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| Name | Class |
|---|---|
| University Hospital Olomouc | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | comparison of baseline and end program body weight | baseline, three months, six months |
| Measure | Description | Time Frame |
|---|---|---|
| change in waist circumference | comparison of baseline, three-month and end-program waist circumference between groups | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Vitadio usability for HCPs | The healthcare professionals' (HCPs) user experience from interacting with Vitadio Health, assessed with the User Experience Questionnaire (UEQ) | six months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| KatarÃna Moravcová, MD | University Hospital Olomouc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Olomouc | Olomouc | 779 00 | Czechia |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D011236 | Prediabetic State |
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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| 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. |
|
| baseline, three months, six months |
| change in haemoglobin A1c | comparison of baseline, three-month and end-program haemoglobin A1c values between groups | 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 | baseline, three months, six months |
| change in blood glucose | comparison of baseline, three-month and end-program blood glucose values between groups | 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 | baseline, three months, six months |
| change in blood pressure | comparison of baseline, three-month and end-program blood pressure between groups | 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 | 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 | baseline, three months, six months |
| change in cardiorespiratory fitness | comparison of baseline, three-month and end-program cardiorespiratory fitness assessed by spiroergometry between groups | 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 | baseline, three months, six months |
| change in fasting insulin levels | comparison of baseline, three-month and end-program fasting insulin levels between groups | 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 | baseline, three months, six months |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |