Abstract
BACKGROUND: Overweight and obesity, due to a Westernized diet and lack of exercise, are serious global problems that negatively affect not only personal health, but national economies as well. To solve these problems, preventative-based approaches should be taken rather than medical treatments after the occurrence of disease. The improvement of individual life habits, through continuous care, is thus a paramount, long-term treatment goal. This study describes the effects of ubiquitous health care (uHealth care) or SmartCare services in the treatment of weight loss and obesity. OBJECTIVE: The aim of this study is to evaluate the effect of SmartCare services on weight loss compared to the effects of existing outpatient treatments in obese patients with metabolic syndrome. METHODS: Metabolic syndrome patients who met the inclusion/exclusion criteria were enrolled in the study and randomized into an intervention or control group. The intervention group was provided with remote monitoring and health care services in addition to the existing treatment. The control group was provided with only the existing treatment. Pedometers were given to all of the patients. Additionally, mobile phones and body composition monitors were provided to the intervention group while body weight scales were provided to the control group. The patients visited the hospitals at 12 and 24 weeks following the baseline examination to receive efficacy and safety evaluations. RESULTS: Mean weight reduction from baseline to week 24 was measured as a primary efficacy evaluation parameter and was found to be 2.21 kg (SD 3.60) and 0.77 kg (SD 2.77) in the intervention and control group, respectively. The intervention group had a larger decrement compared to the control group (P<.001). Among the secondary efficacy evaluation parameters, body mass index (BMI) (P<.001), body fat rate (P=.001), decrement of waist measurement (P<.001), and diet habit (P=.012) improvement ratings from baseline to week 24 were found to be superior in the intervention group compared with the control group. The proportion of patients whose body weight decreased by ≥10%, lipid profiles, blood pressure, prevalence of metabolic syndrome, change in the number of metabolic syndrome elements, smoking rate, drinking rate, and physical activity were not statistically significant between the groups. CONCLUSIONS: The efficacy of SmartCare services was confirmed as the intervention group that received both SmartCare services and the existing treatment had superior results compared with the control group that only received the existing treatment. Importantly, no specific problems with respect to safety concerns were observed. SmartCare service is thus an effective way to control the weight of obese patients with metabolic syndrome. TRIAL REGISTRATION: Clinicaltrials.gov NCT01344811; https://clinicaltrials.gov/ct2/show/NCT01344811 (Archived by Webcite at http://www.webcitation.org/6alT2MmIB).