Effectiveness of a Mobile Phone App for Adults That Uses Physical Activity as a Tool to Manage Cigarette Craving After Smoking Cessation: A Study Protocol for a Randomized Controlled Trial

Abstract

BackgroundResults from studies on the effects of exercise on smoking-related variables have provided strong evidence that physical activity acutely reduces cigarette cravings. Mobile technology may provide some valuable tools to move from explanatory randomized controlled trials to pragmatic randomized controlled trials by testing the acute effectiveness of exercise on quitters under real-life conditions. An mHealth app was developed to be used as a support tool for quitters to manage their cigarette cravings.ObjectiveThe primary aim of this paper is to present the protocol of a study examining the effectiveness of the Physical over smoking app (Ph.o.S) by comparing the point prevalence abstinence rate of a group of users to a comparator group during a 6-month follow-up period.MethodsAfter initial Web-based screening, eligible participants are recruited to attend a smoking cessation program for 3 weeks to set a quit smoking date. Fifty participants who succeed in quitting will be randomly allocated to the comparator and experimental groups. Both groups will separately have 1 more counseling session on how to manage cravings. In this fourth session, the only difference in treatment between the groups is that the experimental group will have an extra 10-15 minutes of guidance on how to use the fully automated Ph.o.S app to manage cravings during the follow-up period. Data will be collected at baseline, as well as before and after the quit day, and follow-up Web-based measures will be collected for a period of 6 months. The primary efficacy outcome is the 7-day point prevalence abstinence rate, and secondary efficacy outcomes are number of relapses and cravings, self-efficacy of being aware of craving experience, self-efficacy in managing cravings, and power of control in managing cravings.ResultsRecruitment for this project commenced in December 2014, and proceeded until May 2015. Follow-up data collection has commenced and will be completed by the end of December 2015.ConclusionsIf the Ph.o.S app is shown to be effective, the study will provide evidence for the use of the app as a support tool for people who are trying to manage cravings during smoking cessation programs. It is anticipated that the results of the study will provide knowledge of how physical activity affects cigarette craving in real-life situations and inform the development and delivery of relapse prevention in smoking cessation treatment.Trial RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN55259451; http://www.controlled-trials.com/ISRCTN55259451 (Archived by WebCite at http://www.webcitation.org/6cKF2mzEI)

Effect of a Mobile Phone Intervention on Quitting Smoking in a Young Adult Population of Smokers: Randomized Controlled Trial

“…To date, the effects of smartphone apps for smoking cessation are largely unknown and this study is one of the very few trials that have been undertaken. A number of larger RCTs are underway to assess the effect of smartphone apps for smoking cessation [ 58 - 61 ]. In the near future, the evidence from these studies will be brought together and reviewed to determine the overall effectiveness of mHealth for smoking cessation, under what conditions and for whom.…”

Evaluating an Adaptive and Interactive mHealth Smoking Cessation and Medication Adherence Program: A Randomized Pilot Feasibility Study

“…Relatively little is known about the effectiveness of mHealth interventions for smoking cessation. While preliminary pilot studies of cessation apps using small samples or short follow-up periods [ 35 - 39 ] and protocols of trials in progress [ 40 - 44 ] have been published, no large scale randomized effectiveness trials have, although several are in progress. Despite this, hundreds of cessation smartphone apps are commercially available.…”

Identification of Users for a Smoking Cessation Mobile App: Quantitative Study

“…Studies on cessation apps focus on different outcomes such as app usage [ 17 - 19 ], changes in psychological state related to cessation behavior [ 20 - 22 ], and satisfaction with the treatment with an app [ 18 , 20 ]. To date, effectiveness outcomes have been reported in 3 studies with self-reported abstinence [ 17 , 18 , 20 , 23 ], and 1 study protocol with biochemically validated abstinence outcome was found [ 22 ]. Thus, although an initial body of research on the use of cessation apps exists, little is known about the factors that influence the use of cessation apps and the characteristics of the users of these mHealth apps.…”