Impact of Self-monitoring of Salt Intake by Salt Meter in Hypertensive Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-11

Study Completion Date

2020-02-28

Brief Summary

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Hypertension is one of the most common chronic medical conditions. The concerned sequelae are the cardiovascular complications, especially acute myocardial infarction and stroke. In Thailand, the incidence of hypertension is increasing each year. Many clinical studies found that salt intake over the reference level (\>5 g/day) would result in elevated blood pressure (BP) and long-term morbidity. Dietary salt reduction campaigns were unsuccessful, in part, due to time limitation in the clinic, lacking of awareness, and the higher threshold to detect salt taste in chronic high salt ingestion. Salt meter is a device used to detect sodium content in daily food. It will facilitate monitoring and control of salt intake. The 24-hour urinary sodium excretion is an acceptable method to reflect the quantity of sodium intake. This study aimed to compare the efficacy of salt meter plus dietary education compared with education alone in terms of salt intake reduction, blood pressure, salt taste sensitivity, and vascular consequence.

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Detailed Description

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A randomized-controlled trial was conducted in hypertensive patients whose BP was uncontrolled (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) despite therapy or antihypertensive-naïve. Patients were randomized to receive salt meter to use in conjunction with dietary education (group A) or receive education only (group B), and were followed up for 8 weeks. Dietary education was provided by certified dietician without awareness of patients' allocation. The primary endpoint was change in 24-hour urinary sodium excretion. Changes in BP, salt taste sensitivity threshold, cardio-ankle vascular index (CAVI), as well as motivation to maintain low salt diet were also analyzed.

Conditions

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Hypertension Salt; Excess

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Salt-meter

Patients received salt-meter in conjunction with dietary education by trained dietician to help monitoring the salt content in food, as well as usual care by their primary physicians.

Group Type EXPERIMENTAL

Salt-meter

Intervention Type DEVICE

Salt-meter, developed by Faculty of Engineering at Mahidol University, is a device to measure sodium chloride content in the food and reflects to user with number and symbols for easy-understanding.

Education

Intervention Type BEHAVIORAL

Program dietary education by certified dietician who did not know the patients arm allocation.

Control

Patients received dietary education by trained dietician and usual care by their primary physicians.

Group Type ACTIVE_COMPARATOR

Education

Intervention Type BEHAVIORAL

Program dietary education by certified dietician who did not know the patients arm allocation.

Interventions

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Salt-meter

Salt-meter, developed by Faculty of Engineering at Mahidol University, is a device to measure sodium chloride content in the food and reflects to user with number and symbols for easy-understanding.

Intervention Type DEVICE

Education

Program dietary education by certified dietician who did not know the patients arm allocation.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Mean SBP 140-179 mmHg or mean DBP 90-109 mmHg (average 3 times)
* Diagnosed of hypertension for at least 3 months
* No adjustment of antihypertensive agents for at least 1 month
* 24h Urine sodium ≥ 90 mmol/day
* eGFR ≥ 45 ml/min/1.73 sq.m.