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  <front>
    <journal-meta>
      <journal-id journal-id-type="publisher-id">JMU</journal-id>
      <journal-id journal-id-type="nlm-ta">JMIR Mhealth Uhealth</journal-id>
      <journal-title>JMIR mHealth and uHealth</journal-title>
      <issn pub-type="epub">2291-5222</issn>
      <publisher>
        <publisher-name>JMIR Publications</publisher-name>
        <publisher-loc>Toronto, Canada</publisher-loc>
      </publisher>
    </journal-meta>
    <article-meta>
      <article-id pub-id-type="publisher-id">v12i1e45942</article-id>
      <article-id pub-id-type="pmid">38335014</article-id>
      <article-id pub-id-type="doi">10.2196/45942</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>Mobile App Intervention of a Randomized Controlled Trial for Patients With Obesity and Those Who Are Overweight in General Practice: User Engagement Analysis Quantitative Study</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="editor">
          <name>
            <surname>Buis</surname>
            <given-names>Lorraine</given-names>
          </name>
        </contrib>
      </contrib-group>
      <contrib-group>
        <contrib contrib-type="reviewer">
          <name>
            <surname>Bell</surname>
            <given-names>Lucinda</given-names>
          </name>
        </contrib>
        <contrib contrib-type="reviewer">
          <name>
            <surname>Job</surname>
            <given-names>Jennifer</given-names>
          </name>
        </contrib>
      </contrib-group>
      <contrib-group>
        <contrib id="contrib1" contrib-type="author" equal-contrib="yes">
          <name name-style="western">
            <surname>Buss</surname>
            <given-names>Vera Helen</given-names>
          </name>
          <degrees>PhD</degrees>
          <xref rid="aff1" ref-type="aff">1</xref>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0001-9963-8693</ext-link>
        </contrib>
        <contrib id="contrib2" contrib-type="author" corresp="yes" equal-contrib="yes">
          <name name-style="western">
            <surname>Barr</surname>
            <given-names>Margo</given-names>
          </name>
          <degrees>PhD</degrees>
          <xref rid="aff1" ref-type="aff">1</xref>
          <address>
            <institution>Centre for Primary Health Care and Equity</institution>
            <institution>University of New South Wales</institution>
            <addr-line>AGSM Building</addr-line>
            <addr-line>High Street, Kensington Campus</addr-line>
            <addr-line>Sydney, 2052</addr-line>
            <country>Australia</country>
            <phone>61 290656041</phone>
            <email>Margo.barr@unsw.edu.au</email>
          </address>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0002-3007-0216</ext-link>
        </contrib>
        <contrib id="contrib3" contrib-type="author" equal-contrib="yes">
          <name name-style="western">
            <surname>Parker</surname>
            <given-names>Sharon M</given-names>
          </name>
          <degrees>MPH</degrees>
          <xref rid="aff1" ref-type="aff">1</xref>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0001-7904-6420</ext-link>
        </contrib>
        <contrib id="contrib4" contrib-type="author" equal-contrib="yes">
          <name name-style="western">
            <surname>Kabir</surname>
            <given-names>Alamgir</given-names>
          </name>
          <degrees>PhD</degrees>
          <xref rid="aff1" ref-type="aff">1</xref>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0002-3762-8307</ext-link>
        </contrib>
        <contrib id="contrib5" contrib-type="author" equal-contrib="yes">
          <name name-style="western">
            <surname>Lau</surname>
            <given-names>Annie Y S</given-names>
          </name>
          <degrees>PhD</degrees>
          <xref rid="aff2" ref-type="aff">2</xref>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0002-3028-4222</ext-link>
        </contrib>
        <contrib id="contrib6" contrib-type="author" equal-contrib="yes">
          <name name-style="western">
            <surname>Liaw</surname>
            <given-names>Siaw-Teng</given-names>
          </name>
          <degrees>PhD</degrees>
          <xref rid="aff3" ref-type="aff">3</xref>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0001-5989-3614</ext-link>
        </contrib>
        <contrib id="contrib7" contrib-type="author" equal-contrib="yes">
          <name name-style="western">
            <surname>Stocks</surname>
            <given-names>Nigel</given-names>
          </name>
          <degrees>MD</degrees>
          <xref rid="aff4" ref-type="aff">4</xref>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0002-9018-0361</ext-link>
        </contrib>
        <contrib id="contrib8" contrib-type="author" equal-contrib="yes">
          <name name-style="western">
            <surname>Harris</surname>
            <given-names>Mark F</given-names>
          </name>
          <degrees>MD</degrees>
          <xref rid="aff1" ref-type="aff">1</xref>
          <ext-link ext-link-type="orcid">https://orcid.org/0000-0002-0705-8913</ext-link>
        </contrib>
      </contrib-group>
      <aff id="aff1">
        <label>1</label>
        <institution>Centre for Primary Health Care and Equity</institution>
        <institution>University of New South Wales</institution>
        <addr-line>Sydney</addr-line>
        <country>Australia</country>
      </aff>
      <aff id="aff2">
        <label>2</label>
        <institution>Australian Institute of Health Innovation</institution>
        <institution>Macquarie University</institution>
        <addr-line>Sydney</addr-line>
        <country>Australia</country>
      </aff>
      <aff id="aff3">
        <label>3</label>
        <institution>School of Population Health</institution>
        <institution>University of New South Wales</institution>
        <addr-line>Sydney</addr-line>
        <country>Australia</country>
      </aff>
      <aff id="aff4">
        <label>4</label>
        <institution>Adelaide Medical School</institution>
        <institution>University of Adelaide</institution>
        <addr-line>Adelaide</addr-line>
        <country>Australia</country>
      </aff>
      <author-notes>
        <corresp>Corresponding Author: Margo Barr <email>Margo.barr@unsw.edu.au</email></corresp>
      </author-notes>
      <pub-date pub-type="collection">
        <year>2024</year>
      </pub-date>
      <pub-date pub-type="epub">
        <day>9</day>
        <month>2</month>
        <year>2024</year>
      </pub-date>
      <volume>12</volume>
      <elocation-id>e45942</elocation-id>
      <history>
        <date date-type="received">
          <day>22</day>
          <month>1</month>
          <year>2023</year>
        </date>
        <date date-type="rev-request">
          <day>20</day>
          <month>4</month>
          <year>2023</year>
        </date>
        <date date-type="rev-recd">
          <day>21</day>
          <month>8</month>
          <year>2023</year>
        </date>
        <date date-type="accepted">
          <day>19</day>
          <month>12</month>
          <year>2023</year>
        </date>
      </history>
      <copyright-statement>©Vera Helen Buss, Margo Barr, Sharon M Parker, Alamgir Kabir, Annie Y S Lau, Siaw-Teng Liaw, Nigel Stocks, Mark F Harris. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 09.02.2024.</copyright-statement>
      <copyright-year>2024</copyright-year>
      <license license-type="open-access" xlink:href="https://creativecommons.org/licenses/by/4.0/">
        <p>This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR mHealth and uHealth, is properly cited. The complete bibliographic information, a link to the original publication on https://mhealth.jmir.org/, as well as this copyright and license information must be included.</p>
      </license>
      <self-uri xlink:href="https://mhealth.jmir.org/2024/1/e45942" xlink:type="simple"/>
      <related-article related-article-type="correction-forward" xlink:title="This is a corrected version. See correction statement in:" xlink:href="https://mhealth.jmir.org/2024/1/e58507" vol="12" page="e58507"> </related-article>
