<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/NCT01733524</url>
  </required_header>
  <id_info>
    <org_study_id>1R03HD071263-01</org_study_id>
    <nct_id>NCT01733524</nct_id>
  </id_info>
  <brief_title>Pet Ownership and Glucose Control in Type 1 Diabetes</brief_title>
  <official_title>Impact of Pet Ownership on Glycemic Control in Youth With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Massachusetts, Worcester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators' long-term goal is to discover novel, inexpensive and feasible strategies&#xD;
      to improve the management and well-being of youth with T1DM. The specific objective of this&#xD;
      proposal is to quantify the impact of responsible pet ownership on the glycemic control and&#xD;
      health related quality of life in youth with T1DM.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Type 1 diabetes mellitus (T1DM) affects 151,000 children and adolescents in the United&#xD;
      States. Youth with T1DM are at a high risk for multiple psychosocial co-morbidities including&#xD;
      poor health related quality of life (HRQoL) which is linked to medication non-compliance and&#xD;
      increased risk for diabetes-related complications. Any reduction in the psychosocial&#xD;
      adjustment difficulties related to T1DM could improve the medical outcome of children with&#xD;
      T1DM.&#xD;
&#xD;
      Current standards for diabetes management reflect the need to maintain glucose control within&#xD;
      a normal range. However, numerous reports indicate that normalization of blood glucose levels&#xD;
      is seldom attainable in children and adolescents. Family cohesion, positive coping&#xD;
      strategies, younger age of onset, social support and adequate self-regulatory behavior are&#xD;
      found to favorably influence glycemic control. One may conclude that the presence of a&#xD;
      companion animal, capable of enhancing the positive factors named above, would augment the&#xD;
      array of tools available for the successful management of chronic illnesses such as T1DM.&#xD;
&#xD;
      There is a lack of studies assessing the impact of pet ownership on the health and well-being&#xD;
      of adolescents. The process of caring for, loving and being loved by a companion animal could&#xD;
      offer direct and/or indirect benefits to the HRQoL in children with T1DM. To the&#xD;
      investigators' knowledge, there are no studies examining the impact of pet ownership on&#xD;
      glycemic control and HRQoL in youth with T1DM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemic control</measure>
    <time_frame>12 months</time_frame>
    <description>Hemoglobin A1c values</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HRQoL</measure>
    <time_frame>9 months</time_frame>
    <description>Generic and diabetes-specific health related quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self Management of Diabetes in Adolescents</measure>
    <time_frame>12 months</time_frame>
    <description>Self management of diabetes in adolescence questionnaire</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Health care burden</measure>
    <time_frame>12 months</time_frame>
    <description>Number of visits to the Emergency Department and inpatient hospitalizations for poor glycemic control</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Picture of a fish</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants will receive a picture of a betta fish.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pet fish</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive a betta fish and the supplies to care for the fish for a one year time period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pet Fish</intervention_name>
    <description>Participants will receive a betta fish and the supplies to care for the fish for a one year time period.</description>
    <arm_group_label>Pet fish</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Picture of a fish</intervention_name>
    <description>Participants will receive a picture of a betta fish.</description>
    <arm_group_label>Picture of a fish</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English-speaking patients&#xD;
&#xD;
          -  10 to 18 years&#xD;
&#xD;
          -  diagnosed with type 1 diabetes for at least 12 months&#xD;
&#xD;
          -  poor diabetes control as defined by having a hemoglobin A1c value &gt; 8%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  type 2 diabetes&#xD;
&#xD;
          -  developmental delay&#xD;
&#xD;
          -  current participation in another study that may impact glycemic control&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olga T Gupta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>June 1, 2016</last_update_submitted>
  <last_update_submitted_qc>June 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Olga Gupta</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>adolescence</keyword>
  <keyword>self care</keyword>
  <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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01733524
org study id: 1R03HD071263-01
nct id: NCT01733524
lead sponsor: 
collaborator: 
has dmc: No
The investigators' long-term goal is to discover novel, inexpensive and feasible strategies
      to improve the management and well-being of youth with T1DM. The specific objective of this
      proposal is to quantify the impact of responsible pet ownership on the glycemic control and
      health related quality of life in youth with T1DM.
Type 1 diabetes mellitus (T1DM) affects 151,000 children and adolescents in the United
      States. Youth with T1DM are at a high risk for multiple psychosocial co-morbidities including
      poor health related quality of life (HRQoL) which is linked to medication non-compliance and
      increased risk for diabetes-related complications. Any reduction in the psychosocial
      adjustment difficulties related to T1DM could improve the medical outcome of children with
      T1DM.

      Current standards for diabetes management reflect the need to maintain glucose control within
      a normal range. However, numerous reports indicate that normalization of blood glucose levels
      is seldom attainable in children and adolescents. Family cohesion, positive coping
      strategies, younger age of onset, social support and adequate self-regulatory behavior are
      found to favorably influence glycemic control. One may conclude that the presence of a
      companion animal, capable of enhancing the positive factors named above, would augment the
      array of tools available for the successful management of chronic illnesses such as T1DM.

      There is a lack of studies assessing the impact of pet ownership on the health and well-being
      of adolescents. The process of caring for, loving and being loved by a companion animal could
      offer direct and/or indirect benefits to the HRQoL in children with T1DM. To the
      investigators' knowledge, there are no studies examining the impact of pet ownership on
      glycemic control and HRQoL in youth with T1DM.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Glycemic control
time frame: 12 months
description: Hemoglobin A1c values
measure: HRQoL
time frame: 9 months
description: Generic and diabetes-specific health related quality of life
measure: Self Management of Diabetes in Adolescents
time frame: 12 months
description: Self management of diabetes in adolescence questionnaire
measure: Health care burden
time frame: 12 months
description: Number of visits to the Emergency Department and inpatient hospitalizations for poor glycemic control
arm group label: Picture of a fish
arm group type: Sham Comparator
description: Participants will receive a picture of a betta fish.
arm group label: Pet fish
arm group type: Active Comparator
description: Participants will receive a betta fish and the supplies to care for the fish for a one year time period.
intervention type: Behavioral
intervention name: Pet Fish
description: Participants will receive a betta fish and the supplies to care for the fish for a one year time period.
arm group label: Pet fish
intervention type: Behavioral
intervention name: Picture of a fish
description: Participants will receive a picture of a betta fish.
arm group label: Picture of a fish
criteria: 
gender: All
minimum age: 10 Years
maximum age: 17 Years
healthy volunteers: No
last name: Olga T Gupta, MD
role: Principal Investigator
affiliation: UT Southwestern
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Olga Gupta
investigator title: Assistant Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1