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Active, Not Recruiting

NCT Number: NCT05408494

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 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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]

Exclusion criteria

  • Medical condition (e.g., cancer, type I diabetes, renal failure), heavy alcohol use, or psychiatric condition (e.g., active substance abuse, eating disorder) that may pose a risk to the participant during intervention or cause a change in weight
  • Recently began or changed the dosage of medication that can cause significant change in weight
  • History of bariatric surgery
  • Weight loss of ≥ 5% in the previous 3 months

Treatment and study plan

Gamified behavioral weight loss treatment

Behavioral

12-month mHealth fully-gamified version of the same program, comprised of a behavior change program with digital reinforcers for attainment of streaks and milestones, and an integrated neurotraining video game

mHealth behavioral weight loss treatment

Behavioral

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

Primary outcomes

  1. Baseline Weight

    Time frame: 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.

  2. Change from Baseline Weight at 1 month

    Time frame: 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.

  3. Change from Baseline Weight at 6 months

    Time frame: 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.

  4. Change from Baseline Weight at 12 months

    Time frame: 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.

Secondary outcomes

  1. Caloric intake measured using the Fitbit app's built-in dietary tracking system

    Time frame: 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.

  2. Physical activity measured in minutes of moderate to vigorous physical activity using wrist-worn activity tracker.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Drexel University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 7, 2022
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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