Sodium Watchers Program - Hypertension
Sodium Watchers Program - Hypertension
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.
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.

 Sodium restriction is believed to decrease blood pressure. According to a recent
 meta-analysis of 24 randomized controlled trials, dietary interventions (e.g., low sodium
 diet, low sodium/high potassium, low sodium/low calorie, Mediterranean diet, and DASH diet)
 were effective in reducing systolic blood pressure by an average of 3.07 mmHg and diastolic
 blood pressure by an average of 1.81 mmHg. These changes are minimal and are often not
 sustained due to the difficulty of following such diets.

 Most interventions for improving adherence to SRD have focused on increasing specific skills,
 including how to read food labels, choose low sodium foods when eating out, and engage family
 support. However, these interventions do not effectively address critical barriers to SRD
 adherence, which include preference of high salt food and habitual dietary patterns. Salt
 taste reception involves the sodium ion movement through sodium channels at the apical end of
 the taste bud. High salt foods become preferable when individuals' taste buds adapt to foods
 high in sodium. Preference for salty foods results in high levels of dietary sodium intake.

 These barriers are particularly salient for older patients as taste bud density decreases
 with age resulting in an increasing preference for salt and consumption of foods high in
 sodium. Combined, low palatability of low sodium foods and preference for high sodium foods
 make dietary changes difficult. Since at least 8-10 weeks of exposure to an SRD is required
 to alter sodium palatability (i.e., alter salt acuity and salt taste preference) abrupt and
 marked reductions in sodium intake are rarely sustained and can have the unintended
 consequence of exacerbating sodium-seeking behaviors. New approaches are needed to improve
 long-term adherence to SRD.

 An innovative dietary self-care intervention has been developed to overcome sensory barriers
 to adherence. Abrupt and marked reductions in sodium intake can lead to sodium-seeking
 behaviors, and thus, changing dietary preferences requires at least 8 weeks to reach a new
 hedonic state and to reset sodium taste buds. Thus, an intervention that uses a gradual
 adaptation strategy should produce the best long-term adherence results. Most educational
 interventions have focused on improving knowledge by teaching patients specific skills
 including how to read food labels, how to choose low sodium foods when eating out, and how to
 modify their usual diet.

 Design: A two-group, randomized, controlled design will be used to determine the effect of
 the SWaP-Hypertension on outcomes of hypertensive adults. A total of 30 eligible participants
 will be randomly assigned to intervention (n=20) or usual care group (n=10). We will assign
 20 participants in the intervention that is two times more than the usual care group in order
 to maximize limited funding sources. The intervention will be delivered for 14 weeks using
 video conferencing on an iPad device. Post-intervention will be measured at 4 months follow
 up to examine short-term effect. Dependent variables included adherence to the SRD, systolic
 and diastolic blood pressure, salt taste preference, and dietary patterns.

 Intervention: Sodium Watchers Program-Hypertension (SWaP-Hypertension): The SWaP- is an
 educational-behavioral intervention that uses an electronic salt monitoring device to promote
 both rural adults with high blood pressure and their family partner's ability to self-monitor
 sodium intake and gradually decrease their appetite for salt. The program consists of 14
 weeks education [4 weekly education sessions (45 minutes) followed by 5 bi-weekly sessions
 (15-20 minutes)] that will be held at the dyads' preferred time delivered to their homes
 using a video conferencing program through a mini iPad. Video conferencing technology is used
 to enhance the feasibility and decrease the burden of participating in the intervention.
 Bi-weekly booster sessions are added to provide on-going support to maintain acquired
 self-care behaviors and individual goals for reductions in dietary sodium. The booster
 sessions include positive reinforcement of success and identification of strategies to
 overcome ongoing or new challenges. A nurse interventionist who experienced in delivering the
 intervention will assist individual goal settings and reinforces strategies in each session.

 Usual care group: The usual care group receive their routine medical and nursing care for
 hypertension that consists of a recommendation to follow an SRD and take medications as
 ordered.

 Measures: Table 2 lists dependent variables and their measurement in the study. To completely
 characterize subjects and monitor potential intervening variables, data about the
 individuals' age, sex, race/ethnicity, education level, comorbidities, medications, and
 cognitive impairment will be collected from the participant interviews or using a structured
 questionnaire. Comorbidity will be measured using the Charlson Comorbidity Index. Data about
 medications will be self-report. Cognitive impairment will be assessed using the Mini-Cog.
 This 3-minute screening instrument consists of drawing a clock and three-word recall. It is
 sensitive, reliable and valid in individuals with low literacy and low socioeconomic status.
 Our research staff has extensive experience in all data collection proposed in this study.

 Procedure: Permission to conduct the study was obtained from the University of Kentucky,
 Institutional Review Board. Hypertensive adults are referred to this project by physicians
 and nurse practitioners from the outpatient cardiology and internal medicine services at the
 University of Kentucky HealthCare at Lexington. After referral, a trained research nurse will
 screen patients for eligibility by medical chart review. For eligible participants, the study
 requirements are explained and signed informed consents are obtained. After we obtain the
 informed consents from eligible participants, urine containers and collection devices
 (urinals for men and toilet "hats" for women) are provided before home visits. The
 participants are instructed how to collect the 24-hour urine specimen, and written standard
 instructions are also provided. Urine is kept in the container and does not need
 refrigeration. Research staff and participants set up the starting day of urine collection
 and pick up urine specimens in their home. During the home visit, they are assisted to
 complete all study questionnaires using the REDCap system and assessment of blood pressure
 and salt taste preference. A trained staff member will deliver education materials and an
 iPad to the participants in the intervention group and instruct them how to use the video
 conference program (i.e., Zoom Mobile app) on iPad by testing trial of a video-conferencing
 program. A toll-free phone number is to call at any time for assistance using the iPad is
 provided. The usual care group will receive a mini iPad with instruction of using emails and
 text message to contact research staff. All participants will follow the same data collection
 procedure as during the baseline assessment for 4-months follow-up time point.
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