Mobile Attention Retraining in Overweight Female Adolescents



Status:Recruiting
Conditions:Healthy Studies, Obesity Weight Loss, Psychiatric
Therapuetic Areas:Endocrinology, Psychiatry / Psychology, Other
Healthy:No
Age Range:12 - 17
Updated:1/25/2019
Start Date:November 29, 2016
End Date:December 31, 2020
Contact:Sarah G Rubin
Email:sarah.rubin@nih.gov
Phone:(301) 496-4168

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Pilot Study of Mobile Attention Training in Overweight Female Adolescents

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
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.

- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
301-496-2563
Phone: 800-411-1222
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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mi
from
Bethesda, MD
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