Examining the Individual Response to a Restricted Sodium Diet in Hypertensive Patients

NCT04764253 | Completed

• 2 other identifiers: HSC20200504HKL2TR002646
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• Change in blood pressure over time

  Blood pressure (BP) will be measured using a Vital Signs Monitor 300 Series model (WelchAllyn, US). The midsection circumference of the dominant upper arm will be measured with a tape measure, and the proper sized cuff will be selected accordingly. Systolic and diastolic BP will be measured in the dominant arm twice with a 2-minute rest period between measures; two measures will be averaged.

  Up to 8 weeks

• Change in adherence to sodium restricted diet over time

  Participants will complete a 24-hour urinary sodium excretion test at baseline and at 8 weeks after the intervention is completed. 24-hour urinary sodium excretion (mg excreted/day) will be tested by collecting all urine excreted over 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 Center for Renal Precision Medicine laboratory.

  Up to 8 weeks

Secondary Outcomes (4)

• Adherence to dietary sodium intake monitoring

  Up to 8 weeks

• Adherence to In-home BP monitoring

  Up to 8 weeks

• Attendance at education sessions

  Up to 8 weeks

• Retention rate

  Up to 8 weeks

Study Arms (2)

Modified Sodium Watcher Program + Digital Self-Monitoring

EXPERIMENTAL

Behavioral: Modified Sodium Watcher Program + Digital Self-Monitoring

Usual care + Digital Self-Monitoring

ACTIVE COMPARATOR

Behavioral: Usual care + Digital Self-Monitoring

Interventions

Modified Sodium Watcher Program + Digital Self-Monitoring BEHAVIORAL

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.

Modified Sodium Watcher Program + Digital Self-Monitoring

Usual care + Digital Self-Monitoring BEHAVIORAL

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.

Usual care + Digital Self-Monitoring

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Ko J, Wang J, Chung ML, Sharma K. Examining the Individual Response to a Low-Sodium Diet in Patients with Hypertension: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Feb 13;12:e39058. doi: 10.2196/39058.

  PMID: 36780210 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jisook Ko, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: February 11, 2021
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)