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临床试验/NCT03693859
NCT03693859Unknown不适用

Smart Gaming for Obesity: A Randomized Trial

Philadelphia College of Osteopathic Medicine0 个研究点目标入组 200 人开始时间: 2019年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
200
主要终点
Weight change

研究概览

简要总结

Obesity (Body Mass Index ≥ 30 kg/m2) is associated with diminished executive functioning. The primary objective of this randomized, controlled trial is to evaluate the efficacy of a behavioral weight loss program coupled with enhanced executive functioning training via serious gaming on weight loss and weight loss maintenance in adults with obesity and executive functioning deficits compared to adults undergoing standard behavioral treatment alone (N = 200). Serious gaming interventions that target the specific cognitive functions needed for weight-loss maintenance may improve long-term weight-loss success.

详细描述

This randomized, controlled study will evaluate the efficacy of a behavioral weight loss program coupled with enhanced executive functioning training via serious gaming (BWL+GAMING) on weight loss and maintenance in adults with obesity and executive functioning deficits compared to standard behavioral treatment alone (BWL) at two urban Philadelphia university-based clinics (PCOM [Philadelphia College of Osteopathic Medicine] and Temple University). Participants will be recruited from the community. All participants (N = 200) will complete 12 weeks of behavioral weight loss treatment. Intervention participants will also complete 30-minutes (5 days per week for 8 weeks) of a serious gaming program, which will feature online games developed specifically to enhance executive functions. The primary outcomes are weight change and weight change maintenance, which will be measured at 12 and 52 weeks, respectively. Neuropsychological testing will evaluate the proposed mechanism of action, changes in executive functioning, before and after treatment (12 and 52 weeks).

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Executive functioning deficits
  • Internet access

排除标准

  • Under 18 years of age
  • Over 65 years of age
  • Taking weight loss medication

研究组 & 干预措施

Behavioral Weight Loss + Gaming

Experimental

Treatment will consist of 12-weekly, one-hour group sessions of approximately 15 participants per group. Participants will provide logs of serious gaming (intervention).

干预措施: Cognitive enhancement program (Behavioral)

Behavioral Weight Loss + Health Segments

Active Comparator

Control participants will be asked to spend 30 minutes watching health segments online, five days per week, for 8 weeks. Participants will provide logs of video segment watching (control).

干预措施: Behavioral Weight Loss + Health Segments (Behavioral)

结局指标

主要结局

Weight change

时间窗: 52 weeks

Weight change maintenance of at least 5%

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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