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Purpose

Excessive dietary sodium intake is an independent risk factor for hypertension and cardiovascular disease. A vast array of efforts have tried to reduce sodium consumption based on evidence indicating a public health benefit. Yet this benefit has been questioned, mainly based on studies showing variability in individual responses to a sodium-restricted diet (SRD). The effects of an SRD on blood pressure vary, and adherence to an SRD is not optimal. The original Sodium Watchers Program (R01NR012967) was developed and implemented by Dr. Misook Chung (University of Kentucky). In this pilot study, the modified Sodium Watchers Program will propose improving adherence to an SRD through education and digital self-monitoring for daily sodium intake and blood pressure. In addition, few studies have examined individuals' metabolic responses to the SRD. In a secondary analysis, we further will examine genetic variants associated with salt sensitivity and whether such a genetic component is associated with sodium excretion and BP control. A total of 40 hypertensive patients will be randomly assigned to the intervention (n=20) or control group (n=20). The intervention group will receive 8-week education sessions remotely using a video conferencing program. All participants will collect a 24-hour urine specimen for sodium excretion and a total of 4.0ml of peripheral blood will be drawn for salt sensitivity during baseline visit. All participants will be asked to log their activities in real-time, including food intake and in-home BP monitoring using Fitbit and accompanied mobile app and BP monitor.

Condition

Eligibility

Eligible Ages
Over 40 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Systolic blood pressure of 120-159 mmHg or diastolic blood pressure of 80-99 mmHg, whether or not taking blood pressure medications. - Smartphone with a data plan - Valid email address - Willing and able to participate in online study videoconferencing visits (Zoom) - Reads and writes in English

Exclusion Criteria

  • Participating in another related research study - Cardiovascular disease event (e.g. stroke, myocardial infarction) in prior 6 months - Active cancer - Recent hospitalization due to psychiatric condition or event - Pregnancy or breastfeeding - current or planned during the study period - Documented dementia - Prisoners - Diabetes Diagnosis - Heart Failure Diagnosis

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Modified Sodium Watcher Program + Digital Self-Monitoring
  • Behavioral: Modified Sodium Watcher Program + Digital Self-Monitoring
    Participants randomized to the experimental group will be asked to follow the modified Sodium Watchers Program intervention along with goal setting for low salt foods. Each participant will be registered to assign a unique ID in the Connected Health Platform developed by the Center on Smart and Connected Health Technologies at UT Health Science Center San Antonio and each account from the individuals' wireless and wearable devices (Fitbit and BP monitor) will be connected to his or her unique ID through this platform. Participants will be instructed to log their activities in real-time, including food intake and in-home BP monitoring using Fitbit and accompanied mobile app and BP monitor. Through the Connected Health Platform, the Fitbit app and BP monitor will transmit the data of the intervention group to the research team.
Active Comparator
Usual care + Digital Self-Monitoring
  • Behavioral: Usual care + Digital Self-Monitoring
    Participants randomized to the control group will be asked to follow usual care which is based on their routine medical and nursing care for hypertension that consists of a recommendation to follow a sodium-restricted diet and take medications as prescribed. The participants will receive wireless and wearable devices (Fitbit wristband, BP monitor). Each participant will be registered to assign a unique ID in the Connected Health Platform at the baseline and each account from the individual's wireless and wearable devices (Fitbit and BP monitor) will be connected to their unique ID through this platform. Participants will be instructed to log their activities in real-time, including food intake and in-home BP monitoring using Fitbit and accompanied mobile app and BP monitor.

More Details

Status
Completed
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.