      <abstract>
        <sec sec-type="background">
          <title>Background</title>
          <p>The Health eLiteracy for Prevention in General Practice trial is a primary health care–based behavior change intervention for weight loss in Australians who are overweight and those with obesity from lower socioeconomic areas. Individuals from these areas are known to have low levels of health literacy and are particularly at risk for chronic conditions, including diabetes and cardiovascular disease. The intervention comprised health check visits with a practice nurse, a purpose-built patient-facing mobile app (mysnapp), and a referral to telephone coaching.</p>
        </sec>
        <sec sec-type="objective">
          <title>Objective</title>
          <p>This study aimed to assess <italic>mysnapp</italic> app use, its user profiles, the duration and frequency of use within the Health eLiteracy for Prevention in General Practice trial, its association with other intervention components, and its association with study outcomes (health literacy and diet) to determine whether they have significantly improved at 6 months.</p>
        </sec>
        <sec sec-type="methods">
          <title>Methods</title>
          <p>In 2018, a total of 22 general practices from 2 Australian states were recruited and randomized by cluster to the intervention or usual care. Patients who met the main eligibility criteria (ie, BMI&#62;28 in the previous 12 months and aged 40-74 years) were identified through the clinical software. The practice staff then provided the patients with details about this study. The intervention consisted of a health check with a practice nurse and a lifestyle app, a telephone coaching program, or both depending on the participants’ choice. Data were collected directly through the app and combined with data from the 6-week health check with the practice nurses, the telephone coaching, and the participants’ questionnaires at baseline and 6-month follow-up. The analyses comprised descriptive and inferential statistics.</p>
        </sec>
        <sec sec-type="results">
          <title>Results</title>
          <p>Of the 120 participants who received the intervention, 62 (52%) chose to use the app. The app and nonapp user groups did not differ significantly in demographics or prior recent hospital admissions. The median time between first and last app use was 52 (IQR 4-95) days, with a median of 5 (IQR 2-10) active days. App users were significantly more likely to attend the 6-week health check (2-sided Fisher exact test; <italic>P&#60;.</italic>001) and participate in the telephone coaching (2-sided Fisher exact test; <italic>P=.</italic>007) than nonapp users. There was no association between app use and study outcomes shown to have significantly improved (health literacy and diet) at 6 months.</p>
        </sec>
        <sec sec-type="conclusions">
          <title>Conclusions</title>
          <p>Recruitment and engagement were difficult for this study in disadvantaged populations with low health literacy. However, app users were more likely to attend the 6-week health check and participate in telephone coaching, suggesting that participants who opted for several intervention components felt more committed to this study.</p>
        </sec>
        <sec sec-type="trial registration">
          <title>Trial Registration</title>
          <p>Australian New Zealand Clinical Trials Registry ACTRN12617001508369; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373505</p>
        </sec>
        <sec sec-type="registered-report">
          <title>International Registered Report Identifier (IRRID)</title>
          <p>RR2-10.1136/bmjopen-2018-023239</p>
        </sec>
      </abstract>
      <kwd-group>
        <kwd>health literacy</kwd>
        <kwd>primary health care</kwd>
        <kwd>mobile application</kwd>
        <kwd>overweight</kwd>
        <kwd>vulnerable populations</kwd>
        <kwd>health behavior</kwd>
        <kwd>mHealth</kwd>
        <kwd>obesity</kwd>
        <kwd>weight loss</kwd>
        <kwd>mysnapp app</kwd>
        <kwd>mobile phone</kwd>
      </kwd-group>
    </article-meta>
  </front>
  <body>
    <sec sec-type="introduction">
      <title>Introduction</title>
      <sec>
        <title>Problem Statement</title>
        <p>Obesity is a major contributor to disease burden, increasing the risk of chronic conditions, including ischemic heart disease, stroke, diabetes mellitus, chronic kidney disease, and hypertensive heart disease [<xref ref-type="bibr" rid="ref1">1</xref>]. According to the Global Burden of Disease Study 2017 [<xref ref-type="bibr" rid="ref2">2</xref>], high BMI was the cause of 4.72 million deaths and 148 million disability-adjusted life-years worldwide, making it the fourth leading risk for mortality in 2017. In 2017 to 2018, an estimated 36% of the Australian adult population were overweight (ie, BMI 25.0-29.9) and 31% of them had obesity (ie, BMI≥30.0) [<xref ref-type="bibr" rid="ref3">3</xref>]. The proportion of people who are overweight or hose with obesity is higher in populations from lower socioeconomic backgrounds [<xref ref-type="bibr" rid="ref3">3</xref>]. In 2017-2018, 72% of Australian adults residing in the lowest socioeconomic areas were overweight or had obesity compared to 62% from the highest, after adjusting for age [<xref ref-type="bibr" rid="ref3">3</xref>]. People from the lowest socioeconomic areas were 1.9 times more likely to have diabetes in 2020 and 1.6 times more likely to have self-reported coronary heart disease in 2017-2018 than those from the highest socioeconomic areas [<xref ref-type="bibr" rid="ref4">4</xref>].</p>
      </sec>
      <sec>
        <title>Rationale for the Study</title>
        <p>Other research has shown that mobile app-based interventions can facilitate weight loss in individuals who are overweight and those with obesity, but it requires regular app use. For example, Patel et al [<xref ref-type="bibr" rid="ref5">5</xref>] reported that consistent weight self-monitoring via a mobile app could lead to clinically meaningful weight loss. However, the study classified only a quarter of participants as consistent trackers, which they defined as self-monitoring weight and diet on at least 6 days per week for at least 75% of the study weeks [<xref ref-type="bibr" rid="ref5">5</xref>]. Their study highlighted that consistent tracking was crucial, but only a minority of participants did so. Similarly, Laing et al [<xref ref-type="bibr" rid="ref6">6</xref>] found that providing access to a weight loss app to primary care patients who are  overweight and those with obesity did not lead to significant weight loss compared to usual care. Only one-third of them logged into the app in the sixth month of the intervention, in which the median number of logins was 0 (IQR 0-2). The authors concluded that prescribing self-monitoring apps for caloric counting may be successful in primary care patients who are particularly motivated to lose weight [<xref ref-type="bibr" rid="ref6">6</xref>]. Chin et al [<xref ref-type="bibr" rid="ref7">7</xref>] analyzed user data from a popular commercial weight loss app and found that in a multivariate logistic regression model, the frequency of entering body weight and consumption of dinner particularly was associated with successful weight loss in app users. Considering other studies, the focus of this study was understanding how participants used a mobile app within the Health eLiteracy for Prevention in General Practice (HeLP-GP) trial and if its use led to improvements in health literacy and diet.</p>
      </sec>
      <sec>
        <title>Description of the Intervention</title>
        <p>The HeLP-GP trial was a behavior change intervention developed for implementation in Australian general practices aimed at Australians who are overweight and those with obesity from lower socioeconomic areas to help them reduce their weight. The intervention was based on the 5As framework (assess, advise, agree, assist, and arrange) [<xref ref-type="bibr" rid="ref8">8</xref>]. It included health check visits with a practice nurse based on the 5As framework, the use of a purpose-built patient-facing mobile app called <italic>mysnapp</italic>, and referral to health coaching via the “Get Healthy” information and coaching service [<xref ref-type="bibr" rid="ref9">9</xref>]. The <italic>mysnapp</italic> is based on a web-based platform developed by Lau et al [<xref ref-type="bibr" rid="ref10">10</xref>].</p>
        <p>The trial was a pragmatic, 2-arm, unblinded cluster randomized controlled trial, which continued for 12 months. Primary outcomes included changes in weight, blood pressure, health literacy, and eHealth literacy [<xref ref-type="bibr" rid="ref11">11</xref>,<xref ref-type="bibr" rid="ref12">12</xref>]. Secondary outcomes included lipids, diet (fruit and vegetable intake), level of physical activity, quality of life, advice received, and referral for diet, physical activity, and weight loss [<xref ref-type="bibr" rid="ref12">12</xref>]. Participants who received the intervention could choose to use the mobile app and access the telephone coaching program. The HeLP-GP trial assessed the intervention’s effectiveness [<xref ref-type="bibr" rid="ref12">12</xref>]. The intervention led to significant improvements at 6 months compared to the controls for health literacy (mean DiD 0.22, 95% CI 0.01-0.44) and diet (mean DiD 0.98, 95% CI 0.50-1.47). There were no associations with any of the other outcomes [<xref ref-type="bibr" rid="ref12">12</xref>].</p>
      </sec>
      <sec>
        <title>Objectives</title>
        <p>The overall aim of this study, within the HeLP-GP trial, was to assess <italic>mysnapp</italic> app use, engagement, its association with other intervention components, and its association with study outcomes shown to have significantly improved (health literacy and diet) at 6 months.</p>
        <p>Our objectives were to (1) explore differences in demographics and hospital admissions between participants who used the app and those who did not, (2) examine the duration and frequency of app use (app engagement) by participants overall and by module, (3) assess the association among app use, app engagement, and participation in other intervention components, and (4) examine the association between app use and app engagement on study outcomes that were shown to be significantly improved at 6 months (ie, health literacy and diet).</p>
      </sec>
    </sec>
    <sec sec-type="methods">
      <title>Methods</title>
      <sec>
        <title>Ethical Considerations</title>
        <p>The University of New South Wales Human Research Ethics Committee (HC17474) approved the trial. The University of Adelaide Human Research Ethics Committee ratified this approval. All participants provided consent to take part in this study.</p>
      </sec>
      <sec>
        <title>Intervention</title>
        <p>The methodology of the randomized controlled trial, of which this study is a subanalysis, was published previously [<xref ref-type="bibr" rid="ref13">13</xref>] and prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12617001508369). In 2018, a total of 22 general practices were recruited from 2 Australian states, New South Wales (South West and Central Sydney) and South Australia (Adelaide), and randomized by cluster to the HeLP-GP intervention (11 practices) or usual care (11 practices). General practices were recruited through the local Primary Health Networks. Practices were located in local government areas with Socio-Economic Indexes for Areas scores [<xref ref-type="bibr" rid="ref14">14</xref>] equal to or below the eighth decile. The Australian Bureau of Statistics reported that these are usually associated with lower health literacy levels in the population [<xref ref-type="bibr" rid="ref15">15</xref>], with health literacy being defined by the Australian Institute of Health and Welfare in their latest Health Literacy Report as “how people access, understand and use health information in ways that benefit their health” [<xref ref-type="bibr" rid="ref16">16</xref>]. In total, 4 strata based on the practice size (&#60;5 general practice [GPs] and ≥5 GPs) and the state were created and then we randomly allocated practices to each stratum’s intervention or usual care group. The intervention comprised a practice nurse–led health check; additionally, participants could choose whether to take up a lifestyle app, a telephone coaching program, or both. Potential participants were identified using the GPs’ software. The general practitioners of the intervention sites also assessed their patients for eligibility. The eligible patients were provided with trial information and consent forms by the reception staff. Recruitment occurred between October 2018 and September 2019.</p>
        <p>At the baseline health check, the practice nurses helped participants with the <italic>mysnapp</italic> setup and access the coaching program. They entered the participant’s height, weight, waist circumference, and blood pressure into the app and set the health goals with the participant. For 6 weeks, the participants received a nutrition-related and a physical activity–related text message weekly. These were preprepared to be sent automatically each week and provided direct advice and a web link for further information. In addition, the telephone coaching program provided free, confidential health support to participants to reach personalized lifestyle goals concerning diet, physical activity, alcohol, and body weight [<xref ref-type="bibr" rid="ref17">17</xref>]. The coaching was available in multiple languages through an interpreter service. The practice nurses conducted a 6-week health check in which they reviewed and revised the participants’ health goals. Additionally, general practitioners conducted a 12-week health review. Text messages reminded participants to attend these follow-up visits.</p>
      </sec>
      <sec>
        <title>Participants</title>
        <p>Individuals were eligible for this study if they were aged 40-74 years, had a BMI of ≥28 and blood pressure levels recorded in the clinical software within the last 12 months, spoke English or Arabic, and had access to a smartphone or tablet. Potential participants were ineligible if they fulfilled any of the following exclusion criteria: recent weight loss (ie, &#62;5% in the past 3 months), taking weight loss drugs (ie, orlistat or phentermine), diagnosed with insulin-dependent diabetes or cardiovascular disease (ie, angina, myocardial infarction, heart failure, heart valve disease, or stroke), cognitive impairment, or physical impairment disallowing them to perform moderate physical activity.</p>
      </sec>
      <sec>
        <title><italic>mysnapp</italic> Design</title>
        <p>The <italic>mysnapp</italic> content was based on a web-based platform designed to help individuals control and maintain their health data and information to manage their health [<xref ref-type="bibr" rid="ref10">10</xref>]. Research by Webb et al [<xref ref-type="bibr" rid="ref18">18</xref>] and DiFilippo et al [<xref ref-type="bibr" rid="ref19">19</xref>] into behavior change through mobile and electronic platforms informed the app design, including goal setting and self-monitoring, and additional methods to interact with individuals, mainly text messaging. The <italic>mysnapp</italic> app consisted of 4 core modules that allowed users to (1) set physical activity– and diet-based goals, (2) monitor their progress over the past 6 weeks, (3) take notes in a diary, and (4) learn about healthy eating and physical activity. Users could choose from the following goal options: set daily servings of fruits or vegetables or physical activity minutes; aim to drink fewer soft drinks, eat smaller portions, or eat fewer snacks or takeaway foods. In the self-monitoring module, they entered how many days of the week they achieved their goals. The educational material consisted of short text summaries and fact sheets about healthy foods, portion sizes, discretionary beverage consumption, physical activity benefits in English or Arabic, and links to simple exercise videos on YouTube.</p>
      </sec>
      <sec>
        <title>Study Measures</title>
        <sec>
          <title>App Use Measure</title>
