Engaging Men in Weight Loss With a Game-based mHealth and Neurotraining Program

Not Applicable

Recruiting

• Conditions: Weight Loss; Obesity
• Interventions: Behavioral: mHealth behavioral weight loss treatment; Behavioral: Gamified behavioral weight loss treatment

• Registration Number: NCT05408494
• Lead Sponsor: Drexel University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-06-03
• Study First Posted: 2022-06-07
• Study Start: 2023-08-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-08
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Non-gamified program with Active ICT	mHealth behavioral weight loss treatment	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.
Non-gamified program with sham ICT	mHealth behavioral weight loss treatment	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.
Gamified program with sham ICT	Gamified behavioral weight loss treatment	One group will receive fully-gamified version of the program with a sham.
Gamified program with Active ICT	Gamified behavioral weight loss treatment	One group will receive fully-gamified version of the program with active neurotraining.

Primary Outcome Measures

Name	Time	Method
Baseline Weight	Assessments will be administered at month zero.	Weight will be measured using the Fitibit Aria wireless scale, accurate to 0.2 kg. We will instruct participants to place the scale on a flat, hard surface; weigh upon waking, without clothes, after using the bathroom, require participants to confirm monthly that they are following instructions, require participants to weigh daily, remove incorrect weights, and use the average of 5 daily weights for each timepoint.
Change from Baseline Weight at 6 months	Assessment will be administered at month sixth.	Weight will be measured using the Fitibit Aria wireless scale, accurate to 0.2 kg. We will instruct participants to place the scale on a flat, hard surface; weigh upon waking, without clothes, after using the bathroom, require participants to confirm monthly that they are following instructions, require participants to weigh daily, remove incorrect weights, and use the average of 5 daily weights for each timepoint.
Change from Baseline Weight at 12 months	Assessment will be administered at month twelve.	Weight will be measured using the Fitibit Aria wireless scale, accurate to 0.2 kg. We will instruct participants to place the scale on a flat, hard surface; weigh upon waking, without clothes, after using the bathroom, require participants to confirm monthly that they are following instructions, require participants to weigh daily, remove incorrect weights, and use the average of 5 daily weights for each timepoint.
Change from Baseline Weight at 1 month	Assessment will be administered at month one.	Weight will be measured using the Fitibit Aria wireless scale, accurate to 0.2 kg. We will instruct participants to place the scale on a flat, hard surface; weigh upon waking, without clothes, after using the bathroom, require participants to confirm monthly that they are following instructions, require participants to weigh daily, remove incorrect weights, and use the average of 5 daily weights for each timepoint.

Secondary Outcome Measures

Name	Time	Method
Caloric intake measured using the Fitbit app's built-in dietary tracking system	Assessments will be administered at months 0, 1, 6 and 12.	Caloric intake and intake of "red" (high calorie, "unhealthy") foods will be measured using the Fitbit app's built-in dietary tracking system and accompanying food item/calorie database. Foods tracked in Fitbit will be categorized as red foods based on their energy density.
Physical activity measured in minutes of moderate to vigorous physical activity using wrist-worn activity tracker.	Assessments will be administered at months 0, 1, 6 and 12.	Physical activity will be measured in minutes of moderate to vigorous physical activity using the Fitbit, a wrist-worn activity tracker.

Trial Locations

Locations (1)

Drexel University; 🇺🇸 Philadelphia, Pennsylvania, United States