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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04573296
Other study ID # 0001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 26, 2020
Est. completion date November 30, 2022

Study information

Verified date August 2023
Source Vitadio s.r.o.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date November 30, 2022
Est. primary completion date November 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
Czechia University Hospital Olomouc Olomouc

Sponsors (2)

Lead Sponsor Collaborator
Vitadio s.r.o. University Hospital Olomouc

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Other Vitadio usability for HCPs The healthcare professionals' (HCPs) user experience from interacting with Vitadio Health, assessed with the User Experience Questionnaire (UEQ) six months
Primary Change in body weight comparison of baseline and end program body weight baseline, three months, six months
Secondary change in waist circumference comparison of baseline, three-month and end-program waist circumference between groups baseline, three months, six months
Secondary 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
Secondary change in haemoglobin A1c comparison of baseline, three-month and end-program haemoglobin A1c values between groups baseline, three months, six months
Secondary 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
Secondary change in blood glucose comparison of baseline, three-month and end-program blood glucose values between groups baseline, three months, six months
Secondary 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
Secondary change in blood pressure comparison of baseline, three-month and end-program blood pressure between groups baseline, three months, six months
Secondary 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
Secondary 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
Secondary change in cardiorespiratory fitness comparison of baseline, three-month and end-program cardiorespiratory fitness assessed by spiroergometry between groups baseline, three months, six months
Secondary 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
Secondary change in fasting insulin levels comparison of baseline, three-month and end-program fasting insulin levels between groups baseline, three months, six months
Secondary 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
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