Intervention for Monitoring of Salt Intake in Hypertensive Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Salt; Excess
• Intervention / Treatment: Behavioral: Education; Behavioral: Reformulation; Behavioral: Environmental change; Device: Salt meter; Behavioral: standard treatment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: PITCHAPORN SONUCH; Phone Number: 022011000; Email: pitch_bell@hotmail.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Recruiting
    • Faculty of Medicine, Ramathibodi Hospital, Mahidol University
    • Contact: PITCHAPORN SONUCH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mahidol University
• Collaborators: World Health Organization; Thai health promotion foundation.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Anticipated): May 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 5, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: hypertension; salt; salt reduction
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: COA. MURA2021/1004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No