Evaluation of the SickKids Team Obesity Management Program (STOMP)
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
- 否
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
Jill Hamilton
Staff Endocrinologist
The Hospital for Sick Children
