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Impact of Digital Therapeutic on Metabolic Parameters

NCT04573296 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-08-31

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University Hospital Olomouc

    collaborator OTHER

  • Vitadio s.r.o.

    lead INDUSTRY

Principal Investigators

  • Katarína Moravcová, MD · University Hospital Olomouc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-26
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04573296 on ClinicalTrials.gov