Clinical trial NCT02977403: Mobile Attention Retraining in Overweight Female Adolescents
Official title: Pilot Study of Mobile Attention Training in Overweight Female Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Binge Eating
Healthy Volunteers
Keywords: Binge Eating
Eating Behavior
Children
Magnetoencephalography
Loss of Control
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2016-11-30
Enrollment: 82
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Overweight youth with loss of control over eating randomized to intervention or control groups Overweight youth without loss of control over eating randomized to intervention or control groups
Primary purpose: PREVENTION

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.

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 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.

Eligibility 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.

Primary outcomes:
measure: Changes in Food-cue Visual Probe Task Attention Bias (AB) Reaction Time
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudate Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudate Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pallidum Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pallidum Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Putamen Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Putamen Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Anterior Cingulate Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Anterior Cingulate Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Anterior Cingulate Cortex Left Hemisphere - During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Anterior Cingulate Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Lateral Orbitofrontal Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Lateral Orbitofrontal Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Medial Orbitofrontal Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Medial Orbitofrontal Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Superior Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Superior Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Opercularis Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Opercularis Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Orbitalis Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Orbitalis Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Triangularis Left Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Triangularis Right Hemisphere During Attention Capture (0-250ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudate Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudate Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pallidum Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pallidum Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Putamen Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Putamen Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Anterior Cingulate Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Anterior Cingulate Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Anterior Cingulate Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Anterior Cingulate Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Lateral Orbitofrontal Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Lateral Orbitofrontal Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Medial Orbitofrontal Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Medial Orbitofrontal Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Superior Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Superior Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Opercularis Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Opercularis Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Orbitalis Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Orbitalis Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Triangularis Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
measure: Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Triangularis Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)
timeFrame: 2-weeks
Secondary outcomes:
measure: Frequency of Loss-of-control Eating Episodes
timeFrame: 2-weeks
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Jack A Yanovski, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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.