Healthy Bodies, Healthy Kids

NCT01222494 | Completed Results DMC

• 2 other identifiers: 10-0425K23MH092435
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Child Mental Disorders; Obesity; Metabolic Syndrome

Keywords

Child Psychiatry; Obesity; Antipsychotic

Outcome Measures

Primary Outcomes (3)

• DEXA-measured Adiposity

  Dual-Energy X-Ray Absorptiometry (DEXA) will be used to assess body fat at baseline and following 16 weeks of participation in a behavioral weight loss intervention.

  Baseline and 16 weeks

• Proton Density Fat Fraction (PDFF)

  1H Magnetic Resonance Spectroscopy (MRS) of liver will be used to assess intracellular triglyceride content at baseline and following 16 weeks of participation in a behavioral weight loss intervention.

  Baseline and 16 weeks

• Carotid Artery Intima Media Thickness (CIMT)

  9-13-MHZ B-mode Carotid Ultrasound will be used to assess intima media thickness at baseline and following 16 weeks of participation in a behavioral weight loss intervention.

  Baseline and 16 weeks

Other Outcomes (1)

• Aberrant Behavior Checklist (ABC)

  Baseline and 16 weeks

Study Arms (3)

Antipsychotic Treated Educational Cntrl

PLACEBO COMPARATOR

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

Antipsychotic Treated Weekly BWL

EXPERIMENTAL

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

Non-antipsychotic Treated Weekly BWL

ACTIVE COMPARATOR

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

Interventions

Behavioral Weight Loss BEHAVIORAL

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.

Antipsychotic Treated Weekly BWL; Non-antipsychotic Treated Weekly BWL

Diet and Exercise Education BEHAVIORAL

Participants assigned to this arm will receive monthly medically validated, individualized diet and exercise education by a trained research professional.

Antipsychotic Treated Educational Cntrl

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Nicol GE, Kolko R, Lenze EJ, Yingling MD, Miller JP, Ricchio AR, Schweiger JA, Findling RL, Wilfley D, Newcomer JW. Adiposity, Hepatic Triglyceride, and Carotid Intima Media Thickness During Behavioral Weight Loss Treatment in Antipsychotic-Treated Youth: A Randomized Pilot Study. J Child Adolesc Psychopharmacol. 2019 Aug;29(6):439-447. doi: 10.1089/cap.2018.0120. Epub 2019 Apr 17.

  PMID: 30994376 DERIVED

MeSH Terms

Conditions

Neurodevelopmental Disorders; Obesity; Metabolic Syndrome

Interventions

Diet

Condition Hierarchy (Ancestors)

Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Dr. Ginger Nicol
• Organization: Washington University

nicolg@wustl.edu

314-362-2461

Study Officials

• Ginger E Nicol, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2010
• First Posted: October 18, 2010
• Study Start: July 1, 2011
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: October 15, 2018
• Results First Posted: October 15, 2018

Record last verified: 2018-10

Locations

US (1)