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Impact of Digital Therapeutic on Metabolic Parameters

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04573296
Recruitment Status : Active, not recruiting
First Posted : October 5, 2020
Last Update Posted : April 4, 2022
Sponsor:
Collaborator:
University Hospital Olomouc
Information provided by (Responsible Party):
Vitadio s.r.o.

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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Prediabetic State Diabetes Mellitus, Type 2 Obesity Device: Vitadio Behavioral: Conventional high-intensity lifestyle intervention program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 26, 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Experimental: Participants using Vitadio
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
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.

Active Comparator: Participants assigned to conventional high-intensity lifestyle intervention program
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
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.




Primary Outcome Measures :
  1. Change in body weight [ Time Frame: baseline, three months, six months ]
    comparison of baseline and end program body weight


Secondary Outcome Measures :
  1. change in waist circumference [ Time Frame: baseline, three months, six months ]
    comparison of baseline, three-month and end-program waist circumference between groups

  2. change in body mass index (BMI) [ Time Frame: baseline, three months, six months ]
    comparison of baseline, three-month and end-program body mass index (BMI) between groups

  3. change in haemoglobin A1c [ Time Frame: baseline, three months, six months ]
    comparison of baseline, three-month and end-program haemoglobin A1c values between groups

  4. change in adherence to lifestyle intervention [ Time Frame: baseline, three months, six months ]
    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

  5. change in blood glucose [ Time Frame: baseline, three months, six months ]
    comparison of baseline, three-month and end-program blood glucose values between groups

  6. change in insulin resistance [ Time Frame: baseline, three months, six months ]
    comparison of baseline, three-month and end-program insulin resistance quantified by HOMA-IR between groups

  7. change in blood pressure [ Time Frame: baseline, three months, six months ]
    comparison of baseline, three-month and end-program blood pressure between groups

  8. change in body composition [ Time Frame: baseline, three months, six months ]
    comparison of baseline, three-month and end-program body composition assessed with the InBody bioelectrical impedance analysis device between groups

  9. change in resting metabolic rate (RMR) [ Time Frame: baseline, three months, six months ]
    comparison of baseline, three-month and end-program resting metabolic rate assessed by indirect calorimetry between groups

  10. change in cardiorespiratory fitness [ Time Frame: baseline, three months, six months ]
    comparison of baseline, three-month and end-program cardiorespiratory fitness assessed by spiroergometry between groups

  11. change in lipid parameters (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides) [ Time Frame: baseline, three months, six months ]
    comparison of baseline, three-month and end-program levels of total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides between groups

  12. change in fasting insulin levels [ Time Frame: baseline, three months, six months ]
    comparison of baseline, three-month and end-program fasting insulin levels between groups

  13. change in liver function tests [ Time Frame: baseline, three months, six months ]
    comparison of baseline, three-month and end-program standard liver panel (ALT, AST, GGT, ALP) values between groups


Other Outcome Measures:
  1. Vitadio usability for HCPs [ Time Frame: six months ]
    The healthcare professionals' (HCPs) user experience from interacting with Vitadio Health, assessed with the User Experience Questionnaire (UEQ)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04573296


Locations
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Czechia
University Hospital Olomouc
Olomouc, Czechia, 779 00
Sponsors and Collaborators
Vitadio s.r.o.
University Hospital Olomouc
Investigators
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Principal Investigator: Katarína Moravcová, MD University Hospital Olomouc
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Responsible Party: Vitadio s.r.o.
ClinicalTrials.gov Identifier: NCT04573296    
Other Study ID Numbers: 0001
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Diabetes Mellitus, Type 2
Insulin Resistance
Prediabetic State
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism