<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02996864</url>
  </required_header>
  <id_info>
    <org_study_id>0304</org_study_id>
    <secondary_id>2R44DP004995</secondary_id>
    <nct_id>NCT02996864</nct_id>
  </id_info>
  <brief_title>Location-based Smartphone Technology to Guide College Students Healthy Choices Ph II</brief_title>
  <official_title>Location-based Smartphone Technology to Guide College Students Healthy Choices Phase II</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Klein Buendel, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Klein Buendel, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      College students are in a newly independent phase of life; many of whom encounter unhealthy&#xD;
      dietary decision- making, barriers to physical activity, and poor sleep behaviors. Healthy&#xD;
      Detours is a location-based smartphone application tailored in real-time to a student's&#xD;
      schedule and locale, and aims to guide students toward healthier eating, exercise, and&#xD;
      lifestyle choices as a way to prevent the onset of damaging and costly health outcomes.&#xD;
      Through a randomized control trial, this Phase II project will test the effectiveness of an&#xD;
      evidence-based smartphone application that will provide students with on-demand,&#xD;
      location-specific information about healthy lifestyle choices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Poor eating habits, sedentary behavior, and deficient sleep quality are problematic for many&#xD;
      college students. Surrounded by numerous unhealthy food choices and physical activity&#xD;
      barriers, students are vulnerable to overweight and chronic diseases such as diabetes, heart&#xD;
      disease, and cancer. Today's college students are more technologically connected than&#xD;
      previous generations positioning mobile devices as an ideal method for reaching this&#xD;
      population with healthy lifestyle information. In a Phase I Small Business Innovation&#xD;
      Research (SBIR), our team developed Healthy Detours, an innovative mobile phone application&#xD;
      (app) designed to assist college students make healthier choices about food and physical&#xD;
      activity on and around their college campus. Specifically, we (a) developed a comprehensive&#xD;
      database to provide user-specific information through the use of location-based services&#xD;
      (LBS) focused on healthy lifestyle choices; (b) conducted an online survey with a national&#xD;
      sample of undergraduates which examined eating and physical activity preferences, interest in&#xD;
      smartphone technology to monitor healthy lifestyle choices, and use of &quot;check-ins&quot; for health&#xD;
      information; (c) conducted focus groups which demonstrated the prototype app's ability to&#xD;
      provide the user with rudimentary aspects of the LBS database to facilitate real-time&#xD;
      decision making for healthier choices; (d) conducted lab and field usability testing of the&#xD;
      app for its accuracy in identifying user location and functionality; and (e) developed a&#xD;
      specifications document to outline the Phase II development plan. The results of the Phase I&#xD;
      activities provided strong support for this project in which we propose to develop an&#xD;
      interactive, mobile app that is guided by the Theory of Planned Behavior (TPB) and Social&#xD;
      Cognitive Theory (SCT). This project will produce a fully functional LBS smartphone app that&#xD;
      will provide (1) immediate and relevant feedback at the point of decision-making to reinforce&#xD;
      healthy lifestyle behaviors, (2) person- and location-specific tailored data, acquired&#xD;
      through activity tracking, to provide users with necessary information to improve future&#xD;
      decision-making, and (3) multiple health-tracking features that will aid in self-monitoring.&#xD;
      Healthy Detours will be evaluated in a randomized controlled trial (n=300) with students at a&#xD;
      large 4-year university. Primary outcomes include changes in dietary intake, physical&#xD;
      activity behavior, sleep quality, and quality of life. Overall, the proposed project has the&#xD;
      potential to significantly impact college students' health and quality of life by providing&#xD;
      them with real-time healthy choices. Healthy Detours is one of the first comprehensive&#xD;
      wellness apps offered to college students, and provides an opportunity via the SBIR funding&#xD;
      mechanism to reach a large number of students as evidenced by the commercialization plan.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 30, 2015</start_date>
  <completion_date type="Actual">February 28, 2018</completion_date>
  <primary_completion_date type="Actual">February 28, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Healthy Eating Index (HEI)</measure>
    <time_frame>Baseline</time_frame>
    <description>The National Cancer Institute's Automated Self-Administered 24-hour Recall (ASA24) will be administered at baseline (pre-test) to calculate the Healthy Eating Index (HEI). The ASA24 measures food intake for 24 hours and calculates the HEI. Scores for the HEI range from 0 to 100. A higher score represents a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Healthy Eating Index (HEI)</measure>
    <time_frame>6 weeks</time_frame>
    <description>The National Cancer Institute's Automated Self-Administered 24-hour Recall (ASA24) will be administered at 6-weeks) to calculate the Healthy Eating Index (HEI). The ASA24 measures food intake for 24 hours and calculates the HEI. Scores for the HEI range from 0 to 100. A higher score represents a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Healthy Eating Index (HEI)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The National Cancer Institute's Automated Self-Administered 24-hour Recall (ASA24) will be administered at 12 weeks to calculate the Healthy Eating Index (HEI). The ASA24 measures food intake for 24 hours and calculates the HEI. Scores for the HEI range from 0 to 100. A higher score represents a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>International Physical Activity Questionnaire Short-form (IPAQ-SF)</measure>
    <time_frame>Baseline</time_frame>
    <description>A nine-item International Physical Activity Questionnaire Short-form (IPAQ-SF) will be administered at baseline. The IPAQ-SF calculates the MET-minutes per week expended. MET minutes represent the amount of energy expended carrying out physical activity. A higher score represents a better outcome. Scores can range from 0 to 10,080.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Measures</measure>
    <time_frame>6 weeks</time_frame>
    <description>A nine-item International Physical Activity Questionnaire Short-form (IPAQ-SF) will be administered at 6 weeks. The IPAQ-SF calculates the MET minutes per week expended. MET minutes represent the amount of energy expended carrying out physical activity. A higher score represents a better outcome. Scores can range from 0 to 10,080.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Physical Activity Questionnaire Short-form (IPAQ-SF)</measure>
    <time_frame>12 weeks</time_frame>
    <description>A nine-item International Physical Activity Questionnaire Short-form (IPAQ-SF) will be administered at 12 weeks. The IPAQ-SF calculates the MET minutes per week expended. MET minutes represent the amount of energy expended carrying out physical activity. A higher score represents a better outcome. Scores can range from 0 to 10,080.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>Baseline</time_frame>
    <description>The Pittsburgh Sleep Quality Index (PSQI) will be administered at baseline (pre-test). The measure consists of 19 individual items that are used to calculate 7 component score and one composite score. Each item is weighted on a 0-3 interval scale. The composite score is calculated by totaling the seven component scores. The composite score ranges 0 to 21. A lower means healthier sleep quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>6 weeks</time_frame>
    <description>The The Pittsburgh Sleep Quality Index (PSQI) will be administered at 6 weeks. The measure consists of 19 individual items that are used to calculate 7 component score and one composite score. Each item is weighted on a 0-3 interval scale. The composite score is calculated by totaling the seven component scores. The composite score ranges 0 to 21. A lower means healthier sleep quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>12 weeks</time_frame>
    <description>The The Pittsburgh Sleep Quality Index (PSQI) will be administered at 12 weeks (post-test). The measure consists of 19 individual items that are used to calculate 7 component score and one composite score. Each item is weighted on a 0-3 interval scale. The composite score is calculated by totaling the seven component scores. The composite score ranges 0 to 21. A lower means healthier sleep quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QOL)</measure>
    <time_frame>Baseline</time_frame>
    <description>The 12-Item Short Form Health Survey (SF-12) will be administered at baseline (pre-test). The SF-12 survey contains categorical questions (e.g., yes/no) that assess limitations in role functioning. The survey also contains Likert response formats on a three-point scale (e.g., not at all, a little bit, moderately, quite a bit, and extremely) to assess pain, and a five-point scale to assesses overall health (excellent, very good, good, fair, and poor). A six-point scale (e.g., all of the time, most of the time, a good bit of the time, some of the time, a little of the time, and none of the time) assesses mental health, vitality, and social functioning. The SF-12 is scored using the recommended Medical Outcomes Study (MOS) SAS software program that creates two summary scores, mental health (MCS12), and physical health (PCS12). The scores are represented as t-scores that are linear transformations with a mean of 50 and a standard deviation of 10 in the general U.S. population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QOL)</measure>
    <time_frame>6 weeks</time_frame>
    <description>The 12-Item Short Form Health Survey (SF-12) survey contains categorical questions (e.g., yes/no) that assess limitations in role functioning. The survey also contains Likert response formats on a three-point scale (e.g., not at all, a little bit, moderately, quite a bit, and extremely) to assess pain, and a five-point scale to assesses overall health (excellent, very good, good, fair, and poor). A six-point scale (e.g., all of the time, most of the time, a good bit of the time, some of the time, a little of the time, and none of the time) assesses mental health, vitality, and social functioning. The SF-12 is scored using the recommended Medical Outcomes Study (MOS) SAS software program that creates two summary scores, mental health (MCS12), and physical health (PCS12). The scores are represented as t-scores that are linear transformations with a mean of 50 and a standard deviation of 10 in the general U.S. population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QOL)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The 12-Item Short Form Health Survey (SF-12) survey contains categorical questions (e.g., yes/no) that assess limitations in role functioning. The survey also contains Likert response formats on a three-point scale (e.g., not at all, a little bit, moderately, quite a bit, and extremely) to assess pain, and a five-point scale to assesses overall health (excellent, very good, good, fair, and poor). A six-point scale (e.g., all of the time, most of the time, a good bit of the time, some of the time, a little of the time, and none of the time) assesses mental health, vitality, and social functioning. The SF-12 is scored using the recommended Medical Outcomes Study (MOS) SAS software program that creates two summary scores, mental health (MCS12), and physical health (PCS12). The scores are represented as t-scores that are linear transformations with a mean of 50 and a standard deviation of 10 in the general U.S. population.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Overweight and Obesity</condition>
  <condition>Health Behavior</condition>
  <condition>Sleep Deprivation</condition>
  <arm_group>
    <arm_group_label>Healthy Detours App</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fat Secret App</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be encouraged to use the FatSecret application daily to track food and physical activity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Healthy Detours App</intervention_name>
    <description>The app features:&#xD;
Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.&#xD;
User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.&#xD;
Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring.</description>
    <arm_group_label>Healthy Detours App</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fat Secret App</intervention_name>
    <description>Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.</description>
    <arm_group_label>Fat Secret App</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18-29&#xD;
&#xD;
          -  enrolled in a university or college on the Denver Auraria campus or Louisiana State&#xD;
             University (LSU) campus&#xD;
&#xD;
          -  own a smartphone&#xD;
&#xD;
          -  able to speak and read English; and&#xD;
&#xD;
          -  consent to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under age of 18 years&#xD;
&#xD;
          -  not a current student at any Denver Auraria campus or at LSU&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Valerie Myers, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klein Buendel, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klein Buendel, Inc.</name>
      <address>
        <city>Golden</city>
        <state>Colorado</state>
        <zip>80401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pennington Biomedical Research Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Cluskey M, Grobe D. College weight gain and behavior transitions: male and female differences. J Am Diet Assoc. 2009 Feb;109(2):325-9. doi: 10.1016/j.jada.2008.10.045.</citation>
    <PMID>19167962</PMID>
  </reference>
  <reference>
    <citation>Ferrara CM. The College Experience: Physical Activity, Nutrition, and Implications for Intervention and Future Research. Journal of Exercise Physiology online. 2009;12(1):23-35.</citation>
  </reference>
  <reference>
    <citation>Hanson TL, Drumheller K, Mallard J, McKee C, Schlegel P. Cell phones, text messaging, and Facebook: competing time demands of today's college students. College Teaching. 2010;59(1):23-30.</citation>
  </reference>
  <reference>
    <citation>Gaultney JF. The prevalence of sleep disorders in college students: impact on academic performance. J Am Coll Health. 2010;59(2):91-7. doi: 10.1080/07448481.2010.483708.</citation>
    <PMID>20864434</PMID>
  </reference>
  <reference>
    <citation>Laska MN, Pelletier JE, Larson NI, Story M. Interventions for weight gain prevention during the transition to young adulthood: a review of the literature. J Adolesc Health. 2012 Apr;50(4):324-33. doi: 10.1016/j.jadohealth.2012.01.016.</citation>
    <PMID>22443834</PMID>
  </reference>
  <reference>
    <citation>Li KK, Concepcion RY, Lee H, Cardinal BJ, Ebbeck V, Woekel E, Readdy RT. An examination of sex differences in relation to the eating habits and nutrient intakes of university students. J Nutr Educ Behav. 2012 May-Jun;44(3):246-50. doi: 10.1016/j.jneb.2010.10.002. Epub 2011 Jul 18.</citation>
    <PMID>21764641</PMID>
  </reference>
  <reference>
    <citation>Lloyd-Richardson EE, Bailey S, Fava JL, Wing R; Tobacco Etiology Research Network (TERN). A prospective study of weight gain during the college freshman and sophomore years. Prev Med. 2009 Mar;48(3):256-61. doi: 10.1016/j.ypmed.2008.12.009. Epub 2008 Dec 24.</citation>
    <PMID>19146870</PMID>
  </reference>
  <reference>
    <citation>Strong KA, Parks SL, Anderson E, Winett R, Davy BM. Weight gain prevention: identifying theory-based targets for health behavior change in young adults. J Am Diet Assoc. 2008 Oct;108(10):1708-1715. doi: 10.1016/j.jada.2008.07.007.</citation>
    <PMID>18926139</PMID>
  </reference>
  <reference>
    <citation>Racette SB, Deusinger SS, Strube MJ, Highstein GR, Deusinger RH. Weight changes, exercise, and dietary patterns during freshman and sophomore years of college. J Am Coll Health. 2005 May-Jun;53(6):245-51. doi: 10.3200/JACH.53.6.245-251.</citation>
    <PMID>15900988</PMID>
  </reference>
  <reference>
    <citation>Zick CD, Smith KR, Brown BB, Fan JX, Kowaleski-Jones L. Physical activity during the transition from adolescence to adulthood. J Phys Act Health. 2007 Apr;4(2):125-37. doi: 10.1123/jpah.4.2.125.</citation>
    <PMID>17570883</PMID>
  </reference>
  <reference>
    <citation>Yeh MC, Matsumori B, Obenchain J, Viladrich A, Das D, Navder K. Validity of a competing food choice construct regarding fruit and vegetable consumption among urban college freshmen. J Nutr Educ Behav. 2010 Sep-Oct;42(5):321-7. doi: 10.1016/j.jneb.2009.08.004. Epub 2010 Jul 22.</citation>
    <PMID>20655281</PMID>
  </reference>
  <reference>
    <citation>Salcedo Aguilar F, Rodriguez Almonacid FM, Monterde Aznar ML, Garcia Jimenez MA, Redondo Martinez P, Marcos Navarro AI. [Sleeping habits and sleep disorders during adolescence: relation to school performance]. Aten Primaria. 2005 May 15;35(8):408-14. doi: 10.1157/13074792. Spanish.</citation>
    <PMID>15882497</PMID>
  </reference>
  <reference>
    <citation>Curcio G, Ferrara M, De Gennaro L. Sleep loss, learning capacity and academic performance. Sleep Med Rev. 2006 Oct;10(5):323-37. doi: 10.1016/j.smrv.2005.11.001. Epub 2006 Mar 24.</citation>
    <PMID>16564189</PMID>
  </reference>
  <reference>
    <citation>Trockel MT, Barnes MD, Egget DL. Health-related variables and academic performance among first-year college students: implications for sleep and other behaviors. J Am Coll Health. 2000 Nov;49(3):125-31. doi: 10.1080/07448480009596294.</citation>
    <PMID>11125640</PMID>
  </reference>
  <reference>
    <citation>Kwan M, Faulkner G. Perceptions and barriers to physical activity during the transition to university. American Journal of Health Studies. 2011;26:87-96.</citation>
  </reference>
  <reference>
    <citation>Wengreen HJ, Moncur C. Change in diet, physical activity, and body weight among young-adults during the transition from high school to college. Nutr J. 2009 Jul 22;8:32. doi: 10.1186/1475-2891-8-32.</citation>
    <PMID>19624820</PMID>
  </reference>
  <reference>
    <citation>Hoffman DJ, Policastro P, Quick V, Lee SK. Changes in body weight and fat mass of men and women in the first year of college: A study of the &quot;freshman 15&quot;. J Am Coll Health. 2006 Jul-Aug;55(1):41-5. doi: 10.3200/JACH.55.1.41-46.</citation>
    <PMID>16889314</PMID>
  </reference>
  <reference>
    <citation>Kopelman P. Health risks associated with overweight and obesity. Obes Rev. 2007 Mar;8 Suppl 1:13-7. doi: 10.1111/j.1467-789X.2007.00311.x. No abstract available.</citation>
    <PMID>17316295</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <results_first_submitted>July 25, 2018</results_first_submitted>
  <results_first_submitted_qc>July 6, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 8, 2021</results_first_posted>
  <last_update_submitted>February 2, 2023</last_update_submitted>
  <last_update_submitted_qc>February 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>college students</keyword>
  <keyword>physical activity</keyword>
  <keyword>sleep behaviors</keyword>
  <keyword>diet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Deprivation</mesh_term>
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 16, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT02996864/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 16, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT02996864/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Healthy Detours App</title>
          <description>Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep.&#xD;
Healthy Detours App: The app features:&#xD;
Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.&#xD;
User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.&#xD;
Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring.</description>
        </group>
        <group group_id="P2">
          <title>Fat Secret App</title>
          <description>Participants will be encouraged to use the FatSecret application daily to track food and physical activity.&#xD;
Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="150"/>
                <participants group_id="P2" count="150"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="142"/>
                <participants group_id="P2" count="136"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Healthy Detours App</title>
          <description>Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep.&#xD;
Healthy Detours App: The app features:&#xD;
Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.&#xD;
User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.&#xD;
Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring.</description>
        </group>
        <group group_id="B2">
          <title>Fat Secret App</title>
          <description>Participants will be encouraged to use the FatSecret application daily to track food and physical activity.&#xD;
Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="150"/>
            <count group_id="B2" value="150"/>
            <count group_id="B3" value="300"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.29" spread="2.66"/>
                    <measurement group_id="B2" value="21.97" spread="3.03"/>
                    <measurement group_id="B3" value="21.63" spread="2.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="112"/>
                    <measurement group_id="B2" value="104"/>
                    <measurement group_id="B3" value="216"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="109"/>
                    <measurement group_id="B2" value="106"/>
                    <measurement group_id="B3" value="215"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="150"/>
                    <measurement group_id="B2" value="150"/>
                    <measurement group_id="B3" value="300"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Healthy Eating Index (HEI)</title>
        <description>The National Cancer Institute's Automated Self-Administered 24-hour Recall (ASA24) will be administered at baseline (pre-test) to calculate the Healthy Eating Index (HEI). The ASA24 measures food intake for 24 hours and calculates the HEI. Scores for the HEI range from 0 to 100. A higher score represents a better outcome.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Detours App</title>
            <description>Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep.&#xD;
Healthy Detours App: The app features:&#xD;
Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.&#xD;
User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.&#xD;
Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring.</description>
          </group>
          <group group_id="O2">
            <title>Fat Secret App</title>
            <description>Participants will be encouraged to use the FatSecret application daily to track food and physical activity.&#xD;
Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.</description>
          </group>
        </group_list>
        <measure>
          <title>Healthy Eating Index (HEI)</title>
          <description>The National Cancer Institute's Automated Self-Administered 24-hour Recall (ASA24) will be administered at baseline (pre-test) to calculate the Healthy Eating Index (HEI). The ASA24 measures food intake for 24 hours and calculates the HEI. Scores for the HEI range from 0 to 100. A higher score represents a better outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="147"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.6" spread="15.1"/>
                    <measurement group_id="O2" value="53.8" spread="14.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Healthy Eating Index (HEI)</title>
        <description>The National Cancer Institute's Automated Self-Administered 24-hour Recall (ASA24) will be administered at 6-weeks) to calculate the Healthy Eating Index (HEI). The ASA24 measures food intake for 24 hours and calculates the HEI. Scores for the HEI range from 0 to 100. A higher score represents a better outcome.</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Detours App</title>
            <description>Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep.&#xD;
Healthy Detours App: The app features:&#xD;
Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.&#xD;
User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.&#xD;
Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring.</description>
          </group>
          <group group_id="O2">
            <title>Fat Secret App</title>
            <description>Participants will be encouraged to use the FatSecret application daily to track food and physical activity.&#xD;
Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.</description>
          </group>
        </group_list>
        <measure>
          <title>Healthy Eating Index (HEI)</title>
          <description>The National Cancer Institute's Automated Self-Administered 24-hour Recall (ASA24) will be administered at 6-weeks) to calculate the Healthy Eating Index (HEI). The ASA24 measures food intake for 24 hours and calculates the HEI. Scores for the HEI range from 0 to 100. A higher score represents a better outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.9" spread="16.4"/>
                    <measurement group_id="O2" value="52.3" spread="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Healthy Eating Index (HEI)</title>
        <description>The National Cancer Institute's Automated Self-Administered 24-hour Recall (ASA24) will be administered at 12 weeks to calculate the Healthy Eating Index (HEI). The ASA24 measures food intake for 24 hours and calculates the HEI. Scores for the HEI range from 0 to 100. A higher score represents a better outcome.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Detours App</title>
            <description>Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep.&#xD;
Healthy Detours App: The app features:&#xD;
Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.&#xD;
User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.&#xD;
Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring.</description>
          </group>
          <group group_id="O2">
            <title>Fat Secret App</title>
            <description>Participants will be encouraged to use the FatSecret application daily to track food and physical activity.&#xD;
Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.</description>
          </group>
        </group_list>
        <measure>
          <title>Healthy Eating Index (HEI)</title>
          <description>The National Cancer Institute's Automated Self-Administered 24-hour Recall (ASA24) will be administered at 12 weeks to calculate the Healthy Eating Index (HEI). The ASA24 measures food intake for 24 hours and calculates the HEI. Scores for the HEI range from 0 to 100. A higher score represents a better outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="141"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.3" spread="15.2"/>
                    <measurement group_id="O2" value="52.1" spread="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>International Physical Activity Questionnaire Short-form (IPAQ-SF)</title>
        <description>A nine-item International Physical Activity Questionnaire Short-form (IPAQ-SF) will be administered at baseline. The IPAQ-SF calculates the MET-minutes per week expended. MET minutes represent the amount of energy expended carrying out physical activity. A higher score represents a better outcome. Scores can range from 0 to 10,080.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Detours App</title>
            <description>Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep.&#xD;
Healthy Detours App: The app features:&#xD;
Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.&#xD;
User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.&#xD;
Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring.</description>
          </group>
          <group group_id="O2">
            <title>Fat Secret App</title>
            <description>Participants will be encouraged to use the FatSecret application daily to track food and physical activity.&#xD;
Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.</description>
          </group>
        </group_list>
        <measure>
          <title>International Physical Activity Questionnaire Short-form (IPAQ-SF)</title>
          <description>A nine-item International Physical Activity Questionnaire Short-form (IPAQ-SF) will be administered at baseline. The IPAQ-SF calculates the MET-minutes per week expended. MET minutes represent the amount of energy expended carrying out physical activity. A higher score represents a better outcome. Scores can range from 0 to 10,080.</description>
          <units>MET minutes a week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="150"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2222.9" spread="1713.3"/>
                    <measurement group_id="O2" value="2521.3" spread="1914.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physical Activity Measures</title>
        <description>A nine-item International Physical Activity Questionnaire Short-form (IPAQ-SF) will be administered at 6 weeks. The IPAQ-SF calculates the MET minutes per week expended. MET minutes represent the amount of energy expended carrying out physical activity. A higher score represents a better outcome. Scores can range from 0 to 10,080.</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Detours App</title>
            <description>Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep.&#xD;
Healthy Detours App: The app features:&#xD;
Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.&#xD;
User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.&#xD;
Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring.</description>
          </group>
          <group group_id="O2">
            <title>Fat Secret App</title>
            <description>Participants will be encouraged to use the FatSecret application daily to track food and physical activity.&#xD;
Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.</description>
          </group>
        </group_list>
        <measure>
          <title>Physical Activity Measures</title>
          <description>A nine-item International Physical Activity Questionnaire Short-form (IPAQ-SF) will be administered at 6 weeks. The IPAQ-SF calculates the MET minutes per week expended. MET minutes represent the amount of energy expended carrying out physical activity. A higher score represents a better outcome. Scores can range from 0 to 10,080.</description>
          <units>MET minutes a week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2467.8" spread="1981.4"/>
                    <measurement group_id="O2" value="2104.1" spread="1943.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>International Physical Activity Questionnaire Short-form (IPAQ-SF)</title>
        <description>A nine-item International Physical Activity Questionnaire Short-form (IPAQ-SF) will be administered at 12 weeks. The IPAQ-SF calculates the MET minutes per week expended. MET minutes represent the amount of energy expended carrying out physical activity. A higher score represents a better outcome. Scores can range from 0 to 10,080.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Detours App</title>
            <description>Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep.&#xD;
Healthy Detours App: The app features:&#xD;
Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.&#xD;
User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.&#xD;
Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring.</description>
          </group>
          <group group_id="O2">
            <title>Fat Secret App</title>
            <description>Participants will be encouraged to use the FatSecret application daily to track food and physical activity.&#xD;
Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.</description>
          </group>
        </group_list>
        <measure>
          <title>International Physical Activity Questionnaire Short-form (IPAQ-SF)</title>
          <description>A nine-item International Physical Activity Questionnaire Short-form (IPAQ-SF) will be administered at 12 weeks. The IPAQ-SF calculates the MET minutes per week expended. MET minutes represent the amount of energy expended carrying out physical activity. A higher score represents a better outcome. Scores can range from 0 to 10,080.</description>
          <units>MET minutes a week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="142"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2231.5" spread="2013.8"/>
                    <measurement group_id="O2" value="2016.84" spread="1830.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sleep Quality</title>
        <description>The Pittsburgh Sleep Quality Index (PSQI) will be administered at baseline (pre-test). The measure consists of 19 individual items that are used to calculate 7 component score and one composite score. Each item is weighted on a 0-3 interval scale. The composite score is calculated by totaling the seven component scores. The composite score ranges 0 to 21. A lower means healthier sleep quality.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Detours App</title>
            <description>Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep.&#xD;
Healthy Detours App: The app features:&#xD;
Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.&#xD;
User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.&#xD;
Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring.</description>
          </group>
          <group group_id="O2">
            <title>Fat Secret App</title>
