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Sodium Watchers Program - Hypertension (SWAPHTN)

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ClinicalTrials.gov Identifier: NCT04076280
Recruitment Status : Recruiting
First Posted : September 2, 2019
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Misook L. Chung, University of Kentucky

Brief Summary:
Hypertensive adults are a vulnerable population at high risk of developing cardiovascular disease. Despite the many interventions tested to reduce hypertension, it remains a major risk factor that is not appropriately managed in the population. Prior dietary interventions were successful on reduction of sodium intake, but the changes were not maintained after the end of the intervention. We propose that changing patients' salt taste preference and including family members will produce long-term changes in sodium intake and blood pressure. The Sodium Watchers Program (SWaP) proposed in this study is designed to improve adherence to a sodium restricted diet through education and self-care strategies for gradual taste adaptation to low salt foods. The purpose of this pilot is to test short-term effects of the SWaP intervention on adherence to the sodium restricted diet, blood pressure, salt taste preference, and dietary patterns in hypertensive adults. A total of 30 hypertensive adults will be randomly assigned to the intervention (n=20) or control group (n=10). The intervention group will receive 16-weeks of education and booster sessions remotely using a video conferencing program on mini-iPads. All participants will collect a 24-hour urine specimen for sodium excretion and complete assessments of blood pressure, salt taste preference testing using salt concentration solutions, and dietary pattern using VioScreen Food Frequency Questionnaire at baseline and post intervention at 4-months. Data will be analyzed using repeated measures analysis of variance.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Sodium Watcher Program-Hypertension Behavioral: Usual Care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sodium Watchers Program - Hypertension
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SWAP Intervention
The participants are randomized using a table of random numbers pre-generated by a computer assigning them to the Sodium Watcher Program.
Behavioral: Sodium Watcher Program-Hypertension
The Sodium Watcher Program -Hypertension intervention consists of 14 weeks of education [4 weekly education sessions (45 minutes)followed by 5 bi-weekly sessions 5-20 minutes] that will be held at the dyads' preferred time delivered to their homes using a video conferencing program through an iPad.

Active Comparator: Usual Care
The participants are randomized using a table of random numbers pre-generated by a computer assigning them to the usual care group.
Behavioral: Usual Care
Participants in the usual care group receive their routine medical and nursing care for hypertension that consists of a recommendation to follow a sodium restricted diet and take medications as ordered. Usual care consists of recommendations to follow a sodium restricted diet, but without explicit skills training including instructions on gradual adaptation to sodium restricted diet, follow-up of progress or provision of monitoring.




Primary Outcome Measures :
  1. Change in oral salt taste sensitivity [ Time Frame: up to 36 weeks ]
    Salt taste acuity will be tested by using the "updown" procedure. In the up trial, samples are given from lowest to highest salt concentration. Patients swish samples in the mouth for 2-3 seconds, expectorate, and then judge the saltiness of solution. The mouth is rinsed with 10 mL of distilled water between samples. When patients detect salt taste in two consecutive samples, the lower concentration of the two samples is recorded as the level of salt taste sensitivity. In the down trial, patients are given samples in reverse order from highest to lowest concentration and when no salt taste is detected in two consecutive samples, the level of salt taste sensitivity is then recorded as the concentration of the immediately preceding sample. Participants will perform this task at baseline and approximately at 20 weeks at the end of the intervention (up to 36 weeks). Data will be presented as the average as their high and low sodium sensitivity over time compared between groups.

  2. Change in blood pressure over time [ Time Frame: up to 36 weeks ]
    Systolic and diastolic blood pressures are preferred for use in hypertension classification. Mercury sphygmomanometers still are the preferred device .The position of the patient can have a sizable impact on blood pressure measurements. For the most accurate measurement, the AHA recommends that the patient be relaxed and seated with legs uncrossed and back and arm supported. For correct cuff placement, the midline of the cuff bladder should be positioned over the arterial pulsation in the patient's upper arm following palpation of the brachial artery in the antecubital fossa.The cuff should be inflated to at least 30 mm Hg above the point at which the radial pulse disappears. The cuff should then be deflated at a rate of 2 to 3 mm Hg per second. At least two readings should be taken, with a one-minute interval between them, and the average of the measurements recorded. Data will be presented as an average of the two measurements taken.

  3. Change in adherence to sodium restricted diet over time [ Time Frame: up to 36 weeks ]
    Participants will complete a 24-hour urinary sodium excretion test at baseline and at 20 weeks after the intervention is complete (up to 36 weeks). 24 hour urinary sodium excretion is tested by collecting all urine excreted over the course of 24 hours. Participants are asked to note the time when they start in a written log, then discard the first urine after that time. They will then collect all urine excreted over the course of the next 24 hours, noting down the time and amount excreted each time in the written log. Urine is stored in a container and does not need refrigeration. 24 Hour Urine Sodium Samples will be analyzed by the University of Kentucky clinical laboratory.Data will be presented as the amount of miligrams excreted per day.


Secondary Outcome Measures :
  1. Change in dietary quality over time [ Time Frame: up to 36 weeks ]
    Participants will complete the Vio-Food Frequency Questionnaire at baseline and 20 weeks after the intervention is complete (up to 36 weeks). This scale is a web-based food frequency questionnaire that was developed by Viocare Technologies, Inc (Princeton, NJ). It will be used to generate the Health Eating Index-20120 score which is comprised of 12 components including total fruit, whole fruit, total vegetables, greens and beans, whole grains, dairy, total protein foods, seafood and plant proteins, fatty acids, refined grains, empty calories and sodium. Each component score ranges from 0 to 100 and the high score indicates better quality of dietary component. Changes in total HEI score as well as changes in the score of each of the 12 components provide an easy, scientifically sound, quantitative way to track changes in eating patterns over time.Data will be presented as change in the Health Eating Index -2010 score over time presented as mean plus or minus standard error.

  2. Change in Depression over time [ Time Frame: up to 36 weeks ]
    Participants will complete the PHQ-9 depression scale at baseline and 20 weeks after the intervention is complete. (up to 36 weeks) This scale measures depression by answering nine questions, each question is scored on a scale of 0-3 where 0 is no depressive symptoms and 3 is considered severe depressive symptoms. A score of 1-4 is minimal depression, a score of 5-9 is mild depression, a score of 10-14 is moderate depression, a score of 15-19 is moderately severe depression, and a score of 20-27 is severe depression. Data will be presented as the change in depression over time presented as the mean plus or minus the standard error.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Systolic Blood Pressure equal to or greater than 140 mmHG and diastolic pressure equal to and greater than 90 mmHG
  • Are Able to speak and write English
  • Are over 40 years of age

Exclusion Criteria:

  • Hypertension below the age of 40
  • Major Clinical cognitive impairment
  • Have major co-morbidities or co-existing terminal illnes
  • Have a dietary prescription that prevents following a 2-3 gram sodium diet

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): NCT04076280


Contacts
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Contact: Jennifer L Smith, PhD 859-323-8907 jennifer.smith7@uky.edu
Contact: Theresa Back, MSN 859-323-6656

Locations
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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40506
Contact: Jennifer L Smith, PhD    859-323-8907    jennifer.smith7@uky.edu   
Sponsors and Collaborators
Misook L. Chung
Investigators
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Principal Investigator: Misook L Chung, PhD University of Kentucky

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Responsible Party: Misook L. Chung, Professor College of Nursing, University of Kentucky
ClinicalTrials.gov Identifier: NCT04076280     History of Changes
Other Study ID Numbers: 44336
First Posted: September 2, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan at this time.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Misook L. Chung, University of Kentucky:
Hypertension
Low Sodium Diet
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases