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N/A N=47 Randomized Treatment

Healthy Bodies, Healthy Kids

Child Mental Disorders · Obesity · Metabolic Syndrome

Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: DEXA-measured Adiposity — 0.76; -0.43; -2.79 kilograms — p=0.01

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Behavioral Weight Loss (Behavioral); Diet and Exercise Education (Behavioral)
Age
Pediatric, Adult · 6+ yrs
Sex
All
Sponsor
Washington University School of Medicine
Primary completion
Mar 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
DEXA-measured Adiposity
0.76; -0.43; -2.79 0.01 sig
PRIMARY
Proton Density Fat Fraction (PDFF)
-0.62; -0.41; -1.75 0.04 sig
PRIMARY
Carotid Artery Intima Media Thickness (CIMT)
-0.0014; 0.0032; 0.0004 0.70

Summary

The US prevalence of childhood-onset obesity and type 2 diabetes, both predictors of cardiovascular risk, have increased to epidemic proportions in recent decades. Children with mental illness, especially those treated with antipsychotic medications, are at additional risk for obesity (adiposity) and related risk conditions. A variety of noninvasive techniques to assess cardiometabolic risk have begun to be applied in children, including body composition measured with dual energy x-ray absorptiometry (DEXA), carotid intima media thickness (CIMT) measured by ultrasound, and hepatic triglyceride content measured using magnetic resonance (MR) imaging-estimated proton density fat fraction (PDFF). These measures allow for the early, noninvasive study of adiposity-related metabolic risk. The overall aim of this two-study research plan is to characterize the level of measurable risk using these sensitive markers in treated and untreated children with mental health disorders, and to evaluate the magnitude of change in risk that can be observed using these biomarkers in children receiving a well established behavioral weight-loss intervention.

Eligibility Criteria

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 sub
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01222494). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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