Measurement of Cardiometabolic Risk in Antipsychotic-Treated Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- DEXA-measured Adiposity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Diet and Exercise Education (Behavioral)
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.
干预措施: Behavioral Weight Loss (Behavioral)
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.
干预措施: Behavioral Weight Loss (Behavioral)
结局指标
主要结局
DEXA-measured Adiposity
时间窗: Baseline and 16 weeks
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.
Proton Density Fat Fraction (PDFF)
时间窗: Baseline and 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 a behavioral weight loss intervention.
Carotid Artery Intima Media Thickness (CIMT)
时间窗: Baseline and 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 a behavioral weight loss intervention.
次要结局
未报告次要终点