xml: <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/NCT06018844</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00002143</org_study_id>
      <nct_id>NCT06018844</nct_id>
    </id_info>
    <brief_title>Novel mHealth Physical Activity Intervention for Youth With Type 1 Diabetes Mellitus</brief_title>
    <official_title>Novel mHealth Physical Activity Intervention for Youth With Type 1 Diabetes Mellitus</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Children's Mercy Hospital Kansas City</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Kansas</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Nemours Children's Clinic</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Children's Mercy Hospital Kansas City</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this longitudinal cohort study is to learn about a mHealth intervention in Type 1&#xD;
        Diabetes (T1D)&#xD;
  &#xD;
        The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  Does the intervention increase the amount of text messages between the mHealth software&#xD;
             and participants?&#xD;
  &#xD;
          -  Do the text messages from the Nudge software increase moderate to vigorous physical&#xD;
             activity (MVPA) in participants?&#xD;
  &#xD;
          -  Does the MVPA encouraged by the Nudge software improve the HbA1c levels of participants?&#xD;
  &#xD;
        Participants will:&#xD;
  &#xD;
          -  Receive text messages from the Nudge software&#xD;
  &#xD;
          -  Report physical activity goals via the text messages to the Nudge software&#xD;
  &#xD;
          -  Wear both an accelerometer and an actigraph for three weeks (spread out across the&#xD;
             beginning, 30 days, and 90 days of participation)&#xD;
  &#xD;
          -  Complete surveys at the beginning of participation&#xD;
  &#xD;
          -  Complete daily surveys while wearing the devices&#xD;
  &#xD;
          -  Complete surveys at the end of participation&#xD;
  &#xD;
          -  Record physical activity in study surveys&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">November 2024</completion_date>
    <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>%daily text messages exchanged between youth and the NUDGE bot</measure>
      <time_frame>Through study completion, an average of 3.5 months</time_frame>
      <description>percent of daily text messages exchanged between youth and the NUDGE bot</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Moderate to Vigorous Physical Activity (MVPA) levels</measure>
      <time_frame>Day 1, 30 and 90</time_frame>
      <description>Participants' MVPA levels</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>%days that youth wear the actigraph</measure>
      <time_frame>Day 1, 30 and 90</time_frame>
      <description>Percent of days that youth wear the actigraph</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>%daily physical activity (PA) schedules that participants complete</measure>
      <time_frame>Day 1, 30 and 90</time_frame>
      <description>percent of daily PA schedules that participants complete</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in participant HbA1c</measure>
      <time_frame>Through study completion, an average of 3.5 months</time_frame>
      <description>Change in participant HbA1c</description>
    </secondary_outcome>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Type 1 Diabetes</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>NUDGE</intervention_name>
      <description>NUDGE is a brief mHealth text messaging intervention designed to promote activity in adolescents by allowing them to set, monitor, and receive feedback on daily PA goals through text message.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients 12.00 to 21.99 with Type 1 Diabetes&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants 12.00-21.99 years old&#xD;
  &#xD;
            -  Participants with a physician confirmed T1D diagnosis.&#xD;
  &#xD;
            -  T1D diagnosis was at least 6 months prior to study enrollment&#xD;
  &#xD;
            -  Participants are on an intensive insulin regiment (either with an insulin pump or&#xD;
               multiple daily injection)&#xD;
  &#xD;
            -  Participants must be using a continuous glucose monitor (CGM)&#xD;
  &#xD;
            -  Participants and parents/legally authorized representatives (LARS) of participants&#xD;
               less than 18.00 speak/read English.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants with evidence of type 2 or monogenic diabetes.&#xD;
  &#xD;
            -  Participants with a comorbid chronic condition (e.g., renal disease).&#xD;
  &#xD;
            -  Participants with presence of severe psychiatric disorders.&#xD;
