Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Smart Gaming in Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03693859
Recruitment Status : Not yet recruiting
First Posted : October 3, 2018
Last Update Posted : October 4, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Philadelphia College of Osteopathic Medicine

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
Obesity Behavioral: Cognitive enhancement program Behavioral: Behavioral Weight Loss + Health Segments Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Weight change [ Time Frame: 52 weeks ]
    Weight change maintenance of at least 5%



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Layout table for additonal information
Responsible Party: Philadelphia College of Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT03693859     History of Changes
Other Study ID Numbers: Lent1018
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms