<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/NCT03016247</url>
  </required_header>
  <id_info>
    <org_study_id>09-16-49</org_study_id>
    <nct_id>NCT03016247</nct_id>
  </id_info>
  <brief_title>TRUST Study of Adolescent Weight Self-Management</brief_title>
  <acronym>TRUST</acronym>
  <official_title>Pilot Study Evaluating the Effects of a Trust-Building Intervention on Adolescent Weight Self-Management Behaviors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospitals Cleveland Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Case Western Reserve University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospitals Cleveland Medical Center</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 pilot study is to evaluate the effect of the Trust-building weight&#xD;
      Self-management Together (TRUST) intervention on weight self-management behaviors and neural&#xD;
      processing in overweight/obese adolescents. Study aims include comparing the effects of the&#xD;
      TRUST intervention with Enhanced Usual Care on BMI and quality of life in overweight/obese&#xD;
      early adolescents and exploring differences in neural processing (DMT/TPN switching and&#xD;
      reward activation).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background Adolescent obesity is a serious concern in the US, placing young people at risk&#xD;
      for multiple chronic conditions. Family-based interventions are most effective with this&#xD;
      challenge1, but adolescents' trust of their parents diminishes around age 14 as a result of&#xD;
      developmental brain changes2-4. This distrust may thwart family-based weight self-management&#xD;
      interventions; therefore, in this study the investigators will assess the effects of building&#xD;
      trust between adolescents ages 10-12 and their parents, alongside weight self-management&#xD;
      skills. Trust is a reciprocal quality between dyads that crosses the cognitive, affective,&#xD;
      and behavioral domains and consists of honesty, receptivity to disclosures, and perceived&#xD;
      compatibility between one's actions and words, which results in a sense of psychological&#xD;
      safety from criticism, embarrassment, or harm.5 Because of its central role in&#xD;
      adolescent-parent social interactions/relationships, trust may be a key factor in acquiring&#xD;
      and sustaining healthy behaviors. Despite literature supporting the importance of&#xD;
      interpersonal social interactions in making behavior change1,6, no studies to date have&#xD;
      simultaneously examined both the biological and behavioral pathways through which trust in&#xD;
      interpersonal interactions elicits behavior change. Thus, we employ a study design that&#xD;
      includes basic research on the role of trust as a putative intervention target for behavior&#xD;
      change in the context of an ongoing experimental clinical study testing the effects of a&#xD;
      family trust-building behavioral intervention designed to reduce BMI in overweight/obese&#xD;
      adolescents. We posit that adolescent-parent trust is a unique and potentially important&#xD;
      interpersonal communication putative target to engage behavior change to improve healthy&#xD;
      eating, physical activity, and sleep in overweight/obese adolescents, which will in turn&#xD;
      reduce BMI.&#xD;
&#xD;
      Research in the area of cognitive processing has identified two broad cortical neural&#xD;
      networks, the Task Positive Network (TPN), which is involved with using skills, knowledge and&#xD;
      self-monitoring for problem solving and goal-directed action, and the Default Mode Network&#xD;
      (DMN), which focuses on emotion-management, self-awareness and relationships. Neural network&#xD;
      activity is consistently observable on fMRI. These broad networks tend to be antagonistic,&#xD;
      such that when one network is activated, the other is inhibited; this inhibition/activation&#xD;
      of the two modes may have important implications for self-management efforts, since an&#xD;
      individual can only efficiently adopt one mode-processing either tasks or emotions--at a&#xD;
      given time.7,8 The Analytic v. Emotional network theory suggests that flexible and balanced&#xD;
      activity between modes is optimal9-11 and may be modified by learning/training, including&#xD;
      practices such as meditation.12&#xD;
&#xD;
      In the work of one of the SMART Center Core leaders 7,13, Dr. Anthony Jack, fMRI revealed&#xD;
      that individuals, when presented with an analytical (mechanical) problem, tended to activate&#xD;
      analytic processing while deactivating empathic (emotional) processing. Conversely, when&#xD;
      presented with a social problem, individuals tended to deactivate the analytic processing&#xD;
      pathways in favor of increased emotional processing. These compelling findings provide an&#xD;
      intriguing new way to examine an individual's approach to health behaviors and provide a new&#xD;
      view into the brain-behavior connection. Jack's work 14,15 has shown that &quot;coaching&quot; exerts a&#xD;
      dose-dependent effect on brain regions associated with motivation. In particular, focused&#xD;
      training increased activity in the ventral-medial prefrontal cortex (VMPFC in left side of&#xD;
      Figure 2) and adjacent regions of sub-genual anterior cingulate and nucleus accumbens. These&#xD;
      regions, which are part of the default mode network, are implicated in motivation. In&#xD;
      addition to identifying differences in brain function and connectivity,15 we are also&#xD;
      examining any structural changes in brain anatomy brought about by the interventions. These&#xD;
      are hypothesized to occur in the same regions as functional changes.16,17 Prior studies have&#xD;
      demonstrated that residual activity in the DMN, during the performance of tasks sub served by&#xD;
      the TPN, causes errors and lapses of attention.18,19 On the other hand, the DMN plays a key&#xD;
      role in social cognition and motivation, specifically the generation of affective meaning&#xD;
      15,20,21 or purpose in life. A key hypothesis is that effective tuning of DMN function is&#xD;
      essential for effective TPN function, which is required for successful self-management.&#xD;
      Although neural and cognitive capacities which underlie self-management behavior may be&#xD;
      non-specific in nature, identifying key mechanisms and signatures of effective interventions&#xD;
      will better inform theoretical frameworks of self-management science.&#xD;
&#xD;
      Significance Our premise is that self-management interventions that target both analytic and&#xD;
      emotional components of neurocognitive processing will be most effective in helping&#xD;
      individuals achieve self-management outcomes. We are using functional magnetic resonance&#xD;
      imaging (fMRI) to examine the relationship between two large-scale cortical networks, the&#xD;
      default mode network (DMN) and the task positive network (TPN), and their contributions to&#xD;
      behavior. Numerous studies have demonstrated that these networks may suppress each other, as&#xD;
      measured both during task performance and in the resting state, which represents a marker of&#xD;
      psychological health 22. The investigators interpret these findings as the ability to&#xD;
      flexibly move between distinct cognitive modes associated with each network 13. A key&#xD;
      hypothesis is that effective tuning of DMN function is essential for effective TPN function,&#xD;
      and in turn, optimal performance of self-management activities. We posit that the TRUST&#xD;
      intervention will influence the adolescent's emotional (DMT) neural processing through the&#xD;
      trust-building component, while the analytic (TPN) neural processing will be influenced by&#xD;
      the skills building component of the intervention, both of which work together to promote&#xD;
      healthy weight self-management behaviors 23. In addition, the investigators hypothesize that&#xD;
      the TRUST intervention will influence the adolescent's neurological reward activation between&#xD;
      social reward and palatable food reward demonstrated in the ventral striatum 24,25.&#xD;
&#xD;
      As demonstrated in our model-consistent with the P30 Center of Excellence in Self-Management&#xD;
      Research (SMART) framework being used for all SMART Center studies-the investigators&#xD;
      hypothesize that an adolescent's weight self-management behaviors are influenced by the&#xD;
      ability of the individual to balance DMT and TPN neural processing. the investigators posit&#xD;
      that a reduction of body mass index (BMI) and an improvement in quality of life (QOL) will&#xD;
      result from weight self-management behaviors (eating, physical activity, sleep) as mediated&#xD;
      by two neural processes (DMT/TPN task-switching, reward activation), adolescent trust of&#xD;
      parent, parent trust of adolescent, adolescent/parent relationship quality, social support,&#xD;
      decision-making, self-efficacy, patient activation, and self-regulation. The influence of&#xD;
      potential moderators (gender, binge-eating, perceived stress, depressive symptoms, executive&#xD;
      functioning, parenting style) will be assessed for their effect on the relationship between&#xD;
      the intervention and the proximal and distal outcomes. The investigators will conduct a&#xD;
      two-group intervention trial to describe the effects of the TRUST intervention on BMI, QOL,&#xD;
      and cognitive task switching between the DMT and TPN neural networks.&#xD;
&#xD;
      If the findings confirm the hypotheses, the intervention can serve as a model for improving&#xD;
      adolescent weight self-management behaviors. The conduct of this project will also provide&#xD;
      invaluable insights on the neurocognitive underpinnings of trust-building and its role as a&#xD;
      facilitator of adolescent weight self-management. Specifically, the knowledge gained from&#xD;
      this project will provide a foundational evidence on how trust-building in primary&#xD;
      relationships can lead to enhanced states of self-management and reward sensitivity.&#xD;
      Improvements in weight self-managements behaviors have shown to improve health outcomes.&#xD;
      Successful weight self-management behaviors are associated with increased survival and&#xD;
      decreased morbidity. If successful, this trust-building weight self-management will provide&#xD;
      an acceptable and feasible self-management intervention that allows parents and adolescents&#xD;
      to work together to improve the health and well-being of the family. In general, the&#xD;
      potential benefits of this project outweighs the potential risks, and we have an experienced&#xD;
      team of investigators and research staff that are prepared to address the minimal risks that&#xD;
      may occur.&#xD;
&#xD;
      Purpose/Aims&#xD;
&#xD;
      The purpose of this pilot study is to evaluate the effect of the Trust-building weight&#xD;
      Self-management Together (TRUST) intervention on weight self-management behaviors and neural&#xD;
      processing in overweight/obese adolescents. The aims of this two-group randomized trial are&#xD;
      to:&#xD;
&#xD;
        1. Compare the effects of the TRUST intervention with Enhanced Usual Care on BMI and QOL in&#xD;
           overweight/obese early adolescents;&#xD;
&#xD;
        2. Determine the extent to which gender, binge-eating, perceived stress, depressive&#xD;
           symptoms, executive functioning, and parenting style moderate the effect of TRUST on BMI&#xD;
           and QOL;&#xD;
&#xD;
        3. Compare the effects of the TRUST intervention with Enhanced Usual Care on weight&#xD;
           self-management behaviors (eating, physical activity, sleep);&#xD;
&#xD;
        4. Determine the extent to which gender, binge-eating, perceived stress, depressive&#xD;
           symptoms, executive functioning, and parenting style moderate the effect of TRUST on&#xD;
           weight self-management behaviors (eating, physical activity, sleep); and&#xD;
&#xD;
        5. Explore differences in neural processing (DMT/TPN task-switching, reward activation) in&#xD;
           the TRUST intervention and Enhanced Usual Care group outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2018</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">June 24, 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>Body Mass Index</measure>
    <time_frame>6 months</time_frame>
    <description>Statistically significant change in BMI from baseline to 3 months and 6 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Eating</measure>
    <time_frame>6 months</time_frame>
    <description>Change in Nutrient Data Systems Report data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>6 months</time_frame>
    <description>Change in accelerometer data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep</measure>
    <time_frame>6 months</time_frame>
