Obesity Clinical Trial
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
Verified date | August 2023 |
Source | Vitadio s.r.o. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | November 30, 2022 |
Est. primary completion date | November 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Czechia | University Hospital Olomouc | Olomouc |
Lead Sponsor | Collaborator |
---|---|
Vitadio s.r.o. | University Hospital Olomouc |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Vitadio usability for HCPs | The healthcare professionals' (HCPs) user experience from interacting with Vitadio Health, assessed with the User Experience Questionnaire (UEQ) | six months | |
Primary | Change in body weight | comparison of baseline and end program body weight | baseline, three months, six months | |
Secondary | change in waist circumference | comparison of baseline, three-month and end-program waist circumference between groups | baseline, three months, six months | |
Secondary | change in body mass index (BMI) | comparison of baseline, three-month and end-program body mass index (BMI) between groups | baseline, three months, six months | |
Secondary | change in haemoglobin A1c | comparison of baseline, three-month and end-program haemoglobin A1c values between groups | baseline, three months, six months | |
Secondary | 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 | |
Secondary | change in blood glucose | comparison of baseline, three-month and end-program blood glucose values between groups | baseline, three months, six months | |
Secondary | 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 | |
Secondary | change in blood pressure | comparison of baseline, three-month and end-program blood pressure between groups | baseline, three months, six months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | change in cardiorespiratory fitness | comparison of baseline, three-month and end-program cardiorespiratory fitness assessed by spiroergometry between groups | baseline, three months, six months | |
Secondary | 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 | |
Secondary | change in fasting insulin levels | comparison of baseline, three-month and end-program fasting insulin levels between groups | baseline, three months, six months | |
Secondary | 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 |
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