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    <front>
        <journal-meta>
            <journal-id journal-id-type="publisher-id">ResProt</journal-id>
            <journal-id journal-id-type="nlm-ta">JMIR Res Protoc</journal-id>
            <journal-title>JMIR Research Protocols</journal-title>
            <issn pub-type="epub">1929-0748</issn>
            <publisher>
                <publisher-name>JMIR Publications Inc.</publisher-name>
                <publisher-loc>Toronto, Canada</publisher-loc>
            </publisher>
        </journal-meta>
        <article-meta>
            <article-id pub-id-type="publisher-id">v4i2e24</article-id>
            <article-id pub-id-type="pmid">26013840</article-id>
            <article-id pub-id-type="doi">10.2196/resprot.2823</article-id>
            <article-categories>
                <subj-group subj-group-type="heading">
                    <subject>Original Paper</subject>
                </subj-group>
                <subj-group subj-group-type="article-type">
                    <subject>Original Paper</subject>
                </subj-group>
            </article-categories>
            <title-group>
                <article-title>Development of the OnTrack Diabetes Program</article-title>
            </title-group>
            <contrib-group>
                <contrib contrib-type="editor">
                    <name>
                        <surname>Eysenbach</surname>
                        <given-names>Gunther</given-names>
                    </name>
                </contrib>
            </contrib-group>
            <contrib-group>
                <contrib contrib-type="reviewer">
                    <name>
                        <surname>Winkley</surname>
                        <given-names>Kirsty</given-names>
                    </name>
                </contrib>
                <contrib contrib-type="reviewer">
                    <name>
                        <surname>Wu</surname>
                        <given-names>Chiung-Jung (Jo)</given-names>
                    </name>
                </contrib>
                <contrib contrib-type="reviewer">
                    <name>
                        <surname>Schmitz</surname>
                        <given-names>Norbert</given-names>
                    </name>
                </contrib>
            </contrib-group>
            <contrib-group>
                <contrib contrib-type="author" id="contrib1" corresp="yes" equal-contrib="yes">
                    <name name-style="western">
                        <surname>Cassimatis</surname>
                        <given-names>Mandy</given-names>
                    </name>
                    <degrees>BA, PGDipPsych,MPsych(Clinical),PhD (Psych)</degrees>
                    <xref rid="aff1" ref-type="aff">1</xref>
                    <address>
                        <institution>Queensland University of Technology</institution>
                        <institution>Institute of Health and Biomedical Innovation</institution>
                        <addr-line>Level 4, 60 Musk Avenue</addr-line>
                        <addr-line>Kelvin Grove</addr-line>
                        <addr-line>Brisbane, 4059</addr-line>
                        <country>Australia</country>
                        <phone>61 3470 4255 ext 4255</phone>
                        <fax>61 4635 5550</fax>
                        <email>mandy.cassimatis@usq.edu.au</email>
                    </address>
                    <xref rid="aff2" ref-type="aff">2</xref>
                    <ext-link ext-link-type="orcid">http://orcid.org/0000-0002-3678-4535</ext-link>
                </contrib>
                <contrib contrib-type="author" id="contrib2" equal-contrib="yes">
                    <name name-style="western">
                        <surname>Kavanagh</surname>
                        <given-names>David J</given-names>
                    </name>
                    <degrees>BA(Hons), Dipl-Psych, MApsych,PhD (Psych)</degrees>
                    <xref rid="aff3" ref-type="aff">3</xref>
                    <ext-link ext-link-type="orcid">http://orcid.org/0000-0001-9072-8828</ext-link>
                </contrib>
                <contrib contrib-type="author" id="contrib3" equal-contrib="yes">
                    <name name-style="western">
                        <surname>Hills</surname>
                        <given-names>Andrew P</given-names>
                    </name>
                    <degrees>BEd, MSc, PhD</degrees>
                    <xref rid="aff4" ref-type="aff">4</xref>
                    <xref rid="aff5" ref-type="aff">5</xref>
                    <ext-link ext-link-type="orcid">http://orcid.org/0000-0002-6849-6116</ext-link>
                </contrib>
                <contrib contrib-type="author" id="contrib4" equal-contrib="yes">
                    <name name-style="western">
                        <surname>Smith</surname>
                        <given-names>Anthony C</given-names>
                    </name>
                    <degrees>BNursing, MEd, PhD</degrees>
                    <xref rid="aff6" ref-type="aff">6</xref>
                    <ext-link ext-link-type="orcid">http://orcid.org/0000-0002-7756-5136</ext-link>
                </contrib>
                <contrib contrib-type="author" id="contrib5" equal-contrib="yes">
                    <name name-style="western">
                        <surname>Scuffham</surname>
                        <given-names>Paul A</given-names>
                    </name>
                    <degrees>BA, PGDip, PhD</degrees>
                    <xref rid="aff7" ref-type="aff">7</xref>
                    <ext-link ext-link-type="orcid">http://orcid.org/0000-0001-5931-642X</ext-link>
