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临床试验/NCT03004378
NCT03004378已完成不适用

The Role of Activity Tracking on Weight Loss in Obese Adolescents

The University of Texas Medical Branch, Galveston2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Feasibility of the pilot trial will be measured by an attrition rate of ≤50%.

研究概览

简要总结

This study will evaluate whether the short-term use of activity tracking devices improves short-term weight loss in adolescents. The investigators will evaluate whether weight loss translates into a change in obesity-related biomarkers associated with adolescent obesity. In addition, the investigators will report outcomes after the implementation of activity tracking devices in conjunction with an intense adolescent weight loss program.

详细描述

This study will evaluate the short-term use of activity tracking devices and their effects on short- and long-term weight loss in adolescents. The investigators plan to establish whether weight loss translates into a change in obesity-related biomarkers associated with adolescent obesity. Each participant with an activity tracking device will have the goal of reaching 10,000 steps per day, in addition to their individual fitness plan.

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

入选标准

  • Ages 12-18 years BMI ≥ 95th percentile for age and sex group Participant able to read and understand English Willingness to be randomized to any condition

排除标准

  • Inability to obtain informed parental consent and/or child assent Inability to participate in the program due to pre-existing conditions (e.g., paralysis, heart failure, severe autism or mental retardation, psychosis) Pregnancy Clinical judgment concerning safety Inability of the participant to speak English

结局指标

主要结局

Feasibility of the pilot trial will be measured by an attrition rate of ≤50%.

时间窗: 18 weeks

We set a study attrition rate of participants at ≤50% as the feasibility measure for the study.

次要结局

  • Body mass index (BMI) (kg/m2)(Change from 0 to 18 weeks)
  • Weight (kg)(Change from 0 to 18 weeks)
  • Change in obesity related biomarkers(Change from 0 to 18 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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