<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/NCT01674920</url>
  </required_header>
  <id_info>
    <org_study_id>1R21HD050962</org_study_id>
    <secondary_id>1R21HD050962</secondary_id>
    <nct_id>NCT01674920</nct_id>
  </id_info>
  <brief_title>CHOICES: Family Physicians Treat Overweight Children</brief_title>
  <acronym>CHOICES</acronym>
  <official_title>CHOICES: Family Physicians Treat Overweight Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Arizona</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      CHOICES is a program to provide children and families with lifetime tools and lifestyle&#xD;
      strategies to achieve and maintain a healthy body size. Both parents and children get active,&#xD;
      learn about the food choices they can make, and about the roles of TV in their lives. Led by&#xD;
      physicians and young adults, the 12 weekly 90 minute sessions provide hands on experiences&#xD;
      that connect into the participants' daily lives. In the study, the families were divided into&#xD;
      two groups, beginning their classes 6 months apart. Body measurements were taken at baseline&#xD;
      and every 4 months to 16 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The specific aim of this pilot study was to use the group office visit model to provide an&#xD;
      obesity treatment intervention for children 8-11 years of age in gender-specific groups and&#xD;
      their parents in a clinic setting. The targeted lifestyle components of the intervention are&#xD;
      less TV viewing, less sweetened beverages, smaller food portions, less fast food/better&#xD;
      choices away from home and more general physical activity. The psychosocial component was&#xD;
      based in Resiliency; the Choices model focused on a non-judgmental approach to empowerment in&#xD;
      relation to personal goals and knowledge of the basics of nutrition and physical activity.&#xD;
&#xD;
      Our aim was to recruit 35-40 children (approximately equal boys and girls) ages 8-11 and&#xD;
      their parents for a 12 weekly sessions group office visit program. Participants were&#xD;
      randomized into 2 groups; one group starting in March 2006 and the lagged intervention&#xD;
      control group starting in September 2006. Physical measurements and data collection were at&#xD;
      baseline, 4, 8, 12, 16 months from randomization.&#xD;
&#xD;
      We evaluated the acceptability and feasibility of the group office visit model and effect&#xD;
      size (body mass index (BMI) and weight-for-age Z-scores). Feasibility and acceptability&#xD;
      included ability to recruit within clinics, attendance, completion, follow-up rates, focus&#xD;
      groups data and interviews of those who drop out. Evaluation of effect size included the&#xD;
      patterns of growth over 15 months from baseline in relation to expected growth patterns and&#xD;
      intervention exposure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2006</start_date>
  <completion_date type="Actual">June 2008</completion_date>
  <primary_completion_date type="Actual">June 2007</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>body mass index age-and-gender specific Z-score</measure>
    <time_frame>9 months post intervention baseline</time_frame>
    <description>body mass index is weight over height squared; z-score described the position of that BMI in relation to the reference population in terms of standard deviation units. It is used to control for growth effects in children.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>weight for age-and-gender specific Z-score</measure>
    <time_frame>9 months post-intervention baseline</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Obesity</condition>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>Choices</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The 3-month twelve-session intervention, &quot;Choices&quot;, included topics on nutrition, physical activity, and resiliency. Parents, boys and girls met separately. The sessions were developed for delivery by a family physician, two family medicine residents, and a nutritionist, who received training in positive psychology and resilience skills. All children were measured on the same dates, but children were randomly assigned to two cohorts, beginning 6 months apart, to facilitate statistical analysis by having one group experience &quot;normal growth&quot; on study prior to intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Choices</intervention_name>
    <description>The 12-week intervention included 1.5 hour classes each week. Topics included nutrition, physical activity, and psychosocial skills based in Resiliency.</description>
    <arm_group_label>Choices</arm_group_label>
    <other_name>Resiliency</other_name>
    <other_name>Nutrition</other_name>
    <other_name>Physical Activity</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children in the 3rd to 5th grades and above the 85th percentile of BMI for age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Conditions that would preclude dietary change or physical activity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cheryl K Ritenbaugh, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arizona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arizona</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>May 18, 2008</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>August 27, 2012</last_update_submitted>
  <last_update_submitted_qc>August 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pediatric obesity</keyword>
  <keyword>resiliency</keyword>
  <keyword>physical activity</keyword>
  <keyword>dietary patterns</keyword>
  <keyword>children</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/NCT01674920
org study id: 1R21HD050962
secondary id: 1R21HD050962
nct id: NCT01674920
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
CHOICES is a program to provide children and families with lifetime tools and lifestyle
      strategies to achieve and maintain a healthy body size. Both parents and children get active,
      learn about the food choices they can make, and about the roles of TV in their lives. Led by
      physicians and young adults, the 12 weekly 90 minute sessions provide hands on experiences
      that connect into the participants' daily lives. In the study, the families were divided into
      two groups, beginning their classes 6 months apart. Body measurements were taken at baseline
      and every 4 months to 16 months.
The specific aim of this pilot study was to use the group office visit model to provide an
      obesity treatment intervention for children 8-11 years of age in gender-specific groups and
      their parents in a clinic setting. The targeted lifestyle components of the intervention are
      less TV viewing, less sweetened beverages, smaller food portions, less fast food/better
      choices away from home and more general physical activity. The psychosocial component was
      based in Resiliency; the Choices model focused on a non-judgmental approach to empowerment in
      relation to personal goals and knowledge of the basics of nutrition and physical activity.

      Our aim was to recruit 35-40 children (approximately equal boys and girls) ages 8-11 and
      their parents for a 12 weekly sessions group office visit program. Participants were
      randomized into 2 groups; one group starting in March 2006 and the lagged intervention
      control group starting in September 2006. Physical measurements and data collection were at
      baseline, 4, 8, 12, 16 months from randomization.

      We evaluated the acceptability and feasibility of the group office visit model and effect
      size (body mass index (BMI) and weight-for-age Z-scores). Feasibility and acceptability
      included ability to recruit within clinics, attendance, completion, follow-up rates, focus
      groups data and interviews of those who drop out. Evaluation of effect size included the
      patterns of growth over 15 months from baseline in relation to expected growth patterns and
      intervention exposure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: body mass index age-and-gender specific Z-score
time frame: 9 months post intervention baseline
description: body mass index is weight over height squared; z-score described the position of that BMI in relation to the reference population in terms of standard deviation units. It is used to control for growth effects in children.
measure: weight for age-and-gender specific Z-score
time frame: 9 months post-intervention baseline
arm group label: Choices
arm group type: Experimental
description: The 3-month twelve-session intervention, "Choices", included topics on nutrition, physical activity, and resiliency. Parents, boys and girls met separately. The sessions were developed for delivery by a family physician, two family medicine residents, and a nutritionist, who received training in positive psychology and resilience skills. All children were measured on the same dates, but children were randomly assigned to two cohorts, beginning 6 months apart, to facilitate statistical analysis by having one group experience "normal growth" on study prior to intervention.
intervention type: Behavioral
intervention name: Choices
description: The 12-week intervention included 1.5 hour classes each week. Topics included nutrition, physical activity, and psychosocial skills based in Resiliency.
arm group label: Choices
other name: Resiliency
other name: Nutrition
other name: Physical Activity
criteria: 
gender: All
minimum age: 8 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cheryl K Ritenbaugh, PhD, MPH
role: Principal Investigator
affiliation: University of Arizona
facility: 
country: United States
responsible party type: Sponsor
mesh term: Overweight