Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-30 @ 9:30 AM
Study NCT ID:
NCT01222494
Status:
COMPLETED
Last Update Posted:
2018-10-15
First Post:
2010-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Healthy Bodies, Healthy Kids
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
Measurement of Cardiometabolic Risk in Antipsychotic-Treated Children
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| K23MH092435 | NIH | None | https://reporter.nih.gov/quic… | View |