Sodium Watchers Program - Hypertension

NCT04076280 | Completed

• 1 other identifier: 44336
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Hypertension; Low Sodium Diet

Outcome Measures

Primary Outcomes (3)

• Change in oral salt taste sensitivity

  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.

  up to 36 weeks

• Change in blood pressure over time

  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.

  up to 36 weeks

• Change in adherence to sodium restricted diet over time

  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.

  up to 36 weeks

Secondary Outcomes (2)

• Change in dietary quality over time

  up to 36 weeks

• Change in Depression over time

  up to 36 weeks

Study Arms (2)

SWAP Intervention

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

Sodium Watcher Program-Hypertension BEHAVIORAL

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.

SWAP Intervention

Usual Care BEHAVIORAL

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.

Usual Care

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Misook L. Chung: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Misook L Chung, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor College of Nursing

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 3, 2019
• Study Start: September 1, 2019
• Primary Completion: August 19, 2021
• Study Completion: August 19, 2021
• Last Updated: December 20, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)