    <description>Change in PROMIS-Sleep 4 scale score and Pediatric Daytime Sleepiness Scale score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Adolescent Obesity</condition>
  <arm_group>
    <arm_group_label>Enhanced Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group will receive a single visit with a Nutritionist for dietary and physical activity counseling</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TRUST intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group will receive parent-adolescent trust-building and weight self-management training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TRUST Intervention</intervention_name>
    <description>The TRUST intervention will be guided by Rotenberg's Framework of Interpersonal Trust 3. The TRUST group will meet with an interventionist trained in weight self-management for eight 90-minute weekly sessions. Each session will include adolescent/parent trust-building exercises (honesty, reliability, emotional connection), didactic content, experiential skills developing (nutrition label reading), behavior-change goal-setting, and problem-solving.</description>
    <arm_group_label>TRUST intervention</arm_group_label>
    <other_name>Trust-building weight Self-management Together</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Usual Care</intervention_name>
    <description>Single meeting with a Nutritionist for physical activity and eating counseling.</description>
    <arm_group_label>Enhanced Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  10-12 year old Cleveland Metropolitan School District student&#xD;
&#xD;
          -  identified as overweight or obese (BMI &gt;85th percentile for age/sex during school&#xD;
             screenings)&#xD;
&#xD;
          -  able to read, speak, and understand the English language&#xD;
&#xD;
          -  able to complete a self-administered questionnaire&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  taking medications that alter appetite or weight&#xD;
&#xD;
          -  stage 2 hypertension or stage 1 hypertension with end organ damage&#xD;
&#xD;
          -  severe behavioral problems that preclude group participation (as reported by&#xD;
             parent/guardian)&#xD;
&#xD;
          -  child involvement in another weight management program&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  family expectation to move from the region within 1 year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heather K Hardin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Case Western Reserve University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Case Western Reserve University</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Heinberg LJ, Kutchman EM, Berger NA, Lawhun SA, Cuttler L, Seabrook RC, Horwitz SM. Parent involvement is associated with early success in obesity treatment. Clin Pediatr (Phila). 2010 May;49(5):457-65. doi: 10.1177/0009922809337531. Epub 2009 Jun 1.</citation>
    <PMID>19487764</PMID>
  </reference>
  <reference>
    <citation>Steinberg L. A Social Neuroscience Perspective on Adolescent Risk-Taking. Dev Rev. 2008 Mar;28(1):78-106. doi: 10.1016/j.dr.2007.08.002.</citation>
    <PMID>18509515</PMID>
  </reference>
  <reference>
    <citation>Jack AI, Dawson AJ, Begany KL, Leckie RL, Barry KP, Ciccia AH, Snyder AZ. fMRI reveals reciprocal inhibition between social and physical cognitive domains. Neuroimage. 2013 Feb 1;66:385-401. doi: 10.1016/j.neuroimage.2012.10.061. Epub 2012 Oct 27.</citation>
    <PMID>23110882</PMID>
  </reference>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>November 26, 2019</last_update_submitted>
  <last_update_submitted_qc>November 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Case Western Reserve University</investigator_affiliation>
    <investigator_full_name>Heather K Hardin</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>magnetic resonance imaging, trust, reward</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified data will be shared for further analysis after main results are published.</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/NCT03016247
org study id: 09-16-49
nct id: NCT03016247
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this pilot study is to evaluate the effect of the Trust-building weight
      Self-management Together (TRUST) intervention on weight self-management behaviors and neural
      processing in overweight/obese adolescents. Study aims include comparing the effects of the
      TRUST intervention with Enhanced Usual Care on BMI and quality of life in overweight/obese
      early adolescents and exploring differences in neural processing (DMT/TPN switching and
      reward activation).
Background Adolescent obesity is a serious concern in the US, placing young people at risk
      for multiple chronic conditions. Family-based interventions are most effective with this
      challenge1, but adolescents' trust of their parents diminishes around age 14 as a result of
      developmental brain changes2-4. This distrust may thwart family-based weight self-management
      interventions; therefore, in this study the investigators will assess the effects of building
      trust between adolescents ages 10-12 and their parents, alongside weight self-management
      skills. Trust is a reciprocal quality between dyads that crosses the cognitive, affective,
      and behavioral domains and consists of honesty, receptivity to disclosures, and perceived
      compatibility between one's actions and words, which results in a sense of psychological
      safety from criticism, embarrassment, or harm.5 Because of its central role in
      adolescent-parent social interactions/relationships, trust may be a key factor in acquiring
      and sustaining healthy behaviors. Despite literature supporting the importance of
      interpersonal social interactions in making behavior change1,6, no studies to date have
      simultaneously examined both the biological and behavioral pathways through which trust in
      interpersonal interactions elicits behavior change. Thus, we employ a study design that
      includes basic research on the role of trust as a putative intervention target for behavior
      change in the context of an ongoing experimental clinical study testing the effects of a
      family trust-building behavioral intervention designed to reduce BMI in overweight/obese
      adolescents. We posit that adolescent-parent trust is a unique and potentially important
      interpersonal communication putative target to engage behavior change to improve healthy
      eating, physical activity, and sleep in overweight/obese adolescents, which will in turn
      reduce BMI.

      Research in the area of cognitive processing has identified two broad cortical neural
      networks, the Task Positive Network (TPN), which is involved with using skills, knowledge and
      self-monitoring for problem solving and goal-directed action, and the Default Mode Network
      (DMN), which focuses on emotion-management, self-awareness and relationships. Neural network
      activity is consistently observable on fMRI. These broad networks tend to be antagonistic,
      such that when one network is activated, the other is inhibited; this inhibition/activation
      of the two modes may have important implications for self-management efforts, since an
      individual can only efficiently adopt one mode-processing either tasks or emotions--at a
      given time.7,8 The Analytic v. Emotional network theory suggests that flexible and balanced
      activity between modes is optimal9-11 and may be modified by learning/training, including
      practices such as meditation.12

      In the work of one of the SMART Center Core leaders 7,13, Dr. Anthony Jack, fMRI revealed
      that individuals, when presented with an analytical (mechanical) problem, tended to activate
      analytic processing while deactivating empathic (emotional) processing. Conversely, when
      presented with a social problem, individuals tended to deactivate the analytic processing
      pathways in favor of increased emotional processing. These compelling findings provide an
      intriguing new way to examine an individual's approach to health behaviors and provide a new
      view into the brain-behavior connection. Jack's work 14,15 has shown that "coaching" exerts a
      dose-dependent effect on brain regions associated with motivation. In particular, focused
      training increased activity in the ventral-medial prefrontal cortex (VMPFC in left side of
      Figure 2) and adjacent regions of sub-genual anterior cingulate and nucleus accumbens. These
      regions, which are part of the default mode network, are implicated in motivation. In
      addition to identifying differences in brain function and connectivity,15 we are also
      examining any structural changes in brain anatomy brought about by the interventions. These
      are hypothesized to occur in the same regions as functional changes.16,17 Prior studies have
      demonstrated that residual activity in the DMN, during the performance of tasks sub served by
      the TPN, causes errors and lapses of attention.18,19 On the other hand, the DMN plays a key
      role in social cognition and motivation, specifically the generation of affective meaning
      15,20,21 or purpose in life. A key hypothesis is that effective tuning of DMN function is
      essential for effective TPN function, which is required for successful self-management.
      Although neural and cognitive capacities which underlie self-management behavior may be
      non-specific in nature, identifying key mechanisms and signatures of effective interventions
      will better inform theoretical frameworks of self-management science.

