MObesity-MHealth for Obesity: Diabetes and Obesity Monitoring and Rehabilitation Integrated System
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Abstract
Background
The prevalence of diabesity (obesity and Type 2 diabetes) and prediabetes is increasing and the related complications are major public health concerns. The effective management of diabesity is crucial for the prevention-limitation of related complications and for the reduction of health care costs. Regardless of clinical approach (life-style change, drugs, bariatric surgery), weight-loss and diabetes control programs involve for a long time repeated face-to-face control visits at clinical centers. Long-term programs that entails continuous monitoring and care are expensive and do not sustain patient motivation and treatment engagement. To face these problems, remote care and monitoring tools have been developed and assessed for feasibility, efficacy and cost effectiveness in few studies.
Objective
The aim of the MObesity project is to develop a telemedicine platform that will improve the management of obesity with Type II diabetes or prediabetes in out-patient settings, providing an e-Health solution for the remote prevention, assessment and treatment of these diseases and related complications, improving a healthy lifestyle too. The project will have a special impact on improving quality of life and contributing to the cost-reduction and "cost-effective health care" improvement.
Methods
10 obese Type II diabetic and prediabetic patients will be recruited in a 6-month non-controlled pilot study aimed to assess the feasibility and usability of the MOBESITY web-platform. The clinical efficacy and cost-effectiveness of the MOBESITY program will be finally assessed within a 12-month RCT with two arms. 100 obese Type II diabetic and prediabetic patients will be randomized to two conditions: MOBESITY program (mHealth-based remote multidisciplinary management program) and standard care (usual state-of-the-art follow-up monitoring and care). Male and female Type II diabetic and prediabetic patients with BMI > 35 will be eligible for inclusion.
Results
The primary expected outcomes are significant BMI (Body Max Index) reduction (at least 10% of baseline weight), weight loss maintenance (at least 5% lower than baseline weight) and glycemic level stabilization in the long-term. Secondary expected outcomes are significant QoL improvement, prevention or control of diabesity-related complications, cost reduction and compliance improvement (we expect a drop-out rate lower that 10%).
Conclusions
MOBesity will ensure:
1) CLINICAL INNOVATION; clinical units will not only collect single ranges of data, but will manage the disease in a multidisciplinary approach including biomedical, psychological, dietary and physical activity data improving the patient knowledge of his/her illness and the impact of rehabilitation procedures.
2) ORGANIZATIONAL INNOVATION; the traditional out-patient care will be provided in a new approach no longer using ambulatories or day-hospital admissions, but through a continuous Web-based monitoring and integrated treatment services that will significantly reduce the costs for the National Health Services and the time spent by patients attending clinics.
3) TECHNOLOGICAL INNOVATION; MOBESITY project will not develop new biomedical devices but will use the gold standard technology available on the market (such as biomedical t-shirts and "disappearing" mobile biosensors) in a new user-friendly "Science Gateway" platform integrated with e-Infrastructure to diagnose the presence of metabolic alterations of diabetes/prediabetes in obesity and to assess the severity or complications of diabesity.
The prevalence of diabesity (obesity and Type 2 diabetes) and prediabetes is increasing and the related complications are major public health concerns. The effective management of diabesity is crucial for the prevention-limitation of related complications and for the reduction of health care costs. Regardless of clinical approach (life-style change, drugs, bariatric surgery), weight-loss and diabetes control programs involve for a long time repeated face-to-face control visits at clinical centers. Long-term programs that entails continuous monitoring and care are expensive and do not sustain patient motivation and treatment engagement. To face these problems, remote care and monitoring tools have been developed and assessed for feasibility, efficacy and cost effectiveness in few studies.
Objective
The aim of the MObesity project is to develop a telemedicine platform that will improve the management of obesity with Type II diabetes or prediabetes in out-patient settings, providing an e-Health solution for the remote prevention, assessment and treatment of these diseases and related complications, improving a healthy lifestyle too. The project will have a special impact on improving quality of life and contributing to the cost-reduction and "cost-effective health care" improvement.
Methods
10 obese Type II diabetic and prediabetic patients will be recruited in a 6-month non-controlled pilot study aimed to assess the feasibility and usability of the MOBESITY web-platform. The clinical efficacy and cost-effectiveness of the MOBESITY program will be finally assessed within a 12-month RCT with two arms. 100 obese Type II diabetic and prediabetic patients will be randomized to two conditions: MOBESITY program (mHealth-based remote multidisciplinary management program) and standard care (usual state-of-the-art follow-up monitoring and care). Male and female Type II diabetic and prediabetic patients with BMI > 35 will be eligible for inclusion.
Results
The primary expected outcomes are significant BMI (Body Max Index) reduction (at least 10% of baseline weight), weight loss maintenance (at least 5% lower than baseline weight) and glycemic level stabilization in the long-term. Secondary expected outcomes are significant QoL improvement, prevention or control of diabesity-related complications, cost reduction and compliance improvement (we expect a drop-out rate lower that 10%).
Conclusions
MOBesity will ensure:
1) CLINICAL INNOVATION; clinical units will not only collect single ranges of data, but will manage the disease in a multidisciplinary approach including biomedical, psychological, dietary and physical activity data improving the patient knowledge of his/her illness and the impact of rehabilitation procedures.
2) ORGANIZATIONAL INNOVATION; the traditional out-patient care will be provided in a new approach no longer using ambulatories or day-hospital admissions, but through a continuous Web-based monitoring and integrated treatment services that will significantly reduce the costs for the National Health Services and the time spent by patients attending clinics.
3) TECHNOLOGICAL INNOVATION; MOBESITY project will not develop new biomedical devices but will use the gold standard technology available on the market (such as biomedical t-shirts and "disappearing" mobile biosensors) in a new user-friendly "Science Gateway" platform integrated with e-Infrastructure to diagnose the presence of metabolic alterations of diabetes/prediabetes in obesity and to assess the severity or complications of diabesity.
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