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临床试验/NCT01757925
NCT01757925已完成4 期

Evaluation of a Commercial Gaming Impact in a Childhood Obesity Intervention

UnitedHealth Group22 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
77
试验地点
22
主要终点
MVPA

研究概览

简要总结

Recently, researchers have been interested in the use of game play, mechanics and psychology for health-related engagement and behavior change. While initial studies have shown some increases in health knowledge and/or behavior through gaming, there remains concern that the vehicle for change is associated with a perceived sedentary behavior (6).

More recently, commercially available gaming devices are able to directly promote physical activity through a new set of "kinetic controllers" added to the gaming experience. UHG plans to evaluate the most recent of these kinetic controller technologies in the context of a second iteration of JOIN (described above) to be implemented among a pilot group of overweight and/or obese children whose BMI percentile is above the 85th.

This study will evaluate the effect of a commercial controller-free Exercise Gaming and Entertainment Experience (EGEE) on physical activity levels in the context of a weight management program in approximately 70 children ages 6 to12. The study will compare the differences in physical activity levels over 16 weeks in two groups of children.

详细描述

The Center for Health Reform and Modernization at UHG will compare levels of physical activity, assessed by accelerometry, among children randomly assigned to WMA or WM+E groups. Specific aims of this evaluation are:

  • Compare the two groups on changes in the daily minutes of physical activity (mild, moderate and vigorous) after sessions 1, 8 and 15, respectively (Sessions are typically one week a part. Due to holiday schedules, there may be a lapse of two weeks between sessions).
  • Compare the two groups on changes in the daily minutes of sedentary behavior after sessions 1, 8 and 15, respectively
  • Compare the two groups on changes in relative weight (weight, BMI percentile, BMI z-score) at sessions 1, 8, and 16 weeks, respectively
  • Compare the two groups on measures of program satisfaction at 1, 8, and 16 weeks, respectively

Participation in the post session one session is required in order to be eligible for the study requirements include:

  • A signed consent/ assent from the parent and child.
  • The child must be able to participate in physical activity similar to exercise gaming
  • The family must have a TV/monitor that supports Microsoft Kinect
  • The family must have internet connection in the home

The family's decision to participate in the study does not affect the child's'/ parent's overall ability to fully participate in the JOIN Program. All JOIN program materials will be the same whether or not JOIN participants agree to be in the study. All aspects of the study will be conducted outside of the standard class time. Interested and eligible participants will be scheduled to attend a study visit immediately after their first JOIN class. During that study visit, written informed consent/assent from the parent/child will be obtained.

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 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children ages 6 - 12 with Parent or Gaurdian.
  • Child must be enroll in JOIN Program,
  • Child must have a BMI in the 85th percentile

排除标准

  • English Speaking Participants only

结局指标

主要结局

MVPA

时间窗: 16 weeks

difference between groups in MVPA at week 16 as assess by accelerometry

次要结局

  • relative weight(16 weeks)
  • quality of life(16 weeks)

研究者

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

Dr. Deneen Vojta

Dr. Deneen Vojta Vice President of Center for Health Reform and Modernization

UnitedHealth Group

研究点 (22)

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