Engaging Men in Weight Loss With a Game-based mHealth and Neurotraining Program (DASH-Man)

March 19, 2026 updated by: Evan Forman PhD, Drexel University

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
228

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Michael C Onu, B.S.
  • Phone Number: ‪(267) 571-7917‬
  • Email: mo654@drexel.edu

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: mHealth behavioral weight loss treatment
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
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.
Behavioral: mHealth behavioral weight loss treatment
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
Experimental: Gamified program with sham ICT
One group will receive fully-gamified version of the program with a sham.
Behavioral: Gamified behavioral weight loss treatment
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
Experimental: Gamified program with Active ICT
One group will receive fully-gamified version of the program with active neurotraining.
Behavioral: Gamified behavioral weight loss treatment
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Assessments will be administered at month zero.
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.
Assessment will be administered at month one.
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.
Assessment will be administered at month sixth.
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.
Assessment will be administered at month twelve.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
Assessments will be administered at months 0, 1, 6 and 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Drexel University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01DK128524 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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