Gamification for Obesity

(STEP 4 Vets Trial)

Overseen By Amol S Navathe, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Physical disability, High activity level, others

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

Compensation: Varies

Number of Visits: Unknown

459 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on physical activity and gamification for obesity.

What data supports the effectiveness of the treatment Behaviorally Designed Gamification with Collaboration and Competition for obesity?

Research shows that gamification can effectively improve health behaviors, such as increasing physical activity and improving nutritional habits, which are important for weight loss. Studies on gamification in diabetes and among children and adolescents have demonstrated its potential to enhance motivation and engagement, suggesting it could be beneficial for obesity treatment as well. ^{1 2 3 4 5}

Is gamification generally safe for use in health-related apps?

The research does not report any safety concerns related to the use of gamification in health-related apps, suggesting it is generally safe for human use. ^{6 7 8 9 10}

How does the treatment 'Behaviorally Designed Gamification with Collaboration and Competition' for obesity differ from other treatments?

This treatment is unique because it uses gamification (applying game design elements in non-game contexts) to enhance engagement and adherence to weight management programs by incorporating social incentives like collaboration and competition, which are not typically used in traditional obesity treatments. ^{2 8 11 12 13}

What is the purpose of this trial?

This trial uses game-like elements to make exercise more fun for obese Veterans with high blood pressure. By encouraging competition or teamwork, it aims to help them be more active and healthier.

Research Team

Scott R Greysen, MD

Principal Investigator

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Amol S. Navathe, MD PhD

Principal Investigator

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Eligibility Criteria

This trial is for Veterans aged 18 or older with obesity (BMI > 30) and high blood pressure (systolic >140mm Hg), who are interested in a 9-month physical activity program. It's not suitable for those already very active (over 7500 steps/day), in another study, unable to walk without help, or for whom the program is unsafe.

Inclusion Criteria

I am a veteran over 18, treated at CMCVAMC, with a BMI over 30.

Veterans who are interested in participating in a 9-month physical activity program

I am a veteran diagnosed with high blood pressure above 140mm Hg.

Exclusion Criteria

Currently participating in another physical activity research study

Infeasibility or safety concerns regarding a 9-month physical activity program

I need help to walk due to a medical condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in a 6-month gamification intervention to increase physical activity, using wearable devices to monitor activity levels.

6 months

Conducted remotely

Follow-up

Participants are monitored for changes in physical activity, weight, and blood pressure after the intervention.

3 months

Treatment Details

Interventions

• Behaviorally Designed Gamification with Collaboration
• Behaviorally Designed Gamification with Competition

Trial Overview The trial tests two types of gamification designed using behavioral economics: one that encourages group collaboration and another that fosters competition among participants to increase their physical activity levels. The effectiveness, costs, and implementation within Veterans Affairs will be evaluated.

Participant Groups

Group I: gamification with competition Experimental Treatment 1 Intervention

participants receive a FitBit and set goals, then are assigned to a group of other participants who will play a game to gain points based on competition with each other

Group II: gamification with collaboration Experimental Treatment 1 Intervention

participants receive a FitBit and set goals, then are assigned to a group of other participants who will play a game to gain points based on collaboration with each other

Group III: attention control Active Control 1 Intervention

participants receive a FitBit and set goals but do no other intervention

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

Gamification interventions significantly improved children's nutritional knowledge and increased their consumption of fruits and vegetables, as shown in a systematic review of 23 randomized controlled trials.

However, these interventions did not lead to significant changes in body mass index z-scores, indicating that while gamification can enhance knowledge and habits, it may not directly impact weight outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gamification for the Improvement of Diet, Nutritional Habits, and Body Composition in Children and Adolescents: A Systematic Review and Meta-Analysis. Suleiman-Martos, N., García-Lara, RA., Martos-Cabrera, MB., et al.[2021]

Digital game-based approaches, including serious games and gamification, can effectively promote health-related information and encourage behavior change, particularly among hard-to-reach audiences.

These playful applications leverage game design elements to enhance motivation and engagement, making them valuable tools in health promotion and training for health professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Game-based approaches to prevention and health promotion: serious games and gamification]. Tolks, D., Lampert, C., Dadaczynski, K., et al.[2021]

The Food Game intervention successfully engaged high school students in Northern Italy through gamification, promoting peer-led activities and competition, although it did not significantly change adherence to the Mediterranean diet.

While there was no notable improvement in dietary adherence, students showed increased pro-environmental behaviors and positive attitudes towards healthy eating, suggesting the program's potential as a motivational strategy for promoting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Process Evaluation of Food Game: A Gamified School-Based Intervention to Promote Healthier and More Sustainable Dietary Choices. Aresi, G., Giampaolo, M., Chiavegatti, B., et al.[2023]

References

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

Gamification and neurotraining to engage men in behavioral weight loss: Protocol for a factorial randomized controlled trial. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

Gamification: what it is and why it matters to digital health behavior change developers. [2022]

3. Iran pubmed.ncbi.nlm.nih.gov

A systematized review on diabetes gamification. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Gamification for the Improvement of Diet, Nutritional Habits, and Body Composition in Children and Adolescents: A Systematic Review and Meta-Analysis. [2021]

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

Strengthening behavioral interventions for weight loss: a randomized trial of food provision and monetary incentives. [2019]

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

Gamifying accelerometer use increases physical activity levels of individuals pre-disposed to type II diabetes. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

Investigating Serious Games That Incorporate Medication Use for Patients: Systematic Literature Review. [2020]

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

Gamification in a Physical Activity App: What Gamification Features Are Being Used, by Whom, and Does It Make a Difference? [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

An Evidence-Based Serious Game App for Public Education on Antibiotic Use and Antimicrobial Resistance: Protocol of a Randomized Controlled Trial. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

[Game-based approaches to prevention and health promotion: serious games and gamification]. [2021]

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

Supplementing a widely available weight loss program with gamified inhibitory control training: A randomized pilot study. [2023]

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

Social incentives to encourage physical activity and understand predictors (STEP UP): Design and rationale of a randomized trial among overweight and obese adults across the United States. [2021]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Process Evaluation of Food Game: A Gamified School-Based Intervention to Promote Healthier and More Sustainable Dietary Choices. [2023]