The Impact of Using a Smartphone Health Application in the Improvement of Cardiovascular Disease Risk Factors in the Omani Population; Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 410
- 主要终点
- Reduced blood cholesterol and triglycerides levels
研究概览
简要总结
This study investigates the effectiveness of Mobile health application (mHealth apps) in the improvement of cardiovascular disease risk factors including metabolic and behavioral factors. The app will be tested on patients with any of the modifiable risk factors of CVD such as hypertension, obesity, hyperlipidemia, and impaired glycemic control/type 2 diabetes mellitus .
详细描述
The investigators aim in this study to reduce the risk of cardiovascular disease in patients with hypercholesterolemia, diabetes, obesity and hypertension. This will be achieved by motivating healthy lifestyle among the participants such as increasing physical activity and intake of healthy diet and reducing alcohol and tobacco consumption. The tool which will be used to motivate healthy lifestyle is a smartphone application which will be specifically designed to motivate behavioral change. Thus, the investigators hypothesis is that participants who have full access to the mobile application will show improved healthy lifestyle, reduced blood pressure, cholesterol and glucose and reduced BMI compared to the participants who don't have access to the mobile application.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presentation with at least one of the following metabolic abnormalities:
- •Hypertensions (systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 85 mmHg)
- •Obesity (waist circumference ≥ 80 cm (women) or ≥ 94 cm (men) and BMI ≥ 25 kg/m2)
- •Dyslipidemia (triglycerides ≥ 1.7 mmol/L or/and HDL-cholesterol ≤ 1.29 mmol/L (women) or ≤ 1.02 mmol/L (men) or/and LDL-Cholesterol > 5.18 mmol/L, serum total cholesterol ≥ 5.2 mmol/l)
- •Impaired glycemia/type 2 diabetes (fasting plasma glucose ≥ 5.6 mmol/L)
- •Arabic or English language speaking and able to read and write in one of these languages
- •Possession of a smart mobile phone Willing to utilize a mobile application for CVD management.
排除标准
- •A history of stroke, myocardial infarction or any related cardiovascular complications Complicated diabetes mellitus e.g., Proliferative diabetic retinopathy, end-stage renal disease
- •Unavailability of a smartphone or any reason that will not allow the participant to use the app properly. (such as; difficulty or inability to use mobile applications, unavailability of network services...etc.).
- •Medical conditions that restrain the participant to be physically active.
- •High chance of loss to follow up at the FAMCO clinic (due to upcoming travel, temporary employment and thus eligibility to be treated at the clinic, irregular visits due to distance from home...etc.)
结局指标
主要结局
Reduced blood cholesterol and triglycerides levels
时间窗: 18 months
Immunoassay based-method will be used to measure lipid profile in the blood samples collected from the study participants. Lipids will be measured in millimole/Liter This outcome will be achieved when the Participants lipid profile is reduced compared to the initial values (measured at the beginning of the study) The assessment will be base don the ranges below: Total Cholesterol (mmol/L): \< 5.2 / TG (mmol/L): (0 - 2.3) / LDL-C (mmol/L): \< 2.59 / HDL-C (mmol/L): \> 1.68 (Female) \>1.45 (Male)
Reduced blood glucose levels
时间窗: 18 months
Glucometer devices for fasting blood glucose and for glycated hemoglobin will be used to asses the improvement in impaired glycemia. Participants who achieve this outcome would have reduced blood glucose compared to the initial values (measured at the beginning of the study) The following measures will be used to asses the glycemic state of the pateints Fasting blood glucose: (Norma \< 5.6 mmol/L), (Impaired glycemia/type 2 diabetes ≥ 5.6 mmol/L) Glycated hemoglobin (HbA1c): (Normal \< 5.7 %), (\> 6.5 Diabetes)
Normalized blood pressure
时间窗: 18 months
systolic blood pressure and diastolic blood pressure of the participants will measured throughout the study using sphygmomanometer The measures below will be used to assess the improvement in the blood pressure of the participants Hypertension: systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 85 mmHg Normal blood pressure: systolic: \< 120 mm Hg/ diastolic \< 80 mm Hg
Reduced BMI and visceral obesity
时间窗: 18 months
Anthropometric measurements (height, weight, waist and hip circumferences) will be taken from the participants throughout the study. Body Mass Index (BMI) will be measured using the formula BMI = weight(kg)/height(m2). Desired BMI is in the range of 18.5 to 24.9, A BMI of 25.0 or more is overweight Visceral obesity will be assed by measuring the waist-to-hip ratio Female: \> 0.85 No visceral obesity, \< 0.85 existing visceral obesity Male: \> 1.0 No visceral obesity, \< 1.0 existing visceral obesity
次要结局
- Increased physical activity and increased intake of healthy diet(18 months)
- Reduced alcohol consumption and tobacco smoking(18)
研究者
Dr. Amani Alkhaifi
Principal Investigator
Sultan Qaboos University