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Impact of Digital Therapeutic on Metabolic Parameters

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ClinicalTrials.gov Identifier: NCT04573296
Recruitment Status : Recruiting
First Posted : October 5, 2020
Last Update Posted : April 6, 2021
Sponsor:
Collaborator:
University Hospital Olomouc
Information provided by (Responsible Party):
Vitadio s.r.o.

Brief Summary:
The purpose of this prospective randomized clinical study is to evaluate the impact of a six-month digitally administered behavioral change programme on weight, metabolic parameters and adherence to healthy lifestyle in obese adults with insulin resistance, prediabetes or type 2 diabetes as compared to conventional high-intensity lifestyle intervention programme administered at a sports medicine clinic of university hospital.

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

Detailed Description:

Vitadio Health is a 6-month digitally administered behavioral change programme focused on lifestyle change, weight loss and metabolic health and promoting self-management and long-term self-sufficiency. The programme includes personalised nutrition/lifestyle education, remote dietitian's one-on-one coaching, weekly goals, diet and activity monitoring tools, recipes and support member community. Personalization and semi-automation of the intervention are achieved by analysis of participant's interactions with the interface.

In this prospective randomized clinical study, obese adults with insulin resistance, prediabetes or diabetes mellitus type 2, patients of a sports medicine clinic of university hospital, are randomized to receive either Vitadio Health or a conventional 6-month high-intensity lifestyle intervention programme at the clinic, consisting of face-to-face nutrition/lifestyle education (at baseline, months 1 to 3 and month 6) and diet self-monitoring. 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, adherence to recommended lifestyle measures 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: A prospective randomized study to assign efficacy of lifestyle intervention using Vitadio Health as compared to conventional lifestyle intervention programme at a sports medicine clinic of university hospital
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Digital Therapeutic Intervention on Weight, Metabolic Parameters and Adherence to Lifestyle Change in Obese Adults With Insulin Resistance, Prediabetes and Type 2 Diabetes as Compared to Conventional Intensive Management
Actual Study Start Date : February 26, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Participants using Vitadio Health
Participants in the intervention arm undergo a 6-month digitally administered behavioral change programme consisting of nutrition/lifestyle education, diet and activity monitoring, remote dietitian's support and promoting self-management and long-term self-sufficiency. In addition, they undergo regular face-to-face medical assessment.
Device: Vitadio Health
A 6-month digitally administered behavioral change programme includes personalised nutrition/lifestyle education, remote dietitian's one-on-one coaching, weekly goals, diet and activity monitoring tools, recipes and support member community. Personalization and semi-automation of the intervention is achieved by analysis of participant's interactions with the interface. The programme consists of a 3-month intensive phase, 3-month maintenance phase and aims towards promoting self-management and long-term self-sufficiency.

Active Comparator: Participants assigned to conventional lifestyle intervention programme
Participants in the control group undergo a 6-month high-intensity lifestyle intervention programme consisting of face-to-face nutrition/lifestyle education, diet monitoring and regular medical assessment.
Behavioral: Conventional high-intensity lifestyle intervention programme
A 6-month high-intensity lifestyle intervention programme consisting of face-to-face nutrition/lifestyle education (at baseline, months 1 to 3 and month 6), diet self-monitoring and regular medical assessment (baseline, month 3, month 6).




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 60 Years   (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
  • device with internet access (notebook, smartphone, tablet)

Exclusion Criteria:

  • pregnancy
  • steroid treatment
  • type 1 diabetes mellitus
  • type 2 diabetes mellitus on insulin therapy
  • severe renal and/or hepatic impairment
  • inability to understand, consent to, or comply with the study protocol for any reason, including inability to read or comprehend Czech language

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


Contacts
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Contact: Lucie Kovarova, MD +420720161580 lucie@vitad.io
Contact: Katarína Moravcová, MD +420776260068 Katarina.Moravcova@fnol.cz

Locations
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Czechia
University Hospital Olomouc Recruiting
Olomouc, Czechia, 779 00
Contact: Katarína Moravcová, MD    +420776260068    Katarina.Moravcova@fnol.cz   
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 6, 2021
Last Verified: April 2021

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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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Diabetes Mellitus, Type 2
Insulin Resistance
Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism