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

The University of Texas System (UT)

Status: Completed

Conditions: Hypertension

Treatments: Behavioral: Usual care + Digital Self-Monitoring; Behavioral: Modified Sodium Watcher Program + Digital Self-Monitoring

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04764253

HSC20200504H

KL2TR002646 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Modified Sodium Watcher Program + Digital Self-Monitoring

Experimental group

Treatment:

Behavioral: Modified Sodium Watcher Program + Digital Self-Monitoring

Usual care + Digital Self-Monitoring

Active Comparator group

Treatment:

Behavioral: Usual care + Digital Self-Monitoring