Smart Gaming in Obesity
Primary Purpose
Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive enhancement program
Behavioral Weight Loss + Health Segments
Sponsored by

About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Behavioral Weight Loss + Gaming
Behavioral Weight Loss + Health Segments
Arm Description
Treatment will consist of 12-weekly, one-hour group sessions of approximately 15 participants per group. Participants will provide logs of serious gaming (intervention).
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).
Outcomes
Primary Outcome Measures
Weight change
Weight change maintenance of at least 5%
Secondary Outcome Measures
Full Information
NCT ID
NCT03693859
First Posted
October 1, 2018
Last Updated
October 2, 2018
Sponsor
Philadelphia College of Osteopathic Medicine
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT03693859
Brief Title
Smart Gaming in Obesity
Official Title
Smart Gaming for Obesity: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2019 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philadelphia College of Osteopathic Medicine
Collaborators
National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Behavioral Weight Loss + Gaming
Arm Type
Experimental
Arm Description
Treatment will consist of 12-weekly, one-hour group sessions of approximately 15 participants per group. Participants will provide logs of serious gaming (intervention).
Arm Title
Behavioral Weight Loss + Health Segments
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive enhancement program
Other Intervention Name(s)
Smart Gaming
Intervention Description
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
Intervention Name(s)
Behavioral Weight Loss + Health Segments
Intervention Description
Control participants will be asked to spend 30 minutes watching health segments online, five days per week, for 8 weeks.
Primary Outcome Measure Information:
Title
Weight change
Description
Weight change maintenance of at least 5%
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Smart Gaming in Obesity
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