Smart Gaming in Obesity
October 2, 2018 updated by: Philadelphia College of Osteopathic Medicine
Smart Gaming for Obesity: A Randomized Trial
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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).
|
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.
Other Names:
|
|
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).
|
Control participants will be asked to spend 30 minutes watching health segments online, five days per week, for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight change
Time Frame: 52 weeks
|
Weight change maintenance of at least 5%
|
52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2019
Primary Completion (Anticipated)
October 1, 2022
Study Completion (Anticipated)
September 1, 2023
Study Registration Dates
First Submitted
October 1, 2018
First Submitted That Met QC Criteria
October 1, 2018
First Posted (Actual)
October 3, 2018
Study Record Updates
Last Update Posted (Actual)
October 4, 2018
Last Update Submitted That Met QC Criteria
October 2, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lent1018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.