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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
Philadelphia College of Osteopathic Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    October 1, 2018
    Last Updated
    October 2, 2018
    Sponsor
    Philadelphia College of Osteopathic Medicine
    Collaborators
    National Institutes of Health (NIH)
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    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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