The mobile assistance for regulating smoking (MARS) micro-randomized trial design protocol

Contemp Clin Trials. 2021 Nov;110:106513. doi: 10.1016/j.cct.2021.106513. Epub 2021 Jul 24.


Smoking is the leading preventable cause of death and disability in the U.S. Empirical evidence suggests that engaging in evidence-based self-regulatory strategies (e.g., behavioral substitution, mindful attention) can improve smokers' ability to resist craving and build self-regulatory skills. However, poor engagement represents a major barrier to maximizing the impact of self-regulatory strategies. This paper describes the protocol for Mobile Assistance for Regulating Smoking (MARS) - a research study designed to inform the development of a mobile health (mHealth) intervention for promoting real-time, real-world engagement in evidence-based self-regulatory strategies. The study will employ a 10-day Micro-Randomized Trial (MRT) enrolling 112 smokers attempting to quit. Utilizing a mobile smoking cessation app, the MRT will randomize each individual multiple times per day to either: (a) no intervention prompt; (b) a prompt recommending brief (low effort) cognitive and/or behavioral self-regulatory strategies; or (c) a prompt recommending more effortful cognitive or mindfulness-based strategies. Prompts will be delivered via push notifications from the MARS mobile app. The goal is to investigate whether, what type of, and under what conditions prompting the individual to engage in self-regulatory strategies increases engagement. The results will build the empirical foundation necessary to develop a mHealth intervention that effectively utilizes intensive longitudinal self-report and sensor-based assessments of emotions, context and other factors to engage an individual in the type of self-regulatory activity that would be most beneficial given their real-time, real-world circumstances. This type of mHealth intervention holds enormous potential to expand the reach and impact of smoking cessation treatments.

Keywords: Engagement; Micro-randomized trial (MRT); Mobile health (mHealth); Self-regulatory strategies; Smoking cessation.

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Humans
  • Mobile Applications*
  • Motivation
  • Randomized Controlled Trials as Topic
  • Smokers
  • Smoking
  • Smoking Cessation*