<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/NCT01708785</url>
  </required_header>
  <id_info>
    <org_study_id>120431</org_study_id>
    <secondary_id>1R01DK094475-01A1</secondary_id>
    <nct_id>NCT01708785</nct_id>
  </id_info>
  <brief_title>Learning Theory to Improve Obesity Treatment</brief_title>
  <acronym>iROC</acronym>
  <official_title>Learning Theory to Improve Obesity Treatment (Intervention for Regulation of Cues)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</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 California, San Diego</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to optimize an obesity treatment program targeting overweight&#xD;
      8-12 year old children using &quot;Cue Exposure Training&quot;.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of the Cue Exposure program is to train children to resist cues to eat unhealthy&#xD;
      foods. Through a series of experimental studies, the investigators will evaluate how many&#xD;
      weekly treatment visits there should be, whether children should be exposed to a single food&#xD;
      or multiple foods during treatment, whether to use partial reinforcement or not, whether&#xD;
      visits should be daily or weekly, and whether the exposures should be in single or multiple&#xD;
      contexts. The investigators will be recruiting parent-child dyads in the San Diego community&#xD;
      to participate in 8 to 16 weekly or daily treatment sessions either in their home, community&#xD;
      center, or our lab, depending on the treatment arm. Parents and children will complete&#xD;
      baseline and post-treatment assessments consisting of collecting psychophysiological data,&#xD;
      completing laboratory tasks, and completing questionnaires. The investigators will be&#xD;
      evaluating which treatment condition reduces overeating (as measured by our laboratory&#xD;
      tasks).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in overeating (Eating in the absence of hunger) from baseline at an average of 3 months and 6 months</measure>
    <time_frame>Change from baseline at an average of 3 months and 6 months</time_frame>
    <description>Reduce overeating or eating in the absence of hunger in response to food cues. Habituation to food cues.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in child weight</measure>
    <time_frame>Change from baseline at an average of 3 and 6 months</time_frame>
    <description>BMI, BMIz</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in parent weight from baseline at average of 3 and 6 months</measure>
    <time_frame>Change from baseline at average of 3 and 6 months</time_frame>
    <description>Measured by BMI (Body Mass Index)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in attention to food cues from baseline at average of 3 and 6 months</measure>
    <time_frame>Change from baseline at average of 3 and 6 months</time_frame>
    <description>Reduce attention to food cues, redirect attention to neutral (non-food cues). Measured by computer program measuring response time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in impulsivity/Inhibition from baseline at average of 3 and 6 months</measure>
    <time_frame>Change from baseline at average of 3 and 6 months</time_frame>
    <description>Reduce impulsive behavior response to both food and non-food cues. Measured by behavioral tasks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in psychophysiological measures of responsivity to food cues from baseline at average of 3 and 6 months</measure>
    <time_frame>Change from baseline at average of 3 and 6 months</time_frame>
    <description>Salivation/swallowing using EMG (electromyography), skin conductance, heart rate and heart rate variability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in level of self-reported cravings in response to palatable food cues from baseline at average of 3 and 6 months</measure>
    <time_frame>Change from baseline at average of 3 and 6 months</time_frame>
    <description>Participants will rate their cravings on a scale of 1-10.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">230</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Single context</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will be exposed to food cues in a single context.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple contexts</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be exposed to food cues in multiple contexts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>8 treatment sessions</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects receive 8 treatment sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>16 treatment sessions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects receive 16 treatment sessions</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Single food Cue Exposure Treatment</intervention_name>
    <description>Subjects will be exposed to the same set of 4 foods in each cue exposure treatment session.</description>
    <arm_group_label>16 treatment sessions</arm_group_label>
    <arm_group_label>8 treatment sessions</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Multiple food Cue Exposure Treatment</intervention_name>
    <description>Subjects will be exposed to a different set of 4 foods in each cue exposure treatment session.</description>
