Smart Gaming in Obesity

Not Applicable

• Conditions: Obesity
• Interventions: Behavioral: Cognitive enhancement program; Behavioral: Behavioral Weight Loss + Health Segments

• Registration Number: NCT03693859
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-01
• Study First Submitted QC: 2018-10-01
• Last Update Submitted: 2018-10-02
• Study First Posted: 2018-10-03
• Last Update Posted: 2018-10-04
• Study Start: 2019-10
• Primary Completion: 2022-10
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral Weight Loss + Gaming	Cognitive enhancement program	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 Weight Loss + Health Segments	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).

Primary Outcome Measures

Name	Time	Method
Weight change	52 weeks	Weight change maintenance of at least 5%