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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in body weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in body weight
时间窗: baseline, three months, six months
comparison of baseline and end program body weight
次要结局
- change in liver function tests(baseline, three months, six months)
- change in body composition(baseline, three months, six months)
- change in haemoglobin A1c(baseline, three months, six months)
- change in body mass index (BMI)(baseline, three months, six months)
- change in insulin resistance(baseline, three months, six months)
- change in blood pressure(baseline, three months, six months)
- change in resting metabolic rate (RMR)(baseline, three months, six months)
- change in cardiorespiratory fitness(baseline, three months, six months)
- change in blood glucose(baseline, three months, six months)
- change in adherence to lifestyle intervention(baseline, three months, six months)
- change in lipid parameters (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides)(baseline, three months, six months)
- change in fasting insulin levels(baseline, three months, six months)
- change in waist circumference(baseline, three months, six months)