Digital vaccine platform to reduce risk of lifestyle and nutrition related diabetes and improve self care among pediatric diabetic patients: Ongoing RCT of longitudinal outcomes

Summary:

Diabetes prevention and management tools for self-care, especially for children and their parents/caregivers, remains an unsolved challenge, given the lack of evidence-based and scientifically validated solutions. While there are patient education materials that range from paper-based brochures to mobile Apps and in person counseling, they lack usability or are scientifically unproven. Unfortunately, when a diabetic child is not adequately educated and empowered to care for themselves, the disease progresses, leading to additional complications. The current tools and medications to manage diabetes are highly expensive glucometers, insulin pumps and additional insulin needed to maintain normal blood glucose levels. However, these solutions do not fix the underlying lifestyle and dietary habits that cause glycemic excursions; i.e., they treat the symptoms, not the underlying causes. "fooya!" is a non-invasive, software-based, digital therapeutic solution that leverages artificial intelligence and neuroscience-based gamification techniques to complement current treatments by engaging and empowering patients and their families and caregivers, to develop healthier habits. Studies have shown that an engaged patient is a healthier patient. Building on findings from an RCT by JHUCCP researchers published in JMIR, an IRB approved 3-arm RCT is underway by Dr Usha Sriram and her team of Endocrinologists at the Voluntary Health Services Hospital in Chennai India. Along with clinical health records of blood work during routine patient visits including blood glucose levels, A1c, lipid profiles, amino acids. Dr Sriram's team will supply the longitudinal clinical data to Dr Rema Padman at Carnegie Mellon University.

Background/Objectives:

Type 1 and Type 2 diabetes (T1D and T2D), particularly arising from obesity, are increasingly common epidemics in children, with serious long-term health consequences and higher healthcare costs (Levi et al. 2012; Ogden et al. 2014; Wright and Prosser 2014). This worldwide problem is especially a concern among the Indian population. As reported by Shashank et al. (2008), every fifth diabetic in the world is an Indian. The prevalence of diabetes in India is especially severe in urban areas, reporting 4 times the prevalence in rural areas (Ramachandran 2005).

Description of Intervention and/or Methods/Design:

The proposed solution is "fooya!", a highly scalable, software-based, mobile App which has undergone several randomized field trials to demonstrate statistically significant improvement in healthy food choices by children in comparison to no exposure to the app. It is an educational, health-focused, animation game-based intervention designed to promote healthy eating and physical activity in children. The game combines Artificial Intelligence (AI) with neuroscience with the aim of achieving personalized behavior reinforcement. Game compulsion loops guide users while getting more difficult over time, with the intention to make players think more deeply and strategically the more they play. Based on experiments and hypotheses derived from pediatric neuropsychology (Bruce et al. 2013, 2014), fooya! was developed to deliver therapeutic entertainment that makes healthy behavior change fun for the children. This RCT will use the generic "fooya!", as well as a newly developed adaptation for Diabetes management.

Results/Lessons Learned:

This study adds to the growing body of evidence that learning about healthy eating in a fun and exciting way via mobile games, acting as Digital Vaccines, can positively impact childrens actual food choices. While promising, additional RCTs in varied and longitudinal settings and deeper analysis of the resulting data are needed to confirm Digital Vaccines' potential to reduce the long-term risk of nutrition-related non- communicable diseases such as cardiovascular disease, hypertension and cancer. Furthermore, immersive gaming on mobile devices also offers an unprecedented opportunity to address the health risks from the double burden of overweight vs. malnutrition and under-nutrition by educating children regarding healthy lifestyle choices.

Discussion/Implications for the Field:

Digital Vaccines and the scientific field established through AI and AR/VR based technology, were featured as the top breakthrough in technology for 2018 by Carnegie Mellon University - https://www.heinz.cmu.edu/media/2018/December/can-kids-game-their-way-t…; With more evidence and larger-scale longitudinal studies to assess population health outcomes, our mission through principles of SBCC is to eradicate the preventable burden of lifestyle-nutrition related lifestyle disease, by creating a standard for clinically proven health education curriculum.

Abstract submitted by: 

Bhargav Sri Prakash - FriendsLearn Inc.