<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/NCT01662570</url>
  </required_header>
  <id_info>
    <org_study_id>807775</org_study_id>
    <secondary_id>R21DK079075</secondary_id>
    <nct_id>NCT01662570</nct_id>
  </id_info>
  <brief_title>Beverage Choice and Lifestyle Modification in Overweight Youth</brief_title>
  <official_title>Beverage Choice and Lifestyle Modification in Overweight Youth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <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>
      The rise in childhood overweightness and concomitant increase in chronic disease risk&#xD;
      warrants exploration into the effectiveness of interventions targeting the eating and&#xD;
      activity habits of overweight youth. This research study developed and tested a &quot;Beverage&#xD;
      Choice and Lifestyle Modification&quot; (BCLM) intervention for 4 to 8 year old children who are&#xD;
      at-risk for being overweight or are overweight and who consume large amounts of sugar&#xD;
      sweetened beverages and juice. The overall study objectives were to test the acceptability&#xD;
      and effectiveness of the BCLM intervention for improving the weight status, energy (kcal)&#xD;
      intake, beverage selections and beverage preferences of children in targeted age and BMI&#xD;
      group. The investigators hypothesized that those children randomized to the BCLM group will&#xD;
      show greater improvements in weight and Body Mass Index (BMI) status, beverage choices,and&#xD;
      energy intake than those assigned to our Nutrition Education (NE) group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2008</start_date>
  <completion_date type="Actual">January 2011</completion_date>
  <primary_completion_date type="Actual">December 2010</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>Body Mass Index (BMI)</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>Change in BMI will be measured from baseline to end of treatment (month 6).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Mass Index z-score (BMI-z)</measure>
    <time_frame>Baseline and month 6</time_frame>
    <description>Change in BMI-z will be measured from baseline to end of treatment (month 6).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Mass Index Percentile (BMI%)</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>Change in BMI% will be measured from baseline to end of treatment (month 6).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Child percent overweight</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>Change in child percent overweight will be measured from baseline to end of treatment (month 6).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Waist Circumference</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Change in waist circumference will be measured from baseline to end of treatment (month 6).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Energy (kcal) intake</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Change in energy intake (kcals/day) will be measured from baseline to end of treatment (month 6) using 3-day food diaries.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sugar-sweetened beverage intake</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Change in sugar-sweetened beverage intake will be measured from baseline to end of treatment (month 6).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment acceptance and satisfaction</measure>
    <time_frame>Month 6</time_frame>
    <description>Overall treatment acceptance and satisfaction will be measured at end of treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Child preferences and motivation for sugar-sweetened beverages</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>Change in child preference and motivation for sugar-sweetened beverages will be measured from baseline to month 6 using a computerized behavioral choice task assessment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Beverage Choice Lifestyle Modification</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The family-based BCLM intervention trained children and parents in self monitoring of sugar sweetened beverage intake and goal-setting, incorporated feedback and reinforcement, and provided water bottles and water filters to promote a reduction in sugar sweetened beverages and overall energy intake.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nutrition Education (NE)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This treatment for parents and children addressed a variety of topics in nutrition including benefits of fruits and vegetables, the food pyramid, vitamins, benefits of eating a variety of foods, and healthy beverage selections. No behavioral change training component was included.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Beverage Choice and Lifestyle Modification</intervention_name>
    <description>The family-based BCLM intervention trained children and parents in self monitoring of sugar sweetened beverage intake and goal-setting, incorporated feedback and reinforcement, and provided water bottles and water filters to promote a reduction in sugar sweetened beverages and overall energy intake. 16 sessions were provided over a 6-month period.</description>
    <arm_group_label>Beverage Choice Lifestyle Modification</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutrition Education (NE)</intervention_name>
    <description>This treatment for parents and children addressed a variety of topics in nutrition including benefits of fruits and vegetables, the food pyramid, vitamins, benefits of eating a variety of foods, and healthy beverage selections. No behavioral change training component was included. 16 sessions over 24 weeks was provided.</description>
    <arm_group_label>Nutrition Education (NE)</arm_group_label>
    <other_name>NE</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 4-8 years old&#xD;
&#xD;
          -  BMI≥85th percentile (based on age and sex)&#xD;
&#xD;
          -  consumes large (≥16 oz.day) sugar sweetened beverages&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child has a serious medical condition&#xD;
&#xD;
          -  Signs of elevated psychopathology are present, as assessed by the Child Behavior&#xD;
             Checklist (CBCL)&#xD;
&#xD;
          -  Parent demonstrates elevated psychiatric problems or eating disorders&#xD;
&#xD;
          -  Failure of parent or child to meet BMI criteria&#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>November 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>
  <keyword>Child Overweight</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</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/NCT01662570
org study id: 807775
secondary id: R21DK079075
nct id: NCT01662570
lead sponsor: 
collaborator: 
has dmc: No
The rise in childhood overweightness and concomitant increase in chronic disease risk
      warrants exploration into the effectiveness of interventions targeting the eating and
      activity habits of overweight youth. This research study developed and tested a "Beverage
      Choice and Lifestyle Modification" (BCLM) intervention for 4 to 8 year old children who are
      at-risk for being overweight or are overweight and who consume large amounts of sugar
      sweetened beverages and juice. The overall study objectives were to test the acceptability
      and effectiveness of the BCLM intervention for improving the weight status, energy (kcal)
      intake, beverage selections and beverage preferences of children in targeted age and BMI
      group. The investigators hypothesized that those children randomized to the BCLM group will
      show greater improvements in weight and Body Mass Index (BMI) status, beverage choices,and
      energy intake than those assigned to our Nutrition Education (NE) group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Body Mass Index (BMI)
time frame: Baseline and Month 6
description: Change in BMI will be measured from baseline to end of treatment (month 6).
measure: Body Mass Index z-score (BMI-z)
time frame: Baseline and month 6
description: Change in BMI-z will be measured from baseline to end of treatment (month 6).
measure: Body Mass Index Percentile (BMI%)
time frame: Baseline and Month 6
description: Change in BMI% will be measured from baseline to end of treatment (month 6).
measure: Child percent overweight
time frame: Baseline and Month 6
description: Change in child percent overweight will be measured from baseline to end of treatment (month 6).
measure: Waist Circumference
time frame: Baseline to Month 6
description: Change in waist circumference will be measured from baseline to end of treatment (month 6).
measure: Energy (kcal) intake
time frame: Baseline to Month 6
description: Change in energy intake (kcals/day) will be measured from baseline to end of treatment (month 6) using 3-day food diaries.
measure: Sugar-sweetened beverage intake
time frame: Baseline to Month 6
description: Change in sugar-sweetened beverage intake will be measured from baseline to end of treatment (month 6).
measure: Treatment acceptance and satisfaction
time frame: Month 6
description: Overall treatment acceptance and satisfaction will be measured at end of treatment.
measure: Child preferences and motivation for sugar-sweetened beverages
time frame: Baseline and Month 6
description: Change in child preference and motivation for sugar-sweetened beverages will be measured from baseline to month 6 using a computerized behavioral choice task assessment.
arm group label: Beverage Choice Lifestyle Modification
arm group type: Active Comparator
description: The family-based BCLM intervention trained children and parents in self monitoring of sugar sweetened beverage intake and goal-setting, incorporated feedback and reinforcement, and provided water bottles and water filters to promote a reduction in sugar sweetened beverages and overall energy intake.
arm group label: Nutrition Education (NE)
arm group type: Other
description: This treatment for parents and children addressed a variety of topics in nutrition including benefits of fruits and vegetables, the food pyramid, vitamins, benefits of eating a variety of foods, and healthy beverage selections. No behavioral change training component was included.
intervention type: Behavioral
intervention name: Beverage Choice and Lifestyle Modification
description: The family-based BCLM intervention trained children and parents in self monitoring of sugar sweetened beverage intake and goal-setting, incorporated feedback and reinforcement, and provided water bottles and water filters to promote a reduction in sugar sweetened beverages and overall energy intake. 16 sessions were provided over a 6-month period.
arm group label: Beverage Choice Lifestyle Modification
intervention type: Other
intervention name: Nutrition Education (NE)
description: This treatment for parents and children addressed a variety of topics in nutrition including benefits of fruits and vegetables, the food pyramid, vitamins, benefits of eating a variety of foods, and healthy beverage selections. No behavioral change training component was included. 16 sessions over 24 weeks was provided.
arm group label: Nutrition Education (NE)
other name: NE
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