Healthy Family Program on population blood pressure: a multicenter, parallel group, cluster randomized, controlled trial in rural China (Healthy Family Program)
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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 random effects at the village and family level to account for the clustering of participants within village and within family, respectively.
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We modified the primary analysis to account for potential correlation of outcomes within families. A mixed effect model was extended with the same set of fixed effects, village random effect, and family random effect (nested within village). However, since the number of participants within a family is relatively small, the estimation of family random effect could be numerically unstable. When the variance of the family random effect could not be estimated, a mixed effect model with village random effect will be conducted instead.
Additional sensitivity analysis is planned at the family level, where family-level mean change in systolic blood pressure will be analyzed using a linear mixed effect model.
Additional subgroup analyses is included by stratifying participants based on family size and township socio-economic level.
In the subgroup analysis, the categorization of the Mini-EAT dietary scale was modified from the original cutoffs of <60 and ≥60 points to new thresholds based on the sample medium (i.e., below the median vs. equal to or above the median).
