<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/NCT03797105</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000487</org_study_id>
    <nct_id>NCT03797105</nct_id>
  </id_info>
  <brief_title>Frequency Needed for School-based Obesity Intervention</brief_title>
  <official_title>Frequency of Intervention Needed to Improve Weight Outcomes of Mexican-American Adolescents With Overweight or Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Houston</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized controlled trial compared changes in Mexican-American, adolescent&#xD;
      standardized body mass index (zBMI) from a school-based obesity intervention given zero, one,&#xD;
      three, or five days a week.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Efficacious school-based interventions have been intensive making it difficult for&#xD;
      interventions to be scaled. The more components there are to an intervention, typically the&#xD;
      better the results. Instead of decreasing intensity via the removal of intervention&#xD;
      components, this randomized controlled trial aimed to compare changes in Mexican-American&#xD;
      adolescent standardized body mass index (zBMI) based on the number of days per week they&#xD;
      received a multi-component intervention. Mexican-American middle school students (n=203) with&#xD;
      overweight or obesity were recruited from an independent school district in Houston. Students&#xD;
      were randomized to receive an obesity intervention with established efficacy zero (control),&#xD;
      one, three, or five days/week. In each condition, 80% of intervention time was allocated to&#xD;
      physical activity and 20% to nutrition. Directly measured height and weight were used to&#xD;
      calculate zBMI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2012</start_date>
  <completion_date type="Actual">September 30, 2014</completion_date>
  <primary_completion_date type="Actual">September 30, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Standardized Body Mass Index (zBMI)</measure>
    <time_frame>baseline, 6, and 12 months</time_frame>
    <description>standardized body mass index</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">243</enrollment>
  <condition>Obesity, Child</condition>
  <arm_group>
    <arm_group_label>Control, 0 days</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>control group, no intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1 day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>received the intervention 1 day/week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 days</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>received the intervention 3 days/week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5 days</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>received the intervention 5 days/week</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>School-Based Obesity Intervention (FLOW)</intervention_name>
    <description>The intervention consisted of nutrition lessons based on the traffic light diet, circuit-based physical activity, behavior modification techniques (token economy system, goal setting, self-monitoring), and parental involvement (materials sent home and monthly parent meetings). 80% of time was spent on physical activity and 20% was spent on nutrition. Behavior modification was incorporated into both physical activity and nutrition time. Specifically, instruction and activity time during PE class lasted approximately 40 minutes.</description>
    <arm_group_label>1 day</arm_group_label>
    <arm_group_label>3 days</arm_group_label>
    <arm_group_label>5 days</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. BMI-for-age (Body Mass Index) percentile ≥ 85&#xD;
&#xD;
          2. Male or female between ages 10 - 17 years&#xD;
&#xD;
          3. Self-identified as Mexican-American&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Student who is pregnant, planning to become pregnant, or becomes pregnant&#xD;
&#xD;
          2. School report of cognitive impairment significantly below average age and/or grade&#xD;
             level&#xD;
&#xD;
          3. Use of any weight-loss medication (prescription or nonprescription) for at least 6&#xD;
             months prior to screening&#xD;
&#xD;
          4. Type 1 or 2 diabetes medical diagnosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Craig A Johnston, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>YES Prep Brays Oaks</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Houston</investigator_affiliation>
    <investigator_full_name>Craig A Johnston</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to make IPD available to other researchers</ipd_description>
  </patient_data>
  <!-- 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/NCT03797105
org study id: STUDY00000487
nct id: NCT03797105
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This randomized controlled trial compared changes in Mexican-American, adolescent
      standardized body mass index (zBMI) from a school-based obesity intervention given zero, one,
      three, or five days a week.
Efficacious school-based interventions have been intensive making it difficult for
      interventions to be scaled. The more components there are to an intervention, typically the
      better the results. Instead of decreasing intensity via the removal of intervention
      components, this randomized controlled trial aimed to compare changes in Mexican-American
      adolescent standardized body mass index (zBMI) based on the number of days per week they
      received a multi-component intervention. Mexican-American middle school students (n=203) with
      overweight or obesity were recruited from an independent school district in Houston. Students
      were randomized to receive an obesity intervention with established efficacy zero (control),
      one, three, or five days/week. In each condition, 80% of intervention time was allocated to
      physical activity and 20% to nutrition. Directly measured height and weight were used to
      calculate zBMI.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Standardized Body Mass Index (zBMI)
time frame: baseline, 6, and 12 months
description: standardized body mass index
arm group label: Control, 0 days
arm group type: No Intervention
description: control group, no intervention
arm group label: 1 day
arm group type: Experimental
description: received the intervention 1 day/week
arm group label: 3 days
arm group type: Experimental
description: received the intervention 3 days/week
arm group label: 5 days
arm group type: Experimental
description: received the intervention 5 days/week
intervention type: Behavioral
intervention name: School-Based Obesity Intervention (FLOW)
description: The intervention consisted of nutrition lessons based on the traffic light diet, circuit-based physical activity, behavior modification techniques (token economy system, goal setting, self-monitoring), and parental involvement (materials sent home and monthly parent meetings). 80% of time was spent on physical activity and 20% was spent on nutrition. Behavior modification was incorporated into both physical activity and nutrition time. Specifically, instruction and activity time during PE class lasted approximately 40 minutes.
arm group label: 1 day
arm group label: 3 days
arm group label: 5 days
criteria: 
gender: All
minimum age: 10 Years
maximum age: 17 Years
healthy volunteers: No
last name: Craig A Johnston, PhD
role: Principal Investigator
affiliation: University of Houston
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Houston
investigator full name: Craig A Johnston
investigator title: Associate Professor
mesh term: Obesity
mesh term: Pediatric Obesity
sharing ipd: No
ipd description: There is no plan to make IPD available to other researchers