 3 time points 12 weeks
See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A
Completed NCT03875768 - Nourish: A Digital Health Program to Promote the DASH Eating Plan Among Adults With High Blood Pressure N/A