<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/NCT02977403</url>
  </required_header>
  <id_info>
    <org_study_id>170014</org_study_id>
    <secondary_id>17-CH-0014</secondary_id>
    <nct_id>NCT02977403</nct_id>
  </id_info>
  <brief_title>Mobile Attention Retraining in Overweight Female Adolescents</brief_title>
  <official_title>Pilot Study of Mobile Attention Training in Overweight Female Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</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>
      Background:&#xD;
&#xD;
      People are constantly exposed to unhealthy foods. Some studies of adults show that training&#xD;
      attention away from unhealthy foods might reduce overeating. Researchers want to see what&#xD;
      happens in the brain when teens train their attention away from food through a program on a&#xD;
      smartphone.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To study the relationship between eating patterns, body weight, and how the brain reacts to&#xD;
      different images.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Right-handed females ages 12-17 who are overweight (Body Mass Index at or above the 85th&#xD;
      percentile for age).&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will have 6 visits over about 8 months.&#xD;
&#xD;
      Visit 1: participants will be screened with:&#xD;
&#xD;
      Height, weight, blood pressure, and waist size measurements&#xD;
&#xD;
      Medical history&#xD;
&#xD;
      Physical exam&#xD;
&#xD;
      Urine sample&#xD;
&#xD;
      DXA scan. Participants will lie on a table while a very small dose of x-rays passes through&#xD;
      the body.&#xD;
&#xD;
      Questions about their general health, social and psychological functioning, and eating habits&#xD;
&#xD;
      Parents or guardians of minor participants will answer questions about their child s&#xD;
      functioning and demographic data.&#xD;
&#xD;
      Before visits 2-6, participants will not eat or drink for about 12 hours. These visits will&#xD;
      include some or all of these procedures:&#xD;
&#xD;
      Blood drawn&#xD;
&#xD;
      MRI scan. Participants will lie on a stretcher that slides in and out of a metal cylinder in&#xD;
      a strong magnetic field. A device will be placed over the head.&#xD;
&#xD;
      Meals provided. Participants will fill out rating forms.&#xD;
&#xD;
      Simple thinking tasks&#xD;
&#xD;
      A cone containing magnetic field detectors placed onto the head&#xD;
&#xD;
      Medical history&#xD;
&#xD;
      Physical exam&#xD;
&#xD;
      Urine sample&#xD;
&#xD;
      Participants will be assigned to a 2-week smartphone program that involves looking at&#xD;
      pictures. Participants will complete short tasks and answer some questions about their eating&#xD;
      habits and mood on the smartphone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over 30% of adolescents are overweight and 20% are obese, but the mechanisms that produce&#xD;
      excessive weight gain in youth remain incompletely elucidated. Some overweight youth appear&#xD;
      to have an attention bias (AB: a tendency to attend selectively to stimuli that have acquired&#xD;
      salience or meaning) toward highly palatable food that may lead to overeating. AB involves&#xD;
      distinct cognitive processes, (1) unconscious reactions (UCR), reflecting initial attention&#xD;
      capture evoked by salient stimuli, and (2) continued attention deployment (AD) to stimuli&#xD;
      relevant to current goals. These rapidly evolving processes are associated with unique&#xD;
      neurocircuitry best measured using high spatial resolution and temporal sensitivity.&#xD;
      Magnetoencephalography (MEG) is a novel neuroimaging technology that has both excellent&#xD;
      temporal and good spatial resolution, thus is uniquely and ideally suited to study&#xD;
      neurocognitive mechanisms of AB. Reducing AB to palatable foods may help some overweight&#xD;
      youth curb their consumption of energy-dense options. Attention retraining (AR) programs can&#xD;
      be used to reduce AB and have been effective in reducing AB to unhealthy food in adults.&#xD;
      Although most AR studies involve computers in the laboratory, using smartphones in the&#xD;
      natural environment may be a particularly effective method to deliver AR to adolescents and&#xD;
      measure AB using ecological momentary assessment. The first aim of the proposed study is to&#xD;
      investigate, using MEG, the impact of a 2-week smartphone AR program on neural responses to&#xD;
      food cues in overweight adolescent (12-17 y/o) girls with and without loss of control (LOC)&#xD;
      eating, defined as a subjective experience of a lack of control over what or how much one is&#xD;
      eating. LOC is a distinct eating behavior phenotype in youth that is a risk factor for excess&#xD;
      weight gain and disordered eating, and is much more prevalent among girls (vs. boys).&#xD;
      Overweight youth who report LOC may be particularly susceptible to AB. Additionally, adults&#xD;
      with LOC demonstrate AB toward socially threatening cues, such as angry or disapproving&#xD;
      faces, and the AB to social threat may be relevant to the relationship between AB to food and&#xD;
      overweight. The second goal is to examine the effect of the 2-week AR program on AB, food&#xD;
      intake, and body composition. An exploratory aim is to examine whether AB to socially&#xD;
      threatening cues, moderates the effects of this novel intervention on AB to food cues, food&#xD;
      intake, and body composition. The proposed study is innovative because no study to date has&#xD;
      examined neurocircuitry of ABs to food using MEG, nor examined the impact of AR delivered in&#xD;
      the natural environment on neurocircuitry of AB in a group of youth prone to AB. These&#xD;
      studies may help further characterize phenomenology of distinct obesity subtypes and may&#xD;
      potentially identify an approach that could prevent undue weight gain in adolescent girls at&#xD;
      risk for obesity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 10, 2017</start_date>
  <completion_date type="Anticipated">October 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2023</primary_completion_date>
  <phase>Phase 2</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neural activity during attention bias task</measure>
    <time_frame>2-weeks</time_frame>
    <description>Neural activity during attention bias task paradigm at the baseline laboratory visit vs. post-EMA visit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in laboratory measured attention bias</measure>
    <time_frame>2-weeks</time_frame>
    <description>Changes in laboratory measured attention bias at the baseline laboratory visit vs. post-EMA visit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in reaction time to palatable foods</measure>
    <time_frame>2-weeks</time_frame>
    <description>Changes in reaction times to palatable foods at the baseline laboratory visit vs. the post-EMA visit), neural activity during the social threat Attention Bias task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in eating pattern</measure>
    <time_frame>2-weeks</time_frame>
    <description>Changes in self-reported eating patterns</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in attention bias</measure>
    <time_frame>2-weeks</time_frame>
    <description>Changes in EMA-measured attention bias</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Obesity</condition>
  <condition>Overweight</condition>
  <condition>Binge Eating</condition>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>AB Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Control condition - the probe is equally likely to replace the food picture and the neutral picture. There is no correlation between picture type and probe location, and no training of attention should occur.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AB Retraining</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active treatment - the probe always replaces the neutral picture. There is a perfect correlation between picture type and probe location.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Booster Training</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>3 months after the randomized program is completed, each subject can elect to use open-label attention bias retraining for 2 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Booster Training - active comparator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>3 months after the randomized program is completed, each subject can elect to use open-label attention bias retraining for 2 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Attention Bias Retraining</intervention_name>
    <description>Attention retraining program on smartphone where the probe always replaces the neutral picture. There is a perfect correlation between picture type and probe location.</description>
    <arm_group_label>AB Control</arm_group_label>
    <arm_group_label>AB Retraining</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Booster Attention Retraining</intervention_name>
    <description>All subjects can opt to undergo attention bias training after the randomized phase of the study is complete</description>
    <arm_group_label>Booster Training</arm_group_label>
    <arm_group_label>Booster Training - active comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
        Volunteers will qualify if they meet the following criteria:&#xD;
&#xD;
          1. Age between 12 and 17 years (at the start of the study).&#xD;
&#xD;
          2. Female sex.&#xD;
&#xD;
          3. BMI at or above the 85th percentile for age and sex according to the Centers for&#xD;
             Disease Control US Standards (101).&#xD;
&#xD;
          4. Right handedness.&#xD;
&#xD;
             LOC sample only:&#xD;
&#xD;
          5. Greater than or equal to 1 episodes of LOC eating during the past month prior to&#xD;
             assessment, assessed using a clinical diagnostic interview for eating disorders.&#xD;
&#xD;
             No-LOC sample only:&#xD;
&#xD;
          6. No episodes of LOC eating during the past month prior to assessment, assessed using a&#xD;
             clinical diagnostic interview for eating disorders.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        Individuals will be excluded (and provided treatment referrals as needed) for the following&#xD;
        reasons:&#xD;
&#xD;
          1. An obesity-related health comorbidity requiring medical treatment, such as&#xD;
             hypertension (defined by age-, sex-, and height-specific standards) or fasting&#xD;
             hyperglycemia consistent with diabetes.&#xD;
&#xD;
          2. Presence of other major illnesses: renal, hepatic, gastrointestinal, most&#xD;
             endocrinologic (e.g., Cushing syndrome, untreated hyper- or hypothyroidism),&#xD;
             hematological problems or pulmonary disorders (other than asthma not requiring&#xD;
             continuous medication). Nonserious&#xD;
&#xD;
             medical illnesses, such as seasonal allergies, will be reviewed on a case-by-case&#xD;
             basis.&#xD;
&#xD;
          3. Regular use of any medication known to affect body weight or eating behavior (e.g.,&#xD;
             stimulants prescribed for attention deficit hyperactivity disorder, or ADHD).&#xD;
             Medication use for non-serious conditions (e.g., acne) will be considered on a&#xD;
             case-by-case basis.&#xD;
&#xD;
          4. Current pregnancy or a history of pregnancy.&#xD;
&#xD;
          5. A significant reduction in weight during the past three months, for any reason,&#xD;
             exceeding 5% of body weight.&#xD;
&#xD;
          6. Presence in the child of any significant, full-threshold psychiatric disorder based on&#xD;
             DSM criteria (102), such as schizophrenia, bipolar disorder, alcohol or substance&#xD;
             abuse, anorexia or bulimia nervosa, or any other disorder that, in the opinion of the&#xD;
             investigators, would impede competence or compliance or possibly hinder completion of&#xD;
             the study. These individuals will not be permitted to enroll in the current study and&#xD;
             will be referred for treatment. Individuals who present with other psychiatric&#xD;
             disorders, including subthreshold psychiatric disorders, will be permitted to enroll&#xD;
             in the study. If, based on the opinion of the investigators, a participant requires&#xD;
             treatment for his/her psychiatric symptoms, the individual will be referred for&#xD;
             treatment. Participants who develop any psychiatric disorder or significant&#xD;
             psychiatric symptoms at any follow-up assessment during the study will be excluded and&#xD;
             be provided with treatment referrals.&#xD;
&#xD;
          7. Current and regular substance use, including the use of alcohol and/or tobacco&#xD;
             products (including e-cigarettes).&#xD;
&#xD;
          8. A history of significant or recent brain injury that may considerably influence&#xD;
             performance (i.e., any history of loss of consciousness greater than or equal to 30&#xD;
             minutes associated with a head injury, any history of memory loss or hospitalization&#xD;
             associated with a head injury, or greater than or equal to 2 concussions within last&#xD;
             year).&#xD;
&#xD;
          9. Current involvement in a weight loss program, participating in psychotherapy aimed at&#xD;
             weight loss or treatment of eating behavior (e.g., binge eating).&#xD;
&#xD;
         10. All parents/guardians will be asked to indicate if their child has any food allergies.&#xD;
             To be conservative, children who report allergies to gluten, nuts, dairy, fruit, or&#xD;
             any other item in the array, will be excluded from the test meal portion of the study.&#xD;
&#xD;
         11. A condition under which MEG is contradicted (e.g., metal in the body, pregnancy,&#xD;
             claustrophobia, history of significant neurological insult or injury).&#xD;
&#xD;
         12. Non-English speaking participants will be excluded from the study as they may be&#xD;
             unable to complete questionnaires and follow the instructions which are only provided&#xD;
             in English.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jack A Yanovski, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bess Bloomer</last_name>
    <phone>(301) 496-4168</phone>
    <email>bess.bloomer@nih.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jack A Yanovski, M.D.</last_name>
    <phone>(301) 496-0858</phone>
    <email>jy15i@nih.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)</last_name>
      <phone>800-411-1222</phone>
      <phone_ext>TTY8664111010</phone_ext>
      <email>prpl@cc.nih.gov</email>
    </contact>
    <contact_backup>
      <last_name>Bess Bloomer</last_name>
      <phone>(301) 496-4168</phone>
      <email>bess.bloomer@nih.gov</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2017-CH-0014.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <reference>
    <citation>Shank LM, Tanofsky-Kraff M, Nelson EE, Shomaker LB, Ranzenhofer LM, Hannallah LM, Field SE, Vannucci A, Bongiorno DM, Brady SM, Condarco T, Demidowich A, Kelly NR, Cassidy O, Simmons WK, Engel SG, Pine DS, Yanovski JA. Attentional bias to food cues in youth with loss of control eating. Appetite. 2015 Apr;87:68-75. doi: 10.1016/j.appet.2014.11.027. Epub 2014 Nov 27.</citation>
    <PMID>25435490</PMID>
  </reference>
  <reference>
    <citation>Waters AM, Lipp OV, Spence SH. Attentional bias toward fear-related stimuli: an investigation with nonselected children and adults and children with anxiety disorders. J Exp Child Psychol. 2004 Dec;89(4):320-37. doi: 10.1016/j.jecp.2004.06.003.</citation>
    <PMID>15560877</PMID>
  </reference>
  <reference>
    <citation>Jarcho JM, Tanofsky-Kraff M, Nelson EE, Engel SG, Vannucci A, Field SE, Romer AL, Hannallah L, Brady SM, Demidowich AP, Shomaker LB, Courville AB, Pine DS, Yanovski JA. Neural activation during anticipated peer evaluation and laboratory meal intake in overweight girls with and without loss of control eating. Neuroimage. 2015 Mar;108:343-53. doi: 10.1016/j.neuroimage.2014.12.054. Epub 2014 Dec 27.</citation>
    <PMID>25550068</PMID>
  </reference>
  <verification_date>June 12, 2023</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>July 12, 2023</last_update_submitted>
  <last_update_submitted_qc>July 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Binge Eating</keyword>
  <keyword>Eating Behavior</keyword>
  <keyword>Children</keyword>
  <keyword>Magnetoencephalography</keyword>
  <keyword>Loss of Control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Bulimia</mesh_term>
    <mesh_term>Binge-Eating Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>.All IPD that underlie results in a publication will be shared.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>NIH subject data will become available starting 6 months after publication of a results paper and will be available from the NIH site for 2 years.</ipd_time_frame>
    <ipd_access_criteria>NIH data with personal identifiers removed will be shared upon reasonable request to the PI, who will review requests. A data sharing agreement will be required to be negotiated with NICHD before sharing takes place.</ipd_access_criteria>
  </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/NCT02977403
org study id: 170014
secondary id: 17-CH-0014
nct id: NCT02977403
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      People are constantly exposed to unhealthy foods. Some studies of adults show that training
      attention away from unhealthy foods might reduce overeating. Researchers want to see what
      happens in the brain when teens train their attention away from food through a program on a
      smartphone.

      Objective:

      To study the relationship between eating patterns, body weight, and how the brain reacts to
      different images.

      Eligibility:

      Right-handed females ages 12-17 who are overweight (Body Mass Index at or above the 85th
      percentile for age).

      Design:

      Participants will have 6 visits over about 8 months.

      Visit 1: participants will be screened with:

      Height, weight, blood pressure, and waist size measurements

      Medical history

      Physical exam

      Urine sample

      DXA scan. Participants will lie on a table while a very small dose of x-rays passes through
      the body.

      Questions about their general health, social and psychological functioning, and eating habits

      Parents or guardians of minor participants will answer questions about their child s
      functioning and demographic data.

      Before visits 2-6, participants will not eat or drink for about 12 hours. These visits will
      include some or all of these procedures:

      Blood drawn

      MRI scan. Participants will lie on a stretcher that slides in and out of a metal cylinder in
      a strong magnetic field. A device will be placed over the head.

      Meals provided. Participants will fill out rating forms.

      Simple thinking tasks

      A cone containing magnetic field detectors placed onto the head

      Medical history

      Physical exam

      Urine sample

      Participants will be assigned to a 2-week smartphone program that involves looking at
      pictures. Participants will complete short tasks and answer some questions about their eating
      habits and mood on the smartphone.
Over 30% of adolescents are overweight and 20% are obese, but the mechanisms that produce
      excessive weight gain in youth remain incompletely elucidated. Some overweight youth appear
      to have an attention bias (AB: a tendency to attend selectively to stimuli that have acquired
      salience or meaning) toward highly palatable food that may lead to overeating. AB involves
      distinct cognitive processes, (1) unconscious reactions (UCR), reflecting initial attention
      capture evoked by salient stimuli, and (2) continued attention deployment (AD) to stimuli
      relevant to current goals. These rapidly evolving processes are associated with unique
      neurocircuitry best measured using high spatial resolution and temporal sensitivity.
      Magnetoencephalography (MEG) is a novel neuroimaging technology that has both excellent
      temporal and good spatial resolution, thus is uniquely and ideally suited to study
      neurocognitive mechanisms of AB. Reducing AB to palatable foods may help some overweight
      youth curb their consumption of energy-dense options. Attention retraining (AR) programs can
      be used to reduce AB and have been effective in reducing AB to unhealthy food in adults.
      Although most AR studies involve computers in the laboratory, using smartphones in the
      natural environment may be a particularly effective method to deliver AR to adolescents and
      measure AB using ecological momentary assessment. The first aim of the proposed study is to
      investigate, using MEG, the impact of a 2-week smartphone AR program on neural responses to
      food cues in overweight adolescent (12-17 y/o) girls with and without loss of control (LOC)
      eating, defined as a subjective experience of a lack of control over what or how much one is
      eating. LOC is a distinct eating behavior phenotype in youth that is a risk factor for excess
      weight gain and disordered eating, and is much more prevalent among girls (vs. boys).
      Overweight youth who report LOC may be particularly susceptible to AB. Additionally, adults
      with LOC demonstrate AB toward socially threatening cues, such as angry or disapproving
      faces, and the AB to social threat may be relevant to the relationship between AB to food and
      overweight. The second goal is to examine the effect of the 2-week AR program on AB, food
      intake, and body composition. An exploratory aim is to examine whether AB to socially
      threatening cues, moderates the effects of this novel intervention on AB to food cues, food
      intake, and body composition. The proposed study is innovative because no study to date has
      examined neurocircuitry of ABs to food using MEG, nor examined the impact of AR delivered in
      the natural environment on neurocircuitry of AB in a group of youth prone to AB. These
      studies may help further characterize phenomenology of distinct obesity subtypes and may
