Gamified Weight Loss Program for Obesity

(DASH-Man Trial)

Overseen By Evan Forman, Ph.D

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Drexel University

Disqualifiers: Cancer, Type I diabetes, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

228 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have recently started or changed the dosage of a medication that can significantly affect your weight, you may not be eligible to participate.

Is the gamified weight loss program safe for humans?

The available research on gamified weight loss programs, such as the SIGMA app, primarily focuses on their design and potential effectiveness rather than safety. However, these programs are based on cognitive behavior therapy principles, which are generally considered safe for most people. ^{1 2 3 4 5}

What makes the Gamified Weight Loss Program for Obesity unique compared to other treatments?

The Gamified Weight Loss Program is unique because it combines cognitive behavior therapy (CBT) principles with a mobile app designed as a game, allowing users to earn points for both in-app activities and real-world physical activities. This approach makes weight loss more engaging and accessible, especially for young adults with maladaptive eating habits, by using a novel scoring system and gamification to encourage behavior change. ^{1 2 3 5 6}

What data supports the effectiveness of the Gamified Weight Loss Program for Obesity treatment?

Research shows that gamified and digital interventions, like the SIGMA app, which use cognitive behavior therapy (CBT) principles, can help with weight loss by addressing unhealthy eating habits. Additionally, studies indicate that using behavior change techniques and incentives in digital programs can lead to weight loss, suggesting that similar gamified approaches may be effective. ^{1 2 5 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Satisfactory completion of all enrollment procedures

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

Exclusion Criteria

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

I recently started or changed the dose of a medication that may significantly affect my weight.

I have had weight loss surgery in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-month mHealth weight loss program with digital self-monitoring, dietary targets, and physical activity, with either a sham or active neurotraining component.

12 months

Follow-up

Participants are monitored for weight loss, diet, and physical activity outcomes, with assessments at months 0, 1, 6, and 12.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Gamified behavioral weight loss treatment
• mHealth behavioral weight loss treatment

Trial Overview 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.

How Is the Trial Designed?

Group I: Gamified program with sham ICT Experimental Treatment 1 Intervention

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

Group II: Gamified program with Active ICT Experimental Treatment 1 Intervention

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

Group III: Non-gamified program with Active ICT Active Control 1 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 ICT Placebo Group 1 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 sham.

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials

160

Recruited

48,600+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

The SIGMA mobile app, based on cognitive behavior therapy principles, aims to help overweight young adults with maladaptive eating habits by gamifying self-help strategies, making it a potentially accessible alternative to traditional in-person therapy.

The intervention will be tested in a randomized, placebo-controlled trial over 2 months, focusing on changes in maladaptive thoughts and eating behaviors, with follow-up on weight and physical activity, highlighting its potential as a cost-effective tool for weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evidence-based gamified mHealth intervention for overweight young adults with maladaptive eating habits: study protocol for a randomized controlled trial. Podina, IR., Fodor, LA., Cosmoiu, A., et al.[2019]

This study is testing a 24-week weight loss intervention for individuals with obesity, using a smartphone app for dietary self-monitoring and daily weight tracking, combined with financial incentives for meeting weight loss goals.

The pilot study aims to assess the feasibility of real-time financial rewards to improve adherence and retention in weight loss programs, potentially leading to effective long-term weight management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for Log2Lose: A feasibility randomized controlled trial to evaluate financial incentives for dietary self-monitoring and interim weight loss in adults with obesity. Voils, CI., Levine, E., Gierisch, JM., et al.[2019]

Automated digital interventions for weight loss showed a small but significant average weight loss of -1.37 kg compared to control groups, based on a systematic review of 66 trials involving 13,672 participants.

The most effective interventions utilized behavior change techniques (BCTs) such as goal-setting and feedback, with social incentive/reward techniques linked to greater weight loss efficacy, although these findings require further validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between behaviour change technique clusters and weight loss outcomes of automated digital interventions: a systematic review and meta-regression. Berry, MP., Chwyl, C., Metzler, AL., et al.[2023]

A new study will evaluate whether a 12-month weight loss program using reinforcement learning (AI) can achieve similar weight loss results as traditional behavioral weight loss methods, but at a lower cost, involving 336 adults with overweight or obesity.

Preliminary results showed that participants using the AI system needed significantly less coaching while achieving nearly the same weight loss as those in the standard program, suggesting that AI could make weight loss support more accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using artificial intelligence to optimize delivery of weight loss treatment: Protocol for an efficacy and cost-effectiveness trial. Forman, EM., Berry, MP., Butryn, ML., et al.[2023]

In a study involving 468 adults with obesity, participants who switched to portion-controlled meals (PCM) after being identified as suboptimal responders to standard behavioral weight loss treatment (SBT) lost more weight at 6 months compared to those who switched to acceptance-based treatment (ABT), although the difference was not statistically significant.

Identifying suboptimal responders as early as Session 3 of treatment led to greater weight loss in those switched to PCM compared to those identified later, suggesting that early intervention may enhance the effectiveness of weight loss strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BestFIT Sequential Multiple Assignment Randomized Trial Results: A SMART Approach to Developing Individualized Weight Loss Treatment Sequences. Sherwood, NE., Crain, AL., Seburg, EM., et al.[2022]

The ENGAGED study involves 96 obese adults and compares three weight loss methods over 12 months, aiming for a 7% weight loss goal through dietary changes and increased physical activity.

The study hypothesizes that the technology-supported behavioral weight loss program (TECH) will lead to greater weight loss than standard methods (STND) and self-guided approaches (SELF) due to better adherence and goal achievement, utilizing a smartphone app for monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A smartphone-supported weight loss program: design of the ENGAGED randomized controlled trial. Pellegrini, CA., Duncan, JM., Moller, AC., et al.[2021]

Digital technology can be effectively used for behavioral weight control, particularly through self-monitoring of weight-related behaviors, making it a promising tool for promoting healthy eating and physical activity habits.

Technology-based interventions offer a cost-effective alternative to traditional face-to-face treatments, allowing for broader reach and accessibility to individuals seeking to manage their weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of innovations in digital health technology to promote weight control. Thomas, JG., Bond, DS.[2021]

In a study of 236 participants from the POWER Hopkins Trial, individual telephone sessions, online weight tracking, and coach reviews were rated as the most helpful components of a behavioral weight loss program, indicating their effectiveness in supporting weight loss efforts.

Demographic factors influenced perceptions of helpfulness, with older adults, Black participants, and those with lower education levels finding the intervention components more beneficial, suggesting the need for tailored approaches in weight loss programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived helpfulness of the individual components of a behavioural weight loss program: results from the Hopkins POWER Trial. Dalcin, AT., Jerome, GJ., Fitzpatrick, SL., et al.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

An evidence-based gamified mHealth intervention for overweight young adults with maladaptive eating habits: study protocol for a randomized controlled trial. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Study protocol for Log2Lose: A feasibility randomized controlled trial to evaluate financial incentives for dietary self-monitoring and interim weight loss in adults with obesity. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Associations between behaviour change technique clusters and weight loss outcomes of automated digital interventions: a systematic review and meta-regression. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Using artificial intelligence to optimize delivery of weight loss treatment: Protocol for an efficacy and cost-effectiveness trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

BestFIT Sequential Multiple Assignment Randomized Trial Results: A SMART Approach to Developing Individualized Weight Loss Treatment Sequences. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A smartphone-supported weight loss program: design of the ENGAGED randomized controlled trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Review of innovations in digital health technology to promote weight control. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Perceived helpfulness of the individual components of a behavioural weight loss program: results from the Hopkins POWER Trial. [2021]