<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/NCT03271801</url>
  </required_header>
  <id_info>
    <org_study_id>906996-1</org_study_id>
    <nct_id>NCT03271801</nct_id>
  </id_info>
  <brief_title>Skills Training Within a Family-based Obesity Treatment Intervention</brief_title>
  <official_title>Skills Training in Stimulus Control of Meals and Snacks Within a Family-based Obesity Treatment Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Delaware</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Delaware</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is investigating the impact of a skills training program in stimulus control of&#xD;
      meals and snacks on zBMI. Participants will be randomized to a standard family-based obesity&#xD;
      treatment intervention with education on child health or a standard family-based obesity&#xD;
      treatment intervention with experiential learning about meal stimulus control strategies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Family-based obesity treatment interventions can successfully reduce weight in children, but&#xD;
      are often limited in the practice of skills being taught during treatment sessions.&#xD;
&#xD;
      Skills training focused on a particular behavioral strategy can provide parents with an&#xD;
      experiential component of learning where the information learned as part of a family-based&#xD;
      obesity treatment intervention is also practiced. Health education simply provides knowledge&#xD;
      to a family about a topic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment Challenges&#xD;
  </why_stopped>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Actual">February 28, 2019</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</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>z-BMI</measure>
    <time_frame>3-months</time_frame>
    <description>Height and weight will be used to calculate BMI (kg/m2) and BMI will be standardized in relation to the population mean and standard deviation for the child's age to sex to determine zBMI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Energy intake</measure>
    <time_frame>3-months</time_frame>
    <description>Based upon a 3-day dietary record analyzed using NDS-R, energy intake will be averaged across the three days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Energy from Fat</measure>
    <time_frame>3-months</time_frame>
    <description>Based upon a 3-day dietary record analyzed using NDS-R, the calories from fat will be divided by total energy intake (calories) to get percentage energy from fat.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food groups servings</measure>
    <time_frame>3-months</time_frame>
    <description>Based upon a 3-day dietary record analyzed using NDS-R, the number of servings consumed from each food group will be averaged over three days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>3-months</time_frame>
    <description>Minutes spent engaging in moderate-to-vigorous physical activity will be measured using the PD-PAR.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Obesity, Childhood</condition>
  <arm_group>
    <arm_group_label>Child Health Education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The child health education condition will participate in a family-based obesity treatment program for the first 40 minutes of each session, followed by 20 minutes designated to education about a child health topic. Parents and children will be asked to self-monitor sugar-sweetened beverages, fruits, vegetables, and minutes of physical activity and screen time.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Skills Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The skills training condition will participate in a family-based obesity treatment program for the first 40 minutes of each session followed by 20 minutes of experiential learning about meal stimulus control strategies. Parents and children will be asked to self-monitor sugar-sweetened beverages, fruits, vegetables, and minutes of physical activity and screen time. In addition they will self-monitor the use the following stimulus control strategies: portion control, energy density and variety.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>child health education</intervention_name>
    <description>10, 60-minute sessions with a family-based obesity treatment program implemented for the first 40-minutes of each session followed by 20 minutes of education about a child health topic.</description>
    <arm_group_label>Child Health Education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>skills training</intervention_name>
    <description>10, 60-minute sessions with a family-based obesity treatment program implemented for the first 40-minutes of each session followed by 20 minutes of experiential learning about stimulus control strategies (portion size, energy density, variety).</description>
    <arm_group_label>Skills Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  caregiver of child is ≥18 years of age;&#xD;
&#xD;
          -  the caregiver has a child between the ages of 4 and 8 years-old who is classified as&#xD;
             overweight (body mass index for age ≥ 85th percentile);&#xD;
&#xD;
          -  the caregiver and child are able to read, speak and understand English due to delivery&#xD;
             of the program in English;&#xD;
&#xD;
          -  has transportation to the University of Delaware; and&#xD;
&#xD;
          -  is willing and able to commit to the 3-month study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the child has a medical condition impacting physical activity or eating (e.g. Type&#xD;
&#xD;
             1 or Type 2 diabetes);&#xD;
&#xD;
          -  the child have a medical condition that affects growth (e.g. Prader Willi Syndrome);&#xD;
&#xD;
          -  the child is currently participating in a weight management program, and/or taking&#xD;
             weight loss medication; or&#xD;
&#xD;
          -  the caregiver or child has an inability to participate in regular physical activity.&#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>Shannon Robson, PhD, MPH, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Delaware</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Delaware</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19716</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>March 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>March 22, 2019</last_update_submitted>
  <last_update_submitted_qc>March 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Delaware</investigator_affiliation>
    <investigator_full_name>Shannon Robson</investigator_full_name>
    <investigator_title>Assistant 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>
  </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/NCT03271801
org study id: 906996-1
nct id: NCT03271801
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is investigating the impact of a skills training program in stimulus control of
      meals and snacks on zBMI. Participants will be randomized to a standard family-based obesity
      treatment intervention with education on child health or a standard family-based obesity
      treatment intervention with experiential learning about meal stimulus control strategies.
