<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/NCT01662557</url>
  </required_header>
  <id_info>
    <org_study_id>807610</org_study_id>
    <secondary_id>R34DK080473</secondary_id>
    <nct_id>NCT01662557</nct_id>
  </id_info>
  <brief_title>Treatment of Early Childhood Overweight in Primary Care: Pilot Study</brief_title>
  <official_title>Treatment of Early Childhood Overweight in Primary Care: Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Geisinger Center for Health Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Childhood overweight continues to increase at an alarming rate and the need exists to find&#xD;
      effective, accessible intervention strategies to prevent and treat children who are at risk&#xD;
      for being overweight or are already overweight. The primary care setting provides an&#xD;
      attractive option for families wishing to receive treatment, yet little is known about the&#xD;
      feasibility, acceptance or efficacy of this intervention setting. The purpose of this study&#xD;
      was to test two different primary care treatments that were intended to increase fruit and&#xD;
      vegetable intake, increase physical activity, and reduce sedentary activity in children ages&#xD;
      4-8, who are overweight or at risk for becoming overweight. Both treatments involved the&#xD;
      child and a parent/caregiver and both were conducted over a four month period. The&#xD;
      parent/child dyads were selected from the pool of families who receive their primary care&#xD;
      within the Geisinger Medical Center geographic area and who have been identified by their&#xD;
      pediatrician as being overweight or at risk for becoming overweight (BMI &gt;85th percentile for&#xD;
      age). One group received weekly mailings which focused on healthy eating, promotion of fruit&#xD;
      and vegetable intake and physical activity, and methods to reduce TV viewing time. The second&#xD;
      group received a group-based intervention at one of the Geisinger Pediatric Clinic sites&#xD;
      using specific behavioral strategies for increasing fruit and vegetable intake, reducing TV&#xD;
      viewing and encouraging physical activity. Changes in overweight percentage, child BMI, lipid&#xD;
      profile, glucose/insulin levels, and anthropometric measurements were analyzed, as well as&#xD;
      treatment satisfaction and acceptance. The investigators hypothesized that children who&#xD;
      receive Family Behavior Modification (FBM) in the primary care setting will show greater&#xD;
      reductions in Body Mass Index (BMI), BMI z-score, percent overweight and waist circumference,&#xD;
      and that children receiving FBM will show greater improvements in dietary intake, increased&#xD;
      physical activity, reduced sedentary activity, and improvements in cardiovascular outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2008</start_date>
  <completion_date type="Actual">March 2011</completion_date>
  <primary_completion_date type="Actual">March 2011</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>Child's Overweight Percentage</measure>
    <time_frame>Baseline and Month 5</time_frame>
    <description>Change in child's overweight percentage will be measured from baseline to end of treatment (month 5)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Mass Index z-score (BMI-z)</measure>
    <time_frame>Baseline and Month 5</time_frame>
    <description>Change in BMI-z score will be measured from baseline to end of treatment (month 5)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Waist Circumference</measure>
    <time_frame>Baseline and Month 5</time_frame>
    <description>Change in child's waist circumference will be measured from baseline to end of treatment (month 5).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>Baseline and Month 5</time_frame>
    <description>Change in BMI will be measured from baseline to end of treatment (month 5).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dietary Intake</measure>
    <time_frame>Baseline and Month 5</time_frame>
    <description>Change in dietary intake (kcals, protein, fat, saturated fat, cholesterol, fiber, carbohydrate, fruit/veg servings, Vitamins A and C) will be assessed from baseline to end of treatment (month 5) using 24-hour recall interviews.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity Level</measure>
    <time_frame>Baseline to Month 5</time_frame>
    <description>Physical activity (sedentary, light, moderate and moderate to vigorous) will be assessed via accelerometry between baseline and end of treatment (month 5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin (uUnits/ml)</measure>
    <time_frame>Baseline and Month 5</time_frame>
    <description>Change in fasting insulin will be measured at baseline and end of treatment (month 5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose (mg/dl)</measure>
