Healthy Bodies, Healthy Kids

This project will utilize sensitive, early biomarkers of disease risk, including whole body
adiposity with DEXA, PDDF and CIMT, directly relevant to diabetes and cardiovascular disease
risk. The primary goals of this study are to deliver an evidence-based weight loss
intervention to the population of youth who are overweight or obese as a result of
antipsychotic treatment, to characterize metabolic risk associated with weight using
sensitive biomarkers, and to evaluate the magnitude of change observed in these biomarkers in
children receiving an established behavioral weight-loss intervention.

Aim 1: To evaluate the main effect of time of 16 weeks of a Behavioral Weight Loss (BWL)
intervention on DEXA-measured whole body adiposity in overweight/obese antipsychotic
(AP)-treated children compared to nonpsychiatric (NP) overweight or obese healthy controls,
and in AP-treated youth randomized to monthly Usual Care (UC).

Aim 2: To evaluate the main effect of time of 16 weeks of a BWL intervention on PDFF in
overweight/obese AP-treated children compared to NP overweight or obese healthy controls, and
in AP-treated youth randomized monthly UC.

Aim 3: To evaluate the main effect of time of 16 weeks of a weekly behavioral weight loss
intervention on CIMT in overweight/obese AP-treated children compared to NP overweight or
obese healthy controls, and in AP-treated youth randomized monthly UC.

INCLUSION CRITERIA

- 6-18 years old (at any point during study participation)

- BMI percentile > 85

- Meet DSM-IV criteria for one or more childhood onset psychiatric disorders including
disruptive behavior disorders (attention deficit disorder, conduct disorder,
oppositional defiant disorder and disruptive behavior disorder not otherwise
specified), affective disorders (bipolar affective disorder, major depressive disorder
and mood disorder not otherwise specified), anxiety disorders (generalized anxiety
disorder, obsessive compulsive disorder, separation anxiety, social and other specific
phobias) as well as other disorders, including autism spectrum disorders (autistic
disorder, Asperger's Syndrome and pervasive developmental disorder not otherwise
specified), psychotic disorders (schizophreniform disorder, schizophrenia and
psychotic disorder not otherwise specified) and movement disorders (tic disorder,
Tourette's Syndrome) as determined by semi-structured diagnostic interview (EXCEPT for
the Obese or Overweight Control Group, none of whom can meet criteria for any DSM-IV
Axis I psychiatric illness)

- Currently treated with an atypical antipsychotic medication (EXCEPT for the Obese or
Overweight Healthy Control Group, none of whom can be treated with any psychotropic
medications Participants treated with any psychotropic medication may not have any
medication changes for 1 month prior to study enrollment at the discretion of the PI,
and Antipsychotic-Treated Participants must be treated with an antipsychotic >
approximately 12 weeks with no antipsychotic medication dose changes for 1 month

- The Healthy Overweight or Obese Control Group may not be currently taking any
prescription medications (multivitamins, over the counter medications, glucocorticoid
nasal spray and inhalers are permitted, as well as non-sedating antihistamines such as
but not limited to Claritin (loratadine) and Zyrtec (cetirizine)

- Participants between 6-17 years old will be able to give assent and have a
parent/guardian that can provide written informed consent, and 18 year-old
participants will be able to provide written informed consent.

EXCLUSION CRITERIA

- Do not meet DSM-IV criteria for any Axis I psychiatric illness per PI discretion
(EXCEPT for Overweight or Obese Healthy reference group)

- Any lifetime use of antipsychotics (EXCEPT for Antipsychotic-Treated Participants,
with the individuals in the latter group possibly having a remote, brief prior
antipsychotic exposure that may be considered for enrollment on a case by case basis
by the PI)

- The presence of any serious medical disorder that may confound the assessment of
relevant biologic measures or diagnoses, including: significant organ system
dysfunction; endocrine disease, including type 1 or type 2 diabetes mellitus;
coagulopathy; anemia; or acute infection; all based on PI discretion Participants
regularly taking within the last 3 months any glucose lowering agent, lipid lowering
agent, exogenous testosterone, recombinant human growth hormone, or any other
endocrine agent that might confound substrate metabolism, oral glucocorticoids
(glucocorticoid nasal spray and inhalers are permitted), sedating antihistamines
(non-sedating antihistamines such as but not limited to Claritin (loratadine) and
Zyrtec (cetirizine) are permitted), and certain mood stabilizing agents including
antiepileptic medications (lamotrigine is permitted) and Lithium, as these medications
may themselves worsen or otherwise alter weight gain, glucose and lipid regulation or
otherwise make it difficult to assess the effects of the antipsychotic alone; (note
that exposure to many psychotropic agents including stimulants, SSRI's and SNRI's are
permitted in the Antipsychotic-Treated and Non-Antipsychotic Treated Groups in Study 1
in order to maintain the generalizability of the sample)

- IQ < 70 (based on school records and/or evaluation by clinician and at the discretion
of the PI)

- Current DSM IV diagnosed substance abuse or dependence

- Past history of, or current dyskinesia

- Stimulant dosage significantly higher (per PI judgment) than the equivalent of
approximately 2 mg/kg/day methylphenidate equivalent dose (EXCEPT in the Obese or
Overweight Control Group, none of whom can be taking stimulant medications)

- Unable to provide assent or informed consent

- Active suicidality or a primary diagnosis of depression

- Unwilling to allow study staff to contact subject's primary care physician to alert to
any significant, abnormal clinical findings or test results obtained as part of study
participation