Healthy Family Program on population blood pressure: a multicenter, parallel group, cluster randomized, controlled trial in rural China (Healthy Family Program)

The Healthy Family Program trial aims to evaluate the effectiveness of a community-based, health instructor led, multifaceted family intervention, as compared with usual care, on blood pressure (BP) management among Chinese rural residents, with or without hypertension. It is designed as a two-arm, parallel, cluster randomized trial of 80 villages for 12 months. This statistical analysis plan pre-specifies the method of analysis for every outcome and key variables conducted in the trial.

The primary outcome is change in systolic BP from baseline to 6 months in all participants, reported as the absolute difference between intervention and control groups. The primary outcome will be modelled using a linear mixed effect model based on a participant-level analysis. The model will include cluster random effects to account for the clustering of participants within a village.