            <description>Participants will be encouraged to use the FatSecret application daily to track food and physical activity.&#xD;
Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep Quality</title>
          <description>The Pittsburgh Sleep Quality Index (PSQI) will be administered at baseline (pre-test). The measure consists of 19 individual items that are used to calculate 7 component score and one composite score. Each item is weighted on a 0-3 interval scale. The composite score is calculated by totaling the seven component scores. The composite score ranges 0 to 21. A lower means healthier sleep quality.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="150"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" spread="2.8"/>
                    <measurement group_id="O2" value="5.5" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sleep Quality</title>
        <description>The The Pittsburgh Sleep Quality Index (PSQI) will be administered at 6 weeks. The measure consists of 19 individual items that are used to calculate 7 component score and one composite score. Each item is weighted on a 0-3 interval scale. The composite score is calculated by totaling the seven component scores. The composite score ranges 0 to 21. A lower means healthier sleep quality.</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Detours App</title>
            <description>Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep.&#xD;
Healthy Detours App: The app features:&#xD;
Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.&#xD;
User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.&#xD;
Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring.</description>
          </group>
          <group group_id="O2">
            <title>Fat Secret App</title>
            <description>Participants will be encouraged to use the FatSecret application daily to track food and physical activity.&#xD;
Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep Quality</title>
          <description>The The Pittsburgh Sleep Quality Index (PSQI) will be administered at 6 weeks. The measure consists of 19 individual items that are used to calculate 7 component score and one composite score. Each item is weighted on a 0-3 interval scale. The composite score is calculated by totaling the seven component scores. The composite score ranges 0 to 21. A lower means healthier sleep quality.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" spread="3.1"/>
                    <measurement group_id="O2" value="5.1" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sleep Quality</title>
        <description>The The Pittsburgh Sleep Quality Index (PSQI) will be administered at 12 weeks (post-test). The measure consists of 19 individual items that are used to calculate 7 component score and one composite score. Each item is weighted on a 0-3 interval scale. The composite score is calculated by totaling the seven component scores. The composite score ranges 0 to 21. A lower means healthier sleep quality.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Detours App</title>
            <description>Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep.&#xD;
Healthy Detours App: The app features:&#xD;
Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.&#xD;
User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.&#xD;
Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring.</description>
          </group>
          <group group_id="O2">
            <title>Fat Secret App</title>
            <description>Participants will be encouraged to use the FatSecret application daily to track food and physical activity.&#xD;
Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep Quality</title>
          <description>The The Pittsburgh Sleep Quality Index (PSQI) will be administered at 12 weeks (post-test). The measure consists of 19 individual items that are used to calculate 7 component score and one composite score. Each item is weighted on a 0-3 interval scale. The composite score is calculated by totaling the seven component scores. The composite score ranges 0 to 21. A lower means healthier sleep quality.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="142"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" spread="3.2"/>
                    <measurement group_id="O2" value="5.0" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life (QOL)</title>
        <description>The 12-Item Short Form Health Survey (SF-12) will be administered at baseline (pre-test). The SF-12 survey contains categorical questions (e.g., yes/no) that assess limitations in role functioning. The survey also contains Likert response formats on a three-point scale (e.g., not at all, a little bit, moderately, quite a bit, and extremely) to assess pain, and a five-point scale to assesses overall health (excellent, very good, good, fair, and poor). A six-point scale (e.g., all of the time, most of the time, a good bit of the time, some of the time, a little of the time, and none of the time) assesses mental health, vitality, and social functioning. The SF-12 is scored using the recommended Medical Outcomes Study (MOS) SAS software program that creates two summary scores, mental health (MCS12), and physical health (PCS12). The scores are represented as t-scores that are linear transformations with a mean of 50 and a standard deviation of 10 in the general U.S. population.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Detours App</title>
            <description>Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep.&#xD;
Healthy Detours App: The app features:&#xD;
Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.&#xD;
User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.&#xD;
Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring.</description>
          </group>
          <group group_id="O2">
            <title>Fat Secret App</title>
            <description>Participants will be encouraged to use the FatSecret application daily to track food and physical activity.&#xD;
Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life (QOL)</title>
          <description>The 12-Item Short Form Health Survey (SF-12) will be administered at baseline (pre-test). The SF-12 survey contains categorical questions (e.g., yes/no) that assess limitations in role functioning. The survey also contains Likert response formats on a three-point scale (e.g., not at all, a little bit, moderately, quite a bit, and extremely) to assess pain, and a five-point scale to assesses overall health (excellent, very good, good, fair, and poor). A six-point scale (e.g., all of the time, most of the time, a good bit of the time, some of the time, a little of the time, and none of the time) assesses mental health, vitality, and social functioning. The SF-12 is scored using the recommended Medical Outcomes Study (MOS) SAS software program that creates two summary scores, mental health (MCS12), and physical health (PCS12). The scores are represented as t-scores that are linear transformations with a mean of 50 and a standard deviation of 10 in the general U.S. population.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="150"/>
                <count group_id="O2" value="150"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.9" spread="6.1"/>
                    <measurement group_id="O2" value="53.1" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life (QOL)</title>
        <description>The 12-Item Short Form Health Survey (SF-12) survey contains categorical questions (e.g., yes/no) that assess limitations in role functioning. The survey also contains Likert response formats on a three-point scale (e.g., not at all, a little bit, moderately, quite a bit, and extremely) to assess pain, and a five-point scale to assesses overall health (excellent, very good, good, fair, and poor). A six-point scale (e.g., all of the time, most of the time, a good bit of the time, some of the time, a little of the time, and none of the time) assesses mental health, vitality, and social functioning. The SF-12 is scored using the recommended Medical Outcomes Study (MOS) SAS software program that creates two summary scores, mental health (MCS12), and physical health (PCS12). The scores are represented as t-scores that are linear transformations with a mean of 50 and a standard deviation of 10 in the general U.S. population.</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Detours App</title>
            <description>Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep.&#xD;
Healthy Detours App: The app features:&#xD;
Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.&#xD;
