Estimating Time-Varying Causal Excursion Effect in Mobile Health with Binary Outcomes

Advances in wearables and digital technology now make it possible to deliver behavioral mobile health interventions to individuals in their everyday life. The micro-randomized trial (MRT) is increasingly used to provide data to inform the construction of these interventions. In an MRT, each individual is repeatedly randomized among multiple intervention options, often hundreds or even thousands of times, over the course of the trial. This work is motivated by multiple MRTs that have been conducted, or are currently in the field, in which the primary outcome is a longitudinal binary outcome. The primary aim of such MRTs is to examine whether a particular time-varying intervention has an effect on the longitudinal binary outcome, often marginally over all but a small subset of the individual's data. We propose the definition of causal excursion effect that can be used in such primary aim analysis for MRTs with binary outcomes. Under rather restrictive assumptions one can, based on existing literature, derive a semiparametric, locally efficient estimator of the causal effect. We, starting from this estimator, develop an estimator that can be used as the basis of a primary aim analysis under more plausible assumptions. Simulation studies are conducted to compare the estimators. We illustrate the developed methods using data from the MRT, BariFit. In BariFit, the goal is to support weight maintenance for individuals who received bariatric surgery.