  &#xD;
            -  Participants with a diagnosis of low vision (vision that cannot be corrected with&#xD;
               contact lenses or eyeglasses).&#xD;
  &#xD;
            -  Participants with limited mobility that would prevent participant from engaging in&#xD;
               daily physical activity, self-assessed by participant.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>13 Years</minimum_age>
      <maximum_age>21 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mark Clements, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Children's Mercy</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Priscilla Connell, MPH</last_name>
      <phone>816-601-4543</phone>
      <email>pcconnell@cmh.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Emily DeWit</last_name>
      <phone>913-515-5173</phone>
      <email>eldewit@cmh.edu</email>
    </overall_contact_backup>
    <reference>
      <citation>Dabelea D. The accelerating epidemic of childhood diabetes. Lancet. 2009 Jun 13;373(9680):1999-2000. doi: 10.1016/S0140-6736(09)60874-6. Epub 2009 May 27. No abstract available.</citation>
      <PMID>19481250</PMID>
    </reference>
    <reference>
      <citation>Vehik K, Hamman RF, Lezotte D, Norris JM, Klingensmith G, Bloch C, Rewers M, Dabelea D. Increasing incidence of type 1 diabetes in 0- to 17-year-old Colorado youth. Diabetes Care. 2007 Mar;30(3):503-9. doi: 10.2337/dc06-1837.</citation>
      <PMID>17327312</PMID>
    </reference>
    <reference>
      <citation>Mayer-Davis EJ, Dabelea D, Lawrence JM. Incidence Trends of Type 1 and Type 2 Diabetes among Youths, 2002-2012. N Engl J Med. 2017 Jul 20;377(3):301. doi: 10.1056/NEJMc1706291. No abstract available.</citation>
      <PMID>28723318</PMID>
    </reference>
    <reference>
      <citation>Miller GF, Coffield E, Leroy Z, Wallin R. Prevalence and Costs of Five Chronic Conditions in Children. J Sch Nurs. 2016 Oct;32(5):357-64. doi: 10.1177/1059840516641190. Epub 2016 Apr 4.</citation>
      <PMID>27044668</PMID>
    </reference>
    <reference>
      <citation>American Diabetes Association. 13. Children and Adolescents: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S163-S182. doi: 10.2337/dc20-S013.</citation>
      <PMID>31862756</PMID>
    </reference>
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      <citation>Riddell MC, Gallen IW, Smart CE, Taplin CE, Adolfsson P, Lumb AN, Kowalski A, Rabasa-Lhoret R, McCrimmon RJ, Hume C, Annan F, Fournier PA, Graham C, Bode B, Galassetti P, Jones TW, Millan IS, Heise T, Peters AL, Petz A, Laffel LM. Exercise management in type 1 diabetes: a consensus statement. Lancet Diabetes Endocrinol. 2017 May;5(5):377-390. doi: 10.1016/S2213-8587(17)30014-1. Epub 2017 Jan 24. Erratum In: Lancet Diabetes Endocrinol. 2017 May;5(5):e3.</citation>
      <PMID>28126459</PMID>
    </reference>
    <reference>
      <citation>Miculis CP, De Campos W, da Silva Boguszweski MC. Correlation between glycemic control and physical activity level in adolescents and children with type 1 diabetes. J Phys Act Health. 2015 Feb;12(2):232-7. doi: 10.1123/jpah.2013-0024. Epub 2014 Feb 5.</citation>
      <PMID>24508755</PMID>
    </reference>
    <reference>
      <citation>Nguyen T, Obeid J, Walker RG, Krause MP, Hawke TJ, McAssey K, Vandermeulen J, Timmons BW. Fitness and physical activity in youth with type 1 diabetes mellitus in good or poor glycemic control. Pediatr Diabetes. 2015 Feb;16(1):48-57. doi: 10.1111/pedi.12117. Epub 2014 Jan 20.</citation>
      <PMID>24444038</PMID>
    </reference>
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      <citation>Tully C, Aronow L, Mackey E, Streisand R. Physical Activity in Youth With Type 1 Diabetes: a Review. Curr Diab Rep. 2016 Sep;16(9):85. doi: 10.1007/s11892-016-0779-6.</citation>
      <PMID>27475093</PMID>
    </reference>
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      <citation>Cushing CC, Mitchell TB, Bejarano CM, Walters RW, Crick CJ, Noser AE. Bidirectional Associations Between Psychological States and Physical Activity in Adolescents: A mHealth Pilot Study. J Pediatr Psychol. 2017 Jun 1;42(5):559-568. doi: 10.1093/jpepsy/jsw099.</citation>
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    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Children's Mercy Hospital Kansas City</investigator_affiliation>
      <investigator_full_name>Mark Clements</investigator_full_name>
      <investigator_title>Principle Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06018844
  org study id: STUDY00002143
  nct id: NCT06018844
  lead sponsor: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this longitudinal cohort study is to learn about a mHealth intervention in Type 1
        Diabetes (T1D)
  
        The main question[s] it aims to answer are:
  
          -  Does the intervention increase the amount of text messages between the mHealth software
             and participants?
  
          -  Do the text messages from the Nudge software increase moderate to vigorous physical
             activity (MVPA) in participants?
  
          -  Does the MVPA encouraged by the Nudge software improve the HbA1c levels of participants?
  
        Participants will:
  
          -  Receive text messages from the Nudge software
  
          -  Report physical activity goals via the text messages to the Nudge software
  
          -  Wear both an accelerometer and an actigraph for three weeks (spread out across the
             beginning, 30 days, and 90 days of participation)
  
          -  Complete surveys at the beginning of participation
  
          -  Complete daily surveys while wearing the devices
  
          -  Complete surveys at the end of participation
  
          -  Record physical activity in study surveys
  observational model: Cohort
  time perspective: Prospective
  measure: %daily text messages exchanged between youth and the NUDGE bot
  time frame: Through study completion, an average of 3.5 months
  description: percent of daily text messages exchanged between youth and the NUDGE bot
  measure: Moderate to Vigorous Physical Activity (MVPA) levels
  time frame: Day 1, 30 and 90
  description: Participants' MVPA levels
  measure: %days that youth wear the actigraph
  time frame: Day 1, 30 and 90
  description: Percent of days that youth wear the actigraph
  measure: %daily physical activity (PA) schedules that participants complete
  time frame: Day 1, 30 and 90
  description: percent of daily PA schedules that participants complete
  measure: Change in participant HbA1c
  time frame: Through study completion, an average of 3.5 months
  description: Change in participant HbA1c
  intervention type: Other
  intervention name: NUDGE
  description: NUDGE is a brief mHealth text messaging intervention designed to promote activity in adolescents by allowing them to set, monitor, and receive feedback on daily PA goals through text message.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 13 Years
  maximum age: 21 Years
  healthy volunteers: No
  last name: Mark Clements, MD
  role: Principal Investigator
  affiliation: Children's Mercy
  last name: Priscilla Connell, MPH
  phone: 816-601-4543
  email: pcconnell@cmh.edu
  last name: Emily DeWit
  phone: 913-515-5173
  email: eldewit@cmh.edu
  citation: Dabelea D. The accelerating epidemic of childhood diabetes. Lancet. 2009 Jun 13;373(9680):1999-2000. doi: 10.1016/S0140-6736(09)60874-6. Epub 2009 May 27. No abstract available.
  PMID: 19481250
  citation: Vehik K, Hamman RF, Lezotte D, Norris JM, Klingensmith G, Bloch C, Rewers M, Dabelea D. Increasing incidence of type 1 diabetes in 0- to 17-year-old Colorado youth. Diabetes Care. 2007 Mar;30(3):503-9. doi: 10.2337/dc06-1837.
  PMID: 17327312
  citation: Mayer-Davis EJ, Dabelea D, Lawrence JM. Incidence Trends of Type 1 and Type 2 Diabetes among Youths, 2002-2012. N Engl J Med. 2017 Jul 20;377(3):301. doi: 10.1056/NEJMc1706291. No abstract available.
  PMID: 28723318
  citation: Miller GF, Coffield E, Leroy Z, Wallin R. Prevalence and Costs of Five Chronic Conditions in Children. J Sch Nurs. 2016 Oct;32(5):357-64. doi: 10.1177/1059840516641190. Epub 2016 Apr 4.
  PMID: 27044668
  citation: American Diabetes Association. 13. Children and Adolescents: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S163-S182. doi: 10.2337/dc20-S013.
  PMID: 31862756
  citation: Riddell MC, Gallen IW, Smart CE, Taplin CE, Adolfsson P, Lumb AN, Kowalski A, Rabasa-Lhoret R, McCrimmon RJ, Hume C, Annan F, Fournier PA, Graham C, Bode B, Galassetti P, Jones TW, Millan IS, Heise T, Peters AL, Petz A, Laffel LM. Exercise management in type 1 diabetes: a consensus statement. Lancet Diabetes Endocrinol. 2017 May;5(5):377-390. doi: 10.1016/S2213-8587(17)30014-1. Epub 2017 Jan 24. Erratum In: Lancet Diabetes Endocrinol. 2017 May;5(5):e3.
  PMID: 28126459
  citation: Miculis CP, De Campos W, da Silva Boguszweski MC. Correlation between glycemic control and physical activity level in adolescents and children with type 1 diabetes. J Phys Act Health. 2015 Feb;12(2):232-7. doi: 10.1123/jpah.2013-0024. Epub 2014 Feb 5.
  PMID: 24508755
  citation: Nguyen T, Obeid J, Walker RG, Krause MP, Hawke TJ, McAssey K, Vandermeulen J, Timmons BW. Fitness and physical activity in youth with type 1 diabetes mellitus in good or poor glycemic control. Pediatr Diabetes. 2015 Feb;16(1):48-57. doi: 10.1111/pedi.12117. Epub 2014 Jan 20.
  PMID: 24444038
  citation: Tully C, Aronow L, Mackey E, Streisand R. Physical Activity in Youth With Type 1 Diabetes: a Review. Curr Diab Rep. 2016 Sep;16(9):85. doi: 10.1007/s11892-016-0779-6.
  PMID: 27475093
  citation: Cushing CC, Mitchell TB, Bejarano CM, Walters RW, Crick CJ, Noser AE. Bidirectional Associations Between Psychological States and Physical Activity in Adolescents: A mHealth Pilot Study. J Pediatr Psychol. 2017 Jun 1;42(5):559-568. doi: 10.1093/jpepsy/jsw099.
  PMID: 28131985
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  responsible party type: Principal Investigator
  investigator affiliation: Children's Mercy Hospital Kansas City
  investigator full name: Mark Clements
  investigator title: Principle Investigator
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 1
  sharing ipd: Undecided