Impact of Digital Therapeutic on Metabolic Parameters

NCT04573296 | Completed DMC

• 1 other identifier: 0001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  comparison of baseline and end program body weight

  baseline, three months, six months

Secondary Outcomes (13)

• change in waist circumference

  baseline, three months, six months

• change in body mass index (BMI)

  baseline, three months, six months

• change in haemoglobin A1c

  baseline, three months, six months

• change in adherence to lifestyle intervention

  baseline, three months, six months

• change in blood glucose

  baseline, three months, six months

Other Outcomes (1)

• Vitadio usability for HCPs

  six months

Study Arms (2)

Participants using Vitadio

EXPERIMENTAL

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

Participants assigned to conventional high-intensity lifestyle intervention program

ACTIVE COMPARATOR

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

Interventions

Vitadio DEVICE

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.

Participants using Vitadio

Conventional high-intensity lifestyle intervention program BEHAVIORAL

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.

Participants assigned to conventional high-intensity lifestyle intervention program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vitadio s.r.o.: lead
• University Hospital Olomouc: collaborator

Study Sites (1)

University Hospital Olomouc

Olomouc, 779 00, Czechia

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katarína Moravcová, MD

  University Hospital Olomouc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 5, 2020
• Study Start: February 26, 2020
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: August 31, 2023

Record last verified: 2023-08

Locations

CZ (1)