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      See Me Smoke-Free: Protocol for a Research Study to Develop and Test the Feasibility of an mHealth App for Women to Address Smoking, Diet, and Physical Activity

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          Abstract

          Background

          This paper presents the protocol for an ongoing research study to develop and test the feasibility of a multi-behavioral mHealth app. Approximately 27 million women smoke in the US, and more than 180,000 women die of illnesses linked to smoking annually. Women report greater difficulties quitting smoking. Concerns about weight gain, negative body image, and low self-efficacy may be key factors affecting smoking cessation among women. Recent studies suggest that a multi-behavioral approach, including diet and physical activity, may be more effective at helping women quit. Guided imagery has been successfully used to address body image concerns and self-efficacy in our 3 target behaviors—exercise, diet and smoking cessation. However, it has not been used simultaneously for smoking, diet, and exercise behavior in a single intervention. While imagery is an effective therapeutic tool for behavior change, the mode of delivery has generally been in person, which limits reach. mHealth apps delivered via smart phones offer a unique channel through which to distribute imagery-based interventions.

          Objective

          The objective of our study is to evaluate the feasibility of an mHealth app for women designed to simultaneously address smoking, diet, and physical activity behaviors. The objectives are supported by three specific aims: (1) develop guided imagery content, user interface, and resources to reduce weight concern, and increase body image and self-efficacy for behavior change among women smokers, (2) program a prototype of the app that contains all the necessary elements of text, graphics, multimedia and interactive features, and (3) evaluate the feasibility, acceptability, and preliminary efficacy of the app with women smokers.

          Methods

          We created the program content and designed the prototype application for use on the Android platform in collaboration with 9 participants in multiple focus groups and in-depth interviews. We programmed and tested the application’s usability with 6 participants in preparation for an open, pre- and posttest trial. Currently, we are testing the feasibility and acceptability of the application, evaluating the relationship of program use to tobacco cessation, dietary behaviors, and physical activity, and assessing consumer satisfaction with approximately 70 women smokers with Android-based smart phones.

          Results

          The study was started January 1, 2014. The app was launched and feasibility testing began in April 1, 2015. Participants were enrolled from April 1-June 30, 2015. During that time, the app was downloaded over 350 times using no paid advertising. Participants were required to use the app “most days” for 30 days or they would be dropped from the study. We enrolled 151 participants. Of those, 78 were dropped or withdrew from the study, leaving 73 participants. We have completed the 30-day assessment, with a 92% response rate. The 90-day assessment is ongoing. During the final phase of the study, we will be conducting data analyses and disseminating study findings via presentations and publications. Feasibility will be demonstrated by successful participant retention and a high level of app use. We will examine individual metrics (eg, duration of use, number of screens viewed, change in usage patterns over time) and engagement with interactive activities (eg, activity tracking).

          Conclusions

          We will aggregate these data into composite exposure scores that combine number of visits and overall duration to calculate correlations between outcome and measures of program exposure and engagement. Finally, we will compare app use between participants and non-participants using Google Analytics.

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          Most cited references109

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          In search of how people change. Applications to addictive behaviors.

          How people intentionally change addictive behaviors with and without treatment is not well understood by behavioral scientists. This article summarizes research on self-initiated and professionally facilitated change of addictive behaviors using the key trans-theoretical constructs of stages and processes of change. Modification of addictive behaviors involves progression through five stages--pre-contemplation, contemplation, preparation, action, and maintenance--and individuals typically recycle through these stages several times before termination of the addiction. Multiple studies provide strong support for these stages as well as for a finite and common set of change processes used to progress through the stages. Research to date supports a trans-theoretical model of change that systematically integrates the stages with processes of change from diverse theories of psychotherapy.
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            Measures of abstinence in clinical trials: issues and recommendations.