    <time_frame>Baseline and Month 5</time_frame>
    <description>Change in fasting glucose levels will be measured from baseline to end of treatment (month 5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides (mg/dl)</measure>
    <time_frame>Baseline and Month 5</time_frame>
    <description>Change in fasting triglyceride levels will be measured from baseline to end of treatment (month 5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL (mg/dl)</measure>
    <time_frame>Baseline and Month 5</time_frame>
    <description>Change in HDL levels will be measured from baseline to end of treatment (month 5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL (mg/dl)</measure>
    <time_frame>Baseline and Month 5</time_frame>
    <description>Change in LDL levels will be measured from baseline to end of treatment (month 5).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Family Behavior Modification</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Family-based behavior modification with parent and child using goal setting, self monitoring, reinforcement, behavioral skills training, and tasting opportunities.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Minimal Nutrition Information</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Weekly mailings emphasizing healthy eating guidelines for families.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Family Behavior Modification</intervention_name>
    <description>5-month intervention for parents and children providing 15 sessions in behavioral skills training in self monitoring, Traffic Light Diet, goal setting, reinforcement and tasting sessions. Of the 15 sessions, 3 were structured as phone sessions.</description>
    <arm_group_label>Family Behavior Modification</arm_group_label>
    <other_name>FBM</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Minimal Nutrition Information</intervention_name>
    <description>Families assigned to MNI received a series of 15 mailings on topics related identifying a healthy body weight for children; energy balance and calorie requirements for children; MyPyramid for Kids; portion control; the benefits of physical activity and screen-time reduction; encouraging fruit and vegetable consumption; healthy snacks and smart shopping; and encouraging family meals.</description>
    <arm_group_label>Minimal Nutrition Information</arm_group_label>
    <other_name>MNI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  4-8 year old children&#xD;
&#xD;
          -  overweight or obese (BMI≥85th percentile, based on age and sex)&#xD;
&#xD;
          -  Parent/primary caregiver willing to attend sessions with child&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failure to meet BMI criteria&#xD;
&#xD;
          -  Child with elevated internalizing or externalizing behavioral problems, as assessed&#xD;
             through Child Behavior Checklist (CBCL)&#xD;
&#xD;
          -  Elevated parent distress, as measured by Symptom Checklist-90 (SCL-90)&#xD;
&#xD;
          -  Child on medications with any weight-altering effect&#xD;
&#xD;
          -  Inability to participate in moderate physical activity or attend study visits&#xD;
&#xD;
          -  Residing &gt;1 hour from study site&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Myles S Faith, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pennsylvania Center for Weight and Eating Disorders</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>January 2011</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>August 14, 2012</last_update_submitted>
  <last_update_submitted_qc>August 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pediatric Obesity</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/NCT01662557
org study id: 807610
secondary id: R34DK080473
nct id: NCT01662557
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Childhood overweight continues to increase at an alarming rate and the need exists to find
      effective, accessible intervention strategies to prevent and treat children who are at risk
      for being overweight or are already overweight. The primary care setting provides an
      attractive option for families wishing to receive treatment, yet little is known about the
      feasibility, acceptance or efficacy of this intervention setting. The purpose of this study
      was to test two different primary care treatments that were intended to increase fruit and
      vegetable intake, increase physical activity, and reduce sedentary activity in children ages
      4-8, who are overweight or at risk for becoming overweight. Both treatments involved the
      child and a parent/caregiver and both were conducted over a four month period. The
      parent/child dyads were selected from the pool of families who receive their primary care
