Comparing Digital Therapeutic Intervention with an Intensive Obesity Management Program: Randomized Controlled Trial

Nutrients. 2022 May 10;14(10):2005. doi: 10.3390/nu14102005.

Abstract

In this study, we evaluated whether the digital program Vitadio achieves comparable results to those of an intensive in-person lifestyle intervention in obesity management. This is a 12-month prospective, randomized controlled trial. Obese patients with insulin resistance, prediabetes or type 2 diabetes were included. The intervention group (IG) used Vitadio. The control group (CG) received a series of in-person consultations. Body weight and various metabolic parameters were observed and analyzed with ANOVA. The trial is ongoing and the presented findings are preliminary. Among 100 participants (29% men; mean age, 43 years; mean BMI, 40.1 kg/m2), 78 completed 3-month follow-up, and 51 have completed the 6-month follow-up so far. Participants significantly (p < 0.01) reduced body weight at 3 months (IG: −5.9 ± 5.0%; CG: −4.2 ± 5.0%) and 6 months (IG: −6.6±6.1%; CG: −7.1 ± 7.1%), and the difference between groups was not significant. The IG achieved favorable change in body composition; significant improvement in TAG (−0.6 ± 0.9 mmol/l, p < 0.01), HDL (0.1 ± 0.1%, p < 0.05), HbA1c (−0.2 ± 0.5%, p < 0.05) and FG (−0.5 ± 1.5 mmol/l, p < 0.05); and a superior (p = 0.02) HOMA-IR reduction (−2.5 ± 5.2, p < 0.01). The digital intervention achieved comparable results to those of the intensive obesity management program. The results suggest that Vitadio is an effective tool for supporting patients in obesity management and diabetes prevention.

Keywords: diabetes mellitus type 2; digital therapeutics; insulin resistance; lifestyle intervention; metabolic syndrome; mobile application; obesity; prevention; randomized controlled trial.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Body Weight
  • Diabetes Mellitus, Type 2* / therapy
  • Female
  • Humans
  • Insulin Resistance*
  • Male
  • Obesity / drug therapy
  • Obesity Management*
  • Prospective Studies