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Mobile Attention Retraining in Overweight Female Adolescents

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ClinicalTrials.gov Identifier: NCT02977403
Recruitment Status : Recruiting
First Posted : November 30, 2016
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Obesity Overweight Binge Eating Healthy Volunteers Behavioral: Attention Bias Retraining Behavioral: Booster Attention Retraining Phase 2

Detailed Description:

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 examine the impact

the a 2-week smartphone AR program on AB 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 aim is to examine, using MEG, the effect of a 2-week smartphone AR program on neural responses to food cues. The third aim is to examine the effect of the AR program on 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 the impact of AR delivered in the natural

environment on AB and its associated neurocircuitry using MEG 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pilot Study of Mobile Attention Training in Overweight Female Adolescents
Actual Study Start Date : February 10, 2017
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Arm Intervention/treatment
Sham Comparator: AB Control
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.
Behavioral: Attention Bias Retraining
Attention retraining program on smartphone where the probe always replaces the neutral picture. There is a perfect correlation between picture type and probe location.

Experimental: AB Retraining
Active treatment - the probe always replaces the neutral picture. There is a perfect correlation between picture type and probe location.
Behavioral: Attention Bias Retraining
Attention retraining program on smartphone where the probe always replaces the neutral picture. There is a perfect correlation between picture type and probe location.

Active Comparator: Booster Training
3 months after the randomized program is completed, each subject can elect to use open-label attention bias retraining for 2 weeks
Behavioral: Booster Attention Retraining
All subjects can opt to undergo attention bias training after the randomized phase of the study is complete

Booster Training other
3 months after the randomized program is completed, each subject can elect to use open-label attention bias retraining for 2 weeks
Behavioral: Booster Attention Retraining
All subjects can opt to undergo attention bias training after the randomized phase of the study is complete




Primary Outcome Measures :
  1. Neural activity during attention bias task [ Time Frame: 2-weeks ]
    Neural activity during attention bias task paradigm at the baseline laboratory visit vs. post-EMA visit

  2. Changes in laboratory measured attention bias [ Time Frame: 2-weeks ]
    Changes in laboratory measured attention bias at the baseline laboratory visit vs. post-EMA visit


Secondary Outcome Measures :
  1. Changes in attention bias [ Time Frame: 2-weeks ]
    Changes in EMA-measured attention bias

  2. Changes in eating pattern [ Time Frame: 2-weeks ]
    Changes in self-reported eating patterns

  3. Changes in reaction times to palatable foods [ Time Frame: 2-weeks ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Volunteers will qualify if they meet the following criteria:

  1. Age between 12 and 17 years (at the start of the study).
  2. Female sex.
  3. BMI at or above the 85th percentile for age and sex according to the Centers for Disease Control US Standards (101).
  4. Right handedness.

    LOC sample only:

  5. Greater than or equal to 1 episodes of LOC eating during the past month prior to assessment, assessed using a clinical diagnostic interview for eating disorders.

    No-LOC sample only:

  6. No episodes of LOC eating during the past month prior to assessment, assessed using a clinical diagnostic interview for eating disorders.

EXCLUSION CRITERIA:

Individuals will be excluded (and provided treatment referrals as needed) for the following reasons:

  1. An obesity-related health comorbidity requiring medical treatment, such as hypertension (defined by age-, sex-, and height-specific standards) or fasting hyperglycemia consistent with diabetes.
  2. Presence of other major illnesses: renal, hepatic, gastrointestinal, most endocrinologic (e.g., Cushing syndrome, untreated hyper- or hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication). Nonserious

    medical illnesses, such as seasonal allergies, will be reviewed on a case-by-case basis.

  3. Regular use of any medication known to affect body weight or eating behavior (e.g., stimulants prescribed for attention deficit hyperactivity disorder, or ADHD). Medication use for non-serious conditions (e.g., acne) will be considered on a case-by-case basis.
  4. Current pregnancy or a history of pregnancy.
  5. A significant reduction in weight during the past three months, for any reason, exceeding 5% of body weight.
  6. Presence in the child of any significant, full-threshold psychiatric disorder based on DSM criteria (102), such as schizophrenia, bipolar disorder, alcohol or substance abuse, anorexia or bulimia nervosa, or any other disorder that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study. These individuals will not be permitted to enroll in the current study and will be referred for treatment. Individuals who present with other psychiatric disorders, including subthreshold psychiatric disorders, will be permitted to enroll in the study. If, based on the opinion of the investigators, a participant requires treatment for his/her psychiatric symptoms, the individual will be referred for treatment. Participants who develop any psychiatric disorder or significant psychiatric symptoms at any follow-up assessment during the study will be excluded and be provided with treatment referrals.
  7. Current and regular substance use, including the use of alcohol and/or tobacco products (including e-cigarettes).
  8. A history of significant or recent brain injury that may considerably influence performance (i.e., any history of loss of consciousness greater than or equal to 30 minutes associated with a head injury, any history of memory loss or hospitalization associated with a head injury, or greater than or equal to 2 concussions within last year).
  9. Current involvement in a weight loss program, participating in psychotherapy aimed at weight loss or treatment of eating behavior (e.g., binge eating).
  10. All parents/guardians will be asked to indicate if their child has any food allergies. To be conservative, children who report allergies to gluten, nuts, dairy, fruit, or any other item in the array, will be excluded from the test meal portion of the study.
  11. A condition under which MEG is contradicted (e.g., metal in the body, pregnancy, claustrophobia, history of significant neurological insult or injury).
  12. Non-English speaking participants will be excluded from the study as they may be unable to complete questionnaires and follow the instructions which are only provided in English.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02977403


Contacts
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Contact: Sarah G Rubin (301) 496-4168 sarah.rubin@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Jack A Yanovski, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional Information:
Publications:
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Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT02977403     History of Changes
Other Study ID Numbers: 170014
17-CH-0014
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 6, 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):
Binge Eating
Eating Behavior
Children
Magnetoencephalography
Loss of Control
Additional relevant MeSH terms:
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Overweight
Bulimia
Binge-Eating Disorder
Body Weight
Signs and Symptoms
Hyperphagia
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders