Clinical trial NCT04573296: Impact of Digital Therapeutic on Metabolic Parameters
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Prediabetic State
Diabetes Mellitus, Type 2
Obesity
Lead sponsor: Vitadio s.r.o.
Sponsor class: INDUSTRY
Collaborators: name: University Hospital Olomouc
First posted: 2020-10-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in body weight
timeFrame: baseline, three months, six months
Secondary outcomes:
measure: change in waist circumference
timeFrame: baseline, three months, six months
measure: change in body mass index (BMI)
timeFrame: baseline, three months, six months
measure: change in haemoglobin A1c
timeFrame: baseline, three months, six months
measure: change in adherence to lifestyle intervention
timeFrame: baseline, three months, six months
measure: change in blood glucose
timeFrame: baseline, three months, six months
measure: change in insulin resistance
timeFrame: baseline, three months, six months
measure: change in blood pressure
timeFrame: baseline, three months, six months
measure: change in body composition
timeFrame: baseline, three months, six months
measure: change in resting metabolic rate (RMR)
timeFrame: baseline, three months, six months
measure: change in cardiorespiratory fitness
timeFrame: baseline, three months, six months
measure: change in lipid parameters (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides)
timeFrame: baseline, three months, six months
measure: change in fasting insulin levels
timeFrame: baseline, three months, six months
measure: change in liver function tests
timeFrame: baseline, three months, six months
Other outcomes:
measure: Vitadio usability for HCPs
timeFrame: six months
Locations:
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
Study officials:
affiliation: University Hospital Olomouc
name: Katarína Moravcová, MD
role: PRINCIPAL_INVESTIGATOR
References: