March 9, 2024 (Toronto, ON) – Health Canada has recently granted approval for trials examining Mobio Interactive’s Class II SaMD treating youth obesity. The intervention, co-developed with the Children’s Hospital of Eastern Ontario, aims to reduce symptoms of depression and anxiety, negative body image, and food impulsivity through psychotherapy and automated feedback on mental wellbeing via the company’s mobile health platform.
Dr. Bechara Saab, CEO & Chief Scientist at Mobio Interactive, emphasised the urgency of obesity rates in youth globally, pointing to long-term health implications: "Even before it kills you, a poor diet will negatively impact your quality of life. Awareness isn’t enough. That’s why we at Mobio, along with partners like CHEO, are building scalable and clinically meaningful solutions that rewire the brain to give kids control over disinhibited eating. We know definitively from neuroscience that the brain’s responses to food and hunger are plastic – they can be changed. So that’s exactly what this digital intervention intends to do, and in time, mechanistic brain imaging research may also show how."
According to the Government of Canada, obesity rates among children and youth have nearly tripled over the past 30 years, leading to increased risks of potentially serious and life-long conditions such as high blood pressure, heart disease, type-2 diabetes, sleep apnea, and depression.
Health Canada Investigational Testing Authorisation (ITA) is a requisite for all unlicensed Class II, III, and IV medical device trials that involve human participants. Approval from Health Canada allows Mobio Interactive to initiate clinical work examining acceptability, efficacy, and mechanism of action for the novel intervention.
This is Mobio Interactive's second ITA approval and highlights the critical need for innovative interventions. Driven by a commitment to make a tangible impact on healthcare, Mark Thoburn, Chief of Content at Mobio Interactive, expressed excitement about the potential of their interventions: "We're thrilled to contribute to the wellbeing of patients and believe our interventions can significantly influence healthcare outcomes."
Mobio Interactive’s proprietary training programme, “Epígnosi” leverages research pioneered by Dr. Jean Kristeller, a leading clinical and research psychologist and co-founder of The Center for Mindful Eating. On almost every measure, training in mindful eating shows greater or comparable effects to standard treatments for eating disorders, helping patients to binge eat less often, consume less food, and lose weight. Adaptation of the mindful eating practices to Mobio Interactive’s mobile platform AmDTx was supported by Dr. Kristeller and Dr. Gary Goldfield, a Senior Scientist at the CHEO Research Institute.
Epígnosi is a 12-week programme tailored for youth aged 12 to 18 with serious eating disorders. While most evidence-based mindfulness programmes are shorter, typically lasting 6 to 8 weeks, Epígnosi takes a different approach, delivering a blend of educational and meditation training content in bite-sized chunks of about 5 minutes over a longer period of time.
The goal of Epígnosi is to support the development of new thinking and eating habits, empowering emotional awareness and impulse control. And while meditations begin at 5 minutes in the first week, they evolve to 20-minute sessions by the final week of the programme.
The Epígnosi programme also includes a journaling activity called Keep it Balanced. The 20-question exercise empowers youth to track their weekly progress and reflect on their eating behaviours, ultimately showcasing improvements in eating habits and awareness over time. Delivered digitally via AmDTx, Epígnosi integrates day-to-day living into its training. Examples include meditating before mealtime and mindful eating with both healthy foods like apples, as well as less healthy foods like potato chips.
The study assesses and measures youth’s participation in several ways, beginning with AmDTx’s objective psychological stress measurement, captured through AI analysis of selfie videos completed before and after each training session. This unique feature provides valuable insights unattainable anywhere else. The end result is enhanced effectiveness through personalised training sessions as well as objective tracking of the programme’s ability to reduce chronic stress associated with disinhibited eating.
About Mobio Interactive
Mobio Interactive is a digital health company that is meeting the exploding demand for efficacious mental healthcare with artificial intelligence-powered digital theragnostics.
For more information, visit mobiointeractive.com.