Family-based obesity treatment interventions can successfully reduce weight in children, but
      are often limited in the practice of skills being taught during treatment sessions.

      Skills training focused on a particular behavioral strategy can provide parents with an
      experiential component of learning where the information learned as part of a family-based
      obesity treatment intervention is also practiced. Health education simply provides knowledge
      to a family about a topic.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: z-BMI
time frame: 3-months
description: Height and weight will be used to calculate BMI (kg/m2) and BMI will be standardized in relation to the population mean and standard deviation for the child's age to sex to determine zBMI.
measure: Energy intake
time frame: 3-months
description: Based upon a 3-day dietary record analyzed using NDS-R, energy intake will be averaged across the three days.
measure: Percent Energy from Fat
time frame: 3-months
description: Based upon a 3-day dietary record analyzed using NDS-R, the calories from fat will be divided by total energy intake (calories) to get percentage energy from fat.
measure: Food groups servings
time frame: 3-months
description: Based upon a 3-day dietary record analyzed using NDS-R, the number of servings consumed from each food group will be averaged over three days.
measure: Physical Activity
time frame: 3-months
description: Minutes spent engaging in moderate-to-vigorous physical activity will be measured using the PD-PAR.
arm group label: Child Health Education
arm group type: Active Comparator
description: The child health education condition will participate in a family-based obesity treatment program for the first 40 minutes of each session, followed by 20 minutes designated to education about a child health topic. Parents and children will be asked to self-monitor sugar-sweetened beverages, fruits, vegetables, and minutes of physical activity and screen time.
arm group label: Skills Training
arm group type: Experimental
description: The skills training condition will participate in a family-based obesity treatment program for the first 40 minutes of each session followed by 20 minutes of experiential learning about meal stimulus control strategies. Parents and children will be asked to self-monitor sugar-sweetened beverages, fruits, vegetables, and minutes of physical activity and screen time. In addition they will self-monitor the use the following stimulus control strategies: portion control, energy density and variety.
intervention type: Behavioral
intervention name: child health education
description: 10, 60-minute sessions with a family-based obesity treatment program implemented for the first 40-minutes of each session followed by 20 minutes of education about a child health topic.
arm group label: Child Health Education
intervention type: Behavioral
intervention name: skills training
description: 10, 60-minute sessions with a family-based obesity treatment program implemented for the first 40-minutes of each session followed by 20 minutes of experiential learning about stimulus control strategies (portion size, energy density, variety).
arm group label: Skills Training
criteria: 
gender: All
minimum age: 4 Years
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shannon Robson, PhD, MPH, RD
role: Principal Investigator
affiliation: University of Delaware
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Delaware
investigator full name: Shannon Robson
investigator title: Assistant Professor
mesh term: Obesity
mesh term: Pediatric Obesity
sharing ipd: No