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Gamified Weight Loss Program for Obesity (DASH-Man Trial)

N/A

Recruiting

Research Sponsored by Drexel University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals must be of overweight or obese BMI (25-50 kg/m)

Individuals must be adults (aged 18-65)

Must not have

Weight loss of ≥ 5% in the previous 3 months

History of bariatric surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessments will be administered at months 0, 1, 6 and 12.

Summary

This trial is testing whether a weight loss program that includes features from video games (such as competition, digital rewards, and an integrated neurotraining video game) is more effective than a standard weight loss program in helping men lose weight.

Who is the study for?

This trial is for overweight or obese men (BMI of 25-50 kg/m²) aged 18-65 who enjoy high-calorie foods and can walk two city blocks without stopping. They must be willing to have their doctor contacted about their physical activity level and rapid weight loss if needed. Men with certain medical conditions, recent significant weight loss, or changes in medications affecting weight are excluded.

What is being tested?

The study tests a gamified mHealth program against a standard mHealth program for weight loss in men. It includes digital self-monitoring, dietary targets, physical activity, and either a control neurotraining game or an integrated one with team competition and rewards designed to train inhibitory control linked to body mass.

What are the potential side effects?

Since this trial involves behavioral interventions rather than medication, traditional side effects are not expected. However, participants may experience discomfort from increased physical activity or changes in diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is between 25 and 50, indicating I am overweight or obese.

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I am between 18 and 65 years old.

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I can walk two city blocks without needing to stop.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have lost 5% or more of my weight in the last 3 months.

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I have had weight loss surgery in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessments will be administered at month zero.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessments will be administered at month zero.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessments will be administered at month zero. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Baseline Weight

Change from Baseline Weight at 1 month

Change from Baseline Weight at 12 months

+1 more

Secondary study objectives

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

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

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Gamified program with sham ICTExperimental Treatment1 Intervention

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

Group II: Gamified program with Active ICTExperimental Treatment1 Intervention

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

Group III: Non-gamified program with Active ICTActive Control1 Intervention

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.

Group IV: Non-gamified program with sham ICTPlacebo Group1 Intervention

0 / 5Eligibility criteria met