      potentially identify an approach that could prevent undue weight gain in adolescent girls at
      risk for obesity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Neural activity during attention bias task
time frame: 2-weeks
description: Neural activity during attention bias task paradigm at the baseline laboratory visit vs. post-EMA visit
measure: Changes in laboratory measured attention bias
time frame: 2-weeks
description: Changes in laboratory measured attention bias at the baseline laboratory visit vs. post-EMA visit
measure: Change in reaction time to palatable foods
time frame: 2-weeks
description: Changes in reaction times to palatable foods at the baseline laboratory visit vs. the post-EMA visit), neural activity during the social threat Attention Bias task
measure: Change in eating pattern
time frame: 2-weeks
description: Changes in self-reported eating patterns
measure: Change in attention bias
time frame: 2-weeks
description: Changes in EMA-measured attention bias
arm group label: AB Control
arm group type: Sham Comparator
description: Control condition - the probe is equally likely to replace the food picture and the neutral picture. There is no correlation between picture type and probe location, and no training of attention should occur.
arm group label: AB Retraining
arm group type: Experimental
description: Active treatment - the probe always replaces the neutral picture. There is a perfect correlation between picture type and probe location.
arm group label: Booster Training
arm group type: Other
description: 3 months after the randomized program is completed, each subject can elect to use open-label attention bias retraining for 2 weeks
arm group label: Booster Training - active comparator
arm group type: Active Comparator
description: 3 months after the randomized program is completed, each subject can elect to use open-label attention bias retraining for 2 weeks
intervention type: Behavioral
intervention name: Attention Bias Retraining
description: Attention retraining program on smartphone where the probe always replaces the neutral picture. There is a perfect correlation between picture type and probe location.
arm group label: AB Control
arm group label: AB Retraining
intervention type: Behavioral
intervention name: Booster Attention Retraining
description: All subjects can opt to undergo attention bias training after the randomized phase of the study is complete
arm group label: Booster Training
arm group label: Booster Training - active comparator
criteria: 
gender: Female
minimum age: 12 Years
maximum age: 21 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jack A Yanovski, M.D.
role: Principal Investigator
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
last name: Bess Bloomer
phone: (301) 496-4168
email: bess.bloomer@nih.gov
last name: Jack A Yanovski, M.D.
phone: (301) 496-0858
email: jy15i@nih.gov
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2017-CH-0014.html
description: NIH Clinical Center Detailed Web Page
citation: Shank LM, Tanofsky-Kraff M, Nelson EE, Shomaker LB, Ranzenhofer LM, Hannallah LM, Field SE, Vannucci A, Bongiorno DM, Brady SM, Condarco T, Demidowich A, Kelly NR, Cassidy O, Simmons WK, Engel SG, Pine DS, Yanovski JA. Attentional bias to food cues in youth with loss of control eating. Appetite. 2015 Apr;87:68-75. doi: 10.1016/j.appet.2014.11.027. Epub 2014 Nov 27.
PMID: 25435490
citation: Waters AM, Lipp OV, Spence SH. Attentional bias toward fear-related stimuli: an investigation with nonselected children and adults and children with anxiety disorders. J Exp Child Psychol. 2004 Dec;89(4):320-37. doi: 10.1016/j.jecp.2004.06.003.
PMID: 15560877
citation: Jarcho JM, Tanofsky-Kraff M, Nelson EE, Engel SG, Vannucci A, Field SE, Romer AL, Hannallah L, Brady SM, Demidowich AP, Shomaker LB, Courville AB, Pine DS, Yanovski JA. Neural activation during anticipated peer evaluation and laboratory meal intake in overweight girls with and without loss of control eating. Neuroimage. 2015 Mar;108:343-53. doi: 10.1016/j.neuroimage.2014.12.054. Epub 2014 Dec 27.
PMID: 25550068
responsible party type: Sponsor
mesh term: Overweight
mesh term: Bulimia
mesh term: Binge-Eating Disorder
sharing ipd: Yes
ipd description: .All IPD that underlie results in a publication will be shared.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: NIH subject data will become available starting 6 months after publication of a results paper and will be available from the NIH site for 2 years.
ipd access criteria: NIH data with personal identifiers removed will be shared upon reasonable request to the PI, who will review requests. A data sharing agreement will be required to be negotiated with NICHD before sharing takes place.