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Results 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.
The 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.
After 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.
Recruitment 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.
If 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.
International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN55259451; http://www.controlled-trials.com/ISRCTN55259451 (Archived by WebCite at http://www.webcitation.org/6cKF2mzEI)
Although smoking cessation treatments such as behavioral support, nicotine replacement therapy (NRT), and pharmacological treatment have been effective in the short term, the long-term relapse rates are high. The percentages of relapse are between 95% for the cold turkey method and 75% for combined therapies of counseling and pharmacotherapy [
Exercise has recently been incorporated as a smoking cessation aid into existing programs with promising results. In general, studies examining the effects of exercise on variables related to smoking cessation have focused on either the long-term effects after long interventions or on the acute effects of exercise on smoking-related variables. A recent review [
The main reason for relapsing is the craving that smokers experience. Results on the effects of exercise on smoking-related variables have provided strong evidence that physical activity acutely reduces cigarette craving [
Evidence of the positive effects of exercise on acute reduction of cravings from experimental laboratory-based studies is strong [
Mobile technologies are a means for providing individual-level support to health care users and a promising platform for health interventions [
Therefore, a mobile phone application has been developed for the needs of this study. The aim of the app is to support quitters in managing their cigarette cravings and abstaining over the long term by using exercise as the main behavioral substitution strategy. The mHealth app called “Physical over Smoking (Ph.o.S)” includes a data collection mechanism to collect real-time data regarding relapses. The Ph.o.S app was developed based on evidence-based practices for relapse prevention after smoking cessation. Following that, a trial has been designed to test the effectiveness of the mHealth app.
The aim of this study is to present the protocol of a study that assesses the effectiveness of the Ph.o.S app, which helps abstaining users to manage their cigarette cravings. The study will examine the quit rates of abstaining users of the app versus the quit rates of a comparator group for a 6-month period after quitting smoking. The trial’s main hypothesis is that users of the Ph.o.S app will have higher 7-day point prevalence abstinence rates during the follow-up measures in comparison to the comparator group (trial registration number ISRCTN55259451).
Four additional hypotheses have been proposed:
Users of the Ph.o.S app will have fewer self-reported relapses during the follow-up measures than the comparator group will.
Users of the Ph.o.S app will report higher self-efficacy from being aware of experiencing cravings than the comparator group will.
Users of the Ph.o.S app will report higher self-efficacy in managing cravings in relapse situations than the comparator group will.
Users of the Ph.o.S app will report a higher power of control to manage cravings in everyday situations than the comparator group will.
This study is a 2-armed randomized clinical trial. Participants identified as eligible and who give their consent to participate will receive a smoking cessation program consisting of 3 group sessions (once per week). After the quit day, participants will be randomly assigned to 2 groups. Both groups will have a separate fourth session where they will receive training on relapse prevention and a plan to cope with cravings. The intervention group will receive an additional short training session on how to use the Ph.o.S app as an additional support tool whenever they experience cravings in their everyday life during the follow-up period. Preintervention, postintervention, and 6-month follow-up assessments will be conducted.
Study timeline: overview of schedule of enrollment, interventions, and assessments.
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Screening for eligibility | Intervention: quit smoking (3 sessions) | Quit day: allocation | Intervention: manage cravings (4th session) | Follow-up assessment |
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The study setting is the Jyväskylä Community Primary Health Care Center in Central Finland.
All interested participants are screened for eligibility by completing a short battery of questions online. Noneligible participants are advised to contact their doctor or nurse for help. Participants are adults (between the ages of 18 and 65) who have been smokers for at least 1 year and who smoke more than 10 cigarettes per day. (Those who use snus only are excluded.) They should have no other addictions (ie, alcohol, prescription drugs, or illegal drugs) according to the behavioral screening tool NIDA Quick Screen V1.0 [
Finally, the Gold Standard Monitoring Form used by the National Health Service in the United Kingdom is completed for each participant [
Recruitment will occur through referrals from the health care units in the Jyväskylä area as well as via the Web pages of Central Finland Respiratory Association, the City of Jyväskylä, Radio Jyväskylä, and Yle News. All interested participants will be screened for eligibility. The enrollment period ended in May 2015. The first 50 eligible participants will start the smoking cessation intervention, which consists of 3 weekly counseling sessions and will help them set a quit date. The rest of the eligible participants will be put on a waiting list and invited to participate in case of dropouts before the quit day/randomization time point. The first 50 participants to reach the quit day/randomization time point will then form the intention-to-treat group that will continue in the study. After the quit day/randomization, participants will be assigned to an experimental group (25 participants) and a comparator group (25 participants), and 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 Ph.o.S app to manage cravings during the follow-up period. Both groups will be followed up for the main and secondary efficacy outcomes of interest for 6 months. The method of randomization is a set of numbers generated by online software [
The presentation of the smoking cessation intervention content has been based mainly on the taxonomy of behavior change techniques in interventions [
All sessions are delivered by the study nurse, who has previous experience with counseling smokers to quit.
The mHealth mobile phone application, Ph.o.S, and its data collection mechanism was developed by a software designer affiliated with the University of Jyvaskyla, as a project researcher at Agora Center. Additional support for the development was provided for graphic design and user interface design by 2 students from the IT department.
During the fourth session, experimental group participants are instructed to use the application whenever they experience cigarette cravings and to give feedback for every use. As a result, data entries are self-initiated whenever participants use the app. The Ph.o.S. app is installed on participants’ personal mobile phones, but if they do not have a mobile phone, then a device is provided by the study team. No incentives are provided to use the app or to complete data during the entire follow-up assessment period. When they need to, participants can use the app without an Internet connection. All information is uploaded to the server as soon as the device is connected. Participants’ identification number and profile settings are entered when the Ph.o.S app is installed on their mobile phones and used for the first time. Profile settings include gender, age, weight, and height, days since quit date, the origin of the decision to quit, and heavy and moderate intensity physical activity history during a typical week (screenshot 1,
Ph.o.S app: examples of database content.
Category | Examples | Behavior change techniques |
Introductory messages | Researchers have found 70 poisonous chemicals in cigarettes which cause cancer. Stay healthy! | Provide information on consequences of behavior in general |
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Your shortness of breath when using stairs is much less now! | Provide information on consequences of behavior to the individual |
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Ex-smokers have less than two cravings a day. You can manage this craving! | Provide normative information about others’ behavior |
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You are a good example to others every day you stay away from smoking! | Prompt identification as role model/position advocate |
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Is it worth giving up what you’ve worked so hard for? Definitely not! | Prompt anticipated regret |
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Walk proudly! You are doing an amazing job quitting! | Prompt rewards contingent on effort or progress toward behavior |
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Physical activities | Walking: Walk and every 10 steps say: You can make it! | Behavioral substitution + Prompt self-talk |
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Brisk walking: Walk briskly and every 15 steps say: You can do this! | Behavioral substitution + Prompt self-talk |
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Stairs: Find a stairway to go up and down! | Behavioral substitution |
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Breathing: Inhale for a count of 4, then exhale for a count of 4. | Behavioral substitution |
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Tension release: Grab a ball and squeeze it with your right hand and then with your left hand. | Behavioral substitution |
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Stretching: Stretch your upper arms. Hold for 10 seconds. | Behavioral substitution |
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Balance: Balance on your right leg and then on your left leg for 5 seconds. | Behavioral substitution |
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Strength: Do as many push-ups as you can in a row. | Behavioral substitution |
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Isometric: Hold the superman position for 5 seconds. | Behavioral substitution |
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Dance: Listen to your favorite song and dance! | Behavioral substitution |
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Gardening, cleaning home physical activities: Do some housework! | Behavioral substitution |
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Motivational messages | Pain is temporary. Quitting is forever! | Facilitate relapse prevention and coping |
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I can keep going! | Enhance self-regulation |
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Never be a slave to cigarettes again! | Motivation to remain abstinent |
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Do not go back! You are a permanent ex-smoker now!/You are a healthy ex-smoker! | Motivation to remain abstinent |
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Concentrate on your goal! | Maintain engagement |
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It’s not the situation; it’s your reaction to the situation! | Provide information on withdrawal symptoms |
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I want to feel like a winner, not miserable after 3 minutes! | Prompt anticipated regret |
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My actions are always within my control. | Self-regulation/self-control |
To prevent missing data, an effort will be made to retain the participants in the trial for the follow-up data collection. However, participants who withdraw their consent will discontinue their participation in the study. Moreover, participants who attend less than 2 out of 3 sessions of the quit smoking intervention will be excluded from the final analysis. Participants who drop out of the trial or who are lost for follow-up are considered to be smoking. The flow of the participants is presented in
The strategies for monitoring and improving adherence to intervention protocols include the following:
Face-to-face adherence reminder. Study participants will be well informed during the first session about the expectations regarding study procedures before they sign the informed consent form. Moreover, a reminder about the expected participation during the follow-up measures takes place during the fourth session when they are asked about their preferred way of follow-up data collection (eg, telephone, mail, email or SMS).
Providing feedback about how well subjects adhere to protocol and achieve target goals whenever possible. During the follow-up period a short SMS or email message will be sent to all participants (ie, both experimental and comparator). The follow-up messages start with an acknowledgment of the participant’s contribution to date (ie, how well they adhere to the protocol), followed by a motivational message that is individualized depending on their progress (ie, relapse or no relapse). Next, information on how to fill out the follow-up questionnaire is provided and, finally, the date of the next follow-up point is reported.
Monitoring adherence to the Ph.o.S app use and intervening when adherence problems emerge. In the experimental group, adherence is monitored by recording through the data collection mechanism of the Ph.o.S app. When participants do not use the Ph.o.S app for 1 week, they are asked, via SMS or email, to verify if they use the Ph.o.S app, to check if there is a technical problem, or if they have stopped using the Ph.o.S app. If they answer that they do not use the app, then they are sent a link to a short questionnaire in order to assess the reasons for discontinuing use of the app. Participants are considered dropouts when they do not respond to the invitation emails for measurement but not when they stop using the app.
Study flowchart: The diagram illustrates the flow of participants.
Point prevalence abstinence (PPA) will be the primary outcome and the primary efficacy parameter for the study. The main outcome analyses are based on 7-day PPA (ie, reported abstinence of at least 7 days prior to each scheduled follow-up). PPA and prolonged abstinence are closely related and can be interconverted with moderate accuracy [
The secondary efficacy parameters for the study include the following measures:
The self-reported number of relapses, which is assessed through a single item asking participants to complete the number of relapses they had the last 7 days. Data are collected from participants at the fourth session (
The self-reported number of cravings, which is assessed through a single item asking participants to complete the number of cravings they experienced in the last 7 days. Data are collected from participants at the fourth session (
Self-efficacy on being aware of experienced cravings, which is assessed with the single item: “How well are you aware of your cigarette cravings?” Answers are given on a 10-point scale from 1 (very poorly) to 10 (very well). Data are collected from participants before the quit day (-
Self-efficacy on managing cravings, which is assessed with the single item: “How well do you manage your cravings?” Answers are given on a 10-point scale from 1 (very poorly) to 10 (very well). Data are collected from participants at -
Power of control in managing cravings is assessed with 6 items. An example item is “If I am in a situation where I celebrate with my friends...,” then, the answer for the experimental group is “It will be more difficult to use Ph.o.S. app to control my craving for tobacco,” and for the comparator group is “It will be more difficult to do something to control my craving for tobacco.” Answers are given on a 7-point scale from 1 (totally agree) to 7 (totally disagree). The other items present similar tempting situations like when participants are stressed or angry. Data are collected from participants before the quit day at -t2 and -t1 and after
Additional measures of mainly psychological variables will be collected in order to use them as possible explanatory variables of the primary or secondary efficacy measures. Moreover, usability, fidelity, and data extracted from the phone database will be collected for validation purposes.
Physical activity behavior. Self-reported data regarding participants’ current physical activity behavior as recorded with the International Physical Ativity Questionaire (IPAQ) [
Relapse situation efficacy as recorded with the Relapse Situation Efficacy Questionnaire (RSEQ) [
Attitude toward, intention to, and perceived behavioral control of increasing physical activity behavior will be measured through a self-reported questionnaire before and after quit day at -
Usability of the Ph.o.S app for the experimental group only will be collected through the System Usability Scale (SUS) self-reported questionnaire [
All participants are asked fidelity check questions during the follow-up measure at
Information from the Ph.o.S app is also collected constantly during the follow-up period for the experimental group from the time they start using it (
Screening data at time point -
Baseline data and behavioral and psychological self-reported data at time points -
Once participants have participated in the final meeting, the researchers will make every reasonable effort to follow the participant for the entire follow-up period of 6 months. Participants may, however, withdraw from the study for any reason at any time. However, early discontinuation of Ph.o.S app for any reason is not a reason for exclusion from the study.
