<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/NCT01693250</url>
  </required_header>
  <id_info>
    <org_study_id>TEENS-2012</org_study_id>
    <nct_id>NCT01693250</nct_id>
  </id_info>
  <brief_title>iStart Smart for Teens for Healthy Weight Management</brief_title>
  <official_title>Phase 1 Study of Fitbit and Apps on Healthy Weight Management in Obese Teens in Primary Care Clinics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The emerging epidemic of type 2 diabetes mellitus (T2DM) in children is coupled with the&#xD;
      increased prevalence of childhood obesity in the last two decades. Obesity during the&#xD;
      adolescent years is associated with many adverse health consequences, including T2DM,&#xD;
      hyperlipidemia, and psychosocial problems. The first step toward effective obesity management&#xD;
      and T2DM prevention is monitoring of physical activity (PA) and dietary intake. With the&#xD;
      rapid expansion of cellular networks, and advancements in smartphone technologies, it is now&#xD;
      possible to monitor PA and dietary intake and at the same time to transmit data digitally to&#xD;
      their primary care providers (PCP). The proposed pilot study will include the collaboration&#xD;
      among UCSF, North East Medical Services (NEMS), mHealth teams, and overweight and/or obese&#xD;
      adolescents. The study will adapt and implement smartphone-based technologies and integrate&#xD;
      these technologies with the Electronic Health Record (EHR) to increase PA and dietary intake.&#xD;
      Two specific aims of this proposed study include: (1) adapt fitbit Ultra applications for the&#xD;
      smartphone-based technologies and EHR and (2) and assess the feasibility and estimate the&#xD;
      effect for patient outcomes (self-efficacy, physical activity, dietary intake, BMI, and lipid&#xD;
      profile), at 3 months post intervention between the intervention and control groups. The&#xD;
      smartphone app for the intervention group will allow the teens to graphically compare daily&#xD;
      PA and dietary intake with the goal, participate in a reward program where they can collect&#xD;
      virtual points for achieving the goal, and play interactive games related to PA and diet. A&#xD;
      total of 40 overweight and/or obese adolescents at NEMS will be recruited and randomized to&#xD;
      the feasibility study (Aim 2).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using evidence to inform the design of clinical practice is a foundational principle of&#xD;
      modern health care practice. In the present pilot study, using evidence from research on&#xD;
      technology in clinical practice facilitated development of a hybrid intervention that&#xD;
      combined lifestyle modification with routine clinical care. Chief among the benefits of this&#xD;
      hybrid smartphone technology-based intervention (STB) was the potential to improve health&#xD;
      outcomes and reduce obesity in overweight and obese adolescents. The purposes of this study&#xD;
      were to (1) measure effects of an innovative smartphone-technology-based (STB) intervention&#xD;
      for overweight and obese adolescents and to (2) examine the intervention's feasibility for&#xD;
      use in primary care clinics.The STB intervention had 3 components: use of Fitbit Flex,&#xD;
      participation in the online educational program, and receipt of bi-weekly text message during&#xD;
      the maintenance phase. A randomized control study design was utilized. Data regard to&#xD;
      anthropometrics (BMI and waist-hip ratio), blood pressure, levels of physical and sedentary&#xD;
      activity, diet, and self-efficacy regarding physical activity and diet were collected at&#xD;
      baseline, 3 month and 6 months after the baseline assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2015</start_date>
  <completion_date type="Actual">December 1, 2016</completion_date>
  <primary_completion_date type="Actual">June 1, 2016</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>
    <intervention_model_description>A randomized control study design with an active control group was used.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
    <masking_description>Primary care providers and outcome assessors were blinded to the group assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>Participants' BMI was determined by dividing body mass (weight) by height squared (kg/m2). Adolescents' weight and height were measured while the adolescents wore light-weight clothes and no shoes. For BMI, adequate sensitivity and specificity has been reported in children and adolescents, with sensitivity ranging from 29% to 88% and specificity ranging from 94% to 100%.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Diastolic Blood Pressure</measure>
    <time_frame>baseline and 6 months</time_frame>
    <description>Systolic blood pressure and diastolic blood pressure were measured by using a mercury sphygmomanometer with specific cuff size appropriate for adolescents (Baumanometer, W. A. Baum Co., Copiague, New York). After participants sat for 10 minutes, blood pressure was measured twice in the adolescent's right arm; blood pressures were measured to the nearest 2 mmHg. Average score of two measures was used.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Overweight</condition>
  <condition>Obese</condition>
  <arm_group>
    <arm_group_label>fitbit ultra</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adolescents in the intervention group will receive a Fitbit Ultra and will download an app to their smartphone. Participants will be asked to wear the Fitbit device and use the app every day for three months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pedometer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After completion of the baseline assessments, adolescents in the control group will be given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>fitbit Ultra</intervention_name>
    <description>Participants will be asked to wear the Fitbit device and use the app every day for three months. The app functions will include tracking of PA and dietary intake progress, setting individualized and realistic goals, monitoring progress related to reaching the goals, providing tips of everyday activities, and having interactive games related to PA and healthy diet.</description>
    <arm_group_label>fitbit ultra</arm_group_label>
    <other_name>Fitbit Ultra and associated apps</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pedometer</intervention_name>
    <description>adolescents in the control group will be given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.</description>
    <arm_group_label>Pedometer</arm_group_label>
    <other_name>Omron HJ-105 pedometer</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  between 13-18 years old&#xD;
&#xD;
          -  have a BMI at ≥ 85th percentile, based on CDC growth chart&#xD;
&#xD;
          -  own a smartphone;&#xD;
&#xD;
          -  have access to a computer with internet access&#xD;
&#xD;
          -  be able to read and speak English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have acute or life-threatening disease&#xD;
&#xD;
          -  not be able to engage in activities of daily living&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jyu-Lin Chen</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCSF School of Nursing</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143-0606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Karnik S, Kanekar A. Childhood obesity: a global public health crisis. Int J Prev Med. 2012 Jan;3(1):1-7.</citation>
    <PMID>22506094</PMID>
  </reference>
  <reference>
    <citation>Wang LY, Chyen D, Lee S, Lowry R. The association between body mass index in adolescence and obesity in adulthood. J Adolesc Health. 2008 May;42(5):512-8. doi: 10.1016/j.jadohealth.2007.10.010. Epub 2008 Jan 31.</citation>
    <PMID>18407047</PMID>
  </reference>
  <reference>
    <citation>Chen JL, Wilkosz ME. Efficacy of technology-based interventions for obesity prevention in adolescents: a systematic review. Adolesc Health Med Ther. 2014 Aug 7;5:159-70. doi: 10.2147/AHMT.S39969. eCollection 2014.</citation>
    <PMID>25177158</PMID>
  </reference>
  <reference>
    <citation>Chen JL, Weiss S, Heyman MB, Cooper B, Lustig RH. The efficacy of the web-based childhood obesity prevention program in Chinese American adolescents (Web ABC study). J Adolesc Health. 2011 Aug;49(2):148-54. doi: 10.1016/j.jadohealth.2010.11.243. Epub 2011 Mar 12.</citation>
    <PMID>21783046</PMID>
  </reference>
  <reference>
    <citation>Delamater AM, Pulgaron ER, Rarback S, Hernandez J, Carrillo A, Christiansen S, Severson HH. Web-based family intervention for overweight children: a pilot study. Child Obes. 2013 Feb;9(1):57-63. doi: 10.1089/chi.2011.0126. Epub 2013 Jan 11.</citation>
    <PMID>23308372</PMID>
  </reference>
  <reference>
    <citation>Sim LA, Lebow J, Wang Z, Koball A, Murad MH. Brief Primary Care Obesity Interventions: A Meta-analysis. Pediatrics. 2016 Oct;138(4):e20160149. doi: 10.1542/peds.2016-0149. Epub 2016 Sep 12.</citation>
    <PMID>27621413</PMID>
  </reference>
  <reference>
    <citation>Al-Khudairy L, Loveman E, Colquitt JL, Mead E, Johnson RE, Fraser H, Olajide J, Murphy M, Velho RM, O'Malley C, Azevedo LB, Ells LJ, Metzendorf MI, Rees K. Diet, physical activity and behavioural interventions for the treatment of overweight or obese adolescents aged 12 to 17 years. Cochrane Database Syst Rev. 2017 Jun 22;6(6):CD012691. doi: 10.1002/14651858.CD012691.</citation>
    <PMID>28639320</PMID>
  </reference>
  <results_reference>
    <citation>Chen JL, Guedes CM, Lung AE. Smartphone-based Healthy Weight Management Intervention for Chinese American Adolescents: Short-term Efficacy and Factors Associated With Decreased Weight. J Adolesc Health. 2019 Apr;64(4):443-449. doi: 10.1016/j.jadohealth.2018.08.022. Epub 2018 Nov 6.</citation>
    <PMID>30409751</PMID>
  </results_reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <results_first_submitted>October 24, 2017</results_first_submitted>
  <results_first_submitted_qc>June 14, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 2, 2019</results_first_posted>
  <last_update_submitted>August 9, 2019</last_update_submitted>
  <last_update_submitted_qc>August 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>technology</keyword>
  <keyword>healthy weight management</keyword>
  <keyword>primary care setting</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The trained research assistant worked with primary care providers at two large community clinics whose patient populations were predominantly Chinese American in northern California. A study invitation letter was posted in the clinics. Pediatricians at the clinics were also given a study invitation letter to give to potential participants.</recruitment_details>
      <pre_assignment_details>An explanation of why potential participants were excluded from the study before assignment to groups was given them.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Fitbit Ultra</title>
          <description>A total of 23 adolescents in the intervention group received a Fitbit Ultra and will download an app to their smartphone. Participants will be asked to wear the Fitbit device and use the app every day for three months.&#xD;
fitbit Ultra: Participants were asked to wear the Fitbit device and use the app every day for three months. The app functions will include tracking of PA and dietary intake progress, setting individualized and realistic goals, monitoring progress related to reaching the goals, providing tips of everyday activities, and having interactive games related to PA and healthy diet.</description>
        </group>
        <group group_id="P2">
          <title>Pedometer</title>
          <description>A total of 17 adolescent included in the control group. After completion of the baseline assessments, adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.&#xD;
Pedometer: adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23">3 months post baseline assessment</participants>
                <participants group_id="P2" count="17">three month post baseline assessment</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21">21 teens completed 6 months post baseline assessment</participants>
                <participants group_id="P2" count="15">15 teens completed 6 months post baseline assessment</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>23 participants were assigned to the fitbit ultra group and 17 were assigned to Pedometer group</population>
      <group_list>
        <group group_id="B1">
          <title>Fitbit Ultra</title>
          <description>Adolescents in the intervention group will receive a Fitbit Ultra and will download an app to their smartphone. Participants will be asked to wear the Fitbit device and use the app every day for three months.&#xD;
fitbit Ultra: Participants will be asked to wear the Fitbit device and use the app every day for three months. The app functions will include tracking of PA and dietary intake progress, setting individualized and realistic goals, monitoring progress related to reaching the goals, providing tips of everyday activities, and having interactive games related to PA and healthy diet.</description>
        </group>
        <group group_id="B2">
          <title>Pedometer</title>
          <description>After completion of the baseline assessments, adolescents in the control group will be given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.&#xD;
Pedometer: adolescents in the control group will be given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.</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="23"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</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>&gt;=65 years</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_list>
            </class>
          </class_list>
        </measure>
        <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="15.0" spread="1.66"/>
                    <measurement group_id="B2" value="14.8" spread="1.69"/>
                    <measurement group_id="B3" value="14.9" spread="1.67"/>
                  </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="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Body Mass Index (BMI)</title>
        <description>Participants' BMI was determined by dividing body mass (weight) by height squared (kg/m2). Adolescents' weight and height were measured while the adolescents wore light-weight clothes and no shoes. For BMI, adequate sensitivity and specificity has been reported in children and adolescents, with sensitivity ranging from 29% to 88% and specificity ranging from 94% to 100%.</description>
        <time_frame>baseline and 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fitbit Ultra</title>
            <description>Participants in the intervention group received a Fitbit Ultra and will download an app to their smartphone. Participants will be asked to wear the Fitbit device and use the app every day for three months.&#xD;
fitbit Ultra: Participants were asked to wear the Fitbit device and use the app every day for three months. The app functions will include tracking of PA and dietary intake progress, setting individualized and realistic goals, monitoring progress related to reaching the goals, providing tips of everyday activities, and having interactive games related to PA and healthy diet.</description>
          </group>
          <group group_id="O2">
            <title>Pedometer</title>
            <description>After completion of the baseline assessments, adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.&#xD;
