<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/NCT02222571</url>
  </required_header>
  <id_info>
    <org_study_id>12JL030</org_study_id>
    <nct_id>NCT02222571</nct_id>
  </id_info>
  <brief_title>Formative Research - Developing a Family-based Obesity Prevention Intervention in the Canadian Context</brief_title>
  <official_title>Formative Research - Developing a Family-based Obesity Prevention Intervention in the Canadian Context</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Guelph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Danone Institute International</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Guelph</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This formative research shows that parents of preschool-aged children are enthusiastic about&#xD;
      learning general parenting skills, such as discipline strategies, but that they are less&#xD;
      interested in information on child nutrition and physical activity needs. To capitalize on&#xD;
      this enthusiasm, Dr. Haines developed Parents and Tots Together (PTT), an intervention that&#xD;
      embeds strategies to improve children's nutrition and activity behaviours within an existing&#xD;
      general skills parenting program. Results from the investigators feasibility trial with 16&#xD;
      Boston-area parents show that PTT is feasible for implementation and is extremely&#xD;
      well-received by parents. Results are also encouraging with respect to changing parent&#xD;
      feeding behaviours and children's nutrition and activity behaviours. What is not known is&#xD;
      whether this program is feasible and contextually appropriate for Canadian families. Thus,&#xD;
      the next step in this research program, and the overall goal of this study, is to assess&#xD;
      Parents and Tots Together (PTT), a family-based intervention to prevent obesity among&#xD;
      children 3 to 5 years of age, within the Canadian context.&#xD;
&#xD;
      To achieve this goal, the investigators will conduct a pilot trial of the PTT program with 60&#xD;
      families recruited through Ontario Early Years Centres (OEYC). The investigators will&#xD;
      randomize 30 families to the 3-month PTT intervention and 30 to a control condition.&#xD;
&#xD;
      The investigators primary objective is to implement and test the feasibility and&#xD;
      acceptability of PTT among families with preschool children so appropriate revisions can be&#xD;
      made to adapt it to a Canadian context. The investigators secondary objective is to compare&#xD;
      the following outcomes among intervention versus control participants:&#xD;
&#xD;
        1. Parent weight-related behaviours (i.e., parent physical activity, intake of&#xD;
           sugar-sweetened beverages, and television/video viewing, as well as responsiveness to&#xD;
           child satiety cues).&#xD;
&#xD;
        2. General parenting behaviours (i.e., use of positive discipline strategies).&#xD;
&#xD;
        3. Child weight-related behaviours (i.e., sleep duration, physical activity, intake of&#xD;
           sugar-sweetened beverages, television/video viewing).&#xD;
&#xD;
        4. Nutritional risk score based on a screening tool for preschoolers.&#xD;
&#xD;
        5. Child change in body mass index (BMI), standardized to age and gender.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Child change in body mass index (BMI), standardized to age and gender.</measure>
    <time_frame>baseline, 6 month follow-up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in child sleep duration</measure>
    <time_frame>baseline, 6-month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in child physical activity</measure>
    <time_frame>baseline, 6-month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in child intake of sugar-sweetened beverages</measure>
    <time_frame>baseline, 6-month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in child Television/video viewing</measure>
    <time_frame>baseline, 6-months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in parent feeding behaviours</measure>
    <time_frame>baseline, 6-months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>9-week parenting group focused on safety</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parents and Tots Together Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parents and Tots Together Program is a 9-week, group-based parenting intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parents and Tots Together Program</intervention_name>
    <description>Group-based parenting program, 9 weeks delivered in a community setting</description>
    <arm_group_label>Parents and Tots Together Program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Supervision for Safety</intervention_name>
    <description>group-based safety intervention for parents</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  We will consider eligible all parents who have a child age 2-5 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  We will exclude: 1) any families who plan to move out of the area during the 9-month&#xD;
             study period; and 2) children with severe health conditions that would prohibit them&#xD;
             from participating in study activities.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jess Haines</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Guelph</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Guelph</name>
      <address>
        <city>Guelph</city>
        <state>Ontario</state>
        <zip>N1G 2W1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>October 21, 2013</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Guelph</investigator_affiliation>
    <investigator_full_name>Jess Haines</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT02222571
org study id: 12JL030
nct id: NCT02222571
lead sponsor: 
collaborator: 
has dmc: Yes
This formative research shows that parents of preschool-aged children are enthusiastic about
      learning general parenting skills, such as discipline strategies, but that they are less
      interested in information on child nutrition and physical activity needs. To capitalize on
      this enthusiasm, Dr. Haines developed Parents and Tots Together (PTT), an intervention that
      embeds strategies to improve children's nutrition and activity behaviours within an existing
      general skills parenting program. Results from the investigators feasibility trial with 16
      Boston-area parents show that PTT is feasible for implementation and is extremely
      well-received by parents. Results are also encouraging with respect to changing parent
      feeding behaviours and children's nutrition and activity behaviours. What is not known is
      whether this program is feasible and contextually appropriate for Canadian families. Thus,
      the next step in this research program, and the overall goal of this study, is to assess
      Parents and Tots Together (PTT), a family-based intervention to prevent obesity among
      children 3 to 5 years of age, within the Canadian context.

      To achieve this goal, the investigators will conduct a pilot trial of the PTT program with 60
      families recruited through Ontario Early Years Centres (OEYC). The investigators will
      randomize 30 families to the 3-month PTT intervention and 30 to a control condition.

      The investigators primary objective is to implement and test the feasibility and
      acceptability of PTT among families with preschool children so appropriate revisions can be
      made to adapt it to a Canadian context. The investigators secondary objective is to compare
      the following outcomes among intervention versus control participants:

        1. Parent weight-related behaviours (i.e., parent physical activity, intake of
           sugar-sweetened beverages, and television/video viewing, as well as responsiveness to
           child satiety cues).

        2. General parenting behaviours (i.e., use of positive discipline strategies).

        3. Child weight-related behaviours (i.e., sleep duration, physical activity, intake of
           sugar-sweetened beverages, television/video viewing).

        4. Nutritional risk score based on a screening tool for preschoolers.

        5. Child change in body mass index (BMI), standardized to age and gender.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Child change in body mass index (BMI), standardized to age and gender.
time frame: baseline, 6 month follow-up
measure: Change in child sleep duration
time frame: baseline, 6-month follow-up
measure: Change in child physical activity
time frame: baseline, 6-month follow-up
measure: Change in child intake of sugar-sweetened beverages
time frame: baseline, 6-month follow-up
measure: Change in child Television/video viewing
time frame: baseline, 6-months
measure: Change in parent feeding behaviours
time frame: baseline, 6-months
arm group label: Control
arm group type: Active Comparator
description: 9-week parenting group focused on safety
arm group label: Parents and Tots Together Program
arm group type: Experimental
description: Parents and Tots Together Program is a 9-week, group-based parenting intervention
intervention type: Behavioral
intervention name: Parents and Tots Together Program
description: Group-based parenting program, 9 weeks delivered in a community setting
arm group label: Parents and Tots Together Program
intervention type: Behavioral
intervention name: Supervision for Safety
description: group-based safety intervention for parents
arm group label: Control
criteria: 
gender: All
minimum age: 2 Years
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jess Haines
role: Principal Investigator
affiliation: University of Guelph
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Guelph
investigator full name: Jess Haines
investigator title: Assistant Professor
mesh term: Obesity