The University of Jyväskylä is responsible for storing and protecting the research data. The research registry is kept at the University of Jyväskylä in a locked cabinet. All electronic data will be stored on a university computer with password protection. Only the principal investigator and the research assistant will have access to the computer-based data. All participants will be assigned a code number in order to protect their confidentiality. All stored data will be under the unique code number. All data will be entered electronically. Original study forms will be entered and kept on file at the participating site. Participant files are stored in numerical order and in a secure and accessible place and manner. Participant files will be stored for a period of 3 years after completion of the study.
Generalized linear mixed models will be used to examine differences between the groups on the dichotomous primary outcome variable: abstinent versus smoker status at the 6-month follow-up time point (ie,
Finally, 3 separate logistic regressions on the primary dichotomous outcome (abstinent-smoker) will be performed using the theory of planned behavior (TPB) constructs of quit smoking behavior and increased physical activity behavior at the -
We determined the power for our primary hypothesis, which stated that the 7-day PPA at the 6-month follow-up would be higher in the experimental group than in the comparator group. In order to detect a difference of 10% in quit rates between the experimental and comparator groups, with an expected quit rate of 25% in the comparator group, the study would require, at 80% power with a two-sided
Ethics approval has been obtained from the Ethics Committee of the Central Finland Health Care District (Keski-Suomen Sairaanhoitopiirin Eettinen Toimikunta).
All eligible participants are given a copy of the information sheet and informed consent form to read. The information sheet provides a summary of the research study and the informed consent document states what the individual is about to participate in, the individual’s rights as a research participant, and information about confidentiality. The study nurse explains all aspects of the study and answers all of the participant’s questions regarding the study. If the person chooses to participate in the study, that person will be asked to sign the informed consent form. No study procedure is performed prior to signing the informed consent form. Subjects who refuse to participate or who withdraw from the study are treated without prejudice. The reason for refusal or withdrawal will be noted on the form if reported.
All study-related information will be stored securely at the study site under a coded identification number in order to maintain participant confidentiality. All records that contain names or other personal identifiers, such as screening data for eligibility and informed consent forms, will be stored separately from study records identified by code number. All local databases are secured with password-protected access systems. Forms, lists, logbooks, appointment books, and any other listings that link participant identification numbers to other identifying information will be stored in a separate, locked file in an area with limited access. Participants’ study information will not be disclosed to third parties.
This trial and its findings will contribute to the evidence available to inform the development and delivery of relapse prevention on smoking cessation treatment. The primary objective of the study is to contribute to the literature calling for the development of mHealth applications that support individuals in remaining abstinent after they quit smoking. The overall implementation of the project can have an impact on participants’ motivation to initiate and adhere to physical activity. Increasing physical activity can reduce health-risk factors and improve self-esteem as well as quality of life. The use of the Ph.o.S app is not restricted to any specific place, time, situation, or quitting method and it is free to use. It can also contribute to the reduction of health care costs. In addition to the impact on public health, the project will have a significant contribution to future research on how physical activity affects cigarette cravings in real-life situations and will offer the potential to improve the understanding of the mechanisms that underlie these effects. Nevertheless, the relatively small sample size due to time and budget limitations, as well as the recruitment and engagement difficulties that are common with smokers in clinical trials [
Recruitment 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.
Study timeline: Schedule of enrollment, interventions, and assessments.
Overview of the smoking cessation interventions content (Sessions 1, 2, and 3).
Overview of the relapse prevention intervention content (Session 4).
Ph.o.S. flow: Examples of screenshots.
CONSORT Checklist form.
Ecological Momentary Assessment Methods
International Physical Ativity Questionaire
Motivation to Stop Smoking Scale
nicotine replacement therapy
Physical over Smoking app
point prevalence abstinence
Relapse Situation Efficacy Questionnaire
Tobacco Dependence Screener
theory of planned behavior
We gratefully acknowledge the support from JYTE. The study is funded by the Finnish National Institute for Health & Welfare (Terveyden ja Hyvinvoinnin Laitos).
MH, MV, TL, TK, and KK conceived of the original idea for the trial and also sought and obtained funding. MH, HT, MV, TL, TK, and RH wrote the study protocol. This protocol paper was written by MH with input from all co-authors. HT manages the day-to-day running of the trial, including all participant follow-ups. RH will undertake all data analyses. All authors read and approved the final manuscript.
None declared.