    <arm_group_label>16 treatment sessions</arm_group_label>
    <arm_group_label>8 treatment sessions</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Partial Reinforcement - Enhanced Cue Exposure Treatment</intervention_name>
    <description>Subjects will take random additional tastes of the food during cue exposure treatment.</description>
    <arm_group_label>Multiple contexts</arm_group_label>
    <arm_group_label>Single context</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Partial Reinforcement -Consistent Cue Exposure Treatment</intervention_name>
    <description>Subjects will consistently take the same tastes of the food during cue exposure treatment.</description>
    <arm_group_label>Multiple contexts</arm_group_label>
    <arm_group_label>Single context</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Response to an advertisement for the study,&#xD;
&#xD;
          -  An overweight or obese child in the family who is between the ages of 8 and 13,&#xD;
&#xD;
          -  The 8-13 year old child must be above the 85th BMI % for age and gender,&#xD;
&#xD;
          -  Parent willing to participate and attend all meetings,&#xD;
&#xD;
          -  Parent who can read at a minimum of a 5th grade level in English,&#xD;
&#xD;
          -  Parent and child willing to commit to attendance and assessments,&#xD;
&#xD;
          -  Child who eats in the absence of hunger.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major child psychiatric disorder diagnoses,&#xD;
&#xD;
          -  An obese child over the 99.9th BMI %&#xD;
&#xD;
          -  Child or parent diagnoses of diabetes for which physician supervision of diet is&#xD;
             needed or diagnosis of serious current physical diseases (such as cancer, multiple&#xD;
             sclerosis, lupus) which could significantly decrease their ability to participate in&#xD;
             the intervention (parent report),&#xD;
&#xD;
          -  Child taking a medication that can affect cognitive functioning, such as attention,&#xD;
             concentration, or mental status.&#xD;
&#xD;
          -  Family with restrictions on types of food, such as food allergies, or religious or&#xD;
             ethnic practices that limit the foods available in the home (these restrictions affect&#xD;
             their ability participate in the food exposures because it would limit the variety of&#xD;
             foods available to do exposures with),&#xD;
&#xD;
          -  Child with an active eating disorder (based on parent and child self-report)&#xD;
&#xD;
          -  Major parent psychiatric or eating disorder.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kerri Boutelle, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCSD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Health Eating and Activity Research</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://obesitytreatment.ucsd.edu</url>
    <description>Center for Healthy Eating and Activity Research</description>
  </link>
  <reference>
    <citation>Boutelle KN, Zucker NL, Peterson CB, Rydell SA, Cafri G, Harnack L. Two novel treatments to reduce overeating in overweight children: a randomized controlled trial. J Consult Clin Psychol. 2011 Dec;79(6):759-71. doi: 10.1037/a0025713.</citation>
    <PMID>22122291</PMID>
  </reference>
  <reference>
    <citation>Epstein LH, Myers MD, Raynor HA, Saelens BE. Treatment of pediatric obesity. Pediatrics. 1998 Mar;101(3 Pt 2):554-70.</citation>
    <PMID>12224662</PMID>
  </reference>
  <reference>
    <citation>Nederkoorn C, Smulders FT, Jansen A. Cephalic phase responses, craving and food intake in normal subjects. Appetite. 2000 Aug;35(1):45-55. doi: 10.1006/appe.2000.0328.</citation>
    <PMID>10896760</PMID>
  </reference>
  <reference>
    <citation>Nederkoorn C, Jansen A. Cue reactivity and regulation of food intake. Eat Behav. 2002 Spring;3(1):61-72. doi: 10.1016/s1471-0153(01)00045-9.</citation>
    <PMID>15001020</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>October 16, 2017</last_update_submitted>
  <last_update_submitted_qc>October 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Kerri Boutelle</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>obesity</keyword>
  <keyword>overweight</keyword>
  <keyword>overweight children</keyword>
  <keyword>overweight parents</keyword>
  <keyword>overeating</keyword>
  <keyword>eating in the absence of hunger</keyword>
  <keyword>families with overweight child</keyword>
  <keyword>body mass index</keyword>
  <keyword>BMI</keyword>
  <keyword>weight</keyword>
  <keyword>childhood obesity</keyword>
  <keyword>treatment</keyword>
  <keyword>cue exposure treatment</keyword>
  <keyword>cravings</keyword>
  <keyword>habituation to food cues</keyword>
  <keyword>psychophysiological response to food cues</keyword>
  <keyword>intervention</keyword>
  <keyword>experiments</keyword>
  <keyword>family based treatment</keyword>
  <keyword>behavioral treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT01708785
org study id: 120431
secondary id: 1R01DK094475-01A1
nct id: NCT01708785
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to optimize an obesity treatment program targeting overweight
      8-12 year old children using "Cue Exposure Training".
