Impact of Digital Therapeutic on Metabolic Parameters
Condition: Insulin Resistance; Prediabetic State; Diabetes Mellitus, Type 2; Obesity
MeSH terms: Obesity; Diabetes Mellitus, Type 2; Insulin Resistance; Prediabetic State
Study type: Interventional

Summary: 
      The purpose of this prospective randomized controlled study is to evaluate the impact of a
      six-month digitally administered behavioral change program on body weight, glycemic control
      and other metabolic parameters in obese adults with insulin resistance, prediabetes or type 2
      diabetes as compared to conventional high-intensity lifestyle intervention program
      administered at a specialized department of a university hospital.
    

Detailed description: 
      In this prospective randomized clinical study, obese adults with insulin resistance,
      prediabetes or diabetes mellitus type 2, patients of the Department of Exercise Medicine and
      Cardiovascular Rehabilitation at the University Hospital Olomouc, are randomized to receive
      either Vitadio or a conventional 6-month high-intensity lifestyle intervention program at the
      clinic.

      Vitadio is a mobile application delivering behavioral change program focused on lifestyle
      change and self-management. The program aims for strengthening patients autonomy with the
      goal to promote weight loss and improve metabolic health. The program includes personalized
      education, adaptive daily tasks and weekly goals, automated motivational and educational
      messaging, monitoring tools, recipes, peer-support group and one-on-one remote coaching.
      Personalization of the intervention is achieved by analyzing participant's interactions with
      the application.

      The conventional therapy consists of 5 face-to-face nutrition/lifestyle education sessions
      (at baseline, at 1st, 2nd and 3rd month, and at month 6). Participants in the control group
      can use an online diary tool for recording meals with an option to receive remote feedback on
      their diet from the educator. In addition, all participants undergo a regular medical
      assessment at the clinic (baseline, month 3, month 6).

      The aim of the study is to assess feasibility and efficacy of digitally administered
      intervention by comparing evolution of weight, physical fitness, laboratory measures of
      metabolic health, blood pressure and other outcomes.
    

Intervention name(s): Vitadio; Conventional high-intensity lifestyle intervention program
Intervention type(s): Device; Behavioral
Intervention description(s): A 6-month digitally administered behavioral change program Vitadio focus on lifestyle change and self-management. The program aims for strengthening patients autonomy with the goal to promote weight loss and improve metabolic health. The program includes personalized education, adaptive daily tasks and weekly goals, automated motivational and educational messaging, monitoring tools, recipes, peer-support group and remote coaching.; A 6-month high-intensity lifestyle intervention program consisting of 5 face-to-face nutrition/lifestyle education sessions. Participants can use an online diary tool for recording meals with an option to receive remote feedback on their diet from the educator.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This prospective randomized controlled study evaluates efficacy of lifestyle intervention using digital application Vitadio as compared to conventional high-intensity lifestyle intervention program administered at a specialized clinic at a University hospital.
Masking: None (Open Label)
Primary purpose: Treatment