<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/NCT01698606</url>
  </required_header>
  <id_info>
    <org_study_id>103011</org_study_id>
    <nct_id>NCT01698606</nct_id>
  </id_info>
  <brief_title>FOR HEALTH: A Family-oriented Healthy Eating, Activity and Lifestyle Intervention for Overweight Preschool Children</brief_title>
  <acronym>FOR HEALTH</acronym>
  <official_title>FOR HEALTH: A Family-ORiented Healthy Eating, Activity and Lifestyle Training With Hands-on Experience for Overweight and Obese Preschool Children and Their Families - a Pilot Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this 3-phase study, following an initial small-scale (phase 1) feasibility trial, the aim&#xD;
      of phase 2 of the project is to investigate whether a community-based, 12-month intervention&#xD;
      for overweight and obese preschool children 2-6 years of age and their families will be&#xD;
      effective in reducing the participants' degree of overweight (BMI z-score) and in improving&#xD;
      quality of life.&#xD;
&#xD;
      In the final phase (phase 3), participating children will be randomized to either receiving a&#xD;
      multidisciplinary lifestyle intervention during the first 6 months (treatment arm), or 6&#xD;
      months later (control or wait list arm), in order to generate more robust effectiveness data.&#xD;
      Participants will receive an additional free 6-month YMCA membership while participating in&#xD;
      the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Phase 1 (Feasibility) completed. Currently no funding to launch Phase 2 (RCT).&#xD;
  </why_stopped>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">April 15, 2019</completion_date>
  <primary_completion_date type="Actual">April 15, 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BMI z-score</measure>
    <time_frame>Baseline, 3, 6, 9, 12 months</time_frame>
    <description>Change in BMI z-score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life Scores (PedsQL 4.0)</measure>
    <time_frame>Baseline, 3, 6, 9, 12 months</time_frame>
    <description>Instrument used: PedsQL 4.0 Generic Core Scales, parent report, for toddlers (age 2-4), or for young children (age 5-6).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical activity score (Netherlands Physical Activity Questionnaire for Young Children, NPAQ)</measure>
    <time_frame>Baseline, 3, 6, 9, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in parent-reported daily screen-time (TV, computer)</measure>
    <time_frame>Baseline, 3, 6, 9, 12 months</time_frame>
    <description>Parent-reported daily screen-time, estimated to the nearest 15 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fruit &amp; vegetable consumption assessed by 3-day food records</measure>
    <time_frame>Baseline, 3, 6, 9, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in dairy-product consumption assessed by 3-day food records</measure>
    <time_frame>Baseline, 3, 6, 9, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in grain-product consumption assessed by 3-day food records</measure>
    <time_frame>Baseline, 3, 6, 9, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in consumption of sugar-sweetened beverages assessed by 3-day food records</measure>
    <time_frame>Baseline, 3, 6, 9, 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in percent overBMI</measure>
    <time_frame>Baseline, 3, 6, 9, 12 months</time_frame>
    <description>Percent overBMI is the percentage above the 50th percentile of BMI for the respective age and gender [(BMI-BMI at 50th percentile)]/BMI at 50th percentile]*100</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in parental BMI (kg/m2)</measure>
    <time_frame>Baseline, 3, 6, 9, 12 months</time_frame>
    <description>Assessment of change in BMI of the caregiver primary attending the intervention with the child.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Childhood Obesity</condition>
  <arm_group>
    <arm_group_label>Secondary lifestyle intervention arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>6-month wait list group. Second arm to receive multidisciplinary, family-centered lifestyle intervention with behavioral counseling, following of completion of main 6-month intervention for arm 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Primary lifestyle intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First arm to receive multidisciplinary, family-centered lifestyle intervention with behavioral counseling</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Multidisciplinary, family-centered lifestyle intervention with behavioral counseling</intervention_name>
    <description>Parent/caregiver education with skill training and practical activities revolving around healthy dietary choices, establishing an active versus a sedentary lifestyle, and behavioral aspects, while children will be engaged in active play.</description>
    <arm_group_label>Primary lifestyle intervention arm</arm_group_label>
    <arm_group_label>Secondary lifestyle intervention arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 2-6 on study entry with primary overweight or obesity, BMI =&gt; 85th&#xD;
             percentile for age and sex on 2010 WHO Growth Charts for Canada&#xD;
&#xD;
          -  Family meets Readiness for change criteria, contemplation or higher stage, according&#xD;
             to Prochaskas Transtheoretical Model.&#xD;
&#xD;
          -  At least one parent/caregiver committed to attend all the program sessions with the&#xD;
             child&#xD;
&#xD;