          <p>Data were collected on app use, specifically, when the study participants in the intervention group had an app account set up.</p>
        </sec>
        <sec>
          <title>App Engagement Measures</title>
          <p>Data were collected on the participants’ app use directly through <italic>mysnapp</italic>. Each month, a cumulative data report was created about app logins and interactions with the different app modules from each participant for 12 months. App engagement included active days, duration of app use, and frequency of accessing app modules.</p>
        </sec>
        <sec>
          <title>Other Intervention Component Measures</title>
          <p>The data from the 6-week health check with the practice nurses (ie, occurrence) and the telephone coaching (ie, occurrence and completion status) were the other intervention component measures.</p>
        </sec>
        <sec>
          <title>Outcome Measures</title>
          <p>The participants’ questionnaires at baseline and 6-month follow-up (ie, self-reported fruit and vegetable intake, and health literacy) were used.</p>
          <p>Specifically, the diet questions were as follows: (1) How many servings of fruit do you usually eat each day? A serving is 1 medium-sized fruit such as an apple or 2 small-sized fruits or 1 cup of fruit pieces. (2) How many servings of vegetables do you usually eat each day? One serving is half a cup of cooked vegetables or 1 cup of salad vegetables. With the diet score being the portions of fruit intake (between 0 and a maximum of 2 per day) plus portions of vegetable intake (between 0 and a maximum of 5 per day) with a range of 0 to 7 based on the sum of fruit and vegetable scores. This diet measure has been validated against food frequency questionnaires [<xref ref-type="bibr" rid="ref20">20</xref>].</p>
          <p>Specifically, the Health Literacy Questionnaire domain 8 questions were used [<xref ref-type="bibr" rid="ref11">11</xref>]: (1) find information about health problems; (2) find health information from several …. ; (3) get information about health so you…; (4) get health information in words you…; and (5) get health information by yourself. There is a 5-point response option scale for each question (cannot do or always difficult, usually difficult, sometimes difficult, usually easy or always easy). The scores are reported as averages for the domain (with a range between 1 and 5) with high scores representing higher health literacy.</p>
          <p><xref ref-type="table" rid="table1">Table 1</xref> contains definitions for study measures. Duration of app use, active days, and consistent use had preset maximum values (365 days or 52 weeks); the values were capped when they exceeded the maximum.</p>
          <table-wrap position="float" id="table1">
            <label>Table 1</label>
            <caption>
              <p>Measures and their definitions.</p>
            </caption>
            <table width="1000" cellpadding="5" cellspacing="0" border="1" rules="groups" frame="hsides">
              <col width="30"/>
              <col width="170"/>
              <col width="200"/>
              <col width="600"/>
              <thead>
                <tr valign="top">
                  <td colspan="2">Measure</td>
                  <td>Type of variable</td>
                  <td>Explanation or definition</td>
                </tr>
              </thead>
              <tbody>
                <tr valign="top">
                  <td colspan="4">
                    <bold>App use measures</bold>
                  </td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>App user</td>
                  <td>Binary and input variable</td>
                  <td>Study participants in the intervention group who had an app account set up</td>
                </tr>
                <tr valign="top">
                  <td colspan="4">
                    <bold>App engagement measures</bold>
                  </td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>Duration of app use</td>
                  <td>Continuous and input variable; maximum value: 365 days</td>
                  <td>Number of days between the first and last time a participant accessed the app</td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>Active days</td>
                  <td>Continuous and input variable; maximum value: 365 days</td>
                  <td>Number of days a participant accessed the app</td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>Consistent app use</td>
                  <td>Continuous and input variable; maximum value: 52 weeks</td>
                  <td>Number of consecutive weeks a participant accessed ≥1 time the app starting from the first app use</td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>App module use</td>
                  <td>Binary and input variable</td>
                  <td>Participant accessed ≥1 the corresponding app module (goal setting, progress tracking, diary, or education)</td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>Frequency of accessing app modules</td>
                  <td>Continuous and input variable</td>
                  <td>Number of times a participant accessed the corresponding app module (goal setting, progress tracking, diary, or education)</td>
                </tr>
                <tr valign="top">
                  <td colspan="4">
                    <bold>Other intervention component measures</bold>
                  </td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>Practice nurse-led health check</td>
                  <td>Categorical and input variable</td>
                  <td>Attended and not attended</td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>Telephone coaching</td>
                  <td>Categorical and input variable</td>
                  <td>Completed, not completed, and not participated</td>
                </tr>
                <tr valign="top">
                  <td colspan="4">
                    <bold>Outcome measures</bold>
                  </td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>Health literacy</td>
                  <td>Continuous and output variable</td>
                  <td>Health literacy, specifically the self-reported ability to find good quality health information, according to domain 8 of the Health Literacy Questionnaire [<xref ref-type="bibr" rid="ref11">11</xref>], at baseline and 6-month follow-up. The scores were reported as averages for the domain (with a range between 1 and 5) with high scores representing higher health literacy.</td>
                </tr>
                <tr valign="top">
                  <td>
                    <break/>
                  </td>
                  <td>Diet score</td>
                  <td>Continuous and output variable</td>
                  <td>Self-reported daily fruit and vegetable intake at baseline and 6-month follow-up. Diet score was the portions of fruit intake (between 0 and a maximum of 2 per day) plus portions of vegetable intake (between 0 and a maximum of 5 per day) with a range between 0 and 7 based on the sum of fruit and vegetable scores.</td>
                </tr>
              </tbody>
            </table>
          </table-wrap>
        </sec>
      </sec>
      <sec>
        <title>Data Analysis</title>
        <p>Descriptive and inferential analyses in RStudio (with the programming language <italic>R</italic>; <italic>R</italic> Foundation for Statistical Computing) using a significance level of .05 for all statistical tests were conducted. Normally distributed continuous variables were summarized using the mean and SD, and nonnormally distributed continuous variables with median and IQR. Box plots compared continuous variables across the categories of nonnumerical variables [<xref ref-type="bibr" rid="ref21">21</xref>]. Normality was tested using the Shapiro-Wilk normality test [<xref ref-type="bibr" rid="ref22">22</xref>-<xref ref-type="bibr" rid="ref24">24</xref>]. The 2-sided Welch <italic>t</italic> test was performed to compare the means of continuous variables between 2 subgroups (eg, participants using <italic>mysnapp</italic> versus those not using it) for normally distributed continuous variables [<xref ref-type="bibr" rid="ref25">25</xref>]. Alternatively, the Wilcoxon signed rank test with continuity correction comparing the medians of nonnormally distributed continuous variables between 2 subgroups was used [<xref ref-type="bibr" rid="ref26">26</xref>,<xref ref-type="bibr" rid="ref27">27</xref>]. The Kruskal-Wallis rank-sum test was performed for more than 2 subgroups and nonnormally distributed continuous variables [<xref ref-type="bibr" rid="ref28">28</xref>]. Pearson chi-square test with Yates continuity correction was used to test for associations between 2 categorical variables and the 2-sided Fisher exact test was used when there were less than 5 participants in any cell of the contingency table of expected frequencies [<xref ref-type="bibr" rid="ref29">29</xref>-<xref ref-type="bibr" rid="ref31">31</xref>].</p>
