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Smart Gaming in Obesity

Sponsor
Philadelphia College of Osteopathic Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03693859
Collaborator
National Institutes of Health (NIH) (NIH)
200
Enrollment
2
Arms
47
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive enhancement program
  • Behavioral: Behavioral Weight Loss + Health Segments
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Smart Gaming for Obesity: A Randomized Trial
Anticipated Study Start Date :
Oct 1, 2019
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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).

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.
Other Names:
  • Smart Gaming

    		•
    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).

    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.

    Outcome Measures

    Primary Outcome Measures

    1. Weight change [52 weeks]

      Weight change maintenance of at least 5%

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Philadelphia College of Osteopathic Medicine
    • National Institutes of Health (NIH)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Philadelphia College of Osteopathic Medicine
    ClinicalTrials.gov Identifier:
    NCT03693859
    Other Study ID Numbers:
    • Lent1018
    First Posted:
    Oct 3, 2018
    Last Update Posted:
    Oct 4, 2018
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Obesity

    Study Results

    No Results Posted as of Oct 4, 2018