NCT04805047

SodiUm Restriction by Behavioral Intervention

Sodium Restriction by Behavioral Intervention: Education and Monitoring

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 14 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the effects and efficacy of dietary sodium restriction by mean of a new healthcare approach in patients with immunoglobulin A nephropathy. The test persons in the intervention group are actively supported to adhere to a restricted sodium diet with a structured education program in combination with regular sodium excretion monitoring.

Detailed description

Patients in the intervention group receive regular sodium-restriction education by a dietician, which entails introducing food types and cooking skills, quantifying salt intake with a special spoon and recording detailed interactive food diary. Sodium excretion was measured using one 24-hour urine collection regularly to assess dietary compliance and enable feedback. The test persons with sodium excretion higher than 90mmol/24h will receive intensive education. Test persons in the control group receive standard care. After 2 weeks in study, all test persons visit the outpatient clinic for measurements and data collection. Within 3 months of total study duration, data collection and measurements take place at the end of every month. At each timepoint blood and 24-hourly urine is collected, test persons fill out questionnaires.

Conditions

• IgA Nephropathy

Interventions

Type	Name	Description
BEHAVIORAL	education and monitoring	regular education programs supported by a dietician in combination with urine sodium monitoring as a feedback

Timeline

• Start date: 2021-05-15
• Primary completion: 2023-05-01
• Completion: 2023-12-01
• First posted: 2021-03-18
• Last updated: 2022-04-28

Locations

1 site across 1 country: China