User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.&#xD;
Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring.</description>
          </group>
          <group group_id="O2">
            <title>Fat Secret App</title>
            <description>Participants will be encouraged to use the FatSecret application daily to track food and physical activity.&#xD;
Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life (QOL)</title>
          <description>The 12-Item Short Form Health Survey (SF-12) survey contains categorical questions (e.g., yes/no) that assess limitations in role functioning. The survey also contains Likert response formats on a three-point scale (e.g., not at all, a little bit, moderately, quite a bit, and extremely) to assess pain, and a five-point scale to assesses overall health (excellent, very good, good, fair, and poor). A six-point scale (e.g., all of the time, most of the time, a good bit of the time, some of the time, a little of the time, and none of the time) assesses mental health, vitality, and social functioning. The SF-12 is scored using the recommended Medical Outcomes Study (MOS) SAS software program that creates two summary scores, mental health (MCS12), and physical health (PCS12). The scores are represented as t-scores that are linear transformations with a mean of 50 and a standard deviation of 10 in the general U.S. population.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.5" spread="6.4"/>
                    <measurement group_id="O2" value="53.9" spread="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life (QOL)</title>
        <description>The 12-Item Short Form Health Survey (SF-12) survey contains categorical questions (e.g., yes/no) that assess limitations in role functioning. The survey also contains Likert response formats on a three-point scale (e.g., not at all, a little bit, moderately, quite a bit, and extremely) to assess pain, and a five-point scale to assesses overall health (excellent, very good, good, fair, and poor). A six-point scale (e.g., all of the time, most of the time, a good bit of the time, some of the time, a little of the time, and none of the time) assesses mental health, vitality, and social functioning. The SF-12 is scored using the recommended Medical Outcomes Study (MOS) SAS software program that creates two summary scores, mental health (MCS12), and physical health (PCS12). The scores are represented as t-scores that are linear transformations with a mean of 50 and a standard deviation of 10 in the general U.S. population.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy Detours App</title>
            <description>Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep.&#xD;
Healthy Detours App: The app features:&#xD;
Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.&#xD;
User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.&#xD;
Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring.</description>
          </group>
          <group group_id="O2">
            <title>Fat Secret App</title>
            <description>Participants will be encouraged to use the FatSecret application daily to track food and physical activity.&#xD;
Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life (QOL)</title>
          <description>The 12-Item Short Form Health Survey (SF-12) survey contains categorical questions (e.g., yes/no) that assess limitations in role functioning. The survey also contains Likert response formats on a three-point scale (e.g., not at all, a little bit, moderately, quite a bit, and extremely) to assess pain, and a five-point scale to assesses overall health (excellent, very good, good, fair, and poor). A six-point scale (e.g., all of the time, most of the time, a good bit of the time, some of the time, a little of the time, and none of the time) assesses mental health, vitality, and social functioning. The SF-12 is scored using the recommended Medical Outcomes Study (MOS) SAS software program that creates two summary scores, mental health (MCS12), and physical health (PCS12). The scores are represented as t-scores that are linear transformations with a mean of 50 and a standard deviation of 10 in the general U.S. population.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="142"/>
                <count group_id="O2" value="137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.8" spread="6.0"/>
                    <measurement group_id="O2" value="54.3" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Healthy Detours App</title>
          <description>Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep.&#xD;
Healthy Detours App: The app features:&#xD;
Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.&#xD;
User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.&#xD;
Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring.</description>
        </group>
        <group group_id="E2">
          <title>Fat Secret App</title>
          <description>Participants will be encouraged to use the FatSecret application daily to track food and physical activity.&#xD;
Fat Secret App: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="150"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Valerie Myers, PhD</name_or_title>
      <organization>Klein Buendel</organization>
      <phone>3035654343</phone>
      <email>vmyers@kleinbuendel.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02996864
org study id: 0304
secondary id: 2R44DP004995
nct id: NCT02996864
lead sponsor: 
collaborator: 
has dmc: No
College students are in a newly independent phase of life; many of whom encounter unhealthy
      dietary decision- making, barriers to physical activity, and poor sleep behaviors. Healthy
      Detours is a location-based smartphone application tailored in real-time to a student's
      schedule and locale, and aims to guide students toward healthier eating, exercise, and
      lifestyle choices as a way to prevent the onset of damaging and costly health outcomes.
      Through a randomized control trial, this Phase II project will test the effectiveness of an
      evidence-based smartphone application that will provide students with on-demand,
      location-specific information about healthy lifestyle choices.
Poor eating habits, sedentary behavior, and deficient sleep quality are problematic for many
      college students. Surrounded by numerous unhealthy food choices and physical activity
      barriers, students are vulnerable to overweight and chronic diseases such as diabetes, heart
      disease, and cancer. Today's college students are more technologically connected than
      previous generations positioning mobile devices as an ideal method for reaching this
      population with healthy lifestyle information. In a Phase I Small Business Innovation
      Research (SBIR), our team developed Healthy Detours, an innovative mobile phone application
      (app) designed to assist college students make healthier choices about food and physical
      activity on and around their college campus. Specifically, we (a) developed a comprehensive
      database to provide user-specific information through the use of location-based services
      (LBS) focused on healthy lifestyle choices; (b) conducted an online survey with a national
      sample of undergraduates which examined eating and physical activity preferences, interest in
      smartphone technology to monitor healthy lifestyle choices, and use of "check-ins" for health
      information; (c) conducted focus groups which demonstrated the prototype app's ability to
      provide the user with rudimentary aspects of the LBS database to facilitate real-time
      decision making for healthier choices; (d) conducted lab and field usability testing of the
      app for its accuracy in identifying user location and functionality; and (e) developed a
      specifications document to outline the Phase II development plan. The results of the Phase I
      activities provided strong support for this project in which we propose to develop an
      interactive, mobile app that is guided by the Theory of Planned Behavior (TPB) and Social
      Cognitive Theory (SCT). This project will produce a fully functional LBS smartphone app that
      will provide (1) immediate and relevant feedback at the point of decision-making to reinforce
      healthy lifestyle behaviors, (2) person- and location-specific tailored data, acquired
      through activity tracking, to provide users with necessary information to improve future
      decision-making, and (3) multiple health-tracking features that will aid in self-monitoring.
      Healthy Detours will be evaluated in a randomized controlled trial (n=300) with students at a
      large 4-year university. Primary outcomes include changes in dietary intake, physical
      activity behavior, sleep quality, and quality of life. Overall, the proposed project has the
      potential to significantly impact college students' health and quality of life by providing
      them with real-time healthy choices. Healthy Detours is one of the first comprehensive
      wellness apps offered to college students, and provides an opportunity via the SBIR funding
      mechanism to reach a large number of students as evidenced by the commercialization plan.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Healthy Eating Index (HEI)
time frame: Baseline
description: The National Cancer Institute's Automated Self-Administered 24-hour Recall (ASA24) will be administered at baseline (pre-test) to calculate the Healthy Eating Index (HEI). The ASA24 measures food intake for 24 hours and calculates the HEI. Scores for the HEI range from 0 to 100. A higher score represents a better outcome.
measure: Healthy Eating Index (HEI)
time frame: 6 weeks
description: The National Cancer Institute's Automated Self-Administered 24-hour Recall (ASA24) will be administered at 6-weeks) to calculate the Healthy Eating Index (HEI). The ASA24 measures food intake for 24 hours and calculates the HEI. Scores for the HEI range from 0 to 100. A higher score represents a better outcome.
measure: Healthy Eating Index (HEI)
time frame: 12 weeks
description: The National Cancer Institute's Automated Self-Administered 24-hour Recall (ASA24) will be administered at 12 weeks to calculate the Healthy Eating Index (HEI). The ASA24 measures food intake for 24 hours and calculates the HEI. Scores for the HEI range from 0 to 100. A higher score represents a better outcome.
measure: International Physical Activity Questionnaire Short-form (IPAQ-SF)
time frame: Baseline
description: A nine-item International Physical Activity Questionnaire Short-form (IPAQ-SF) will be administered at baseline. The IPAQ-SF calculates the MET-minutes per week expended. MET minutes represent the amount of energy expended carrying out physical activity. A higher score represents a better outcome. Scores can range from 0 to 10,080.
measure: Physical Activity Measures
time frame: 6 weeks
description: A nine-item International Physical Activity Questionnaire Short-form (IPAQ-SF) will be administered at 6 weeks. The IPAQ-SF calculates the MET minutes per week expended. MET minutes represent the amount of energy expended carrying out physical activity. A higher score represents a better outcome. Scores can range from 0 to 10,080.
measure: International Physical Activity Questionnaire Short-form (IPAQ-SF)
time frame: 12 weeks
description: A nine-item International Physical Activity Questionnaire Short-form (IPAQ-SF) will be administered at 12 weeks. The IPAQ-SF calculates the MET minutes per week expended. MET minutes represent the amount of energy expended carrying out physical activity. A higher score represents a better outcome. Scores can range from 0 to 10,080.
measure: Sleep Quality
time frame: Baseline
description: The Pittsburgh Sleep Quality Index (PSQI) will be administered at baseline (pre-test). The measure consists of 19 individual items that are used to calculate 7 component score and one composite score. Each item is weighted on a 0-3 interval scale. The composite score is calculated by totaling the seven component scores. The composite score ranges 0 to 21. A lower means healthier sleep quality.
measure: Sleep Quality
time frame: 6 weeks
description: The The Pittsburgh Sleep Quality Index (PSQI) will be administered at 6 weeks. The measure consists of 19 individual items that are used to calculate 7 component score and one composite score. Each item is weighted on a 0-3 interval scale. The composite score is calculated by totaling the seven component scores. The composite score ranges 0 to 21. A lower means healthier sleep quality.
measure: Sleep Quality
time frame: 12 weeks
description: The The Pittsburgh Sleep Quality Index (PSQI) will be administered at 12 weeks (post-test). The measure consists of 19 individual items that are used to calculate 7 component score and one composite score. Each item is weighted on a 0-3 interval scale. The composite score is calculated by totaling the seven component scores. The composite score ranges 0 to 21. A lower means healthier sleep quality.
measure: Quality of Life (QOL)
time frame: Baseline
description: The 12-Item Short Form Health Survey (SF-12) will be administered at baseline (pre-test). The SF-12 survey contains categorical questions (e.g., yes/no) that assess limitations in role functioning. The survey also contains Likert response formats on a three-point scale (e.g., not at all, a little bit, moderately, quite a bit, and extremely) to assess pain, and a five-point scale to assesses overall health (excellent, very good, good, fair, and poor). A six-point scale (e.g., all of the time, most of the time, a good bit of the time, some of the time, a little of the time, and none of the time) assesses mental health, vitality, and social functioning. The SF-12 is scored using the recommended Medical Outcomes Study (MOS) SAS software program that creates two summary scores, mental health (MCS12), and physical health (PCS12). The scores are represented as t-scores that are linear transformations with a mean of 50 and a standard deviation of 10 in the general U.S. population.
measure: Quality of Life (QOL)
time frame: 6 weeks
description: The 12-Item Short Form Health Survey (SF-12) survey contains categorical questions (e.g., yes/no) that assess limitations in role functioning. The survey also contains Likert response formats on a three-point scale (e.g., not at all, a little bit, moderately, quite a bit, and extremely) to assess pain, and a five-point scale to assesses overall health (excellent, very good, good, fair, and poor). A six-point scale (e.g., all of the time, most of the time, a good bit of the time, some of the time, a little of the time, and none of the time) assesses mental health, vitality, and social functioning. The SF-12 is scored using the recommended Medical Outcomes Study (MOS) SAS software program that creates two summary scores, mental health (MCS12), and physical health (PCS12). The scores are represented as t-scores that are linear transformations with a mean of 50 and a standard deviation of 10 in the general U.S. population.