      Significance Our premise is that self-management interventions that target both analytic and
      emotional components of neurocognitive processing will be most effective in helping
      individuals achieve self-management outcomes. We are using functional magnetic resonance
      imaging (fMRI) to examine the relationship between two large-scale cortical networks, the
      default mode network (DMN) and the task positive network (TPN), and their contributions to
      behavior. Numerous studies have demonstrated that these networks may suppress each other, as
      measured both during task performance and in the resting state, which represents a marker of
      psychological health 22. The investigators interpret these findings as the ability to
      flexibly move between distinct cognitive modes associated with each network 13. A key
      hypothesis is that effective tuning of DMN function is essential for effective TPN function,
      and in turn, optimal performance of self-management activities. We posit that the TRUST
      intervention will influence the adolescent's emotional (DMT) neural processing through the
      trust-building component, while the analytic (TPN) neural processing will be influenced by
      the skills building component of the intervention, both of which work together to promote
      healthy weight self-management behaviors 23. In addition, the investigators hypothesize that
      the TRUST intervention will influence the adolescent's neurological reward activation between
      social reward and palatable food reward demonstrated in the ventral striatum 24,25.

      As demonstrated in our model-consistent with the P30 Center of Excellence in Self-Management
      Research (SMART) framework being used for all SMART Center studies-the investigators
      hypothesize that an adolescent's weight self-management behaviors are influenced by the
      ability of the individual to balance DMT and TPN neural processing. the investigators posit
      that a reduction of body mass index (BMI) and an improvement in quality of life (QOL) will
      result from weight self-management behaviors (eating, physical activity, sleep) as mediated
      by two neural processes (DMT/TPN task-switching, reward activation), adolescent trust of
      parent, parent trust of adolescent, adolescent/parent relationship quality, social support,
      decision-making, self-efficacy, patient activation, and self-regulation. The influence of
      potential moderators (gender, binge-eating, perceived stress, depressive symptoms, executive
      functioning, parenting style) will be assessed for their effect on the relationship between
      the intervention and the proximal and distal outcomes. The investigators will conduct a
      two-group intervention trial to describe the effects of the TRUST intervention on BMI, QOL,
      and cognitive task switching between the DMT and TPN neural networks.

      If the findings confirm the hypotheses, the intervention can serve as a model for improving
      adolescent weight self-management behaviors. The conduct of this project will also provide
      invaluable insights on the neurocognitive underpinnings of trust-building and its role as a
      facilitator of adolescent weight self-management. Specifically, the knowledge gained from
      this project will provide a foundational evidence on how trust-building in primary
      relationships can lead to enhanced states of self-management and reward sensitivity.
      Improvements in weight self-managements behaviors have shown to improve health outcomes.
      Successful weight self-management behaviors are associated with increased survival and
      decreased morbidity. If successful, this trust-building weight self-management will provide
      an acceptable and feasible self-management intervention that allows parents and adolescents
      to work together to improve the health and well-being of the family. In general, the
      potential benefits of this project outweighs the potential risks, and we have an experienced
      team of investigators and research staff that are prepared to address the minimal risks that
      may occur.