                </contrib>
                <contrib contrib-type="author" id="contrib6">
                    <name name-style="western">
                        <surname>Edge</surname>
                        <given-names>Steven</given-names>
                    </name>
                    <degrees>B Tech (IT)</degrees>
                    <xref rid="aff3" ref-type="aff">3</xref>
                    <ext-link ext-link-type="orcid">http://orcid.org/0000-0002-9414-3621</ext-link>
                </contrib>
                <contrib contrib-type="author" id="contrib7">
                    <name name-style="western">
                        <surname>Gibson</surname>
                        <given-names>Jeremy</given-names>
                    </name>
                    <degrees>B Tech (IT)</degrees>
                    <xref rid="aff3" ref-type="aff">3</xref>
                    <ext-link ext-link-type="orcid">http://orcid.org/0000-0002-2249-1045</ext-link>
                </contrib>
                <contrib contrib-type="author" id="contrib8">
                    <name name-style="western">
                        <surname>Gericke</surname>
                        <given-names>Christian</given-names>
                    </name>
                    <degrees>B Med, MD research doctorate, MSc, Diploma, MSc Public Health, PG Cert in Medical Quality Management</degrees>
                    <xref rid="aff2" ref-type="aff">2</xref>
                </contrib>
            </contrib-group>
            <aff id="aff1">
                <sup>1</sup>
                <institution>Queensland University of Technology</institution>
                <institution>Institute of Health and Biomedical Innovation</institution>
                <addr-line>Brisbane</addr-line>
                <country>Australia</country>
            </aff>
            <aff id="aff2">
                <sup>2</sup>
                <institution>The Wesley Health and Medical Research Institute</institution>
                <institution>Level 8 East Wing, The Wesley Hospital</institution>
                <institution>451 Coronation Drive, Auchenflower, 4066</institution>
                <addr-line>Brisbane</addr-line>
                <country>Australia</country>
            </aff>
            <aff id="aff3">
                <sup>3</sup>
                <institution>Queensland University of Technology</institution>
                <institution>Institute of Health and Biomedical Innovation</institution>
                <institution>Level 4, 60 Musk Avenue, Kelvin Grove, 4059</institution>
                <addr-line>Brisbane</addr-line>
                <country>Australia</country>
            </aff>
            <aff id="aff4">
                <sup>4</sup>
                <institution>Mater Mothers' Hospital, Mater Medical Research Institute</institution>
                <institution>Level 3 Aubigny Place</institution>
                <institution>Raymond Terrace, South Brisbane, 4101</institution>
                <addr-line>Brisbane</addr-line>
                <country>Australia</country>
            </aff>
            <aff id="aff5">
                <sup>5</sup>
                <institution>Griffith Health Institute</institution>
                <institution>Griffith University</institution>
                <addr-line>Brisbane</addr-line>
                <country>Australia</country>
            </aff>
            <aff id="aff6">
                <sup>6</sup>
                <institution>University of Queensland Centre for Online Health</institution>
                <institution>Ground floor, Main Building, Princess Alexandra Hospital</institution>
                <institution>Woolloongabba, 4102</institution>
                <addr-line>Brisbane</addr-line>
                <country>Australia</country>
            </aff>
            <aff id="aff7">
                <sup>7</sup>
                <institution>Griffith University</institution>
                <institution>School of Medicine &#38; Griffith Health Institute</institution>
                <institution>University Drive, Meadowbrook, 4131</institution>
                <addr-line>Brisbane</addr-line>
                <country>Australia</country>
            </aff>
            <author-notes>
                <corresp>Corresponding Author: Mandy Cassimatis <email>mandy.cassimatis@usq.edu.au</email>
                </corresp>
            </author-notes>
            <pub-date pub-type="collection">
                <season>Apr-Jun</season>
                <year>2015</year>
            </pub-date>
            <pub-date pub-type="epub">
                <day>26</day>
                <month>05</month>
                <year>2015</year>
            </pub-date>
            <volume>4</volume>
            <issue>2</issue>
            <elocation-id>e24</elocation-id>
            <!--history from ojs - api-xml-->
            <history>
                <date date-type="received">
                    <day>11</day>
                    <month>07</month>
                    <year>2013</year>
                </date>
                <date date-type="rev-request">
                    <day>16</day>
                    <month>09</month>
                    <year>2013</year>
                </date>
                <date date-type="rev-recd">
                    <day>01</day>
                    <month>04</month>
                    <year>2014</year>
                </date>
                <date date-type="accepted">
                    <day>28</day>
                    <month>07</month>
                    <year>2014</year>
                </date>
            </history>
            <!--(c) the authors - correct author names and publication date here if necessary. Date in form ', dd.mm.yyyy' after jmir.org-->
            <copyright-statement>&#169;Mandy Cassimatis, David J Kavanagh, Andrew P Hills, Anthony C Smith, Paul A Scuffham, Steven Edge, Jeremy Gibson, Christian Gericke. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 26.05.2015. </copyright-statement>
            <copyright-year>2015</copyright-year>
            <license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/2.0/">
                <p>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.</p>
            </license>
            <self-uri xlink:href="http://www.researchprotocols.org/2015/2/e24/" xlink:type="simple" />
            <abstract>
                <sec sec-type="background">
                    <title>Background</title>
                    <p>Type 2 diabetes affects an estimated 347 million people worldwide and often leads to serious complications including blindness, kidney disease, and limb amputation.  Comorbid dysphoria is common and is an independent risk factor for poor glycaemic control.  Professional support for diabetes self-management and dysphoria has limited availability and involves high costs, especially after regular hours, and in rural and remote areas.  Web-based cognitive behavior therapy offers highly accessible, acceptable, and cost-effective support for people with diabetes.  This paper describes the development of OnTrack Diabetes, a self-guided, Web-based program to promote improved physical and emotional self-management in people with Type 2 diabetes.</p>
                </sec>
                <sec sec-type="objective">
                    <title>Objective</title>
                    <p>The objective of the study is to describe the development of the OnTrack Diabetes program, which is a self-guided, Web-based program aimed to promote euthymia and improved disease self-management in people with Type 2 diabetes.</p>
                </sec>
                <sec sec-type="methods">
                    <title>Methods</title>
                    <p>Semistructured interviews with 12 general practitioners and 13 patients with Type 2 diabetes identified enablers of and barriers to effective diabetes self-management, requirements for additional support, and potential program elements.  Existing resources and research data informed the development of content, and consultants from relevant disciplines provided feedback on draft segments and reviewed the program before release.  Using a self-guided delivery format contained costs, in addition to adapting program features and modules from an existing OnTrack program.</p>
                </sec>
                <sec sec-type="results">
                    <title>Results</title>
                    <p>A separate paper describes the protocol for a randomized controlled trial to provide this required evaluation.</p>
                </sec>
                <sec sec-type="conclusions">
                    <title>Conclusions</title>
                    <p>Development of the OnTrack Diabetes program demonstrates strategies that help ensure that a program is acceptable to users.  The next stages involve testing users&#8217; experiences and examining the program&#8217;s effectiveness and cost-effectiveness in randomized controlled trials.</p>
                </sec>
                <sec>
                    <title>Trial Registration</title>
                    <p>The Australian New Zealand Clinical Trials Registry (ACTRN): 12614001126606;
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12614001126606 (Archived by WebCite at
http://www.webcitation.org/6U0Fh3vOj).</p>
                </sec>
            </abstract>
            <kwd-group>
                <kwd>type 2 diabetes</kwd>
                <kwd>depression</kwd>
                <kwd>anxiety</kwd>
                <kwd>self-management</kwd>
                <kwd>Internet</kwd>
                <kwd>online</kwd>
                <kwd>intervention</kwd>
                <kwd>randomized</kwd>
                <kwd>protocol</kwd>
            </kwd-group>
        </article-meta>
    </front>
    <body>
        <sec sec-type="introduction">
            <title>Introduction</title>
            <sec>
                <title>Type 2 Diabetes Self-Management</title>
                <p>Type 2 diabetes is a burgeoning epidemic that affects an estimated 347 million people worldwide [<xref ref-type="bibr" rid="ref1">1</xref>], and is becoming one of the leading causes of global disease burden [<xref ref-type="bibr" rid="ref1">1</xref>]. Inadequate diabetes self-care is strongly associated with poor glycaemic control [<xref ref-type="bibr" rid="ref2">2</xref>,<xref ref-type="bibr" rid="ref3">3</xref>], which increases the risk of diabetes complications including peripheral limb amputation, blindness, and end-stage renal disease [<xref ref-type="bibr" rid="ref1">1</xref>], as well as cardiovascular disease and stroke [<xref ref-type="bibr" rid="ref4">4</xref>]. A 21% decrease in the incidence of diabetes complications occurs with each 1% improvement (reduction) in glycosylated haemoglobin A1c level [<xref ref-type="bibr" rid="ref5">5</xref>], which indicates the utility of improving diabetes self-management. However, patients often struggle to meet recommended treatment targets and find it difficult to implement the behavioral changes required to achieve such improvements.</p>
                <p>Diabetes patients are two to three times more likely than people without diabetes to experience depression, anxiety, stress, and reduced well-being [<xref ref-type="bibr" rid="ref6">6</xref>-<xref ref-type="bibr" rid="ref8">8</xref>]. Dysphoria appears to be both a consequence of Type 2 diabetes and to have a role in the condition&#8217;s pathogenesis [<xref ref-type="bibr" rid="ref9">9</xref>], impairing glycaemic control both directly via physiological mechanisms, and indirectly via reduced diabetes self-care [<xref ref-type="bibr" rid="ref10">10</xref>,<xref ref-type="bibr" rid="ref11">11</xref>]. As a result, dysphoric patients have an increased risk of diabetes complications [<xref ref-type="bibr" rid="ref12">12</xref>,<xref ref-type="bibr" rid="ref13">13</xref>] and premature mortality [<xref ref-type="bibr" rid="ref14">14</xref>]. Optimal diabetes management therefore requires that both mood and behavioral disease self-management be targeted.</p>
                <p>Controlled trials of diabetes self-management interventions have shown that effective components include diabetes education [<xref ref-type="bibr" rid="ref15">15</xref>,<xref ref-type="bibr" rid="ref16">16</xref>], promotion of adherence to blood glucose self-monitoring [<xref ref-type="bibr" rid="ref17">17</xref>,<xref ref-type="bibr" rid="ref18">18</xref>], physical activity [<xref ref-type="bibr" rid="ref19">19</xref>,<xref ref-type="bibr" rid="ref20">20</xref>], dietary [<xref ref-type="bibr" rid="ref21">21</xref>], and medication regimes [<xref ref-type="bibr" rid="ref22">22</xref>], and emotional support [<xref ref-type="bibr" rid="ref23">23</xref>]. Interventions that incorporate only behavioral components have generally failed to produce robust and sustained improvements in psychological and emotional outcomes [<xref ref-type="bibr" rid="ref23">23</xref>]. Similarly, interventions that specifically target depression or anxiety have typically failed to produce substantial improvements in diabetes self-management and physical outcomes [<xref ref-type="bibr" rid="ref24">24</xref>]. Even for high-functioning individuals, the complexity of the Type 2 diabetes treatment regime exposes patients to a range of daily physical and emotional challenges [<xref ref-type="bibr" rid="ref8">8</xref>]. A holistic intervention that incorporates both behavioral and psychological support may therefore offer optimum efficacy.</p>
                <p>While some key components of effective support for Type 2 diabetes self-management have been identified, health system limitations prevent their reliable provision [<xref ref-type="bibr" rid="ref25">25</xref>], especially after regular hours or in more remote locations, where greater population spread and reduced practitioner to population ratios conspire to reduce access. Diabetes self-management support services that offer wide outreach and cost-effectiveness are needed.</p>
            </sec>
            <sec>
                <title>Web-Based Programs for Type 2 Diabetes</title>
                <p>Over recent years, Web-based interventions, and in particular those based on cognitive-behavior therapy (CBT), have produced substantial improvements in emotional and behavioral outcomes in a range of problem areas [<xref ref-type="bibr" rid="ref26">26</xref>], with effects similar in size to those of face-to-face treatments [<xref ref-type="bibr" rid="ref27">27</xref>]. CBT-based Type 2 diabetes interventions similarly have produced significant improvements in diabetes self-care [<xref ref-type="bibr" rid="ref28">28</xref>,<xref ref-type="bibr" rid="ref29">29</xref>], and psychosocial outcomes. These programs have also shown high user uptake, acceptability, and usability, even in older users [<xref ref-type="bibr" rid="ref30">30</xref>].</p>
                <p>Globally, Web access is increasing rapidly; with the proliferation of cable and mobile networks increasingly bridging geographical and even socioeconomic divides [<xref ref-type="bibr" rid="ref31">31</xref>]. Web-based delivery of intervention programs may assist with meeting the need for improved access to additional disease self-management support for people with Type 2 diabetes [<xref ref-type="bibr" rid="ref25">25</xref>], conveying the advantages of 24-hour availability, broad access, privacy, and lack of stigma. Self-guided programs also show steeply falling unit costs as user numbers increase.</p>
                <p>Web programs based on empirically well-established theories have shown superior efficacy in improving diabetes self-management outcomes compared with programs that do not have a strong theoretical and empirical basis [<xref ref-type="bibr" rid="ref28">28</xref>]; in particular, chronic disease self-management programs that use social cognitive theory (SCT) [<xref ref-type="bibr" rid="ref31">31</xref>] as their theoretical underpinning have demonstrated efficacy [<xref ref-type="bibr" rid="ref32">32</xref>]. SCT is appropriate to chronic disease self-management intervention, as it specifies predictors of human motivation and behavior that can be targeted in self-management [<xref ref-type="bibr" rid="ref33">33</xref>], including specific skills, self-efficacy [<xref ref-type="bibr" rid="ref32">32</xref>,<xref ref-type="bibr" rid="ref34">34</xref>], goals, and self-administered incentives [<xref ref-type="bibr" rid="ref31">31</xref>]. SCT encourages patient empowerment, positing that humans actively make sense of the world and shape their own experiences, giving them the capacity to exercise choice and change their behavior. The theory holds that environmental, interpersonal, and intrapersonal variables are interlocked in processes of reciprocal determinism. Research that demonstrates that diabetes self-management [<xref ref-type="bibr" rid="ref35">35</xref>-<xref ref-type="bibr" rid="ref38">38</xref>] and mood [<xref ref-type="bibr" rid="ref39">39</xref>,<xref ref-type="bibr" rid="ref40">40</xref>] have strong associations with cognitive and psychosocial factors is consistent with this view, and lends support to diabetes interventions being based on SCT principles.</p>
                <p>While Web-based CBT has shown efficacy in reducing depression and anxiety symptoms in people with diabetes [<xref ref-type="bibr" rid="ref41">41</xref>], interventions primarily focused on targeting mood have yielded mixed results in terms of their effects on glycaemic control [<xref ref-type="bibr" rid="ref42">42</xref>]. Similarly, behaviorally focused Type 2 diabetes interventions have demonstrated improved glycaemic control and behavioral outcomes, but they do not typically produce substantial differential improvements in psychological well-being [<xref ref-type="bibr" rid="ref28">28</xref>]. Programs that simultaneously address behavioral aspects of Type 2 diabetes self-care are needed [<xref ref-type="bibr" rid="ref42">42</xref>]. Such interventions would be appropriate for implementation in the mainstream Type 2 diabetic population and may support those experiencing primarily psychosocial barriers to self-care, as well as those with co-occurring distress.</p>
                <p>Most current Web-based CBT interventions are guided programs that incorporate support from a health professional [<xref ref-type="bibr" rid="ref43">43</xref>,<xref ref-type="bibr" rid="ref44">44</xref>]. However, studies that compare guided CBT-based programs with minimal support have similar impacts on clinical [<xref ref-type="bibr" rid="ref44">44</xref>,<xref ref-type="bibr" rid="ref45">45</xref>] and behavioral [<xref ref-type="bibr" rid="ref46">46</xref>] outcomes, as well as user engagement [<xref ref-type="bibr" rid="ref47">47</xref>]. Self-guided Web-based interventions have shown equal effectiveness to guided interventions [<xref ref-type="bibr" rid="ref48">48</xref>] and offer the advantages of self-paced learning and skill acquisition, and higher perceived autonomy and privacy. Further, Web-based programs encourage users to adopt an independent role in their disease management, which may enhance patient empowerment. There remains a need for further research on self-guided, Web-based Type 2 diabetes self-management programs that incorporate mood support.</p>
                <p>This paper describes the development of the OnTrack Diabetes program [<xref ref-type="bibr" rid="ref49">49</xref>], which attempts to address the need for a Web-based program that targets both Type 2 diabetes self-management and dysphoria. SCT [<xref ref-type="bibr" rid="ref31">31</xref>] and Elaborated Intrusion Theory [<xref ref-type="bibr" rid="ref50">50</xref>-<xref ref-type="bibr" rid="ref52">52</xref>] inform OnTrack Diabetes, which incorporates both CBT and motivational strategies. The program is designed to provide a holistic approach to improving Type 2 diabetes self-management and mood, and to endorse user empowerment by encouraging users with diabetes to take an autonomous role in managing their condition; it can also be used in either a self-guided or therapist-assisted mode. Practitioners can also use the program to guide sessions supporting patients&#8217; self-management; they are given a separate log-in.</p>
            </sec>
        </sec>
        <sec sec-type="methods">
            <title>Methods</title>
            <sec>
                <title>Development of the OnTrack Diabetes Program</title>
                <sec>
                    <title>Step 1. Qualitative Research</title>
                    <p>
                        <xref ref-type="fig" rid="figure1">Figure 1</xref> shows the Steps in the development of the program. Semistructured interviews were conducted to explore enablers and barriers associated with effective Type 2 diabetes self-care, together with diabetes-related emotional challenges, requirements for additional disease management support, and suggestions for elements in an online support program. The sample comprised 13 people with Type 2 diabetes and 12 general practitioners (GPs). GPs were asked the circumstances in which they would refer patients to an online Type 2 diabetes self-management support program, and the factors that may inhibit patient referral. Results revealed that patients and GPs shared most perspectives on diabetes self-management. Both the patients with diabetes and GPs identified a need for additional informational, motivational, emotional, and social support. Suggestions for program content included self-monitoring tools, informational support, motivational assistance with improving and maintaining physical activity and diet, goal setting assistance, progress feedback, social support via a chat room and accessibility to health professionals. Detailed results are available in a separate paper [<xref ref-type="bibr" rid="ref53">53</xref>].</p>
                    <fig id="figure1" position="float">
                        <label>Figure 1</label>
                        <caption>
                            <p>Steps involved in OnTrack Diabetes program development.</p>
                        </caption>
                        <graphic xlink:href="resprot_v4i1e24_fig1.jpg" alt-version="no" mimetype="image" position="float" xlink:type="simple" />
                    </fig>
                </sec>
                <sec>
                    <title>Step 2. Basic Structure and Functionality</title>
                    <p>The existing OnTrack Alcohol and Depression program [<xref ref-type="bibr" rid="ref54">54</xref>] was proposed as a basis for the layout of OnTrack Diabetes, and the appropriateness of this was confirmed by a review of its structure. Motivational videos, mindfulness and relaxation audios, and information technology coding from some of the self-monitoring and program tools were adapted for use in OnTrack Diabetes.</p>
                </sec>
                <sec>
                    <title>Step 3. Assembly of Information Resources</title>
                    <p>Sources that informed the development of OnTrack Diabetes information resources and tools included the Diabetes Australia guidelines for Type 2 diabetes management [<xref ref-type="bibr" rid="ref55">55</xref>]; National Health and Medical Research Council Physical Activity and Nutrition Guidelines for Australian Adults [<xref ref-type="bibr" rid="ref56">56</xref>]; Optometrists Association Australia [<xref ref-type="bibr" rid="ref57">57</xref>]; Australasian Podiatry Council [<xref ref-type="bibr" rid="ref58">58</xref>]; Medicare Australia [<xref ref-type="bibr" rid="ref59">59</xref>], and relevant peer-reviewed empirical literature. A nutritionist, ophthalmologist, and podiatrist were consulted to discuss proposed content.</p>
                </sec>
                <sec>
                    <title>Step 4. Content Development</title>
                    <p>MC compiled the obtained information and discussed proposed content inclusions with DK. The program content addressed the barriers to Type 2 diabetes self-care identified in qualitative research, and attempted to maximize enhancers. Information resources complement the program&#8217;s interactive tools and provide the impetus for goal setting and planning, while providing material that can be integrated into primary care. For example, the &#8220;My Feet Check&#8221; resource contains a diagram of feet on which the date and any changes can be marked, and a checklist to tick off symptoms that can be taken to podiatry appointments.</p>
                </sec>
                <sec>
                    <title>Step 5. Programming</title>
                    <p>OnTrack Diabetes information technology programming logic is based on eXtensive Markup coding developed for OnTrack Alcohol and Depression by SE and JG. In collaboration with them, MC coded tools and guidebook pages for the site. Programming modifications and the development of new features exclusive to OnTrack Diabetes was then undertaken. The administration site was built to include functions specific to this trial, including data recording and storage, access to study measures, and a schedule of follow-up study measure reminders. A graphic designer designed the website interface, inserted relevant images, and formatted the program.</p>
                </sec>
                <sec>
                    <title>Step 6. Preliminary Testing</title>
                    <p>Both the information technology programmers and external observers tested OnTrack Diabetes several times for bugs, errors in functionality, and design issues.</p>
                </sec>
                <sec>
                    <title>Step 7. Test of the Live Program</title>
                    <p>OnTrack Diabetes then had a soft initial launch to enable further screening for bugs and tests for functionality by MC and programmers.</p>
                </sec>
                <sec>
                    <title>Step 8. Expert Review</title>
                    <p>An endocrinologist and diabetes educator were invited to provide feedback on OnTrack Diabetes&#8217; contents, and AH, AS, PS, and two people with Type 2 diabetes who participated in the qualitative interviews (Step 1) also reviewed the program and provided feedback.</p>
                </sec>
                <sec>
                    <title>Step 9. Program Revision</title>
                    <p>The program content was revised in response to the reviews that were undertaken in Stage 8. Specifically, some information fact sheets were added, including on providing ideas for safe physical activity for individuals with limited physical capacity. Further, modifications were made to the program&#8217;s information technology functionality, as the reviewers had provided feedback regarding bugs that they had found while testing the site&#8217;s tools and resources.</p>
                </sec>
                <sec>
                    <title>Step 10. Launch and Efficacy Trial</title>
                    <p>A randomized controlled trial was commenced with potential participants registering interest on the site&#8217;s home page.</p>
                </sec>
            </sec>
            <sec>
                <title>OnTrack Diabetes Program Content</title>
                <sec>
                    <title>Key Elements</title>
                    <p>
                        <xref ref-type="fig" rid="figure2">Figure 2</xref> shows the initial screen in the program, which includes the key elements.</p>
                    <fig id="figure2" position="float">
                        <label>Figure 2</label>
                        <caption>
                            <p>Screenshot of the OnTrack Diabetes program layout.</p>
                        </caption>
                        <graphic xlink:href="resprot_v4i1e24_fig2.jpg" alt-version="no" mimetype="image" position="float" xlink:type="simple" />
                    </fig>
                </sec>
                <sec>
                    <title>Self-Monitoring and Goal Attainment Scaling</title>
                    <p>The &#8220;My Diary&#8221; tab provides an electronic self-monitoring record of daily goal attainments in relation to physical activity, eating, and health routines (on a sliding scale from 0% to 100%); highest and lowest blood glucose levels; and mood (on a scale from best to worst). <xref ref-type="fig" rid="figure3">Figure 3</xref> shows a diary page. Entries are represented in feedback graphs that are shown under the &#8220;How I&#8217;m Doing&#8221; tab. The graphs display averages per day over the previous month, and averages per week over the previous 3 months, for each self-monitoring area. Users are encouraged to recognize correlations between the different outcomes, in order to better understand their interrelationship and how they can improve their diabetic and dysphoria control. The monitoring and feedback functions emphasize the SCT focus on goals and on the motivational effects of feedback on goal attainment.</p>
                    <fig id="figure3" position="float">
                        <label>Figure 3</label>
                        <caption>
                            <p>Diary for self-monitoring.</p>
                        </caption>
                        <graphic xlink:href="resprot_v4i1e24_fig3.jpg" alt-version="no" mimetype="image" position="float" xlink:type="simple" />
                    </fig>
                </sec>
                <sec>
                    <title>Resources</title>
                    <p>At the top right of each screen, a &#8220;Resources&#8221; tab provides access to over 40 fact sheets and quizzes on diabetes and its management, and also to 8 mindfulness audios to guide practice sessions, which can be accessed on the computer as audios or text, or downloaded onto mobile phones in the MP3 format.</p>
                </sec>
                <sec>
                    <title>Journey Map</title>
                    <p>Based on our previous research on user preferences concerning Web program formats [<xref ref-type="bibr" rid="ref60">60</xref>], modules in OnTrack Diabetes are available in any order and at any time, using the tabs shown under the &#8220;Journey Map&#8221; at the right hand side of <xref ref-type="fig" rid="figure2">Figure 2</xref>. All of the tools within the program are also available at any time under the respective tabs at the top of the screen. However, users are advised to apply the strategies in a module for at least a couple of weeks before working on another, and the natural order of the program (by clicking &#8220;next&#8221;) leads them through a logical sequence of resources and skills.</p>
                    <p>The overall program (&#8220;My Journey&#8221;) contains five modules (&#8220;signposts&#8221;), which each includes a series of interactive tools. Tools are preceded by &#8220;guidebook&#8221; screens, which inform them about the tool and its relevance to diabetes. All tools produce a printable summary page, which can later be reviewed under the tab &#8220;What I&#8217;ve Done&#8221; at the top of the screen. In advertisement-length videos, actors illustrate key concepts such as reconceptualizing a problem. Users with low bandwidth Web connections can access the script of these videos. Throughout the program, written material is kept below a secondary school (Year 7) reading level, to maximize accessibility for users with limited education.</p>
                </sec>
                <sec>
                    <title>OnTrack Diabetes Signposts</title>
                    <p>As shown on the right side of <xref ref-type="fig" rid="figure2">Figure 2</xref>, the program has five signposts or modules: (1) &#8220;Keeping Active and Feeling Great&#8221;, (2) &#8220;Eating Well and Feeling Healthy&#8221;, (3) &#8220;Health Routines&#8221;, (4) &#8220;Thinking Well and Feeling Fine&#8221;, and (5) &#8220;Keeping OnTrack&#8221;. All but the last two have two sections. The first section of signposts on activity, diet, and medical regimens, asks users to select potential behavioral strategies, to imagine undertaking one, consider and image advantages of that action (<xref ref-type="fig" rid="figure4">Figure 4</xref> shows this), and consider strategies to address potential barriers. Self-efficacy is boosted by a consideration of past relevant successes, and a detailed stepwise plan is formulated, including the timing of those steps and a consideration of sources of potential social support (<xref ref-type="fig" rid="figure5">Figure 5</xref> shows this).</p>
                    <p>The second section of each signpost (&#8220;More on...&#8221;) contains tools that assist with making behavioral changes routine. For example, users can plan to add incidental and short bursts of activity to their week, as well as longer physical activity sessions, and specify the times and days that they will do them. It also includes a problem-solving tool [<xref ref-type="bibr" rid="ref61">61</xref>] to assist with overcoming challenges to reaching users&#8217; personalized goals. This tool can also be used to solve other problems, including threats to emotional well-being.</p>
                    <p>Users are asked to focus on practicing the skills learned in each section for 1-2 weeks before moving forward in the program. In the meantime they are encouraged to log on to the site regularly to self-monitor, use resources, undertake, and revisit tools as needed. The signpost &#8220;Keeping OnTrack&#8221; provides support while aiming to support the maintenance of progress. It focuses on moving on from past maladaptive behaviors and maintaining positive, new beginnings in the broader context of the individual&#8217;s life. Users are asked to evaluate positive changes since starting the program without losing sight of other life goals (eg, education, travel).</p>
                    <fig id="figure4" position="float">
                        <label>Figure 4</label>
                        <caption>
                            <p>Example screen from OnTrack Diabetes: Consideration of good things about a selected physical activity.</p>
                        </caption>
                        <graphic xlink:href="resprot_v4i1e24_fig4.jpg" alt-version="no" mimetype="image" position="float" xlink:type="simple" />
                    </fig>
                    <fig id="figure5" position="float">
                        <label>Figure 5</label>
                        <caption>
                            <p>A sample summary sheet: Plan for increasing an activity.</p>
                        </caption>
                        <graphic xlink:href="resprot_v4i1e24_fig5.jpg" alt-version="no" mimetype="image" position="float" xlink:type="simple" />
                    </fig>
                </sec>
                <sec>
                    <title>Self-Screening by Quizzes</title>
                    <p>There are four self-administered quizzes that enable users to evaluate their participation in diabetes self-care activities [<xref ref-type="bibr" rid="ref62">62</xref>], mood [<xref ref-type="bibr" rid="ref63">63</xref>], physical activity participation [<xref ref-type="bibr" rid="ref64">64</xref>], and fat and fiber intake [<xref ref-type="bibr" rid="ref65">65</xref>]. Self-screening enhances early recognition of distress and depression [<xref ref-type="bibr" rid="ref66">66</xref>,<xref ref-type="bibr" rid="ref67">67</xref>], which are important foci for ongoing assessment in diabetes patients [<xref ref-type="bibr" rid="ref6">6</xref>], and commonly remain undetected in primary care [<xref ref-type="bibr" rid="ref68">68</xref>]. Participants receive instantaneous, automated feedback on their results via the program, which provides a brief description of what their score indicates about how they have doing in each of the above areas.</p>
                </sec>
                <sec>
                    <title>OnTrack Diabetes Program Information Resources</title>
                    <p>Information resources on a number of Type 2 diabetes-related areas are included as printable fact sheets within the program. Specifically, information and resources are provided in the areas of: (1) general Type 2 diabetes information; (2) hyper- and hypo-glycaemia; (3) weight management; (4) physical activity guidelines and steps to increasing physical activity; (5) nutritional guidance including reading nutrition labels, counting carbohydrates, sugars, the glycaemic index and glycaemic load, protein, fats, fiber, dairy, salt intake, and alcohol; (6) eye care; (7) foot care; and (8) erectile dysfunction. Information sheets detail the roles of each primary care professional to diabetes management and include Web addresses to relevant organizations that allow a search for primary care professionals within any area of Australia to be performed.</p>
                </sec>
                <sec>
                    <title>Additional Resources, Mindfulness Resources, and Videos</title>
                    <p>The &#8220;Resources&#8221; section also contains mindfulness audios that provide spoken instructions on performing various forms of mindfulness (eg, mindfulness meditation and mindfulness of pleasure). Users are encouraged to listen to the audios on their computer or download them to an MP3 player for use offline. Guidebook pages throughout the program refer users to the most relevant mindfulness resources to each area. Inclusion of these resources is based on evidence regarding the deleterious effects of stress on glycaemic control and its tendency to increase susceptibility to dysphoria and diabetes-specific distress. Users are trained to mitigate worrying thoughts by meditative practice.</p>
                    <p>Brief videos that feature role models on key health-related and behavior change areas (eg, alcohol modification, physical activity) are also included, and provide vicarious experience.</p>
                </sec>
            </sec>
        </sec>
        <sec sec-type="results">
            <title>Results</title>
            <p>A separate paper describes the protocol for a randomized controlled trial to provide this required evaluation [<xref ref-type="bibr" rid="ref69">69</xref>].</p>
        </sec>
        <sec sec-type="discussion">
            <title>Discussion</title>
            <p>This paper provides information on the processes involved in developing a self-guided, Web, CBT-based intervention for Type 2 diabetes self-management and dysphoria. Providing details about Web program development has implications for researchers with an interest in developing or refining current Web interventions. The focus of the current project is to provide Web-based self-guided support. Once these foundations have been evaluated, there will be scope to consider additional features that may increase its efficacy, such as the addition of a chat room or blog site to increase access to social support.</p>
        </sec>
    </body>
    <back>
        <glossary>
            <title>Abbreviations</title>
            <def-list>
                <def-item>
                    <term id="abb1">CBT</term>
                    <def>
                        <p>cognitive-behavior therapy</p>
                    </def>
                </def-item>
                <def-item>
                    <term id="abb2">GPs</term>
                    <def>
                        <p>general practitioners</p>
                    </def>
                </def-item>
                <def-item>
                    <term id="abb3">SCT</term>
                    <def>
                        <p>social cognitive theory</p>
                    </def>
                </def-item>
            </def-list>
        </glossary>
        <ack>
            <p>Sources of Support: Funding for this project was received from the Mitsubishi Centre for Rural and Remote Health, Wesley Research Institute, Brisbane, Australia, supported through an unrestricted grant from Mitsubishi Development Pty Ltd.</p>
        </ack>
        <fn-group>
            <fn fn-type="conflict">
                <p>None declared.</p>
            </fn>
        </fn-group>
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