Insulin ResistanceNCT04573296
Impact of Digital Therapeutic on Metabolic Parameters
A study testing Vitadio and Conventional high-intensity lifestyle intervention program in people with Insulin Resistance and Prediabetic State, run by Vitadio s.r.o. at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insulin Resistance, Prediabetic State, Diabetes Mellitus, Type 2
- What is being tested?
- Vitadio and Conventional high-intensity lifestyle intervention program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 26 Feb 2020to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Vitadio, Conventional high-intensity lifestyle intervention program
- Medical subject headings
- Insulin Resistance, Prediabetic State, Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitadioDevice
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.
Conventional high-intensity lifestyle intervention programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Conventional high-intensity lifestyle intervention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
comparison of baseline and end program body weight
Measured: baseline, three months, six months
Secondary outcomes (13)
change in waist circumference
comparison of baseline, three-month and end-program waist circumference between groups
Measured: baseline, three months, six months
change in body mass index (BMI)
comparison of baseline, three-month and end-program body mass index (BMI) between groups
Measured: baseline, three months, six months
change in haemoglobin A1c
comparison of baseline, three-month and end-program haemoglobin A1c values between groups
Measured: baseline, three months, six months
change in adherence to lifestyle intervention
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
Measured: baseline, three months, six months
change in blood glucose
comparison of baseline, three-month and end-program blood glucose values between groups
Measured: baseline, three months, six months
change in insulin resistance
comparison of baseline, three-month and end-program insulin resistance quantified by HOMA-IR between groups
Measured: baseline, three months, six months
change in blood pressure
comparison of baseline, three-month and end-program blood pressure between groups
Measured: baseline, three months, six months
change in body composition
comparison of baseline, three-month and end-program body composition assessed with the InBody bioelectrical impedance analysis device between groups
Measured: baseline, three months, six months
change in resting metabolic rate (RMR)
comparison of baseline, three-month and end-program resting metabolic rate assessed by indirect calorimetry between groups
Measured: baseline, three months, six months
change in cardiorespiratory fitness
comparison of baseline, three-month and end-program cardiorespiratory fitness assessed by spiroergometry between groups
Measured: baseline, three months, six months
change in lipid parameters (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides)
comparison of baseline, three-month and end-program levels of total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides between groups
Measured: baseline, three months, six months
change in fasting insulin levels
comparison of baseline, three-month and end-program fasting insulin levels between groups
Measured: baseline, three months, six months
change in liver function tests
comparison of baseline, three-month and end-program standard liver panel (ALT, AST, GGT, ALP) values between groups
Measured: baseline, three months, six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start26 Feb 2020
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitadio s.r.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Olomouc
- Responsible party
- Sponsor
- Investigators
- Katarína Moravcová, MD, Principal investigator, University Hospital Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573296
- Sponsor's protocol ID
- 0001
- Status last verified
- Aug 2023
- First submitted
- 29 Sep 2020
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04573296
- Acronym / sponsor ID
- 0001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Vitadio s.r.o.Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Olomouc
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Participants using Vitadio | Experimental | Device: VitadioParticipants 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. |
| Participants assigned to conventional high-intensity lifestyle intervention program | Active comparator | Behavioral: Conventional high-intensity lifestyle intervention programParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VitadioA 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. | Device | Participants using Vitadio |
| Conventional high-intensity lifestyle intervention programA 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. | Behavioural | Participants assigned to conventional high-intensity lifestyle intervention program |
Primary outcome
Change in body weight
Time frame: baseline, three months, six months
comparison of baseline and end program body weight
13 secondary outcomes
change in waist circumference
Time frame: baseline, three months, six months
change in body mass index (BMI)
Time frame: baseline, three months, six months
change in haemoglobin A1c
Time frame: baseline, three months, six months
change in adherence to lifestyle intervention
Time frame: baseline, three months, six months
change in blood glucose
Time frame: baseline, three months, six months
change in insulin resistance
Time frame: baseline, three months, six months
change in blood pressure
Time frame: baseline, three months, six months
change in body composition
Time frame: baseline, three months, six months
change in resting metabolic rate (RMR)
Time frame: baseline, three months, six months
change in cardiorespiratory fitness
Time frame: baseline, three months, six months
change in lipid parameters (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides)
Time frame: baseline, three months, six months
change in fasting insulin levels
Time frame: baseline, three months, six months
change in liver function tests
Time frame: baseline, three months, six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarína Moravcová, MD principal investigator
University Hospital Olomouc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitadio and Conventional high-intensity lifestyle intervention program in people with Insulin Resistance and Prediabetic State, run by Vitadio s.r.o. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: baseline, three months, six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.