<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/NCT02186379</url>
  </required_header>
  <id_info>
    <org_study_id>12-009540</org_study_id>
    <nct_id>NCT02186379</nct_id>
  </id_info>
  <brief_title>Eating RePace Study</brief_title>
  <acronym>REPACE</acronym>
  <official_title>Eating Pace Retraining in Childhood Obesity Prevention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital of Philadelphia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aims of this study are to develop a novel family-based behavioral intervention (Re-Pace)&#xD;
      to help children at risk for obesity (children who eat rapidly and have an overweight&#xD;
      parent/legal guardian) develop a more normal eating rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Childhood obesity is one of nation's foremost public health epidemics, for which more potent&#xD;
      and enduring prevention interventions are needed. The goal of this program of research is to&#xD;
      study novel methods which may help to prevent childhood obesity. The purpose of this&#xD;
      randomized, controlled pilot study is to retrain children at risk for obesity (4-7 years of&#xD;
      age in the 65th - &lt;96th BMI percentile for age and sex, who have rapid eating and an obese&#xD;
      participating parent/legal guardian [ N = 15]) to reduce their rate of eating&#xD;
      (mouthfuls/minute) during a laboratory test meal, compared with participants in usual care&#xD;
      control condition (UCC),which receives a brief educational intervention to promote healthy&#xD;
      eating after the final assessment) (N=15). Between group change scores in mouthfuls/min&#xD;
      (baseline Lab meal 1 to Lab meal 2) will be assessed. The investigators hypothesize that the&#xD;
      children in the Re-Pace group will have a greater reduction in the rate of eating (mouthfuls&#xD;
      of food/min) from baseline to week 6, compared to those in the UCC group.&#xD;
&#xD;
      As the sample size is relatively small, the aim is to develop an &quot;effect size estimation,&quot;&#xD;
      i.e., to generate an effect size that will be used to power an extramural grant application.&#xD;
      Specifically, the investigators will generate Cohen's D as the effect size estimate, which is&#xD;
      calculated as the difference in the group means divided by the pooled standard deviation.&#xD;
      Cohen's D is an established quantitative measure for effect size estimation and informing&#xD;
      power analysis for study design.&#xD;
&#xD;
      In addition, this study's objective is to develop and pilot a novel family-based eating&#xD;
      behavior program for a prevention intervention in at risk children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</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>Reduction of eating rate (mouthfuls/min)</measure>
    <time_frame>6 weeks</time_frame>
    <description>The purpose of this randomized, controlled pilot study is to retrain children at risk for obesity (4-7 years of age in the 65th - &lt;96th BMI percentile for age and sex, who have rapid eating and an obese participating parent/legal guardian [ N = 15]) to reduce their rate of eating (mouthfuls/minute) during a laboratory test meal, compared with participants in usual care control condition (UCC),which receives a brief educational intervention to promote healthy eating after the final assessment) (N=15). Between group change scores in mouthfuls/min (baseline Lab meal 1 to Lab meal 2) will be assessed. We hypothesize that the children in the Re-Pace group will have a greater reduction in the rate of eating (mouthfuls of food/min) from baseline to week 6, compared to those in the UCC group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction of food consumption</measure>
    <time_frame>6 weeks</time_frame>
    <description>Reduce the rate of food consumption (kcal/min) and total kcal intake during the test meals (baseline Lab Meal 1 to Lab Meal 2). We also aim for participants to consume more fruits and vegetables during the test meal (baseline to week 6).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Obesity</condition>
  <condition>Rapid Eating Style</condition>
  <arm_group>
    <arm_group_label>RePace Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Re-Pace intervention-five weekly intervention sessions lasting about 1 hour each.&#xD;
Lab Test Meal-2 test meals 6-8 weeks apart.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One 25 minute education session (week 6) 2 lab test meals 6-8 weeks apart (baseline and week 6)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>RePace Intervention</intervention_name>
    <description>The Re-Pace intervention will provide children and parents/caregivers training in strategies to promote slower eating pace and greater awareness of satiety levels. These skill building strategies can be classified as follows: 1) learning to slow eating rate, 2) awareness-raising activities; 3) role play activities; 4) self-monitoring training; 5) goal setting challenges; and 6) parent training. A core strategy for achieving slower eating pace and improved satiety will be to increase fruit and vegetable intake to meet United States Department of Agriculture (USDA) guidelines (www.myplate.gov). There are 5 intervention visits lasting about 1 to 1.25 hours each. See Section 4.3.1 for more details of the Re-Pace intervention.</description>
    <arm_group_label>RePace Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care Control</intervention_name>
    <description>Following the second test meal session, parents and children will receive a brief (25 minute) instruction on healthy eating using materials from www.ChooseMyPlate.gov site, including &quot;What's on Your Plate&quot; and &quot;My Plate for Kids&quot; mini-posters.</description>
    <arm_group_label>Usual Care Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Children:&#xD;
&#xD;
          -  Males or females 4 to 7 years of age.&#xD;
&#xD;
          -  Participants (the children) have a body mass index (BMI) for age and sex between the&#xD;
             65th-&lt;96th percentile (thus, the children will not have a BMI at the 97th percentile&#xD;
             or more).&#xD;
&#xD;
          -  Parental/guardian permission (informed consent).&#xD;
&#xD;
          -  Have an overweight or obese participating parent/guardian with a BMI of &gt; 27 kg/m2&#xD;
&#xD;
          -  Increased child eating rate as reported on the questionnaire (Child Eating Behavior&#xD;
             Questionnaire) by the parent/guardian&#xD;
&#xD;
        Parents:&#xD;
&#xD;
          -  Parent/legal guardian of subject.&#xD;
&#xD;
          -  Age 21 years and above.&#xD;
&#xD;
          -  Have a BMI of &gt; 27 kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Children:&#xD;
&#xD;
          -  Children who have any developmental, medical, or psychiatric condition which might&#xD;
             affect study compliance, as described by parental (caregiver) report.&#xD;
&#xD;
          -  Children who have serious medical conditions or use of medications (e.g., chronic oral&#xD;
             steroids, antipsychotic medications) known to affect food intake or body weight, as&#xD;
             described by parental report.&#xD;
&#xD;
          -  Children who have food allergies which may influence consumption of test foods, as&#xD;
             reported by the parent; any child with reported peanut allergy.&#xD;
&#xD;
          -  Parents/guardians or subjects who, in the opinion of the Investigator, may be&#xD;
             non-compliant with study schedules or procedures.&#xD;
&#xD;
        Parents:&#xD;
&#xD;
          -  Parents/guardians who, in the opinion of the Investigator, may be non-compliant with&#xD;
             study schedules or procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert I Berkowitz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital of Philadelphia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>April 23, 2015</last_update_submitted>
  <last_update_submitted_qc>April 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Obesity Prevention</keyword>
  <keyword>Childhood obesity prevention</keyword>
  <keyword>Rapid Eating Style</keyword>
  <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/NCT02186379
org study id: 12-009540
nct id: NCT02186379
lead sponsor: 
has dmc: No
The aims of this study are to develop a novel family-based behavioral intervention (Re-Pace)
      to help children at risk for obesity (children who eat rapidly and have an overweight
      parent/legal guardian) develop a more normal eating rate.
