An interventional study of Education and Reformulation in Hypertension and Salt; Excess, sponsored by Mahidol University. Status unknown at 1 site in Thailand. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-06-08.
Sponsored by Mahidol University · Not applicable, Interventional, and Treatment
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.
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.
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This study's planned enrollment of 240 is above the median of 90 across 5,095 interventional studies indexed under Hypertension.
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Exclusion Criteria:
Education, Reformulation, Environmental change, Used salt meter
Behavioral: Education · Behavioral: Reformulation · Behavioral: Environmental change · Device: Salt meter
standard treatment with standard education
Behavioral: standard treatment
\- Education: Education about risk of high sodium intake, type of sodium, nutrition ingredients
\- Reformulation: Dietary recommendation in low sodium intake
\- Environmental change: Encourage about low sodium intake in community
\- Used salt meter: at least 3 times/wk
standard treatment
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
Time frame: 12 weeks
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
Time frame: 4, 8 12 weeks
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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