<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/NCT02976636</url>
  </required_header>
  <id_info>
    <org_study_id>1R01DK106157</org_study_id>
    <secondary_id>R01DK106157</secondary_id>
    <nct_id>NCT02976636</nct_id>
  </id_info>
  <brief_title>Reinforced Enhanced - Families Responsibility Education Support and Health</brief_title>
  <acronym>Re-FRESH</acronym>
  <official_title>Parent Training Program to Improve Outcomes in Childhood Obesity Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</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 California, San Diego</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this application is to evaluate whether a pediatric weight control program&#xD;
      that incorporates comprehensive parenting training with behavioral therapy can increase&#xD;
      weight loss in children compared to traditional family-based behavioral therapy programs.&#xD;
      Since certain parenting styles are associated with greater weight loss during interventions&#xD;
      and appear to enhance the impact of key behavioral strategies, adding parenting training to&#xD;
      these interventions may increase the overall effectiveness of these programs and increase our&#xD;
      ability to help children obtain a healthy weight. This project could result in identifying an&#xD;
      improved method of pediatric obesity treatment that provides additional benefits to the&#xD;
      growth and development of children via improved self-regulatory behaviors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Authoritative parenting style has been associated with decreased obesity risk in children,&#xD;
      increased weight loss during interventions, and can modify the delivery and impact of weight&#xD;
      control strategies, making them more effective. At this time, gold-standard treatment for&#xD;
      childhood obesity is family-based behavioral therapy (FBT). This treatment relies on&#xD;
      behavioral strategies and the use of praise and a positive reinforcement system to change&#xD;
      eating and activity behaviors, but does not target other aspects of parenting. Broadening&#xD;
      parenting instruction to include effective limit-setting behaviors, parent-child&#xD;
      communication, and authoritative parenting may increase parents' confidence and ability to&#xD;
      successfully make behavior changes and modify the impact of the behavioral strategies being&#xD;
      used. In this application, the investigators propose to test the efficacy of a 20-week weight&#xD;
      control program that combines traditional family-based behavioral therapy with comprehensive&#xD;
      parenting training (FBT-PT) and compare it to traditional family-based behavioral therapy&#xD;
      (FBT). The investigators hypothesize that there will be an additive effect of parenting&#xD;
      training such that FBT-PT will have a greater effect on child weight loss (measured by BMI&#xD;
      z-score) than traditional FBT. In addition, the investigators will measure parenting style,&#xD;
      parenting strategies, behavioral strategies, and child factors (like impulsive behavior and&#xD;
      temperament) to better understand the mediators and moderators of weight loss. These measures&#xD;
      will be obtained by standard self-report measures and videotape encounters, allowing one to&#xD;
      more objectively measure parenting dimensions. Clinical outcomes, like drop-out and&#xD;
      acceptability, will also be assessed from the two treatment arms. The purpose of this study&#xD;
      is to evaluate the effect of adding a comprehensive parenting training to traditional FBT. If&#xD;
      successful, this program will be able to increase our ability to help children successfully&#xD;
      lose weight.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 17, 2017</start_date>
  <completion_date type="Actual">November 2, 2022</completion_date>
  <primary_completion_date type="Actual">November 2, 2022</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>
    <masking_description>The assessors will not know which arm of the study each family is in.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in BMI percentile</measure>
    <time_frame>6 months and 18 months</time_frame>
    <description>Change in BMI percentile at the end of treatment and follow-up period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent of families who Drop-out of study</measure>
    <time_frame>6 months</time_frame>
    <description>Difference in percent of families who drop-out between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Report of Parent Behavior Inventory</measure>
    <time_frame>6 months and 18 months</time_frame>
    <description>Change in parenting style from baseline to post-treatment and follow-up between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of sessions attended between groups</measure>
    <time_frame>6 months</time_frame>
    <description>Difference in percentage of sessions attended between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of families who adhered to treatment goals</measure>
    <time_frame>6 months</time_frame>
    <description>Difference in percent of families who adhered to treatment goals between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child feeding questionnaire</measure>
    <time_frame>6 months and 18 months</time_frame>
    <description>Change in child feed behaviors from baseline to post-treatment and follow-up between groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Pediatric Obesity</condition>
  <arm_group>
    <arm_group_label>Family-based behavioral therapy (FBT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Family-based behavioral therapy for pediatric weight loss</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parenting training and FBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Family-based behavioral therapy for pediatric weight loss + parenting training to enhance outcomes</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Family-based behavioral therapy</intervention_name>
    <description>Traditional family-based, group-based behavioral therapy for weight loss. Parent and child groups will be held separately. Intervention will consist of 20 sessions: 16 weekly sessions, and then every other week for 4 sessions.</description>
    <arm_group_label>Family-based behavioral therapy (FBT)</arm_group_label>
    <arm_group_label>Parenting training and FBT</arm_group_label>
    <other_name>FBT</other_name>
    <other_name>FRESH</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parenting training</intervention_name>
    <description>Parenting skills training for parents. Parent and child groups will be held separately and only parents will receive this training. Children will not receive any additional materials. Intervention will consist of 20 sessions: 16 weekly sessions, and then every other week for 4 sessions.</description>
    <arm_group_label>Parenting training and FBT</arm_group_label>
    <other_name>Re-FRESH</other_name>
    <other_name>FBT + PT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Children between the ages of 7 and 12 years old;&#xD;
&#xD;
          2. BMI ≥85th percentile but &lt;100% overweight, so as to limit those children who are&#xD;
             morbidly obese and are in need of more intense medical treatment;&#xD;
&#xD;
          3. Children with mothers who are willing to attend 20 weekly group sessions and be&#xD;
             randomized to either treatment arm;&#xD;
&#xD;
          4. Have at least one parent who is overweight or obese (BMI≥25); and&#xD;
&#xD;
          5. Parents who speak English at a 5th grade level.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Children with serious medical conditions that affect their weight;&#xD;
&#xD;
          2. Children taking medication that affect appetite or weight;&#xD;
&#xD;
          3. Children with severe developmental delay or disability that would affect&#xD;
             participation;&#xD;
&#xD;
          4. Children or parents with psychological illness that would limit treatment&#xD;
             participation;&#xD;
&#xD;
          5. Families who will move out of the area within the time frame of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California, San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>May 15, 2023</last_update_submitted>
  <last_update_submitted_qc>May 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2023</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>Kay Rhee</investigator_full_name>
    <investigator_title>Associate Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Obesity treatment</keyword>
  <keyword>Parenting training</keyword>
  <keyword>Parenting style</keyword>
  <keyword>Family-based behavioral therapy</keyword>
  <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/NCT02976636
org study id: 1R01DK106157
secondary id: R01DK106157
nct id: NCT02976636
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this application is to evaluate whether a pediatric weight control program
      that incorporates comprehensive parenting training with behavioral therapy can increase
      weight loss in children compared to traditional family-based behavioral therapy programs.
      Since certain parenting styles are associated with greater weight loss during interventions
      and appear to enhance the impact of key behavioral strategies, adding parenting training to
      these interventions may increase the overall effectiveness of these programs and increase our
      ability to help children obtain a healthy weight. This project could result in identifying an
      improved method of pediatric obesity treatment that provides additional benefits to the
      growth and development of children via improved self-regulatory behaviors.
Authoritative parenting style has been associated with decreased obesity risk in children,
      increased weight loss during interventions, and can modify the delivery and impact of weight
      control strategies, making them more effective. At this time, gold-standard treatment for
      childhood obesity is family-based behavioral therapy (FBT). This treatment relies on
      behavioral strategies and the use of praise and a positive reinforcement system to change
      eating and activity behaviors, but does not target other aspects of parenting. Broadening
      parenting instruction to include effective limit-setting behaviors, parent-child
      communication, and authoritative parenting may increase parents' confidence and ability to
      successfully make behavior changes and modify the impact of the behavioral strategies being
      used. In this application, the investigators propose to test the efficacy of a 20-week weight
      control program that combines traditional family-based behavioral therapy with comprehensive
      parenting training (FBT-PT) and compare it to traditional family-based behavioral therapy
      (FBT). The investigators hypothesize that there will be an additive effect of parenting
      training such that FBT-PT will have a greater effect on child weight loss (measured by BMI
      z-score) than traditional FBT. In addition, the investigators will measure parenting style,
      parenting strategies, behavioral strategies, and child factors (like impulsive behavior and
      temperament) to better understand the mediators and moderators of weight loss. These measures
      will be obtained by standard self-report measures and videotape encounters, allowing one to
      more objectively measure parenting dimensions. Clinical outcomes, like drop-out and
      acceptability, will also be assessed from the two treatment arms. The purpose of this study
      is to evaluate the effect of adding a comprehensive parenting training to traditional FBT. If
      successful, this program will be able to increase our ability to help children successfully
      lose weight.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The assessors will not know which arm of the study each family is in.
measure: Change in BMI percentile
time frame: 6 months and 18 months
description: Change in BMI percentile at the end of treatment and follow-up period
measure: Percent of families who Drop-out of study
time frame: 6 months
description: Difference in percent of families who drop-out between groups
measure: Child Report of Parent Behavior Inventory
time frame: 6 months and 18 months
description: Change in parenting style from baseline to post-treatment and follow-up between groups
measure: Percentage of sessions attended between groups
time frame: 6 months
description: Difference in percentage of sessions attended between groups
measure: Percent of families who adhered to treatment goals
time frame: 6 months
description: Difference in percent of families who adhered to treatment goals between groups
measure: Child feeding questionnaire
time frame: 6 months and 18 months
description: Change in child feed behaviors from baseline to post-treatment and follow-up between groups
arm group label: Family-based behavioral therapy (FBT)
arm group type: Active Comparator
description: Family-based behavioral therapy for pediatric weight loss
arm group label: Parenting training and FBT
arm group type: Experimental
description: Family-based behavioral therapy for pediatric weight loss + parenting training to enhance outcomes
intervention type: Behavioral
intervention name: Family-based behavioral therapy
description: Traditional family-based, group-based behavioral therapy for weight loss. Parent and child groups will be held separately. Intervention will consist of 20 sessions: 16 weekly sessions, and then every other week for 4 sessions.
arm group label: Family-based behavioral therapy (FBT)
arm group label: Parenting training and FBT
other name: FBT
other name: FRESH
intervention type: Behavioral
intervention name: Parenting training
description: Parenting skills training for parents. Parent and child groups will be held separately and only parents will receive this training. Children will not receive any additional materials. Intervention will consist of 20 sessions: 16 weekly sessions, and then every other week for 4 sessions.
arm group label: Parenting training and FBT
other name: Re-FRESH
other name: FBT + PT
criteria: 
gender: All
minimum age: 7 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Kay Rhee
investigator title: Associate Professor of Pediatrics
mesh term: Obesity
mesh term: Pediatric Obesity
sharing ipd: No