Clinical Outcomes Associated with the Use of a Family-Based Digital Support Program in Patients with Pharmacologic...

Background/Objectives: The Adhera^® Caring Digital Program (ACDP) is a digitally delivered intervention aimed at enhancing the mental and physical well-being of family caregivers of children with chronic conditions. Tailored for the context of childhood obesity, ACDP leverages the Adhera AI Precision Digital Companion to support caregivers in promoting effective treatment adherence and healthy behaviors at home. While children in this study received GLP-1 receptor agonist treatment as part of their obesity management, the ACDP was designed to empower caregivers through educational, behavioral, and emotional support tools. The aim of this study was to determine the relationship between engagement with the ACDP as a DHI and clinical outcomes in participants receiving GLP-1 receptor agonist treatment for obesity. Methods: This study analyzed data from approximately 40 pediatric patients receiving GLP-1-based pharmacological treatment for obesity and their caregivers enrolled in the ACDP. Caregiver engagement was assessed through a composite score derived from digital activity metrics and classified as low, medium, or high. Children's clinical parameters (BMI, weight, fat mass %, muscle mass %, and waist circumference) were collected at baseline and Day 150. Biometric, physical activity, and sleep data were also collected through a wearable device, enabling continuous and objective monitoring of participants' physiological and behavioral patterns in real-world conditions. Statistical analyses included paired comparisons, Pearson correlations, and group comparisons by engagement level. Results: Data from 40 pediatric participants and their caregivers were analyzed over 150 days. Observed changes over the time in children showed a reduction in waist circumference (-6.0%, p = 0.0056) and a modest decrease in BMI. Higher levels of caregiver engagement with the Adhera^® Caring Digital Program correlated with reduction in body fat (ΔFat% r ≈ 0.5, p = 0.091) representing the strongest correlation observed in the study, albeit not reaching statistical significance. From baseline to Day 150, significant improvements were observed across all clinical outcomes, including reductions in BMI (-4.51 kg/m²), body weight (-11.42 kg), body fat percentage (-5.63%), and waist circumference (-8.69 cm), alongside an increase in muscle mass (+4.47%) (all p < 0.0001). Conclusions: At the mid-point of the intervention, combined GLP-1 pharmacotherapy and the Adhera^® Caring Digital Program led to meaningful improvements in BMI, adiposity, and central obesity. While caregiver engagement was not significantly associated with short-term outcomes, observed trends suggest that digital support may provide complementary benefits to pharmacological treatment, warranting further evaluation at Day 300.