Healthy Bodies, Healthy Kids

NCT ID: NCT01222494

Last Updated: 2018-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2017-03-31

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.

Detailed Description

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.

Conditions

Child Mental Disorders; Obesity; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Antipsychotic Treated Educational Cntrl

Antipsychotic treated participants randomized to this arm will receive diet and exercise education at monthly intervals with a study clinician or coordinator.

Group Type: PLACEBO_COMPARATOR

Diet and Exercise Education

Intervention Type: BEHAVIORAL

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

Antipsychotic Treated Weekly BWL

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.

Group Type: EXPERIMENTAL

Behavioral Weight Loss

Intervention Type: 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.

Non-antipsychotic Treated Weekly BWL

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.

Group Type: ACTIVE_COMPARATOR

Behavioral Weight Loss

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ginger E Nicol, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30994376 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K23MH092435

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10-0425

Identifier Type: -

Identifier Source: org_study_id