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Healthy Bodies, Healthy Kids

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01222494
First received: October 5, 2010
Last updated: May 11, 2017
Last verified: May 2017
  Purpose
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 (HTGC) measured by 1H Magnetic Resonance Spectroscopy (MRS). 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.

Condition Intervention
Child Mental Disorders
Obesity
Metabolic Syndrome
Behavioral: Behavioral Weight Loss
Behavioral: Diet and Exercise Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Measurement of Cardiometabolic Risk in Antipsychotic-Treated Children

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • DEXA-measured adiposity [ Time Frame: 16 weeks ]
    To evaluate the effect of participation in a 16-week behavioral weight loss program on adiposity.

  • Hepatic Triglyceride Content (HTGC) [ Time Frame: 16 weeks ]
    1H Magnetic Resonance Spectroscopy (MRS) of liver will be used to assess intracellular triglyceride content at baseline and following 16 weeks of participation in an intensive behavioral weight loss intervention.

  • Carotid Artery Intima Media Thickness (CIMT) [ Time Frame: 16 weeks ]
    9-13-MHZ B-mode Carotid Ultrasound will be used to assess intima media thickness at baseline and following 16 weeks of participation in an intensive behavioral weight loss intervention.


Secondary Outcome Measures:
  • Fasting blood tests [ Time Frame: 16 weeks ]
    To evaluate the effect of participation in a 16-week behavioral weight loss program has on fasting laboratory measures of cardiometabolic risk, including fasting lipids, insulin, glucose and adiponectin.

  • Non-fasting blood tests [ Time Frame: 16 weeks ]
    To evaluate the effect of participation in a 16-week behavioral weight loss program on non-fasting measures of cardiometabolic risk, including fibrinogen and high sensitivity C-reactive protein.


Enrollment: 50
Actual Study Start Date: July 2011
Study Completion Date: March 2017
Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Antipsychotic Treated Educational Control
Antipsychotic treated participants randomized to this arm will receive diet and exercise education at monthly intervals with a study clinician or coordinator.
Behavioral: Diet and Exercise Education
Participants assigned to this arm will receive monthly medically validated, individualized diet and exercise education by a trained research professional.
Experimental: Antipsychotic Treated Weekly Behavioral Weight Loss
Antipsychotic treated participants randomized to this arm will engage in an evidence-based, 16 week manualized behavioral weight loss intervention that includes weekly meetings and phone check-ins with a trained study therapist.
Behavioral: Behavioral Weight Loss
This intervention is a family-based, behavioral weight loss program that has been employed in studies with overweight and obese children, as well as with children who have diabetes. For the proposed study, the program has been modified to fit the needs of disruptive and behaviorally disturbed youth and their families. The modified program includes 16 weeks of weekly visits with a study interventionist, and supplemental phone contacts as needed. Phone contacts will only replace in-person visits if absolutely necessary to achieve the visit.
Active Comparator: Non-antipsychotic Treated Weekly Behavioral Weight Loss
Participants assigned to this arm will engage in an evidence-based, 16 week manualized behavioral weight loss intervention that includes weekly meetings and phone check-ins with a trained study therapist.
Behavioral: Behavioral Weight Loss
This intervention is a family-based, behavioral weight loss program that has been employed in studies with overweight and obese children, as well as with children who have diabetes. For the proposed study, the program has been modified to fit the needs of disruptive and behaviorally disturbed youth and their families. The modified program includes 16 weeks of weekly visits with a study interventionist, and supplemental phone contacts as needed. Phone contacts will only replace in-person visits if absolutely necessary to achieve the visit.

Detailed Description:

This project will utilize sensitive, early biomarkers of disease risk, including whole body adiposity with DEXA, HTGC 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. This study will completed in two phases.

Study Phase 1, Aim 1: To test the feasibility of delivering an existing family-based behavioral weight loss program in families of psychiatrically ill youth who are overweight or obese.

Study Phase 2, Aim 1: To evaluate the effect of 16 weeks of the behavioral weight loss intervention on DEXA-measured whole body adiposity in overweight/obese antipsychotic-treated children.

Study Phase 2, Aim 2: To evaluate the effect of 16 weeks of the behavioral weight loss intervention on HTGC in overweight/obese antipsychotic-treated children.

Study Phase 2, Aim 3: To evaluate the effect of 16 weeks of the behavioral weight loss intervention on carotid CIMT in overweight/obese antipsychotic-treated children.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01222494

Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Ginger E Nicol, MD Washington University School of Medicine
  More Information

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01222494     History of Changes
Other Study ID Numbers: 10-0425
Study First Received: October 5, 2010
Last Updated: May 11, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Washington University School of Medicine:
Child Psychiatry
Obesity
Antipsychotic

Additional relevant MeSH terms:
Metabolic Syndrome X
Mental Disorders
Psychotic Disorders
Neurodevelopmental Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Schizophrenia Spectrum and Other Psychotic Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 24, 2017