Comparing the Efficacy of Digital and In-Person Weight Loss Interventions for Patients with Obesity and Glycemic Disorders: Evidence from a Randomized Non-Inferiority Trial.

Digital weight loss interventions present a viable and cost-effective alternative to traditional therapy. However, further evidence is needed to establish the equal effectiveness of both approaches. This randomized controlled non-inferiority trial aimed to compare the effects of an intensive in-person weight loss intervention program with Vitadio digital therapy. One hundred patients with obesity and diagnosed with type 2 diabetes, prediabetes, or insulin resistance were enrolled and randomly assigned to one of the two treatment groups. Over a 6-month period, the control group received five in-person consultations with a physician who specialized in obesity treatment, a dietitian and/or a nutrition nurse, while the intervention group followed the digital program based on a multimodal therapeutic approach. The extent of weight loss was assessed and compared between the groups. Additionally, changes in body composition and metabolic parameters for the digital intervention group were analyzed. The study results demonstrated comparable effectiveness of both treatments for weight reduction. The positive effects of Vitadio were further evidenced by favorable changes in body composition and lipid metabolism and improved glycemic control in the intervention group. These findings suggest that Vitadio is an effective tool for assisting patients with managing obesity and preventing diabetes progression.

Impact of a Digital Lifestyle Intervention on Diabetes Self-Management: A Pilot Study.

The aim of this study was to provide preliminary evidence on the impact of the digital health application Vitadio on improving glycemic control in patients with type 2 diabetes mellitus. This was a 3-month, prospective, multicenter, open-label trial with an intraindividual control group. Participants received a digital lifestyle intervention. HbA1c levels were observed at 3 time points: retrospectively, at 3 months before app use; at baseline, at the start of usage; and 3 months after the start of use. In addition, changes in other metabolic parameters (fasting glucose, body weight, and waist circumference), patient reported outcomes (quality of life, self-efficacy, and depression), and data generated within the app (frequency of use, steps, and photos of meals) were evaluated. Repeated measures analysis of variance with the Bonferroni correction was used to assess the overall difference in HbA1c values between the intervention and the intraindividual control group, with p < 0.05 considered significant. Participants (n = 42) were 57 ± 7.4 years old, 55% male, and with a mean baseline HbA1c of 7.9 ± 1.0%. An average HbA1c reduction of −0.9 ± 1.1% (p < 0.001) was achieved. The digital health application was effective in significantly reducing body weight (−4.3 ± 4.5 kg), body mass index (−1.4 ± 1.5 kg/m2), waist circumference (−5.7 ± 15 cm), and fasting glucose (−0.6 ± 1.3 mmol/L). The digital therapy achieved a clinically meaningful and significant HbA1c reduction as well as a positive effect on metabolic parameters. These results provide preliminary evidence that Vitadio may be effective in supporting patient diabetes management by motivating patients to adopt healthier lifestyles and improving their self-management.