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临床试验/NCT02121132
NCT02121132已完成不适用

Establishment of the Pediatric Obesity Weight Evaluation Registry (POWER): A Prospective Pilot Project of Children and Adolescents Presenting for Weight Management

Children's Hospital Medical Center, Cincinnati38 个研究点 分布在 1 个国家目标入组 4,276 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,276
试验地点
38
主要终点
Assess Patient Response to Weight Management Program

研究概览

简要总结

The main objective of this study is to establish a national pediatric obesity registry known as POWER (Pediatric Obesity Weight Evaluation Registry). This registry will contain clinical data from individual comprehensive pediatric weight management programs around the United States for overweight and obese youth.

详细描述

All patients 18 years of age or younger who have completed an initial medical assessment between March 1, 2014 through April 30, 2020 will be approached for this study.

Data from individual follow up visits or group intervention sessions, depending on the program design of each institution, will be collected through October 31, 2020. The data included in this study will be collected during routine medical care. Information that could identify a participant will be removed from the data. Data will be entered into a secure database called Medidata Rave® CDMS. This database will be managed by the Data Coordinating Center (DCC) at Cincinnati Children's Hospital Medical Center (CCHMC).

The DCC will combine all the data from each site. Additional data cleaning and data quality monitoring will be performed. Combined datasets for analysis will be provided by the DCC in a format agreed upon by the POWER Governance Board. Data will be stored in a secure and protected format and will not include any written or electronic protected health information (PHI/EPHI). The DCC will store the data on a secure server.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • age 18 years or younger
  • overweight or obese patient
  • initial medical evaluation in a pediatric weight management program between March 1, 2014-April 30, 2020.

排除标准

  • no exclusion criteria

结局指标

主要结局

Assess Patient Response to Weight Management Program

时间窗: 2 years

This is a composite outcome measure that will be measured with changes in patient weight and BMI, fasting lipid profile, liver enzymes, fasting glucose and insulin, hemoglobin A1C and blood pressure.

次要结局

  • Measure Program Retention(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (38)

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