Children s Growth and Behavior Study

This study aims to disentangle the varying disinhibited eating patterns, or eating behavior
endophenotypes, that lead to excessive weight gain and obesity-related comorbidities in
youth. Extensive baseline evaluations, including three separate experimental paradigms, and
annual follow-up assessments will assist with identifying biopsychosocial mechanisms that
appear to increase risk for, and maintain, these eating behaviors and lead to weight gain.
Illumination of early risk factors for specific eating behavior endophenotypes and their
associated health outcomes will inform the development of targeted interventions for
pediatric obesity. Participants for the current study will include 500 healthy obese and
non-obese boys and girls (8 to 17yo at baseline) and their parents/caregivers. Youth will
first complete two visits in order to ensure study eligibility and to evaluate
self-regulatory, motivational, and neurocognitive factors that appear to be salient to the
development and maintenance of disinhibited eating behavior, including: psychological
distress, sleep behavior, food reinforcement, reward sensitivity, executive functioning,
attention bias, and a range of related genetic and physiological factors. Eating behavior
will be observed in the laboratory using several validated paradigms. For two weeks,
participants will monitor their sleep using wrist actigraphy, as well as record their mood,
eating behavior, and eating cognitions using smart phones (via ecological momentary
assessment methods). Youth will then be invited to complete up to three separate experimental
paradigms designed to further elucidate cognitive, emotional, and physiological processes
associated with disinhibited eating behavior. All participants will then complete annual
evaluations of weight and adiposity for a total of six years, with more extensive evaluations
of self-regulatory, motivational and neurocognitive functioning every three years. Studying
children and adolescents longitudinally will allow for examination of the independent and
shared risk factors for pediatric disinhibited eating and excess weight. Data from these
evaluations will not only be used to test specific hypotheses, but will also be
hypothesis-generating in that they will inform the development of additional empirical
questions and subsequent experiments. Thus, the current protocol will offer the flexibility
to examine potentially critical contributions to weight gain in children as they continue
their biopsychosocial development.

- INCLUSION CRITERIA:

Volunteers will qualify if they meet the following criteria.

- Age 8 17 years.

- Weight, height and BMI greater than or equal to 5th percentile for age and sex
according to Centers for Disease Control and Prevention 2000 US standard.

- Cognitively capable of completing study procedures (FSIQ greater than or equal to 70).

- Good general health based on a normal history and physical examination (with the
exception of overweight and minor, well-controlled illnesses).

EXCLUSION CRITERIA:

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

- History of major cardiovascular disease or any other serious obesity-related
complication as assessed during history and physical exam. Individuals with untreated
or major illnesses relating to the endocrine and/or cardiovascular systems are
excluded because these illnesses will likely influence outcomes. Such obesity-related
comorbidities include hypertension (defined by age- sex- and height- specific
standards, and fasting hyperglycemia consistent with diabetes (fasting glucose > 126
mg/dL).

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

- Regular use of any medication known to affect body weight or eating behavior (e.g.,
many medications 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.

- Current pregnancy or a history of pregnancy. A negative pregnancy test before starting
the study will be required for postmenarcheal girls.

- Current and regular use of tobacco products and/or alcohol.

- A significant reduction in weight during the past three months, for any reason,
exceeding 5% of body weight.

- A history of significant or recent brain injury that may considerably influence
performance on neurocognitive measures (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).

- Presence of any significant, full-threshold psychiatric disorder based on DSM criteria
such as schizophrenia, bipolar disorder, alcohol or substance abuse, anorexia or
bulimia nervosa, or any 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
sub-threshold psychiatric disorders, will be permitted to enroll in the study.
Sub-threshold psychiatric disorders include symptoms that do not meet diagnostic
threshold based on the DSM criteria for mental disorders, but which are nevertheless
significantly impairing or distressing. 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 not
be excluded, but will be provided with treatment referrals.

- Any other condition in the child or parents/guardians that, in the opinion of the
investigators, would impede compliance or possibly hinder completion of the study
(e.g., significant Learning Disorder).

Additional exclusions for (optional) stool sample collection include:

Stool Sample only:

- Diagnosis or history of inflammatory bowel disease, including ulcerative colitis or
Crohn's disease, celiac sprue, irritable bowel syndrome, or other inflammatory
disorders of the intestine.

- Diarrhea within 1 week prior to sampling.

- Antibiotic use within 4 weeks prior to sampling.

In addition, Experiments 1 and 2 have specific additional exclusions:

Experiment 1 only:

- Regular use of medications that could influence autonomic or endocrine functioning,
including alpha and beta blockers, oral contraceptives, or prescription pain
medication.

- Scoring as "highly active" on the International Physical Activity Questionnaire (due
to decreased cortisol reactivity).

Experiment 2 only:

- Participants will be excluded if MRI and MEG is contraindicated (metal in body,
braces, glasses required to correct vision, presence of non-organic [e.g., cochlear]
implants or cerebral clips, permanent tattooed makeup or general tattoos in a
dangerous location on the body or made with colors whose content in iron cannot be
definitely ruled out.

- Youth will be excluded if they are left-handed.

All participants will receive a written explanation of the purposes, procedures, and
potential hazards of the study. Communication of this information and of the participant s
assent as well as the consent of the parent or guardian will be documented in the medical
record and copies of all signed documents given to each family. All participants will be
informed of their right to withdraw from the study.