            A workgroup formed by the Society for Research on Nicotine and Tobacco reviewed the literature on abstinence measures used in trials of smoking cessation interventions. We recommend that trials report multiple measures of abstinence. However, at a minimum we recommend that trial: (a) report prolonged abstinence (i.e., sustained abstinence after an initial period in which smoking is not counted as a failure) as the preferred measure, plus point prevalence as a secondary measure; (b) use 7 consecutive days of smoking or smoking on > or = 1 day of 2 consecutive weeks to define treatment failure; (c) include non-cigarette tobacco use, but not nicotine medications in definitions of failure; and (d) report results from survival analysis to describe outcomes more fully. Trials of smokers willing to set a quit date should tie all follow-ups to the quit date and report 6- and/or 12-month abstinence rates. For these trials, we recommend an initial 2-week grace period for prolonged abstinence definitions; however, the period may vary, depending on the presumed mechanism of the treatment. Trials of smokers who may not be currently trying to quit should tie follow-up to the initiation of the intervention and should report a prolonged abstinence measure of > or = 6-month duration and point prevalence rates at 6- and 12-month follow-ups. The grace period for these trials will depend on the time necessary for treatment dissemination, which will vary depending on the treatment, setting, and population. Trials that use short-term follow-ups ( or = 4 weeks. We again recommend a 2-week grace period; however, that period can vary.
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              The prevalence and clustering of four major lifestyle risk factors in an English adult population.

              The aim of this study was to examine the clustering of four major lifestyle risk factors (smoking, heavy drinking, lack of fruit and vegetables consumption, and lack of physical activity), and to examine the variation across different socio-demographic groups in the English adult population. The study population was derived from the 2003 Health Survey for England (n=11,492). Clustering was examined by comparing the observed and expected prevalence of the different possible combinations. A multinomial multilevel regression model was conducted to examine the socio-demographic variation in the clustering of the four risk factors. The study found that, when using British health recommendations, a majority of the English population have multiple lifestyle risk factors at the same time. Clustering was found at both ends of the lifestyle spectrum and was more pronounced for women than for men. Overall, multiple risk factors were more prevalent among men, lower social class households, singles, and people who are economically inactive, but less prevalent among home owners and older age groups. The clustering of multiple risk factors provides support for multiple-behavior interventions as opposed to single-behavior interventions.
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                Author and article information

                Contributors
                Journal
                JMIR Res Protoc
                JMIR Res Protoc
                ResProt
                JMIR Research Protocols
                JMIR Publications Inc. (Toronto, Canada )
                1929-0748
                Jan-Mar 2016
                21 January 2016
                : 5
                : 1
                : e12
                Affiliations
                [1] 1Sport Sciences, Epidemiology West Virginia University Morgantown, WVUnited States
                [2] 2Nutritional Sciences University of Arizona Tucson, AZUnited States
                [3] 3Computing Sciences University of Arizona Tucson, AZUnited States
                [4] 4Family and Community Medicine University of Arizona Tucson, AZUnited States
                Author notes
                Corresponding Author: Peter Giacobbi Jr peter.giacobbi@ 123456mail.wvu.edu
                Author information
                http://orcid.org/0000-0003-1978-7424
                http://orcid.org/0000-0002-6696-5601
                http://orcid.org/0000-0002-8300-9195
                http://orcid.org/0000-0001-7747-5969
                http://orcid.org/0000-0001-8787-9190
                http://orcid.org/0000-0002-5911-4219
                Article
                v5i1e12
                10.2196/resprot.5126
                4742619
                26795257
                30286f4d-1d72-4f37-9f93-5809ac8112ea
                ©Peter Giacobbi Jr, Melanie Hingle, Thienne Johnson, James K. Cunningham, Julie Armin, Judith S. Gordon. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 21.01.2016.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                : 11 September 2015
                : 9 October 2015
                : 22 October 2015
                : 5 November 2015
                Categories
                Original Paper
                Original Paper

                smoking cessation, mhealth, diet, exercise, imagery, cell phone, handheld app

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