<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/NCT02222766</url>
  </required_header>
  <id_info>
    <org_study_id>190331-41</org_study_id>
    <nct_id>NCT02222766</nct_id>
  </id_info>
  <brief_title>Parents and Tots Together: A Family-Based Obesity Prevention Intervention</brief_title>
  <acronym>PTT</acronym>
  <official_title>Parents and Tots Together: A Family-Based Intervention to Promote Healthy Eating and Activity Behaviors Among Preschool Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Guelph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Heart Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Harvard Medical School (HMS and HSDM)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Guelph</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The obesity epidemic has spared no age group, including our youngest children. My and others'&#xD;
      formative research shows that ethnically-diverse, low-income parents of young children are&#xD;
      enthusiastic about learning general parenting skills, such as discipline strategies, but less&#xD;
      interested in nutrition and physical activity. To capitalize on this enthusiasm, I will&#xD;
      create and test an intervention that embeds strategies to improve child weight-related&#xD;
      behaviors within a general skills parenting program.&#xD;
&#xD;
      The overall goal of this study is to assess Parents and Tots Together (PTT), a family-based&#xD;
      intervention to prevent obesity among children age 2 through 5 years. To achieve this goal,&#xD;
      my colleagues and I will conduct a randomized controlled trial (RCT) among ethnically&#xD;
      diverse, primarily low-income families. Our specific aims are to:&#xD;
&#xD;
        1. Determine the extent to which the intervention, compared with a control condition,&#xD;
           results in a smaller age-associated increase in body mass index (BMI) among children&#xD;
           after a 3- month intervention and a 9-month follow-up period (primary outcome).&#xD;
&#xD;
        2. Determine the extent to which the intervention, compared with a control condition,&#xD;
           results in:&#xD;
&#xD;
             1. Improved parent general parenting behaviors, i.e., increased use of positive&#xD;
                discipline strategies.&#xD;
&#xD;
             2. Improved parent feeding practices, i.e., increased responsiveness to child satiety&#xD;
                cues.&#xD;
&#xD;
             3. Improved child weight-related behaviors, i.e., increased sleep duration and&#xD;
                physical activity, and reduced sugar-sweetened beverage intake and television/video&#xD;
                viewing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body mass index (BMI), adjusted for age and gender</measure>
    <time_frame>baseline, post-intervention, 9-month follow-up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in parent general parenting behaviors, i.e., use of positive discipline strategies.</measure>
    <time_frame>baseline, post-intervention, 9-month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in child weight-related behaviors, i.e., sleep duration and physical activity, and sugar-sweetened beverage intake and television/video viewing.</measure>
    <time_frame>baseline, post-intervention, 9-month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in parental feeding behaviors, i.e., controlling feeding practices</measure>
    <time_frame>baseline, post-intervention, 9-month follow-up</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Parents and Tots Together Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>9-week group-based parenting program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Minimal attention control- weekly mailed information on general child development for 9 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parents and Tots Together Program</intervention_name>
    <description>Group-based parenting program, 9 sessions offered weekly</description>
    <arm_group_label>Parents and Tots Together Program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Minimal attention control- 9 weekly mailed information on general child development</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  parents who have a child aged 2-5 years&#xD;
&#xD;
          -  respond to interviews and questionnaires in English or Spanish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any families who plan to move during the study period&#xD;
&#xD;
          -  children or parents with severe health conditions that would prohibit them from&#xD;
             participating in study activities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jess Haines, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Guelph</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Harvard Pilgrim Health Care</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 20, 2014</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>August 20, 2014</last_update_submitted>
  <last_update_submitted_qc>August 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2014</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>Associate 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/NCT02222766
org study id: 190331-41
nct id: NCT02222766
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The obesity epidemic has spared no age group, including our youngest children. My and others'
      formative research shows that ethnically-diverse, low-income parents of young children are
      enthusiastic about learning general parenting skills, such as discipline strategies, but less
      interested in nutrition and physical activity. To capitalize on this enthusiasm, I will
      create and test an intervention that embeds strategies to improve child weight-related
      behaviors within a general skills parenting program.

      The overall goal of this study is to assess Parents and Tots Together (PTT), a family-based
      intervention to prevent obesity among children age 2 through 5 years. To achieve this goal,
      my colleagues and I will conduct a randomized controlled trial (RCT) among ethnically
      diverse, primarily low-income families. Our specific aims are to:

        1. Determine the extent to which the intervention, compared with a control condition,
           results in a smaller age-associated increase in body mass index (BMI) among children
           after a 3- month intervention and a 9-month follow-up period (primary outcome).

        2. Determine the extent to which the intervention, compared with a control condition,
           results in:

             1. Improved parent general parenting behaviors, i.e., increased use of positive
                discipline strategies.

             2. Improved parent feeding practices, i.e., increased responsiveness to child satiety
                cues.

             3. Improved child weight-related behaviors, i.e., increased sleep duration and
                physical activity, and reduced sugar-sweetened beverage intake and television/video
                viewing.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in body mass index (BMI), adjusted for age and gender
time frame: baseline, post-intervention, 9-month follow-up
measure: Change in parent general parenting behaviors, i.e., use of positive discipline strategies.
time frame: baseline, post-intervention, 9-month follow-up
measure: Change in child weight-related behaviors, i.e., sleep duration and physical activity, and sugar-sweetened beverage intake and television/video viewing.
time frame: baseline, post-intervention, 9-month follow-up
measure: Change in parental feeding behaviors, i.e., controlling feeding practices
time frame: baseline, post-intervention, 9-month follow-up
arm group label: Parents and Tots Together Program
arm group type: Experimental
description: 9-week group-based parenting program
arm group label: Control
arm group type: Active Comparator
description: Minimal attention control- weekly mailed information on general child development for 9 weeks
intervention type: Behavioral
intervention name: Parents and Tots Together Program
description: Group-based parenting program, 9 sessions offered weekly
arm group label: Parents and Tots Together Program
intervention type: Behavioral
intervention name: Control
description: Minimal attention control- 9 weekly mailed information on general child development
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jess Haines, PhD
role: Principal Investigator
affiliation: University of Guelph
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Guelph
investigator full name: Jess Haines
investigator title: Associate Professor
mesh term: Obesity