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NCT05408494 · ClinicalTrials.gov registry record · NA

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

A NA study of Obesity and Weight Loss, sponsored by Drexel University.

Active
Registry status
NA
Development phase
228
Enrollment target
1
Study location

NCT05408494 is a NA study of Obesity and Weight Loss that is active but no longer recruiting, run by Drexel University. The registered enrollment target is 228 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05408494, a NA study of Obesity and Weight Loss, is active but no longer recruiting, sponsored by Drexel University.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
228 participants
Enrollment target
1
Study location

Study 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 Co

Conditions Studied

Interventions

  • BEHAVIORAL Gamified behavioral weight loss treatment
  • BEHAVIORAL mHealth behavioral weight loss treatment

Study Locations (1)

Pennsylvania

  • Drexel University - Philadelphia

Trial Details

FieldValue
Enrollment Target 228 participants
Start Date 2023-09-01
Est. Completion 2027-03-01
Phase NA

Sponsor

Drexel University

92 total trials

What the Registry Record Tells You About NCT05408494

The ClinicalTrials.gov registry entry for NCT05408494 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 228 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (72% lower). The listed sponsor is Drexel University, which has 92 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Gamified behavioral weight loss treatment is the first listed.

NCT05408494 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT05408494 about?

NCT05408494 is a clinical study titled "Engaging Men in Weight Loss With a Game-based mHealth and Neurotraining Program". 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 ...

What is the current status of trial NCT05408494?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 228 participants. The study started on 2023-09-01. Estimated completion is 2027-03-01.

What conditions does trial NCT05408494 study?

This clinical trial studies the following conditions: Obesity, Weight Loss.

What interventions are being tested in trial NCT05408494?

The interventions under investigation include: Gamified behavioral weight loss treatment (BEHAVIORAL), mHealth behavioral weight loss treatment (BEHAVIORAL).

Who is sponsoring clinical trial NCT05408494?

This trial is sponsored by Drexel University, which has 92 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05408494 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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