Impact of Digital Therapeutic on Metabolic Parameters
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Change in body weight [baseline, three months, six months]
comparison of baseline and end program body weight
Secondary Outcome Measures
- change in waist circumference [baseline, three months, six months]
comparison of baseline, three-month and end-program waist circumference between groups
- change in body mass index (BMI) [baseline, three months, six months]
comparison of baseline, three-month and end-program body mass index (BMI) between groups
- change in haemoglobin A1c [baseline, three months, six months]
comparison of baseline, three-month and end-program haemoglobin A1c values between groups
- change in adherence to lifestyle intervention [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
- change in blood glucose [baseline, three months, six months]
comparison of baseline, three-month and end-program blood glucose values between groups
- change in insulin resistance [baseline, three months, six months]
comparison of baseline, three-month and end-program insulin resistance quantified by HOMA-IR between groups
- change in blood pressure [baseline, three months, six months]
comparison of baseline, three-month and end-program blood pressure between groups
- change in body composition [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
- change in resting metabolic rate (RMR) [baseline, three months, six months]
comparison of baseline, three-month and end-program resting metabolic rate assessed by indirect calorimetry between groups
- change in cardiorespiratory fitness [baseline, three months, six months]
comparison of baseline, three-month and end-program cardiorespiratory fitness assessed by spiroergometry between groups
- change in lipid parameters (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides) [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
- change in fasting insulin levels [baseline, three months, six months]
comparison of baseline, three-month and end-program fasting insulin levels between groups
- change in liver function tests [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
- Vitadio usability for HCPs [six months]
The healthcare professionals' (HCPs) user experience from interacting with Vitadio Health, assessed with the User Experience Questionnaire (UEQ)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Olomouc | Olomouc | Czechia | 779 00 |
Sponsors and Collaborators
- Vitadio s.r.o.
- University Hospital Olomouc
Investigators
- Principal Investigator: Katarína Moravcová, MD, University Hospital Olomouc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0001