        <p>For objective 4, we used 1-sided tests to assess whether app use versus nonapp use, or app engagement was associated with health literacy or diet between baseline and 6-month follow-up. Correlations between the app engagement and health literacy or diet score were measured with the Kendall rank correlation test (if variables did not follow a normal distribution) or Pearson product-moment correlation test (if they followed a normal distribution) [<xref ref-type="bibr" rid="ref32">32</xref>,<xref ref-type="bibr" rid="ref33">33</xref>].</p>
      </sec>
    </sec>
    <sec sec-type="results">
      <title>Results</title>
      <sec>
        <title>App Users</title>
        <p>In total, 120 participants received the intervention, of which 62 (52%) people chose to use <italic>mysnapp</italic>. Among the 62 app users, 38 (61%) also opted for telephone coaching. <xref ref-type="table" rid="table2">Table 2</xref> shows the results for the first objective, comparing the demographic characteristics of the participants who chose not to use <italic>mysnapp</italic> to those who decided to use it. There were no significant differences between app users and nonapp users.</p>
        <table-wrap position="float" id="table2">
          <label>Table 2</label>
          <caption>
            <p>Demographic characteristics of participants in the intervention group (N=120).</p>
          </caption>
          <table width="1000" cellpadding="5" cellspacing="0" border="1" rules="groups" frame="hsides">
            <col width="250"/>
            <col width="180"/>
            <col width="170"/>
            <col width="310"/>
            <col width="90"/>
            <thead>
              <tr valign="top">
                <td>Variables</td>
                <td>Nonapp users (n=58)</td>
                <td>App users (n=62)</td>
                <td>Test statistics for differences between groups</td>
                <td><italic>P</italic> value</td>
              </tr>
            </thead>
            <tbody>
              <tr valign="top">
                <td>Age (years), mean (SD)</td>
                <td>58 (8)</td>
                <td>61 (9)</td>
                <td><italic>t</italic><sub>115</sub>=–1.56</td>
                <td>.12</td>
              </tr>
              <tr valign="top">
                <td>Women, n (%)</td>
                <td>28 (48)</td>
                <td>32 (52)</td>
                <td><italic>χ</italic><sup>2</sup><sub>1</sub>&#60;0.1</td>
                <td>.86</td>
              </tr>
              <tr valign="top">
                <td>Born in Australia, n (%)</td>
                <td>27 (47)</td>
                <td>39 (63)</td>
                <td><italic>χ</italic><sup>2</sup><sub>1</sub>=2.6</td>
                <td>.11</td>
              </tr>
              <tr valign="top">
                <td>Preferred language is English, n (%)</td>
                <td>54 (93)</td>
                <td>58 (94)</td>
                <td>OR<sup>a</sup> 0.93, 95% CI 0.16-5.26</td>
                <td>&#62;.99</td>
              </tr>
              <tr valign="top">
                <td>Hospital admission in past 12 months, n (%)</td>
                <td>15 (26)</td>
                <td>12 (19)</td>
                <td><italic>χ</italic><sup>2</sup><sub>1</sub>=0.4</td>
                <td>.53</td>
              </tr>
              <tr valign="top">
                <td>Location New South Wales, n (%)</td>
                <td>50 (86)</td>
                <td>49 (79)</td>
                <td><italic>χ</italic><sup>2</sup><sub>1</sub>=0.6</td>
                <td>.43</td>
              </tr>
            </tbody>
          </table>
          <table-wrap-foot>
            <fn id="table2fn1">
              <p><sup>a</sup>OR: odds ratio.</p>
            </fn>
          </table-wrap-foot>
        </table-wrap>
      </sec>
      <sec>
        <title>App Engagement</title>
        <p>The median duration of app use was 52 (IQR 4-95) days. Further, 2 participants used <italic>mysnapp</italic> weekly throughout the 12 months (<xref ref-type="table" rid="table3">Table 3</xref>). Active days ranged from 1 to 117 days, with a median of 5 (IQR 2-10) days. The median number of weeks participants consistently used <italic>mysnapp</italic> from baseline was 1 (IQR 1-2). Of the 62 app users, 60 (97%) opened the goal setting module, 55 (89%) the education module, 39 (63%) the progress tracking module, and 25 (39%) the diary. <xref ref-type="table" rid="table3">Table 3</xref> shows the consistency of app use and how many modules the app users accessed over the entire period of the intervention. Of the 19 app users who had opened 3 of the 4 modules, 17 (89%) had accessed the goal setting, progress tracking, and education modules. Among the 16 who had opened 2 modules, 14 (88%) had accessed the goal setting and education modules.</p>
        <table-wrap position="float" id="table3">
          <label>Table 3</label>
          <caption>
            <p>Consistency of app use and frequency of accessing app modules (n=62).</p>
          </caption>
          <table width="1000" cellpadding="5" cellspacing="0" border="1" rules="groups" frame="hsides">
            <col width="30"/>
            <col width="670"/>
            <col width="0"/>
            <col width="300"/>
            <thead>
              <tr valign="top">
                <td colspan="2">Variables and values</td>
                <td colspan="2">Participants, n (%)</td>
              </tr>
            </thead>
            <tbody>
              <tr valign="top">
                <td colspan="4">
                  <bold>Consistent app use (weeks)</bold>
                </td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">1</td>
                <td>45 (73)</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">2-4</td>
                <td>10 (16)</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">5-19</td>
                <td>5 (8)</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">20-52</td>
                <td>2 (3)</td>
              </tr>
              <tr valign="top">
                <td colspan="4">
                  <bold>Number of modules accessed</bold>
                </td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">0</td>
                <td>1 (2)</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">1</td>
                <td>5 (8)</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">2</td>
                <td>16 (26)</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">3</td>
                <td>19 (31)</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">4</td>
                <td>21 (34)</td>
              </tr>
              <tr valign="top">
                <td colspan="4">
                  <bold>Frequency of accessing the goal setting module</bold>
                </td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">0-3</td>
                <td>54 (87)</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">4-7</td>
                <td>6 (10)</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">8-15</td>
                <td>2 (3)</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">&#62;15</td>
                <td>0 (0)</td>
              </tr>
              <tr valign="top">
                <td colspan="4">
                  <bold>Frequency of accessing the progress tracking module</bold>
