- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01344811
Effects of Telemonitoring Service for Obesity Care (Smart-OB)
A Randomized, Open, Parallel, Multi-center Trial to Evaluate Weight Loss Efficacy of Smart Care Service in Obese Patients With Metabolic Syndrome.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
- Objectives : To evaluate superiority of U(Ubiquitous)-Healthcare(hereinafter referred to as Smart Care) Service being combined conventional treatment with health care service, in comparison to conventional treatment in obese patients with metabolic syndrome.
Test and control group
- Test groups : The subject group who is receiving health care services using conventional treatment (hospital visit) and Smart Care Service (Telemonitoring).
- Control group : The subject group who is receiving conventional treatment (hospital visit).
- Target Subject: Obese patients with metabolic syndrome.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Seoul, Republica da Coréia
- Seoul National University Hospital
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Seoul, Republica da Coréia
- Yonsei University Health System
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age: More than 20 years of age and under 70 years of age.
- BMI ≥ 25kg/m2
Patients with metabolic syndrome (who have more than three of following 5 components of metabolic syndrome) and who are able to receive outpatient treatment.
A. Abdominal obesity: Waist circumference≥90cm(Male), 85cm(Female) B. Patients whose blood pressure ≥130/85mmHg(systolic blood pressure over 130 or, diastolic blood pressure over 85) or patients who are taking blood pressure medication.
C. Fasting Blood Glucose (FPG)≥ 100mg/dl. D. Patients whose triglyceride ≥150 mg/dl or patients who are taking fibrate. E. High-density lipoprotein cholesterol (HDL) < 40 mg/dl (Male), 50 mg/dl(Female)
- Patients who are able to understand the purpose of this trial and to read and write.
- Patients who are able to use U-healthcare Smartphone for this trial.
- Patients who participate voluntarily and sign the informed consent.
Exclusion Criteria:
- Type I diabetes mellitus patients and type II diabetes mellitus patients requiring insulin therapy.
- Patients currently being hospitalized or planning to hospitalize during the study period.
- Patients were diagnosed with myocardial infarction or stroke within 1 year
- End Stage Renal Disease patients requiring renal replacement therapy, Serum creatinine level is greater than 1.5 times the upper limit of normal.
- Females who are pregnant
- Hepatic failure (severe hepatic dysfunction). Liver Function Test (AST or ALT) is greater than 3 times the upper limit of normal.
- Uncontrolled chronic lung disease.
- Patients with known gallstone.
- Patients who have cognitive disorder or psychiatric problems.
- Patients who are taking anti-obesity medications such as Reductil, Xenical, etc., or patients are planning to receive the medications.
- Patients who are taking Synthroid, diabetes medications or psychiatric medications which may affect on body weight.
- Any clinically significant medical condition including neurologic disease, gastrointestinal disease or malignant tumor, etc., which may affect the test results, or any other medical condition which in the opinion of the investigator makes the patients unsuitable for participation in the trial.
- Patients who have participated in other clinical trial (except for the observational study) within 12 weeks prior to screening visit.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Telemonitoring group
|
The Telemonitoring group will be provided the Smartphone, body composition analyzer and pedometer.
They should visit the site once per every 3 months (12 weeks), and measure their body composition during study period.
After measurement of body composition, the subjects should make transmit measured information through Smartphone into a centralized server of Smart Care Center.
At Smart care Center, care manager will provide remote body composition and activity monitoring and individual obesity case management
Outros nomes:
|
Outro: Control group
|
The control group will receive a weighting scale and pedometer.
They should perform the same weight measurement (minimum three times a week) like the intervention group during the study, and measured results should be recorded in a diary of self body weight and the number of steps.
In addition, the subjects should visit the site once per every three months (12 weeks).
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Weight Change from Baseline to 24 weeks
Prazo: 0 and 24 weeks
|
0 and 24 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Body Mass Index (BMI) changes
Prazo: 0 and 24 weeks
|
Reduces of body mass index - BMI=Body weight (kg)/Height2(m) |
0 and 24 weeks
|
Proportion of subjects whose body weight decreased more than 10%
Prazo: 0 and 24 weeks
|
0 and 24 weeks
|
|
Changes in body fat rate
Prazo: 0 and 24 weeks
|
Reduces in body fat rate
|
0 and 24 weeks
|
Changes in waist circumference
Prazo: 0 and 24 weeks
|
Reduces waist circumference
|
0 and 24 weeks
|
Changes in lipid profile
Prazo: 0 and 24 weeks
|
Changes in lipid profile(total cholesterol, HDL cholesterol, LDL cholesterol triglycerides)
|
0 and 24 weeks
|
Changes in blood pressure
Prazo: 0 and 24 weeks
|
Blood pressure value when hospital visiting
|
0 and 24 weeks
|
Changes in prevalence rate of metabolic syndrome
Prazo: 0 and 24 weeks
|
0 and 24 weeks
|
|
Changes in the number of metabolic syndrome components
Prazo: 0 and 24 weeks
|
Reduce the number of metabolic syndrome components
|
0 and 24 weeks
|
Changes in lifestyle
Prazo: 0 and 24 weeks
|
Changes in lifestyle such as smoking, drinking, dietary and physical activity, etc
|
0 and 24 weeks
|
Patients' satisfaction
Prazo: 24 weeks
|
applicable to Only Telemonitoring group
|
24 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Bi-Ryong Cho, Seoul National University Hospital
Publicações e links úteis
Publicações Gerais
- Oh B, Yi GH, Han MK, Kim JS, Lee CH, Cho B, Kang HC. Importance of Active Participation in Obesity Management Through Mobile Health Care Programs: Substudy of a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jan 3;6(1):e2. doi: 10.2196/mhealth.8719.
- Oh B, Cho B, Han MK, Choi H, Lee MN, Kang HC, Lee CH, Yun H, Kim Y. The Effectiveness of Mobile Phone-Based Care for Weight Control in Metabolic Syndrome Patients: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2015 Aug 20;3(3):e83. doi: 10.2196/mhealth.4222.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SmartCare-OB
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