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

NCT05408494 | Active Not Recruiting

• 1 other identifier: R01DK128524
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity; Weight Loss

Outcome Measures

Primary Outcomes (4)

• Baseline Weight

  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.

  Assessments will be administered at month zero.

• Change from Baseline Weight at 1 month

  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.

  Assessment will be administered at month one.

• Change from Baseline Weight at 6 months

  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.

  Assessment will be administered at month sixth.

• Change from Baseline Weight at 12 months

  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.

  Assessment will be administered at month twelve.

Secondary Outcomes (2)

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

  Assessments will be administered at months 0, 1, 6 and 12.

• 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.

Study Arms (4)

Non-gamified program with sham ICT

SHAM COMPARATOR

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.

Behavioral: mHealth behavioral weight loss treatment

Non-gamified program with Active ICT

ACTIVE COMPARATOR

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.

Behavioral: mHealth behavioral weight loss treatment

Gamified program with sham ICT

EXPERIMENTAL

One group will receive fully-gamified version of the program with a sham.

Behavioral: Gamified behavioral weight loss treatment

Gamified program with Active ICT

EXPERIMENTAL

One group will receive fully-gamified version of the program with active neurotraining.

Behavioral: Gamified behavioral weight loss treatment

Interventions

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

Gamified program with Active ICT; Gamified program with sham ICT

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

Non-gamified program with Active ICT; Non-gamified program with sham ICT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: All participants will identify as male.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\]

You may not qualify if:

• 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

Sponsors & Collaborators

• Drexel University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will be blind to condition.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychological and Brain Sciences

Model Details: Utilizing a 2 x 2 factorial design, participants will be randomized to a mobile weight loss program that includes digital self-monitoring, simplified and self-selected dietary targets program alone or to a fully-gamified version of the program, comprised of a mobile behavior change program featuring team-based competition and digital reinforcers for attainment of streaks and milestones. Participants are also randomized to receive sham or active neurotraining, which will be integrated into the program they receive.

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 7, 2022
• Study Start: September 1, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)