          -  Parent/caregiver is agreeing to complete the study questionnaires at the required time&#xD;
             points&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic medical conditions potentially impacting program participation or associated&#xD;
             with a potentially increased risk in participation (e.g. type 1 diabetes mellitus,&#xD;
             heart-, gastrointestinal-, or kidney diseases, uncontrolled asthma, other physical,&#xD;
             developmental or psychological disabilities that could limit extent of study&#xD;
             participation&#xD;
&#xD;
          -  Regular use of medications that could limit extent of study participation&#xD;
&#xD;
          -  Other concurrent or recently (last 12 months)received obesity treatment&#xD;
&#xD;
          -  Inability to read, speak, and/or verbally understand English&#xD;
&#xD;
          -  Living outside of the greater London, Ontario, area&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dirk E. Bock, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Western Ontario, Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital, London Health Sciences Centre, University of Western Ontario</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>May 24, 2019</last_update_submitted>
  <last_update_submitted_qc>May 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>Dirk Bock</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>childhood obesity</keyword>
  <keyword>multidisciplinary</keyword>
  <keyword>preschool children</keyword>
  <keyword>community-based</keyword>
  <keyword>lifestyle intervention</keyword>
  <keyword>family-centered</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Pediatric 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/NCT01698606
org study id: 103011
nct id: NCT01698606
lead sponsor: 
has dmc: No
In this 3-phase study, following an initial small-scale (phase 1) feasibility trial, the aim
      of phase 2 of the project is to investigate whether a community-based, 12-month intervention
      for overweight and obese preschool children 2-6 years of age and their families will be
      effective in reducing the participants' degree of overweight (BMI z-score) and in improving
      quality of life.

      In the final phase (phase 3), participating children will be randomized to either receiving a
      multidisciplinary lifestyle intervention during the first 6 months (treatment arm), or 6
      months later (control or wait list arm), in order to generate more robust effectiveness data.
      Participants will receive an additional free 6-month YMCA membership while participating in
      the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: BMI z-score
time frame: Baseline, 3, 6, 9, 12 months
description: Change in BMI z-score
measure: Change in Quality of Life Scores (PedsQL 4.0)
time frame: Baseline, 3, 6, 9, 12 months
description: Instrument used: PedsQL 4.0 Generic Core Scales, parent report, for toddlers (age 2-4), or for young children (age 5-6).
measure: Change in physical activity score (Netherlands Physical Activity Questionnaire for Young Children, NPAQ)
time frame: Baseline, 3, 6, 9, 12 months
measure: Change in parent-reported daily screen-time (TV, computer)
time frame: Baseline, 3, 6, 9, 12 months
description: Parent-reported daily screen-time, estimated to the nearest 15 minutes.
measure: Change in fruit & vegetable consumption assessed by 3-day food records
time frame: Baseline, 3, 6, 9, 12 months
measure: Change in dairy-product consumption assessed by 3-day food records
time frame: Baseline, 3, 6, 9, 12 months
measure: Change in grain-product consumption assessed by 3-day food records
time frame: Baseline, 3, 6, 9, 12 months
measure: Change in consumption of sugar-sweetened beverages assessed by 3-day food records
time frame: Baseline, 3, 6, 9, 12 months
measure: Change in percent overBMI
time frame: Baseline, 3, 6, 9, 12 months
description: Percent overBMI is the percentage above the 50th percentile of BMI for the respective age and gender [(BMI-BMI at 50th percentile)]/BMI at 50th percentile]*100
measure: Change in parental BMI (kg/m2)
time frame: Baseline, 3, 6, 9, 12 months
description: Assessment of change in BMI of the caregiver primary attending the intervention with the child.
arm group label: Secondary lifestyle intervention arm
arm group type: Active Comparator
description: 6-month wait list group. Second arm to receive multidisciplinary, family-centered lifestyle intervention with behavioral counseling, following of completion of main 6-month intervention for arm 1.
arm group label: Primary lifestyle intervention arm
arm group type: Experimental
description: First arm to receive multidisciplinary, family-centered lifestyle intervention with behavioral counseling
intervention type: Behavioral
intervention name: Multidisciplinary, family-centered lifestyle intervention with behavioral counseling
description: Parent/caregiver education with skill training and practical activities revolving around healthy dietary choices, establishing an active versus a sedentary lifestyle, and behavioral aspects, while children will be engaged in active play.
arm group label: Primary lifestyle intervention arm
arm group label: Secondary lifestyle intervention arm
criteria: 
gender: All
minimum age: 2 Years
maximum age: 6 Years
healthy volunteers: No
last name: Dirk E. Bock, M.D.
role: Principal Investigator
affiliation: University of Western Ontario, Canada
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: Dirk Bock
investigator title: Principal Investigator
mesh term: Overweight
mesh term: Pediatric Obesity