Effects of a Supportive Mobile Health for Life Style Modification on Blood Pressure and Insulin Resistance Improvement in People With Metabolic Abnormalities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Change in systolic/diastolic blood pressures
研究概览
简要总结
The purpose of this randomized study is to assess the efficacy of a mobile application for the improvement of blood pressure and insulin resistance in people with metabolic abnormalities.
详细描述
The purpose of this randomized study is to assess the efficacy of a mobile application for the improvement of blood pressure and insulin resistance in people with metabolic syndrome.
This study is a 24 week follow up randomized prevention trial. Participants visit for a screening test, then eligible participants are randomly assigned for one of the following arms; 1 intervention group using a mobile application to monitor their life style behaviors, 1 intervention group using a mobile application for personal coaching on purpose of improving their life style behavior, and 1 control group providing education about managing life style behaviors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
A designated researcher will be responsible for the random allocation and mask the results, so the investigators and the outcomes assessor do know the which group the participants are been allocated in.
入排标准
- 年龄范围
- 30 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •"Etiologic study on cardiovascular and metabolic diseases: prospective cohort study (Severance Hospital IRB No. 4-2013-0661)" participants
- •Smartphone user
- •Metabolic abnormality. Having 2 or more components of metabolic syndrome described below:
- •Central obesity : waist circumference ≥ 90cm in male, ≥ 80cm in female
- •Systolic/diastolic blood pressure ≥ 130/85 mmHg
- •Serum triglyceride ≥ 150 mg/dL
- •Serum high density lipoprotein cholesterol < 40 mg/dL in male, 50 mg/dL in female
- •Fasting glucose ≥ 100mg/dL
排除标准
- •Presently or planning for pregnant/breastfeeding during the study. Or confirmed pregnancy by a urine test.
- •Currently taking medication (including insulin injection) for hypertension, dyslipidemia, or diabetes.
- •Presently using a mobile application for lifestyle modification
研究组 & 干预措施
No intervention (Education)
Participants in this group is provided education. Education includes information of metabolic syndrome, methods to manage lifestyle (diet, physical activity).
干预措施: Education (Other)
Mobile Application (Self monitoring)
Participants in this group will be introduced to use a mobile application to self record and monitor their life style behaviors. They will be also be provided education same as the control group.
干预措施: Mobile application for self monitoring (Other)
Mobile Application (Personal coaching)
Participants in this group will be introduced to use a mobile application. Personal coaches such as dietitian, sports manager encourage to improve their life style behaviors. They will be also be provided education same as the control group.
干预措施: Mobile application for personal coaching (Other)
结局指标
主要结局
Change in systolic/diastolic blood pressures
时间窗: 24 weeks
Change of systolic/diastolic blood pressures and insulin resistance are the differences between the last visit and baseline (screening visit).
次要结局
- Change in the eligibility criteria for metabolic syndrome(24 weeks)