                </td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">0-3</td>
                <td>43 (69)</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">4-7</td>
                <td>11 (18)</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">8-15</td>
                <td>6 (10)</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">&#62;15</td>
                <td>2 (3)</td>
              </tr>
              <tr valign="top">
                <td colspan="4">
                  <bold>Frequency of accessing the diary module</bold>
                </td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">0-3</td>
                <td>48 (77)</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">4-7</td>
                <td>5 (8)</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">8-15</td>
                <td>4 (6)</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">&#62;15</td>
                <td>5 (8)</td>
              </tr>
              <tr valign="top">
                <td colspan="4">
                  <bold>Frequency of accessing the education module</bold>
                </td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">0-3</td>
                <td>41 (66)</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">4-7</td>
                <td>12 (19)</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">8-15</td>
                <td>6 (10)</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td colspan="2">&#62;15</td>
                <td>3 (5)</td>
              </tr>
            </tbody>
          </table>
        </table-wrap>
      </sec>
      <sec>
        <title>Association With Other Intervention Components</title>
        <p>The difference in telephone coaching uptake between the app and nonapp users was statistically significant (Freeman-Halton extension of 2-sided Fisher exact test <italic>P</italic>&#60;.001, <xref ref-type="table" rid="table4">Table 4</xref>). The median number of days using <italic>mysnapp</italic> for the app users who completed the telephone coaching was 3.5 (IQR 1-7) days, for the app users who did not complete the telephone coaching it was 7 (IQR 2.5-9.5) days, and for the app users who did not undertake the telephone coaching it was 3.5 (IQR 2-9) days (<xref rid="figure1" ref-type="fig">Figure 1</xref>). The difference in median active days by telephone coaching completion status was not statistically significant (<italic>χ</italic><sup>2</sup><sub>19</sub>=13.2, <italic>P</italic>=.83).</p>
        <table-wrap position="float" id="table4">
          <label>Table 4</label>
          <caption>
            <p>Association of app use with other intervention components (N=120).</p>
          </caption>
          <table width="1000" cellpadding="5" cellspacing="0" border="1" rules="groups" frame="hsides">
            <col width="30"/>
            <col width="270"/>
            <col width="0"/>
            <col width="200"/>
            <col width="200"/>
            <col width="0"/>
            <col width="0"/>
            <col width="300"/>
            <thead>
              <tr valign="top">
                <td colspan="3">Other intervention components and status</td>
                <td>Nonapp users (n =58), n (%)</td>
                <td colspan="2">App users (n=62), n (%)</td>
                <td colspan="2">Test for differences between groups</td>
              </tr>
            </thead>
            <tbody>
              <tr valign="top">
                <td colspan="7">
                  <bold>Telephone coaching program</bold>
                </td>
                <td>Freeman-Halton extension of Fisher exact test (2-tailed) <italic>P</italic>&#60;.001</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td>Not participated</td>
                <td colspan="2">47 (81)</td>
                <td>24 (39)</td>
                <td colspan="3"/>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td>Not completed</td>
                <td colspan="2">8 (14)</td>
                <td>16 (26)</td>
                <td colspan="3"/>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td>Completed</td>
                <td colspan="2">3 (5)</td>
                <td>22 (35)</td>
                <td colspan="3"/>
              </tr>
              <tr valign="top">
                <td colspan="7">
                  <bold>A 6-week health check</bold>
                </td>
                <td>Fisher exact test (2-tailed) <italic>P</italic>=.007</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td>Not attended</td>
                <td colspan="2">54 (93)</td>
                <td>46 (74)</td>
                <td colspan="3"/>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td>Attended</td>
                <td colspan="2">4 (7)</td>
                <td>16 (26)</td>
                <td colspan="3"/>
              </tr>
            </tbody>
          </table>
        </table-wrap>
        <fig id="figure1" position="float">
          <label>Figure 1</label>
          <caption>
            <p>Box plots of the number of days actively using mysnapp depending on the participation in telephone coaching; outliers excluded (two for no telephone coaching: 30 and 105 days, one for not completed: 117 days, and one for completed: 105 days).</p>
          </caption>
          <graphic xlink:href="mhealth_v12i1e45942_fig1.png" alt-version="no" mimetype="image" position="float" xlink:type="simple"/>
        </fig>
        <p>The difference in the attendance rate of the 6-week health check between app users and nonusers was significant (2-sided Fisher exact test <italic>P</italic>=.007, <xref ref-type="table" rid="table4">Table 4</xref>). Those app users who attended the 6-week health check with the practice nurse did not have significantly more active days using <italic>mysnapp</italic> (median active days for 6-week health check attendees: 6, IQR 2-10 days, and for nonattendees: 4, IQR 2-10 days; <italic>W</italic>=374, <italic>P</italic>=.46).</p>
      </sec>
      <sec>
        <title>Impact of App Use and App Engagement on Behavioral and Biomedical Outcome Measures</title>
        <p>Differences in outcome measures between app users and nonusers, and app engagement were not significant (<xref ref-type="table" rid="table5">Tables 5</xref> and <xref ref-type="table" rid="table6">6</xref>) for study outcomes which were shown to be significantly improved at 6 months (ie, health literacy and diet).</p>
        <table-wrap position="float" id="table5">
          <label>Table 5</label>
          <caption>
            <p>Health literacy and diet score at 2 time points for app and nonapp users, test for significant changes, and sensitivity analysis.</p>
          </caption>
          <table width="1000" cellpadding="5" cellspacing="0" border="1" rules="groups" frame="hsides">
            <col width="30"/>
            <col width="270"/>
            <col width="130"/>
            <col width="130"/>
            <col width="0"/>
            <col width="130"/>
            <col width="130"/>
            <col width="0"/>
            <col width="180"/>
            <thead>
              <tr valign="top">
                <td colspan="2">Outcome variable and measure</td>
                <td colspan="3">App users (n=62)</td>
                <td colspan="3">Nonapp users (n=58)</td>
                <td>Test statistic<sup>a</sup></td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td>
                  <break/>
                </td>
                <td>Baseline</td>
                <td>6 months</td>
                <td colspan="2">Baseline</td>
                <td>6 months</td>
                <td colspan="2">
                  <break/>
                </td>
              </tr>
            </thead>
            <tbody>
              <tr valign="top">
                <td colspan="9">
                  <bold>HLQ<sup>b</sup> domain 8</bold>
                </td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td>Data available, n (%)</td>
                <td>52 (84)</td>
                <td>44 (76)</td>
                <td colspan="2">50 (86)</td>
                <td>20 (34)</td>
                <td colspan="2">N/A<sup>c</sup></td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td>Median (IQR)</td>
