Impact of Digital Therapeutic on Metabolic Parameters

Vitadio

Status: Completed

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

Treatments: Behavioral: Conventional high-intensity lifestyle intervention program; Device: Vitadio

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04573296

0001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Participants using Vitadio

Experimental group

Description:

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.

Treatment:

Device: Vitadio

Participants assigned to conventional high-intensity lifestyle intervention program

Active Comparator group

Description:

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.

Treatment:

Behavioral: Conventional high-intensity lifestyle intervention program