The goal of the Cue Exposure program is to train children to resist cues to eat unhealthy
      foods. Through a series of experimental studies, the investigators will evaluate how many
      weekly treatment visits there should be, whether children should be exposed to a single food
      or multiple foods during treatment, whether to use partial reinforcement or not, whether
      visits should be daily or weekly, and whether the exposures should be in single or multiple
      contexts. The investigators will be recruiting parent-child dyads in the San Diego community
      to participate in 8 to 16 weekly or daily treatment sessions either in their home, community
      center, or our lab, depending on the treatment arm. Parents and children will complete
      baseline and post-treatment assessments consisting of collecting psychophysiological data,
      completing laboratory tasks, and completing questionnaires. The investigators will be
      evaluating which treatment condition reduces overeating (as measured by our laboratory
      tasks).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in overeating (Eating in the absence of hunger) from baseline at an average of 3 months and 6 months
time frame: Change from baseline at an average of 3 months and 6 months
description: Reduce overeating or eating in the absence of hunger in response to food cues. Habituation to food cues.
measure: Change in child weight
time frame: Change from baseline at an average of 3 and 6 months
description: BMI, BMIz
measure: Change in parent weight from baseline at average of 3 and 6 months
time frame: Change from baseline at average of 3 and 6 months
description: Measured by BMI (Body Mass Index)
measure: Change in attention to food cues from baseline at average of 3 and 6 months
time frame: Change from baseline at average of 3 and 6 months
description: Reduce attention to food cues, redirect attention to neutral (non-food cues). Measured by computer program measuring response time
measure: Change in impulsivity/Inhibition from baseline at average of 3 and 6 months
time frame: Change from baseline at average of 3 and 6 months
description: Reduce impulsive behavior response to both food and non-food cues. Measured by behavioral tasks
measure: Change in psychophysiological measures of responsivity to food cues from baseline at average of 3 and 6 months
time frame: Change from baseline at average of 3 and 6 months
description: Salivation/swallowing using EMG (electromyography), skin conductance, heart rate and heart rate variability.
measure: Change in level of self-reported cravings in response to palatable food cues from baseline at average of 3 and 6 months
time frame: Change from baseline at average of 3 and 6 months
description: Participants will rate their cravings on a scale of 1-10.
arm group label: Single context
arm group type: Active Comparator
description: Subjects will be exposed to food cues in a single context.
arm group label: Multiple contexts
arm group type: Experimental
description: Subjects will be exposed to food cues in multiple contexts.
arm group label: 8 treatment sessions
arm group type: Active Comparator
description: Subjects receive 8 treatment sessions.
arm group label: 16 treatment sessions
arm group type: Experimental
description: Subjects receive 16 treatment sessions
intervention type: Behavioral
intervention name: Single food Cue Exposure Treatment
description: Subjects will be exposed to the same set of 4 foods in each cue exposure treatment session.
arm group label: 16 treatment sessions
arm group label: 8 treatment sessions
intervention type: Behavioral
intervention name: Multiple food Cue Exposure Treatment
description: Subjects will be exposed to a different set of 4 foods in each cue exposure treatment session.
arm group label: 16 treatment sessions
arm group label: 8 treatment sessions
intervention type: Behavioral
intervention name: Partial Reinforcement - Enhanced Cue Exposure Treatment
description: Subjects will take random additional tastes of the food during cue exposure treatment.
arm group label: Multiple contexts
arm group label: Single context
intervention type: Behavioral
intervention name: Partial Reinforcement -Consistent Cue Exposure Treatment
description: Subjects will consistently take the same tastes of the food during cue exposure treatment.
arm group label: Multiple contexts
arm group label: Single context
criteria: 
gender: All
minimum age: 8 Years
maximum age: 13 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kerri Boutelle, Ph.D.
role: Principal Investigator
affiliation: UCSD
facility: 
country: United States
url: http://obesitytreatment.ucsd.edu
description: Center for Healthy Eating and Activity Research
citation: Boutelle KN, Zucker NL, Peterson CB, Rydell SA, Cafri G, Harnack L. Two novel treatments to reduce overeating in overweight children: a randomized controlled trial. J Consult Clin Psychol. 2011 Dec;79(6):759-71. doi: 10.1037/a0025713.
PMID: 22122291
citation: Epstein LH, Myers MD, Raynor HA, Saelens BE. Treatment of pediatric obesity. Pediatrics. 1998 Mar;101(3 Pt 2):554-70.
PMID: 12224662
citation: Nederkoorn C, Smulders FT, Jansen A. Cephalic phase responses, craving and food intake in normal subjects. Appetite. 2000 Aug;35(1):45-55. doi: 10.1006/appe.2000.0328.
PMID: 10896760
citation: Nederkoorn C, Jansen A. Cue reactivity and regulation of food intake. Eat Behav. 2002 Spring;3(1):61-72. doi: 10.1016/s1471-0153(01)00045-9.
PMID: 15001020
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Kerri Boutelle
investigator title: Associate Professor
mesh term: Obesity
sharing ipd: No