Smart Gaming in Obesity

NCT ID: NCT03693859

Last Updated: 2018-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-31

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Cognitive enhancement program

Intervention Type BEHAVIORAL

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 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).

Group Type ACTIVE_COMPARATOR

Behavioral Weight Loss + Health Segments

Intervention Type BEHAVIORAL

Control participants will be asked to spend 30 minutes watching health segments online, five days per week, for 8 weeks.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Smart Gaming

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Philadelphia College of Osteopathic Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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Lent1018

Identifier Type: -

Identifier Source: org_study_id

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