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临床试验/NCT01515904
NCT01515904招募中不适用

Evaluation of the SickKids Team Obesity Management Program (STOMP)

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
Body Mass Index

研究概览

简要总结

In January 2010 a new interdisciplinary clinic (STOMP) was created to provide care for children and adolescents with severe 'complex' obesity. As part of the program, a subset of adolescents undergo bariatric surgery. There is a paucity of literature evaluating outcomes of children and adolescents participating in a 'clinical' setting and even fewer reports of outcomes of severely obese pediatric patients. Previously, the investigators evaluated clinical outcomes of children with craniopharyngioma and hypothalamic obesity attending an outpatient interdisciplinary program at SickKids (The Comprehensive Care Clinic for Children with Central Tumours) and found significant benefit to those attending, including reduction of weight gain (or weight loss), improved psychosocial functioning, and increased care satisfaction. STOMP is a natural extension of this program, incorporating some core elements (e.g., interdisciplinary team, frequent visits, individualized care plans for medically-complex adolescents) and building on other aspects, such as increased psychosocial intervention; involvement of a "key worker" (nurse practitioner) to support families; provision of continuity of care with other health providers in all settings, community services and schools; a more diverse patient population; and group support sessions. Evaluation of the outcomes of this clinic is needed to inform best practice for children and adolescents with severe complex obesity

详细描述

The primary objective is to conduct an evaluation of the STOMP clinic as a model of care with a specific focus on: (i) patient outcomes (anthropometric, metabolic, and psychosocial); and (ii) care coordination and care satisfaction.

Patient outcomes will be compared against baseline evaluation data over time, and to a control group of patients not enrolled in the program, but who expressed interest in the program and were unable to attend.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All patients enrolled in the STOMP program are eligible to participate in the study.
  • Control participants must be between 12-18 years of age with a BMI >95th percentile for age.

排除标准

  • Control participants cannot be enrolled in the STOMP program.

结局指标

主要结局

Body Mass Index

时间窗: 12 months

BMI will be measured at Baseline and 12 months after treatment to evaluate change

次要结局

  • Systolic and Diastolic Blood Pressure(Baseline, 12 months)
  • Glycemic control and Insulin resistance(Baseline and 12 months)
  • Lipid profile(Baseline and 12 months)
  • Health and weight-related quality of life(Baseline and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jill Hamilton

Staff Endocrinologist

The Hospital for Sick Children

研究点 (1)

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