Skip to main content
OpenTrials
Completed

NCT Number: NCT04573296

Impact of Digital Therapeutic on Metabolic Parameters

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Insulin Resistance Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Prediabetic State Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Olomouc

Olomouc, 779 00, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • obesity with body mass index (BMI) above 30 kg/m^2
  • insulin resistance or prediabetes or type 2 diabetes mellitus
  • acess to device with internet access (notebook, smartphone, tablet)
  • willingness and ability to comply with all scheduled visits, laboratory tests, lifestyle considerations and other study procedures

Exclusion criteria

  • pregnancy
  • steroid treatment
  • type 2 diabetes mellitus on insulin therapy
  • severe renal and/or hepatic impairment
  • any impairments including mental and psychological or conditions which, in the opinion of the investigator, would seriously compromise the integrity of the study
  • inability to understand, consent to, or comply with the study protocol for any reason, including inability to read or comprehend Czech language
  • inability to comply with study procedures

Treatment and study plan

Vitadio

Device

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.

Conventional high-intensity lifestyle intervention program

Behavioral

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.

Primary outcomes

  1. Change in body weight

    Time frame: baseline, three months, six months

    comparison of baseline and end program body weight

Secondary outcomes

  1. change in waist circumference

    Time frame: baseline, three months, six months

    comparison of baseline, three-month and end-program waist circumference between groups

  2. change in body mass index (BMI)

    Time frame: baseline, three months, six months

    comparison of baseline, three-month and end-program body mass index (BMI) between groups

  3. change in haemoglobin A1c

    Time frame: baseline, three months, six months

    comparison of baseline, three-month and end-program haemoglobin A1c values between groups

  4. change in adherence to lifestyle intervention

    Time frame: baseline, three months, six months

    comparison of baseline, three-month and end-program adherence to healthy lifestyle assigned both by subjective (adapted questionnaire) and objective (program usage frequency, attrition) measures between groups

  5. change in blood glucose

    Time frame: baseline, three months, six months

    comparison of baseline, three-month and end-program blood glucose values between groups

  6. change in insulin resistance

    Time frame: baseline, three months, six months

    comparison of baseline, three-month and end-program insulin resistance quantified by HOMA-IR between groups

  7. change in blood pressure

    Time frame: baseline, three months, six months

    comparison of baseline, three-month and end-program blood pressure between groups

  8. change in body composition

    Time frame: baseline, three months, six months

    comparison of baseline, three-month and end-program body composition assessed with the InBody bioelectrical impedance analysis device between groups

  9. change in resting metabolic rate (RMR)

    Time frame: baseline, three months, six months

    comparison of baseline, three-month and end-program resting metabolic rate assessed by indirect calorimetry between groups

  10. change in cardiorespiratory fitness

    Time frame: baseline, three months, six months

    comparison of baseline, three-month and end-program cardiorespiratory fitness assessed by spiroergometry between groups

  11. change in lipid parameters (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides)

    Time frame: baseline, three months, six months

    comparison of baseline, three-month and end-program levels of total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides between groups

  12. change in fasting insulin levels

    Time frame: baseline, three months, six months

    comparison of baseline, three-month and end-program fasting insulin levels between groups

  13. change in liver function tests

    Time frame: baseline, three months, six months

    comparison of baseline, three-month and end-program standard liver panel (ALT, AST, GGT, ALP) values between groups

Other outcomes

  1. Vitadio usability for HCPs

    Time frame: six months

    The healthcare professionals' (HCPs) user experience from interacting with Vitadio Health, assessed with the User Experience Questionnaire (UEQ)

Sponsors and collaborators

Lead sponsor

Vitadio s.r.o.

Industry

Collaborators

  • University Hospital Olomouc

Registry information

Official study title

Impact of Digital Therapeutic Intervention on Metabolic Parameters in Obese Adults With Insulin Resistance, Prediabetes and Type 2 Diabetes as Compared to Conventional Intensive Obesity Management Programme

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 5, 2020
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.