                <td>4 (4-5)</td>
                <td>4 (4-5)</td>
                <td colspan="2">4 (4-4)</td>
                <td>4 (4-5)</td>
                <td colspan="2"><italic>W</italic>=230.5, <italic>P</italic>=.10</td>
              </tr>
              <tr valign="top">
                <td colspan="9">
                  <bold>Diet score</bold>
                </td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td>Data available, n (%)</td>
                <td>57 (92)</td>
                <td>54 (93)</td>
                <td colspan="2">46 (74)</td>
                <td>20 (34)</td>
                <td colspan="2">N/A</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td>Mean (SD)</td>
                <td>3 (2-5)</td>
                <td>4 (4-5)</td>
                <td colspan="2">3 (2-4)</td>
                <td>4 (3-5)</td>
                <td colspan="2">t<sub>36</sub><italic>=</italic>0.32, <italic>P</italic>=.37</td>
              </tr>
            </tbody>
          </table>
          <table-wrap-foot>
            <fn id="table5fn1">
              <p><sup>a</sup>Test for greater change in app users versus nonapp users from baseline to 6 months.</p>
            </fn>
            <fn id="table5fn2">
              <p><sup>b</sup>HLQ: Health Literacy Questionnaire.</p>
            </fn>
            <fn id="table5fn3">
              <p><sup>c</sup>N/A: not applicable.</p>
            </fn>
          </table-wrap-foot>
        </table-wrap>
        <table-wrap position="float" id="table6">
          <label>Table 6</label>
          <caption>
            <p>Correlation between app engagement and change in health literacy or diet score.</p>
          </caption>
          <table width="1000" cellpadding="5" cellspacing="0" border="1" rules="groups" frame="hsides">
            <col width="30"/>
            <col width="570"/>
            <col width="400"/>
            <thead>
              <tr valign="top">
                <td colspan="2">Outcome variable and measure for app use</td>
                <td>Test statistics for differences</td>
              </tr>
            </thead>
            <tbody>
              <tr valign="top">
                <td colspan="3">
                  <bold>HLQ<sup>a</sup> domain 8</bold>
                </td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td>Active days</td>
                <td><italic>z</italic>=–0.24, <italic>P</italic>=.81, τ=–0.03</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td>Consistent app use</td>
                <td><italic>z</italic>=0.43, <italic>P</italic>=.67, τ=0.06</td>
              </tr>
              <tr valign="top">
                <td colspan="3">
                  <bold>Diet score</bold>
                </td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td>Active days</td>
                <td><italic>z</italic>=0.55, <italic>P</italic>=.58, τ=0.07</td>
              </tr>
              <tr valign="top">
                <td>
                  <break/>
                </td>
                <td>Consistent app use</td>
                <td><italic>z</italic>=0.43, <italic>P</italic>=.67, τ=0.06</td>
              </tr>
            </tbody>
          </table>
          <table-wrap-foot>
            <fn id="table6fn1">
              <p><sup>a</sup>HLQ: Health Literacy Questionnaire.</p>
            </fn>
          </table-wrap-foot>
        </table-wrap>
      </sec>
    </sec>
    <sec sec-type="discussion">
      <title>Discussion</title>
      <sec>
        <title>Principal Results</title>
        <p>The overall aim of this study was to assess <italic>mysnapp</italic> app use within the HeLP-GP trial and its association with study outcomes shown to have significantly improved (health literacy and diet) at 6 months. With regard to the specific objectives, (1) there were no significant differences in demographics between participants who used <italic>mysnapp</italic> and those who did not; (2) among app users, the median duration of app use was 52 days, with a median of 5 active days; (3) more participants who chose to use <italic>mysnapp</italic> also attended the 6-week health check with the practice nurse and opted for telephone coaching; and (4) there was no association between app use and study outcomes shown to have significantly improved (health literacy and diet) at 6 months.</p>
      </sec>
      <sec>
        <title>Length and Frequency of App Use and Module Access</title>
        <p>Turner-McGrievy et al [<xref ref-type="bibr" rid="ref34">34</xref>] aimed to identify the best criteria for defining adherence to dietary self-monitoring with mobile devices when predicting weight loss. They found that adherence, defined as the number of days participants tracked at least 2 meal times, explained the most variance in weight loss at 6 months [<xref ref-type="bibr" rid="ref34">34</xref>]. We were not able to measure this because the diary, available for recording meals, could also be used for other reasons such as activities, appointments, plans for the future, and thoughts about progress. In the study by Jacobs et al [<xref ref-type="bibr" rid="ref35">35</xref>], they analyzed data from 7680 users of a commercial weight loss app; high adherence to self-monitoring (ie, logging at least 1 food event within a reasonable time after a meal) was associated with increased weight loss. However, they also found that app users with higher adherence rates had significantly lower body weight at baseline than those with lower adherence rates [<xref ref-type="bibr" rid="ref35">35</xref>]. The analysis only comprised people who entered data in the app at least once a week for 12 weeks. In our study, 4.9% (n=3) of the app users were still entering data at week 12. Analyzing data from the same commercial app, Carey et al [<xref ref-type="bibr" rid="ref36">36</xref>] found significant differences in 7 different engagement measures (ie, number of articles read, meals logged, steps recorded, messages to coach, exercise logged, weigh-ins, and days with 1 meal logged per week) between app users with moderate or high weight loss (ie, 5%-10% or &#62;10% body weight loss, respectively) and individuals with no change in body weight (ie, ±1% body weight). Their analysis indicated that people with moderate to high weight loss engaged with all app sections [<xref ref-type="bibr" rid="ref36">36</xref>]. In our study, only 34% (n=21) of the app users had accessed all of the modules.</p>
      </sec>
      <sec>
        <title>Impact of App Use and App Engagement on Behavioral and Biomedical Outcome Measures</title>
        <p>Other studies showed promising results for weight loss apps, for example, Carter et al [<xref ref-type="bibr" rid="ref37">37</xref>], Patel et al [<xref ref-type="bibr" rid="ref5">5</xref>], and Antoun et al [<xref ref-type="bibr" rid="ref38">38</xref>]. Specifically, Carter et al [<xref ref-type="bibr" rid="ref37">37</xref>] conducted a pilot study of 128 volunteers who are overweight comparing a smartphone app (My Meal Mate) with a website and paper diary. They found the mean weight loss over 6 months for the app was higher (4.6 kg, 95% CI 3.0-6.2) than for the diary group (2.9 kg, 95% CI 1.1-4.7) or the website group (1.3 kg, 95% CI 0.1-2.7). Antoun et al [<xref ref-type="bibr" rid="ref38">38</xref>] in their review of 34 studies that evaluated the use of smartphones for weight loss found an overall mean loss of 2.8 kg (95% CI 2.6-3.0) at 6 months. Patel et al [<xref ref-type="bibr" rid="ref5">5</xref>] found that consistent tracking was associated with greater weight loss than inconsistent tracking at 6 months (2.1 kg, 95% CI 0.3-4.0). A difference between these studies and ours was that they did not specifically target disadvantaged populations with low health literacy. Therefore, their apps were more complex than ours. In contrast, Lanpher et al [<xref ref-type="bibr" rid="ref39">39</xref>] developed a weight loss intervention suitable for individuals with low health literacy. A computer algorithm automatically allocated the self-monitoring goals (eg, no sugary drinks, no snacking after dinner, eating 5 fruits and vegetables a week). Participants reported whether they achieved the goals via interactive voice response calls [<xref ref-type="bibr" rid="ref39">39</xref>]. The algorithm decided which goals to assign next based on previous adherence to goals so that individuals would rather receive goals to which they were receptive [<xref ref-type="bibr" rid="ref40">40</xref>]. They also received tailored skills training through verbal calls and materials, one-on-one counseling calls, and a membership at the gym [<xref ref-type="bibr" rid="ref39">39</xref>]. The results showed that the intervention group maintained or lost weight over 12 months, independent of their level of health literacy [<xref ref-type="bibr" rid="ref38">38</xref>].</p>
        <p>Bennett et al [<xref ref-type="bibr" rid="ref40">40</xref>] extended the intervention to comprise a mobile app. They evaluated its effectiveness in a randomized controlled trial including socioeconomically disadvantaged patients with increased cardiovascular risk by comparing the intervention to usual care [<xref ref-type="bibr" rid="ref40">40</xref>]. The app used interactive voice responses or text messaging to simplify self-monitoring, like in the previous study. Additionally, participants received in-person coaching and personalized feedback messages immediately after entering data [<xref ref-type="bibr" rid="ref40">40</xref>]. The intervention group achieved meaningful weight loss, with more than 40% of participants reducing their body weight by at least 5% compared to 17% of participants in the usual care group [<xref ref-type="bibr" rid="ref39">39</xref>]. Comparing this intervention to ours raises the question of whether the way people had to select and track their goals in our app contributed to the low engagement and the nonsignificant findings. Locke and Latham [<xref ref-type="bibr" rid="ref41">41</xref>] explained that goal commitment, goal importance, self-efficacy, feedback, and task complexity act as moderators between goals and performance. Potentially, the app did not sufficiently address all 5 moderators.</p>
      </sec>
      <sec>
        <title>Association With Other Intervention Components</title>
        <p>This study showed that <italic>mysnapp</italic> users were more likely to attend the 6-week face-to-face health check with the practice nurse and to participate in the telephone coaching program than nonusers. Potentially, these individuals were more motivated to lose weight and, therefore, more willing to engage in the other intervention components. Another explanation could be that participants who opted for several intervention components felt more committed to study participation and, therefore, made more use of the individual intervention components. Griauzde et al [<xref ref-type="bibr" rid="ref42">42</xref>] proposed a similar hypothesis in their mobile health–based prediabetes intervention study; they assumed that participants who received a more robust intervention were more committed to the study and subsequently more likely to complete the 12-week survey. Hutchesson et al [<xref ref-type="bibr" rid="ref43">43</xref>] concluded that adding nondigital components, such as face-to-face visits and telephone coaching, to mobile health interventions can improve participants’ accountability even though these additional features may not be necessary for the intervention’s effectiveness.</p>
      </sec>
      <sec>
        <title>Limitations</title>
        <p>The plan for the randomized controlled trial was to recruit 800 study participants; however, only 215 individuals were able to be recruited (120 in the intervention and 95 in the control group) [<xref ref-type="bibr" rid="ref13">13</xref>]. Further, despite targeting low socioeconomic areas, this study failed to recruit many participants with low health literacy. One needs to be cautious when interpreting the results of this study due to the small sample size and the high dropout. Despite considerable efforts and additional time to recruit participating practices and patients, the anticipated sample size was not achieved. Research by Perkins et al [<xref ref-type="bibr" rid="ref44">44</xref>] has shown an ongoing issue with recruitment through Australian general practices. Another problem with the study was that the uptake of intervention components was determined by the clinician and patient. Thus, some chose to just have the app and others to just have the phone coaching. Additionally, the study may not be generalizable to other settings. Since recruitment was from 2 Australian urban areas, results could differ in rural areas or other urban areas. Diet score and health literacy level were self-reported, posing a risk of bias. Further, caution is required when interpreting the results in the context of low health literacy because the baseline health literacy levels were higher than anticipated [<xref ref-type="bibr" rid="ref12">12</xref>]. According to data from the National Health Survey 2018, the health literacy level in this study’s sample was comparable to that of Australians who are overweight or those with obesity in the general population [<xref ref-type="bibr" rid="ref45">45</xref>]. A potential explanation is that this study’s requirements (randomization, completing the questionnaire, and undertaking the health check) stopped people with low health literacy from participating. This rationale is in line with results from Kripalani et al [<xref ref-type="bibr" rid="ref46">46</xref>], who found that people with low health literacy or numeracy were significantly less interested in participating in research.</p>
      </sec>
      <sec>
        <title>Conclusions</title>
        <p>There was no association between app use and study outcomes shown to have significantly improved (health literacy and diet) at 6 months. Recruitment and engagement were difficult for this study in disadvantaged populations with low health literacy. A potential explanation could be related to the self-selection of the goals and the weekly submission of the goal achievements. The practice nurses assisted participants at the beginning with the selection of goals. However, these may not have been relevant to participants, and nurses did not receive specific training in selecting meaningful goals for individuals.</p>
        <p>However, app users were more likely to attend the 6-week health check and participate in telephone coaching, suggesting that participants who opted for several intervention components felt more committed to this study.</p>
      </sec>
    </sec>
  </body>
  <back>
    <app-group>
      <supplementary-material id="app1">
        <label>Multimedia Appendix 1</label>
        <p>CONSORT-eHEALTH checklist (V 1.6.1).</p>
        <media xlink:href="mhealth_v12i1e45942_app1.pdf" xlink:title="PDF File  (Adobe PDF File), 1102 KB"/>
      </supplementary-material>
    </app-group>
    <glossary>
      <title>Abbreviations</title>
      <def-list>
        <def-item>
          <term id="abb1">GP</term>
          <def>
            <p>general practice</p>
          </def>
        </def-item>
        <def-item>
          <term id="abb2">HeLP-GP</term>
          <def>
            <p>Health eLiteracy for Prevention in General Practice</p>
          </def>
        </def-item>
      </def-list>
    </glossary>
    <ack>
      <p>The authors would like to acknowledge the contribution to this research by An Tran, Carmel McNamara, Elizabeth Denney-Wilson, Katrina Paine, and Shoko Saito. We also acknowledge Louise Thomas for contributing to the trial protocol and early development. We are grateful for the partnership and support of the South Western Sydney, Adelaide and Nepean and Blue Mountains Primary Health Networks and the Australian Institute of Health Innovation. We would like to acknowledge the general practices and their staff and patients for participating in the research and consumers affiliated with Adelaide PHN for piloting <italic>mysnapp</italic>. This work was supported by the National Health and Medical Research Council of Australia (grant APP1125681, 2017).</p>
    </ack>
    <fn-group>
      <fn fn-type="conflict">
        <p>None declared.</p>
      </fn>
    </fn-group>
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