A town level comprehensive intervention study to reduce salt intake in China: protocol for a cluster randomised controlled trial.

Introduction: Salt intake in China (≈12 g/day) is more than twice the upper limit recommended by the WHO (5 g/day). To reduce salt intake, Action on Salt China (ASC) was launched in 2017. As one of four randomised controlled trials (RCTs) in the ASC programme, a comprehensive intervention study was designed to test whether all the components of the interventions adopted by other RCTs are acceptable, scalable and effective when provided to a region in the real world.

Methods And Analysis: Using a cluster RCT design, 2688 participants were selected from 48 towns (clusters) in 12 counties in 6 provinces and assigned to the intervention group or the control group. Randomisation was performed after the baseline survey was completed. Information on salt-related knowledge, attitude and practice (KAP), blood pressure and 24-hour urinary sodium were collected. The intervention includes government engagement, health education and other intervention components targeting restaurants, home cooks and primary school students and their families that have been used in other RCTs. The control group will not receive the intervention. The project will be followed up for 2 years, with the intervention being carried out for the first year only. The primary outcome is salt intake measured by 24-hour urinary sodium excretion after 1 year. The secondary outcomes are the long-lasting effectiveness on salt intake and blood pressure measured by the same method, as well as salt-related KAP and blood pressure at the 1-year and 2-year follow-ups. Process evaluation and health economics analysis will be conducted as well.

Ethics And Dissemination: The study was reviewed and approved by the Institutional Review Board of the National Center for Chronic and Noncommunicable Disease Control and Prevention, the Chinese Center for Disease Control and Prevention, and Queen Mary Research Ethics Committee. Results will be disseminated through presentations, publications and social media.

Trial Registration Number: ChiCTR1800018119.