      Purpose/Aims

      The purpose of this pilot study is to evaluate the effect of the Trust-building weight
      Self-management Together (TRUST) intervention on weight self-management behaviors and neural
      processing in overweight/obese adolescents. The aims of this two-group randomized trial are
      to:

        1. Compare the effects of the TRUST intervention with Enhanced Usual Care on BMI and QOL in
           overweight/obese early adolescents;

        2. Determine the extent to which gender, binge-eating, perceived stress, depressive
           symptoms, executive functioning, and parenting style moderate the effect of TRUST on BMI
           and QOL;

        3. Compare the effects of the TRUST intervention with Enhanced Usual Care on weight
           self-management behaviors (eating, physical activity, sleep);

        4. Determine the extent to which gender, binge-eating, perceived stress, depressive
           symptoms, executive functioning, and parenting style moderate the effect of TRUST on
           weight self-management behaviors (eating, physical activity, sleep); and

        5. Explore differences in neural processing (DMT/TPN task-switching, reward activation) in
           the TRUST intervention and Enhanced Usual Care group outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Body Mass Index
time frame: 6 months
description: Statistically significant change in BMI from baseline to 3 months and 6 months
measure: Eating
time frame: 6 months
description: Change in Nutrient Data Systems Report data
measure: Physical Activity
time frame: 6 months
description: Change in accelerometer data
measure: Sleep
time frame: 6 months
description: Change in PROMIS-Sleep 4 scale score and Pediatric Daytime Sleepiness Scale score
arm group label: Enhanced Usual Care
arm group type: Active Comparator
description: Group will receive a single visit with a Nutritionist for dietary and physical activity counseling
arm group label: TRUST intervention
arm group type: Experimental
description: Group will receive parent-adolescent trust-building and weight self-management training.
intervention type: Behavioral
intervention name: TRUST Intervention
description: The TRUST intervention will be guided by Rotenberg's Framework of Interpersonal Trust 3. The TRUST group will meet with an interventionist trained in weight self-management for eight 90-minute weekly sessions. Each session will include adolescent/parent trust-building exercises (honesty, reliability, emotional connection), didactic content, experiential skills developing (nutrition label reading), behavior-change goal-setting, and problem-solving.
arm group label: TRUST intervention
other name: Trust-building weight Self-management Together
intervention type: Behavioral
intervention name: Enhanced Usual Care
description: Single meeting with a Nutritionist for physical activity and eating counseling.
arm group label: Enhanced Usual Care
criteria: 
gender: All
minimum age: 10 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Heather K Hardin, PhD
role: Principal Investigator
affiliation: Case Western Reserve University
facility: 
country: United States
citation: Heinberg LJ, Kutchman EM, Berger NA, Lawhun SA, Cuttler L, Seabrook RC, Horwitz SM. Parent involvement is associated with early success in obesity treatment. Clin Pediatr (Phila). 2010 May;49(5):457-65. doi: 10.1177/0009922809337531. Epub 2009 Jun 1.
PMID: 19487764
citation: Steinberg L. A Social Neuroscience Perspective on Adolescent Risk-Taking. Dev Rev. 2008 Mar;28(1):78-106. doi: 10.1016/j.dr.2007.08.002.
PMID: 18509515
citation: Jack AI, Dawson AJ, Begany KL, Leckie RL, Barry KP, Ciccia AH, Snyder AZ. fMRI reveals reciprocal inhibition between social and physical cognitive domains. Neuroimage. 2013 Feb 1;66:385-401. doi: 10.1016/j.neuroimage.2012.10.061. Epub 2012 Oct 27.
PMID: 23110882
responsible party type: Principal Investigator
investigator affiliation: Case Western Reserve University
investigator full name: Heather K Hardin
investigator title: Assistant Professor
mesh term: Pediatric Obesity
sharing ipd: Yes
ipd description: De-identified data will be shared for further analysis after main results are published.