Childhood obesity is one of nation's foremost public health epidemics, for which more potent
      and enduring prevention interventions are needed. The goal of this program of research is to
      study novel methods which may help to prevent childhood obesity. The purpose of this
      randomized, controlled pilot study is to retrain children at risk for obesity (4-7 years of
      age in the 65th - <96th BMI percentile for age and sex, who have rapid eating and an obese
      participating parent/legal guardian [ N = 15]) to reduce their rate of eating
      (mouthfuls/minute) during a laboratory test meal, compared with participants in usual care
      control condition (UCC),which receives a brief educational intervention to promote healthy
      eating after the final assessment) (N=15). Between group change scores in mouthfuls/min
      (baseline Lab meal 1 to Lab meal 2) will be assessed. The investigators hypothesize that the
      children in the Re-Pace group will have a greater reduction in the rate of eating (mouthfuls
      of food/min) from baseline to week 6, compared to those in the UCC group.

      As the sample size is relatively small, the aim is to develop an "effect size estimation,"
      i.e., to generate an effect size that will be used to power an extramural grant application.
      Specifically, the investigators will generate Cohen's D as the effect size estimate, which is
      calculated as the difference in the group means divided by the pooled standard deviation.
      Cohen's D is an established quantitative measure for effect size estimation and informing
      power analysis for study design.

      In addition, this study's objective is to develop and pilot a novel family-based eating
      behavior program for a prevention intervention in at risk children.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Reduction of eating rate (mouthfuls/min)
time frame: 6 weeks
description: The purpose of this randomized, controlled pilot study is to retrain children at risk for obesity (4-7 years of age in the 65th - <96th BMI percentile for age and sex, who have rapid eating and an obese participating parent/legal guardian [ N = 15]) to reduce their rate of eating (mouthfuls/minute) during a laboratory test meal, compared with participants in usual care control condition (UCC),which receives a brief educational intervention to promote healthy eating after the final assessment) (N=15). Between group change scores in mouthfuls/min (baseline Lab meal 1 to Lab meal 2) will be assessed. We hypothesize that the children in the Re-Pace group will have a greater reduction in the rate of eating (mouthfuls of food/min) from baseline to week 6, compared to those in the UCC group.
measure: Reduction of food consumption
time frame: 6 weeks
description: Reduce the rate of food consumption (kcal/min) and total kcal intake during the test meals (baseline Lab Meal 1 to Lab Meal 2). We also aim for participants to consume more fruits and vegetables during the test meal (baseline to week 6).
arm group label: RePace Intervention Group
arm group type: Experimental
description: Re-Pace intervention-five weekly intervention sessions lasting about 1 hour each.
Lab Test Meal-2 test meals 6-8 weeks apart.
arm group label: Usual Care Control Group
arm group type: Active Comparator
description: One 25 minute education session (week 6) 2 lab test meals 6-8 weeks apart (baseline and week 6)
intervention type: Behavioral
intervention name: RePace Intervention
description: The Re-Pace intervention will provide children and parents/caregivers training in strategies to promote slower eating pace and greater awareness of satiety levels. These skill building strategies can be classified as follows: 1) learning to slow eating rate, 2) awareness-raising activities; 3) role play activities; 4) self-monitoring training; 5) goal setting challenges; and 6) parent training. A core strategy for achieving slower eating pace and improved satiety will be to increase fruit and vegetable intake to meet United States Department of Agriculture (USDA) guidelines (www.myplate.gov). There are 5 intervention visits lasting about 1 to 1.25 hours each. See Section 4.3.1 for more details of the Re-Pace intervention.
arm group label: RePace Intervention Group
intervention type: Behavioral
intervention name: Usual Care Control
description: Following the second test meal session, parents and children will receive a brief (25 minute) instruction on healthy eating using materials from www.ChooseMyPlate.gov site, including "What's on Your Plate" and "My Plate for Kids" mini-posters.
arm group label: Usual Care Control Group
criteria: 
gender: All
minimum age: 4 Years
maximum age: 7 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Robert I Berkowitz, MD
role: Principal Investigator
affiliation: Children's Hospital of Philadelphia
facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity