Engaging Men in Weight Loss With a Game-based mHealth and Neurotraining Program: A 2 x 2 Randomized Design

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Men in the United States have an exceptionally high prevalence of overweight and obesity, i.e., 71.3%, and 42% of men are currently attempting weight loss. However, men are dramatically underrepresented in weight loss programs. Attempts to modestly adapt standard weight loss programs have seen only minimal success. Mobile applications (mHealth apps) have attractive features, but have low male enrollment and poor efficacy as conventionally delivered. A gamified mHealth program offers the possibility of engaging men and enhancing efficacy given that (1) video gaming is highly appealing to men; (2) gamification features (e.g., digital rewards for attaining streaks and milestones, competition) are known enhance enjoyment and motivation and facilitate desired behaviors; and (3) neurotraining video games featuring repetitive action mechanics, adaptive difficulty, and feedback can train inhibitory control, a basic brain capacity to inhibit intrinsically-generated approach responses that is strongly linked to body mass and the consumption of high-calorie foods. This project evaluates long-term engagement and outcomes of a professionally-designed, game-based weight loss program. As such, 228 overweight men will be randomized to: (1) a 12-month mHealth weight loss program that includes digital self-monitoring, simplified and self-selected dietary targets, physical activity and a control (sham) non-game neurotraining, or (2) a fully-gamified version of this same program, comprised of a behavior change program featuring team-based competition, digital reinforcers for attainment of streaks and milestones, and an integrated neurotraining video game. Aims include evaluating the efficacy of the gamified program in terms of weight loss, diet and physical activity at 12 months, as well as evaluating hypothesized mediators (inhibitory control and engagement), (enjoyment and compliance) and moderators (baseline frequency of video game play and implicit preferences for Inhibitory Control Training-targeted foods).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:

• Individuals must be of overweight or obese BMI (25-50 kg/m)

• Individuals must be adults (aged 18-65)

• Able to engage in physical activity (defined as walking two city blocks without stopping)

• Individuals must also provide consent for the research team to contact their personal physician, if necessary, to provide clearance for the prescribed level of physical activity (i.e., walking) or to consult about rapid weight loss

• Have moderate-to-high implicit preference for high-calorie foods

• Satisfactory completion of all enrollment procedures\]

Locations
United States
Pennsylvania
Drexel University
RECRUITING
Philadelphia
Contact Information
Primary
Michael C Onu, B.S.
mo654@drexel.edu
‪(267) 571-7917‬
Backup
Evan M Forman, Ph.D.
wellcenter@drexel.edu
215-553-7100
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 228
Treatments
Sham_comparator: Non-gamified program with sham ICT
One group will be assigned to a 12-month mobile weight loss program that includes digital self-monitoring, simplified and self-selected dietary targets (to align with neurotraining and promote autonomy , and behavioral strategies with sham.
Active_comparator: Non-gamified program with Active ICT
One group will be assigned to a 12-month mobile weight loss program that includes digital self-monitoring, simplified and self-selected dietary targets (to align with neurotraining and promote autonomy , and behavioral strategies with active neurotraining.
Experimental: Gamified program with sham ICT
One group will receive fully-gamified version of the program with a sham.
Experimental: Gamified program with Active ICT
One group will receive fully-gamified version of the program with active neurotraining.
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Drexel University

This content was sourced from clinicaltrials.gov

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