Impact of Digital Therapeutic on Metabolic Parameters

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes Mellitus, Type 2; Insulin Resistance; Prediabetic State
• Intervention / Treatment: Device: Vitadio; Behavioral: Conventional high-intensity lifestyle intervention program

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Olomouc, Czechia, 779 00
    • University Hospital Olomouc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants using Vitadio; 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; 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.
Active Comparator: Participants assigned to conventional high-intensity lifestyle intervention program; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitadio usability for HCPs	The healthcare professionals' (HCPs) user experience from interacting with Vitadio Health, assessed with the User Experience Questionnaire (UEQ)	six months

Collaborators and Investigators

• Sponsor: Vitadio s.r.o.
• Collaborators: University Hospital Olomouc
• Investigators: Principal Investigator: Katarína Moravcová, MD, University Hospital Olomouc

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2020
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Hyperinsulinism; Diabetes Mellitus, Type 2; Obesity; Prediabetic State; Insulin Resistance
• Other Study ID Numbers: 0001 (Researcher)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No