measure: Quality of Life (QOL)
time frame: 12 weeks
description: The 12-Item Short Form Health Survey (SF-12) survey contains categorical questions (e.g., yes/no) that assess limitations in role functioning. The survey also contains Likert response formats on a three-point scale (e.g., not at all, a little bit, moderately, quite a bit, and extremely) to assess pain, and a five-point scale to assesses overall health (excellent, very good, good, fair, and poor). A six-point scale (e.g., all of the time, most of the time, a good bit of the time, some of the time, a little of the time, and none of the time) assesses mental health, vitality, and social functioning. The SF-12 is scored using the recommended Medical Outcomes Study (MOS) SAS software program that creates two summary scores, mental health (MCS12), and physical health (PCS12). The scores are represented as t-scores that are linear transformations with a mean of 50 and a standard deviation of 10 in the general U.S. population.
arm group label: Healthy Detours App
arm group type: Experimental
description: Participants will be encouraged to use the Healthy Detours app daily to track food, physical activity, and sleep.
arm group label: Fat Secret App
arm group type: Placebo Comparator
description: Participants will be encouraged to use the FatSecret application daily to track food and physical activity.
intervention type: Other
intervention name: Healthy Detours App
description: The app features:
Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.
User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.
Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring.
arm group label: Healthy Detours App
intervention type: Other
intervention name: Fat Secret App
description: Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.
arm group label: Fat Secret App
criteria: 
gender: All
minimum age: 18 Years
maximum age: 29 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Valerie Myers, PhD
role: Principal Investigator
affiliation: Klein Buendel, Inc.
facility: 
facility: 
country: United States
citation: Cluskey M, Grobe D. College weight gain and behavior transitions: male and female differences. J Am Diet Assoc. 2009 Feb;109(2):325-9. doi: 10.1016/j.jada.2008.10.045.
PMID: 19167962
citation: Ferrara CM. The College Experience: Physical Activity, Nutrition, and Implications for Intervention and Future Research. Journal of Exercise Physiology online. 2009;12(1):23-35.
citation: Hanson TL, Drumheller K, Mallard J, McKee C, Schlegel P. Cell phones, text messaging, and Facebook: competing time demands of today's college students. College Teaching. 2010;59(1):23-30.
citation: Gaultney JF. The prevalence of sleep disorders in college students: impact on academic performance. J Am Coll Health. 2010;59(2):91-7. doi: 10.1080/07448481.2010.483708.
PMID: 20864434
citation: Laska MN, Pelletier JE, Larson NI, Story M. Interventions for weight gain prevention during the transition to young adulthood: a review of the literature. J Adolesc Health. 2012 Apr;50(4):324-33. doi: 10.1016/j.jadohealth.2012.01.016.
PMID: 22443834
citation: Li KK, Concepcion RY, Lee H, Cardinal BJ, Ebbeck V, Woekel E, Readdy RT. An examination of sex differences in relation to the eating habits and nutrient intakes of university students. J Nutr Educ Behav. 2012 May-Jun;44(3):246-50. doi: 10.1016/j.jneb.2010.10.002. Epub 2011 Jul 18.
PMID: 21764641
citation: Lloyd-Richardson EE, Bailey S, Fava JL, Wing R; Tobacco Etiology Research Network (TERN). A prospective study of weight gain during the college freshman and sophomore years. Prev Med. 2009 Mar;48(3):256-61. doi: 10.1016/j.ypmed.2008.12.009. Epub 2008 Dec 24.
PMID: 19146870
citation: Strong KA, Parks SL, Anderson E, Winett R, Davy BM. Weight gain prevention: identifying theory-based targets for health behavior change in young adults. J Am Diet Assoc. 2008 Oct;108(10):1708-1715. doi: 10.1016/j.jada.2008.07.007.
PMID: 18926139
citation: Racette SB, Deusinger SS, Strube MJ, Highstein GR, Deusinger RH. Weight changes, exercise, and dietary patterns during freshman and sophomore years of college. J Am Coll Health. 2005 May-Jun;53(6):245-51. doi: 10.3200/JACH.53.6.245-251.
PMID: 15900988
citation: Zick CD, Smith KR, Brown BB, Fan JX, Kowaleski-Jones L. Physical activity during the transition from adolescence to adulthood. J Phys Act Health. 2007 Apr;4(2):125-37. doi: 10.1123/jpah.4.2.125.
PMID: 17570883
citation: Yeh MC, Matsumori B, Obenchain J, Viladrich A, Das D, Navder K. Validity of a competing food choice construct regarding fruit and vegetable consumption among urban college freshmen. J Nutr Educ Behav. 2010 Sep-Oct;42(5):321-7. doi: 10.1016/j.jneb.2009.08.004. Epub 2010 Jul 22.
PMID: 20655281
citation: Salcedo Aguilar F, Rodriguez Almonacid FM, Monterde Aznar ML, Garcia Jimenez MA, Redondo Martinez P, Marcos Navarro AI. [Sleeping habits and sleep disorders during adolescence: relation to school performance]. Aten Primaria. 2005 May 15;35(8):408-14. doi: 10.1157/13074792. Spanish.
PMID: 15882497
citation: Curcio G, Ferrara M, De Gennaro L. Sleep loss, learning capacity and academic performance. Sleep Med Rev. 2006 Oct;10(5):323-37. doi: 10.1016/j.smrv.2005.11.001. Epub 2006 Mar 24.
PMID: 16564189
citation: Trockel MT, Barnes MD, Egget DL. Health-related variables and academic performance among first-year college students: implications for sleep and other behaviors. J Am Coll Health. 2000 Nov;49(3):125-31. doi: 10.1080/07448480009596294.
PMID: 11125640
citation: Kwan M, Faulkner G. Perceptions and barriers to physical activity during the transition to university. American Journal of Health Studies. 2011;26:87-96.
citation: Wengreen HJ, Moncur C. Change in diet, physical activity, and body weight among young-adults during the transition from high school to college. Nutr J. 2009 Jul 22;8:32. doi: 10.1186/1475-2891-8-32.
PMID: 19624820
citation: Hoffman DJ, Policastro P, Quick V, Lee SK. Changes in body weight and fat mass of men and women in the first year of college: A study of the "freshman 15". J Am Coll Health. 2006 Jul-Aug;55(1):41-5. doi: 10.3200/JACH.55.1.41-46.
PMID: 16889314
citation: Kopelman P. Health risks associated with overweight and obesity. Obes Rev. 2007 Mar;8 Suppl 1:13-7. doi: 10.1111/j.1467-789X.2007.00311.x. No abstract available.
PMID: 17316295
responsible party type: Sponsor
mesh term: Sleep Deprivation
mesh term: Overweight
sharing ipd: No
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