Impact of Digital Therapeutic on Metabolic Parameters
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetes Mellitus - Type 2
- Insulin Resistance
- Obesity
- Prediabetic State
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A prospective randomized study to assign efficacy of lifestyle intervention using Vitadio Health as compared to conventional lifestyle intervention programme at a sports medicine clinic of university hospitalMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 60 years
- Gender
- Both males and females
Description
Vitadio Health is a 6-month digitally administered behavioral change programme focused on lifestyle change, weight loss and metabolic health and promoting self-management and long-term self-sufficiency. The programme includes personalised nutrition/lifestyle education, remote dietitian's one-on-one ...
Vitadio Health is a 6-month digitally administered behavioral change programme focused on lifestyle change, weight loss and metabolic health and promoting self-management and long-term self-sufficiency. The programme includes personalised nutrition/lifestyle education, remote dietitian's one-on-one coaching, weekly goals, diet and activity monitoring tools, recipes and support member community. Personalization and semi-automation of the intervention are achieved by analysis of participant's interactions with the interface. In this prospective randomized clinical study, obese adults with insulin resistance, prediabetes or diabetes mellitus type 2, patients of a sports medicine clinic of university hospital, are randomized to receive either Vitadio Health or a conventional 6-month high-intensity lifestyle intervention programme at the clinic, consisting of face-to-face nutrition/lifestyle education (at baseline, months 1 to 3 and month 6) and diet self-monitoring. 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, adherence to recommended lifestyle measures and other outcomes.
Tracking Information
- NCT #
- NCT04573296
- Collaborators
- University Hospital Olomouc
- Investigators
- Principal Investigator: Katarína Moravcová, MD University Hospital Olomouc
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