      within the Geisinger Medical Center geographic area and who have been identified by their
      pediatrician as being overweight or at risk for becoming overweight (BMI >85th percentile for
      age). One group received weekly mailings which focused on healthy eating, promotion of fruit
      and vegetable intake and physical activity, and methods to reduce TV viewing time. The second
      group received a group-based intervention at one of the Geisinger Pediatric Clinic sites
      using specific behavioral strategies for increasing fruit and vegetable intake, reducing TV
      viewing and encouraging physical activity. Changes in overweight percentage, child BMI, lipid
      profile, glucose/insulin levels, and anthropometric measurements were analyzed, as well as
      treatment satisfaction and acceptance. The investigators hypothesized that children who
      receive Family Behavior Modification (FBM) in the primary care setting will show greater
      reductions in Body Mass Index (BMI), BMI z-score, percent overweight and waist circumference,
      and that children receiving FBM will show greater improvements in dietary intake, increased
      physical activity, reduced sedentary activity, and improvements in cardiovascular outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Child's Overweight Percentage
time frame: Baseline and Month 5
description: Change in child's overweight percentage will be measured from baseline to end of treatment (month 5)
measure: Body Mass Index z-score (BMI-z)
time frame: Baseline and Month 5
description: Change in BMI-z score will be measured from baseline to end of treatment (month 5)
measure: Waist Circumference
time frame: Baseline and Month 5
description: Change in child's waist circumference will be measured from baseline to end of treatment (month 5).
measure: Body Mass Index (BMI)
time frame: Baseline and Month 5
description: Change in BMI will be measured from baseline to end of treatment (month 5).
measure: Dietary Intake
time frame: Baseline and Month 5
description: Change in dietary intake (kcals, protein, fat, saturated fat, cholesterol, fiber, carbohydrate, fruit/veg servings, Vitamins A and C) will be assessed from baseline to end of treatment (month 5) using 24-hour recall interviews.
measure: Activity Level
time frame: Baseline to Month 5
description: Physical activity (sedentary, light, moderate and moderate to vigorous) will be assessed via accelerometry between baseline and end of treatment (month 5).
measure: Insulin (uUnits/ml)
time frame: Baseline and Month 5
description: Change in fasting insulin will be measured at baseline and end of treatment (month 5).
measure: Glucose (mg/dl)
time frame: Baseline and Month 5
description: Change in fasting glucose levels will be measured from baseline to end of treatment (month 5).
measure: Triglycerides (mg/dl)
time frame: Baseline and Month 5
description: Change in fasting triglyceride levels will be measured from baseline to end of treatment (month 5).
measure: HDL (mg/dl)
time frame: Baseline and Month 5
description: Change in HDL levels will be measured from baseline to end of treatment (month 5).
measure: LDL (mg/dl)
time frame: Baseline and Month 5
description: Change in LDL levels will be measured from baseline to end of treatment (month 5).
arm group label: Family Behavior Modification
arm group type: Active Comparator
description: Family-based behavior modification with parent and child using goal setting, self monitoring, reinforcement, behavioral skills training, and tasting opportunities.
arm group label: Minimal Nutrition Information
arm group type: Other
description: Weekly mailings emphasizing healthy eating guidelines for families.
intervention type: Behavioral
intervention name: Family Behavior Modification
description: 5-month intervention for parents and children providing 15 sessions in behavioral skills training in self monitoring, Traffic Light Diet, goal setting, reinforcement and tasting sessions. Of the 15 sessions, 3 were structured as phone sessions.
arm group label: Family Behavior Modification
other name: FBM
intervention type: Other
intervention name: Minimal Nutrition Information
description: Families assigned to MNI received a series of 15 mailings on topics related identifying a healthy body weight for children; energy balance and calorie requirements for children; MyPyramid for Kids; portion control; the benefits of physical activity and screen-time reduction; encouraging fruit and vegetable consumption; healthy snacks and smart shopping; and encouraging family meals.
arm group label: Minimal Nutrition Information
other name: MNI
criteria: 
gender: All
minimum age: 4 Years
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Myles S Faith, Ph.D.
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
responsible party type: Sponsor
mesh term: Overweight
mesh term: Pediatric Obesity