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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
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.
University Hospital Olomouc
Olomouc, Czechia
Change in body weight
comparison of baseline and end program body weight
Time frame: baseline, three months, six months
change in waist circumference
comparison of baseline, three-month and end-program waist circumference between groups
Time frame: 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
Time frame: baseline, three months, six months
change in haemoglobin A1c
comparison of baseline, three-month and end-program haemoglobin A1c values between groups
Time frame: 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
Time frame: baseline, three months, six months
change in blood glucose
comparison of baseline, three-month and end-program blood glucose values between groups
Time frame: 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
Time frame: baseline, three months, six months
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change in blood pressure
comparison of baseline, three-month and end-program blood pressure between groups
Time frame: 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
Time frame: 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
Time frame: baseline, three months, six months
change in cardiorespiratory fitness
comparison of baseline, three-month and end-program cardiorespiratory fitness assessed by spiroergometry between groups
Time frame: 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
Time frame: baseline, three months, six months
change in fasting insulin levels
comparison of baseline, three-month and end-program fasting insulin levels between groups
Time frame: 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
Time frame: baseline, three months, six months