Pedometer: adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <description>Participants' BMI was determined by dividing body mass (weight) by height squared (kg/m2). Adolescents' weight and height were measured while the adolescents wore light-weight clothes and no shoes. For BMI, adequate sensitivity and specificity has been reported in children and adolescents, with sensitivity ranging from 29% to 88% and specificity ranging from 94% to 100%.</description>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.37" spread="3.26"/>
                    <measurement group_id="O2" value="28.35" spread="4.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.93" spread="3.42"/>
                    <measurement group_id="O2" value="29.18" spread="3.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This is a feasibility and pilot study. We acknowledge that our sample size will not have adequate power to detect any statistically significant outcomes. We chose a sample size that would be large enough to assess feasibility and effect size and to accommodate recruitment within the study time and budget of this application. We hope to be able to estimate the effect size of the intervention.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.68</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>.5</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Diastolic Blood Pressure</title>
        <description>Systolic blood pressure and diastolic blood pressure were measured by using a mercury sphygmomanometer with specific cuff size appropriate for adolescents (Baumanometer, W. A. Baum Co., Copiague, New York). After participants sat for 10 minutes, blood pressure was measured twice in the adolescent's right arm; blood pressures were measured to the nearest 2 mmHg. Average score of two measures was used.</description>
        <time_frame>baseline and 6 months</time_frame>
        <population>Adolescents who are overweight or obese were invited to participate in this study,</population>
        <group_list>
          <group group_id="O1">
            <title>Fitbit Ultra</title>
            <description>A total of 23 adolescents in the intervention group received a Fitbit Ultra and will download an app to their smartphone. Participants will be asked to wear the Fitbit device and use the app every day for three months.&#xD;
fitbit Ultra: Participants were asked to wear the Fitbit device and use the app every day for three months. The app functions will include tracking of PA and dietary intake progress, setting individualized and realistic goals, monitoring progress related to reaching the goals, providing tips of everyday activities, and having interactive games related to PA and healthy diet.</description>
          </group>
          <group group_id="O2">
            <title>Pedometer</title>
            <description>A total of 17 adolescent included in the control group. After completion of the baseline assessments, adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.&#xD;
Pedometer: adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.</description>
          </group>
        </group_list>
        <measure>
          <title>Diastolic Blood Pressure</title>
          <description>Systolic blood pressure and diastolic blood pressure were measured by using a mercury sphygmomanometer with specific cuff size appropriate for adolescents (Baumanometer, W. A. Baum Co., Copiague, New York). After participants sat for 10 minutes, blood pressure was measured twice in the adolescent's right arm; blood pressures were measured to the nearest 2 mmHg. Average score of two measures was used.</description>
          <population>Adolescents who are overweight or obese were invited to participate in this study,</population>
          <units>mmhg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.74" spread="8.07"/>
                    <measurement group_id="O2" value="69.94" spread="11.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.15" spread="7.53"/>
                    <measurement group_id="O2" value="72.14" spread="8.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>We hypothesized the intervention group will have significant reduction of systematic blood pressure compared to the control group at 6 month follow up.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The study period is 6 months, therefore, adverse event data were collected over 6 months.</time_frame>
      <desc>Any adverse event happened during the study period will be reported to UCSF Institutional Review Board. The IRB will review the adverse event report and determine if a) the risk-benefit ratio continues to be acceptable, b) the research protocol and informed consent document accurately and completely present risk information, c) current subjects should be advised of newly identified risks and d) the event meets the definition of an Unanticipated Problem involving risk to participants or others.</desc>
      <group_list>
        <group group_id="E1">
          <title>Fitbit Ultra</title>
          <description>A total of 23 adolescents in the intervention group received a Fitbit Ultra and will download an app to their smartphone. Participants will be asked to wear the Fitbit device and use the app every day for three months.&#xD;
fitbit Ultra: Participants were asked to wear the Fitbit device and use the app every day for three months. The app functions will include tracking of PA and dietary intake progress, setting individualized and realistic goals, monitoring progress related to reaching the goals, providing tips of everyday activities, and having interactive games related to PA and healthy diet.</description>
        </group>
        <group group_id="E2">
          <title>Pedometer</title>
          <description>A total of 17 adolescent included in the control group. After completion of the baseline assessments, adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.&#xD;
Pedometer: adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.</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="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </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="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </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>Dr. Jyu-Lin Chen</name_or_title>
      <organization>University of California San Francisco</organization>
      <phone>415-502-6015</phone>
      <email>jyu-lin.chen@ucsf.edu</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/NCT01693250
org study id: TEENS-2012
nct id: NCT01693250
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The emerging epidemic of type 2 diabetes mellitus (T2DM) in children is coupled with the
      increased prevalence of childhood obesity in the last two decades. Obesity during the
      adolescent years is associated with many adverse health consequences, including T2DM,
      hyperlipidemia, and psychosocial problems. The first step toward effective obesity management
      and T2DM prevention is monitoring of physical activity (PA) and dietary intake. With the
      rapid expansion of cellular networks, and advancements in smartphone technologies, it is now
      possible to monitor PA and dietary intake and at the same time to transmit data digitally to
      their primary care providers (PCP). The proposed pilot study will include the collaboration
      among UCSF, North East Medical Services (NEMS), mHealth teams, and overweight and/or obese
      adolescents. The study will adapt and implement smartphone-based technologies and integrate
      these technologies with the Electronic Health Record (EHR) to increase PA and dietary intake.
      Two specific aims of this proposed study include: (1) adapt fitbit Ultra applications for the
      smartphone-based technologies and EHR and (2) and assess the feasibility and estimate the
      effect for patient outcomes (self-efficacy, physical activity, dietary intake, BMI, and lipid
      profile), at 3 months post intervention between the intervention and control groups. The
      smartphone app for the intervention group will allow the teens to graphically compare daily
      PA and dietary intake with the goal, participate in a reward program where they can collect
      virtual points for achieving the goal, and play interactive games related to PA and diet. A
      total of 40 overweight and/or obese adolescents at NEMS will be recruited and randomized to
      the feasibility study (Aim 2).
Using evidence to inform the design of clinical practice is a foundational principle of
      modern health care practice. In the present pilot study, using evidence from research on
      technology in clinical practice facilitated development of a hybrid intervention that
      combined lifestyle modification with routine clinical care. Chief among the benefits of this
      hybrid smartphone technology-based intervention (STB) was the potential to improve health
      outcomes and reduce obesity in overweight and obese adolescents. The purposes of this study
      were to (1) measure effects of an innovative smartphone-technology-based (STB) intervention
      for overweight and obese adolescents and to (2) examine the intervention's feasibility for
      use in primary care clinics.The STB intervention had 3 components: use of Fitbit Flex,
      participation in the online educational program, and receipt of bi-weekly text message during
      the maintenance phase. A randomized control study design was utilized. Data regard to
      anthropometrics (BMI and waist-hip ratio), blood pressure, levels of physical and sedentary
      activity, diet, and self-efficacy regarding physical activity and diet were collected at
      baseline, 3 month and 6 months after the baseline assessment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A randomized control study design with an active control group was used.
primary purpose: Prevention
masking: Double (Care Provider, Outcomes Assessor)
masking description: Primary care providers and outcome assessors were blinded to the group assignment.
measure: Body Mass Index (BMI)
time frame: baseline and 6 months
description: Participants' BMI was determined by dividing body mass (weight) by height squared (kg/m2). Adolescents' weight and height were measured while the adolescents wore light-weight clothes and no shoes. For BMI, adequate sensitivity and specificity has been reported in children and adolescents, with sensitivity ranging from 29% to 88% and specificity ranging from 94% to 100%.
measure: Diastolic Blood Pressure
time frame: baseline and 6 months
description: Systolic blood pressure and diastolic blood pressure were measured by using a mercury sphygmomanometer with specific cuff size appropriate for adolescents (Baumanometer, W. A. Baum Co., Copiague, New York). After participants sat for 10 minutes, blood pressure was measured twice in the adolescent's right arm; blood pressures were measured to the nearest 2 mmHg. Average score of two measures was used.
arm group label: fitbit ultra
arm group type: Experimental
description: Adolescents in the intervention group will receive a Fitbit Ultra and will download an app to their smartphone. Participants will be asked to wear the Fitbit device and use the app every day for three months.
arm group label: Pedometer
arm group type: Active Comparator
description: After completion of the baseline assessments, adolescents in the control group will be given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.
intervention type: Behavioral
intervention name: fitbit Ultra
description: Participants will be asked to wear the Fitbit device and use the app every day for three months. The app functions will include tracking of PA and dietary intake progress, setting individualized and realistic goals, monitoring progress related to reaching the goals, providing tips of everyday activities, and having interactive games related to PA and healthy diet.
arm group label: fitbit ultra
other name: Fitbit Ultra and associated apps
intervention type: Behavioral
intervention name: Pedometer
description: adolescents in the control group will be given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.
arm group label: Pedometer
other name: Omron HJ-105 pedometer
criteria: 
gender: All
minimum age: 13 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jyu-Lin Chen
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
citation: Karnik S, Kanekar A. Childhood obesity: a global public health crisis. Int J Prev Med. 2012 Jan;3(1):1-7.
PMID: 22506094
citation: Wang LY, Chyen D, Lee S, Lowry R. The association between body mass index in adolescence and obesity in adulthood. J Adolesc Health. 2008 May;42(5):512-8. doi: 10.1016/j.jadohealth.2007.10.010. Epub 2008 Jan 31.
PMID: 18407047
citation: Chen JL, Wilkosz ME. Efficacy of technology-based interventions for obesity prevention in adolescents: a systematic review. Adolesc Health Med Ther. 2014 Aug 7;5:159-70. doi: 10.2147/AHMT.S39969. eCollection 2014.
PMID: 25177158
citation: Chen JL, Weiss S, Heyman MB, Cooper B, Lustig RH. The efficacy of the web-based childhood obesity prevention program in Chinese American adolescents (Web ABC study). J Adolesc Health. 2011 Aug;49(2):148-54. doi: 10.1016/j.jadohealth.2010.11.243. Epub 2011 Mar 12.
PMID: 21783046
citation: Delamater AM, Pulgaron ER, Rarback S, Hernandez J, Carrillo A, Christiansen S, Severson HH. Web-based family intervention for overweight children: a pilot study. Child Obes. 2013 Feb;9(1):57-63. doi: 10.1089/chi.2011.0126. Epub 2013 Jan 11.
PMID: 23308372
citation: Sim LA, Lebow J, Wang Z, Koball A, Murad MH. Brief Primary Care Obesity Interventions: A Meta-analysis. Pediatrics. 2016 Oct;138(4):e20160149. doi: 10.1542/peds.2016-0149. Epub 2016 Sep 12.
PMID: 27621413
citation: Al-Khudairy L, Loveman E, Colquitt JL, Mead E, Johnson RE, Fraser H, Olajide J, Murphy M, Velho RM, O'Malley C, Azevedo LB, Ells LJ, Metzendorf MI, Rees K. Diet, physical activity and behavioural interventions for the treatment of overweight or obese adolescents aged 12 to 17 years. Cochrane Database Syst Rev. 2017 Jun 22;6(6):CD012691. doi: 10.1002/14651858.CD012691.
PMID: 28639320
citation: Chen JL, Guedes CM, Lung AE. Smartphone-based Healthy Weight Management Intervention for Chinese American Adolescents: Short-term Efficacy and Factors Associated With Decreased Weight. J Adolesc Health. 2019 Apr;64(4):443-449. doi: 10.1016/j.jadohealth.2018.08.022. Epub 2018 Nov 6.
PMID: 30409751
responsible party type: Sponsor
mesh term: Overweight
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 