Sodium Watchers Program - Hypertension
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 29
- Locations
- 2
- Primary Endpoint
- Change in oral salt taste sensitivity
Study Overview
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.
Detailed Description
Hypertension or high blood pressure is known as a silent killer because it can exist for decades without producing symptoms while leading to chronic cardiovascular disease and stroke. The long-term objective of this program of research is to improve blood pressure control and prevent cardiovascular disease development in adults with hypertension by increasing adherence to a sodium-restricted diet (SRD). The Sodium Watchers Program is an innovative self-management intervention using a gradual sodium adaptation strategy that allows individuals to monitor, and over time, reduce sodium content in their food, thereby increasing the ability to maintain an SRD long term. The purpose of the proposed randomized, controlled trial is to test the effects of the Sodium Watchers Program-Hypertension(SWaP-Hypertension), designed to improve blood pressure control of hypertensive adults using a gradual sodium reduction adaptation strategy.
The SWaP-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 participants' preferred time delivered to their homes using a video conferencing program through a mini iPad. Using a 2-group design [SWaP-Hypertension (n=20) versus Usual care (n=10)], randomized, controlled trial with 30 hypertensive adults, the effects of the SWaP-Hypertension program on adherence to SRD, systolic and diastolic blood pressure, salt taste preference, and dietary patterns will be determined at 4 months. Data will be analyzed using repeated measures analysis of variance.
Specific Aim 1: To compare sodium intake (as reflected by 24-hour urinary sodium excretion), systolic and diastolic blood pressure, salt taste preference, and dietary patterns in the SWaP-Hypertension intervention group with the usual care group at 4 months.
Hypothesis 1: The intervention group will have a greater decline in 24-hour urinary sodium excretion and systolic and diastolic blood pressure, lower salt taste preference, and shift dietary patterns toward lower sodium foods than the usual care group at 4 months.
High blood pressure (systolic blood pressure ≥140 mmHg or diastolic blood pressure≥ 90 mm Hg), is a leading risk factor for cardiovascular disease and stroke.1 More than 80 million adult Americans have high blood pressure and it is projected that 41.4% of US adults will have hypertension by 2030.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
- Change in dietary quality over time(up to 36 weeks)
- Change in Depression over time(up to 36 weeks)
Investigators
Misook L. Chung
Professor College of Nursing
University of Kentucky