Clinical trial NCT05408494: Engaging Men in Weight Loss With a Game-based mHealth and Neurotraining Program
Official title: Engaging Men in Weight Loss With a Game-based mHealth and Neurotraining Program: A 2 x 2 Randomized Design
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Weight Loss
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-06-07
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Baseline Weight
timeFrame: Assessments will be administered at month zero.
measure: Change from Baseline Weight at 1 month
timeFrame: Assessment will be administered at month one.
measure: Change from Baseline Weight at 6 months
timeFrame: Assessment will be administered at month sixth.
measure: Change from Baseline Weight at 12 months
timeFrame: Assessment will be administered at month twelve.
Secondary outcomes:
measure: Caloric intake measured using the Fitbit app's built-in dietary tracking system
timeFrame: Assessments will be administered at months 0, 1, 6 and 12.
measure: Physical activity measured in minutes of moderate to vigorous physical activity using wrist-worn activity tracker.
timeFrame: Assessments will be administered at months 0, 1, 6 and 12.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
References: