Impact of Digital Therapeutic on Metabolic Parameters

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Obesity, Insulin Resistance, Prediabetic State, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Vitadio
* Behavioral: Conventional high-intensity lifestyle intervention program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants using Vitadio<br>Participants in the intervention arm undergo a 6-month digitally administered behavioral change program Vitadio 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. In addition, they undergo regular face-to-face medical assessment. | Device: Vitadio<br>* 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.<br>|
| Active Comparator: Participants assigned to conventional high-intensity lifestyle intervention program<br>Participants in the control group undergo a 6-month high-intensity lifestyle intervention program consisting of 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. In addition, they undergo regular face-to-face medical assessment. | Behavioral: Conventional high-intensity lifestyle intervention program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight | comparison of baseline and end program body weight | baseline, three months, six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in waist circumference | comparison of baseline, three-month and end-program waist circumference between groups | baseline, three months, six months | 
| change in body mass index (BMI) | comparison of baseline, three-month and end-program body mass index (BMI) between groups | baseline, three months, six months | 
| change in haemoglobin A1c | comparison of baseline, three-month and end-program haemoglobin A1c values between groups | baseline, three months, six months | 
| change in adherence to lifestyle intervention | 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 | baseline, three months, six months | 
| change in blood glucose | comparison of baseline, three-month and end-program blood glucose values between groups | baseline, three months, six months | 
| change in insulin resistance | comparison of baseline, three-month and end-program insulin resistance quantified by HOMA-IR between groups | baseline, three months, six months | 
| change in blood pressure | comparison of baseline, three-month and end-program blood pressure between groups | baseline, three months, six months | 
| change in body composition | comparison of baseline, three-month and end-program body composition assessed with the InBody bioelectrical impedance analysis device between groups | baseline, three months, six months | 
| change in resting metabolic rate (RMR) | comparison of baseline, three-month and end-program resting metabolic rate assessed by indirect calorimetry between groups | baseline, three months, six months | 
| change in cardiorespiratory fitness | comparison of baseline, three-month and end-program cardiorespiratory fitness assessed by spiroergometry between groups | baseline, three months, six months | 
| change in lipid parameters (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides) | comparison of baseline, three-month and end-program levels of total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides between groups | baseline, three months, six months | 
| change in fasting insulin levels | comparison of baseline, three-month and end-program fasting insulin levels between groups | baseline, three months, six months | 
| change in liver function tests | comparison of baseline, three-month and end-program standard liver panel (ALT, AST, GGT, ALP) values between groups | baseline, three months, six months |