Intervention for Monitoring of Salt Intake in Hypertensive Patients

Study Overview
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Brief Summary
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Sodium is an essential nutrient for humans, but excessive sodium consumption is causally associated with high blood pressure and increase risk of cardiovascular diseases. Dietary sodium consumption of greater than the recommended daily amount of 5 grams of salt or 2,000 mg of sodium is a major risk factor for CVD-related mortality. From recent national survey, Thai people had consumed more than 9.1 g of salt per day, which was nearly two times above WHO reference level. Dietary salt reduction was unsuccessful because of lacking awareness, and the higher threshold to detect salt taste in chronic high salt ingestion. To create awareness in the community, we should be educated, managed the environmental for salt reduction, and used salt meter to detect sodium content in daily food. This study aimed to compare the efficacy of intervention; education, reformulation, environmental change and used salt meter compared with standard treatment alone in terms of salt intake reduction and blood pressure.

Detailed Description
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A randomized-controlled trial was conducted in adult 18-70 years old with hypertensive patients (SBP>130 mmHg) in Uthaithani. Participants were randomized to intervention groups (education, reformulation, environmental change and used salt meter) and control group (standard education and treatment). Trial was followed up for 12 weeks. The primary objective was change in 24-hour urinary sodium excretion between groups and secondary objectives was change in systolic and diastolic blood pressure.

Official Title
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Community-based Intervention for Monitoring of Salt Intake in Hypertensive Patients

Conditions
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Hypertension, Salt; Excess

Intervention / Treatment
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* Behavioral: Education
* Behavioral: Reformulation
* Behavioral: Environmental change
* Device: Salt meter
* Behavioral: standard treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18-70 years of age with hypertension Systolic blood pressure > 130 mmHg Provided informed consent to participate in the study Exclusion Criteria: Participants with end stage kidney disease History of adjust antihypertensive agents or diuretic within 2 weeks before enrollment Pregnant or breastfeeding women Adjustment of any antihypertensive agents during study period Participants with salt supplement

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigator<br>Education, Reformulation, Environmental change, Used salt meter | Behavioral: Education<br>* - Education: Education about risk of high sodium intake, type of sodium, nutrition ingredients<br>Behavioral: Reformulation<br>* - Reformulation: Dietary recommendation in low sodium intake<br>Behavioral: Environmental change<br>* - Environmental change: Encourage about low sodium intake in community<br>Device: Salt meter<br>* - Used salt meter: at least 3 times/wk<br>|
| Active Comparator: Control<br>standard treatment with standard education | Behavioral: standard treatment<br>* standard treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour urine sodium excretion | Compare the change of 24-hour urine sodium excretion between intervention group, received education, reformulation, environmental change and monitoring of salt intake by salt meter and control group, received standard treatment | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure | Compare the change systolic and diastolic blood pressure between intervention group, received education, reformulation, environmental change and monitoring of salt intake by salt meter and control group, received standard treatment | 4, 8 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, salt, salt reduction