Smart Gaming in Obesity

赞助:

合作者:

信息的提供 (责任方):

，

追踪信息

首次提交日期 ^ICMJE

October 1, 2018

首次发布日期e ^ICMJE

October 3, 2018

最后更新发布日期

October 4, 2018

预计研究开始日期 ^ICMJE

October 2019

预计主要完成日期

October 2022 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Weight change[ Time Frame: 52 weeks ]

Weight change maintenance of at least 5%

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

[ Time Frame: ]

描述性信息

简略标题 ^ICMJE

Smart Gaming in Obesity

正式标题 ^ICMJE

Smart Gaming for Obesity: A Randomized Trial

简要概况

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.

详细说明

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).

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Behavioral: Cognitive enhancement program
The cognitive enhancement condition (BWL+GAMING) will both teach the behavioral skills necessary for weight loss and strengthen the executive functions that underlie these skills.
Behavioral: Behavioral Weight Loss + Health Segments
Control participants will be asked to spend 30 minutes watching health segments online, five days per week, for 8 weeks.

研究工具

Experimental: Behavioral Weight Loss + Gaming
Treatment will consist of 12-weekly, one-hour group sessions of approximately 15 participants per group. Participants will provide logs of serious gaming (intervention).
Active Comparator: Behavioral Weight Loss + Health Segments
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).

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

200

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

September 2023

预计主要完成日期

October 2022 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Obesity - Executive functioning deficits - Internet access Exclusion Criteria: - Under 18 years of age - Over 65 years of age - Taking weight loss medication - Pregnant

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：65 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

Undecided

责任方

，

研究赞助商 ^ICMJE

Philadelphia College of Osteopathic Medicine

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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