Effects of a Smartphone-based Weight Loss Programme Targeting Chinese Overweight Adults With Pre-diabetes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 282
- 试验地点
- 1
- 主要终点
- Percent weight change
研究概览
简要总结
Type 2 diabetes (T2DM) is a serious chronic condition and one of the world's fastest growing health problems. The onset of T2DM is gradual, with most individuals progressing through a state of pre-diabetes, which provides an important window of opportunity for the prevention of T2DM and its complications. This project aims to translate the evidence-based diabetes prevention strategies into community setting and utilize mobile health technology to reduce diabetes risks in Hong Kong.
详细描述
Type 2 diabetes (T2DM) is a major global health issue and the cost to community is high and escalating. The Asia-Pacific region carries a high disease burden, with more than 60% of the global diabetic population living in Asian region. The onset of T2DM is gradual, with most individuals progressing through a state of pre-diabetes. A National Survey conducted in China in 2010 revealed that 50.1% of people aged 18 or older have pre-diabetes. People with pre-diabetes, defined as having impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or elevated glycated haemoglobulin (HbA1C) , are at increased risk of developing T2DM and its associated complications, such as heart diseases and retinopathy, which can develop even in the absence of progression to overt T2DM. Hence, it is essential that people with pre-diabetes are targeted for early intervention to prevent T2DM and related complications.
Obesity is a major risk factor for developing T2DM. International trials demonstrate that lifestyle interventions (which includes diet, physical activity and behavioural modification components) targeting at least 5% weight loss in individuals with pre-diabetes can reduce 3-year diabetes incidence by 58%. Growing evidence suggests that smartphones may be a promising platform for delivery of behavioural lifestyle intervention to achieve weight loss.
This project aims to translate the evidence-based diabetes prevention strategies into community setting and utilize mobile health technology to reduce diabetes risks in Hong Kong.
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
- Single (Outcomes Assessor)
盲法说明
All outcome assessors will be blinded to group allocation
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 40 - 60 years old
- •Overweight (BMI ≥ 23kg/m2) or obese (BMI ≥ 25 kg/m2)
- •With at least one blood test result showing IGT (7.8-11.0 mmol/L after a two-hour glucose tolerance test), IFG (fasting glucose 5.6 - 6.9 mmol/L) or impaired HbA1c 5.7% - 6.4%
- •Owns a smartphone
- •Able to read Chinese and speak Cantonese.
排除标准
- •With current or clinical history of T2DM, or with co-morbid conditions that may limit participation in the study, such as recent history of an acute cardiovascular event, uncontrolled hypertension, cancer or major psychiatric or cognitive problems
- •Already participating in a weight loss programme
- •Receiving drug treatment for pre-diabetes or long-term use of medicines known to influence glucose metabolism (e.g. corticosteroids)
结局指标
主要结局
Percent weight change
时间窗: % weight change at 4 and 12 months from baseline
% weight change from baseline
次要结局
- Haemoglobin A1C (HbA1C)(Changes of HbA1c at 4 and 12-months from baseline)
- Systolic and diastolic blood pressure (SBP, DBP)(Changes of SBP and DBP to 4 and 12-months from baseline)
- Blood lipid profile(Changesof blood lipid at 12-months from baseline)
- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)(Changes of insulin sensitivity at 12-months from baseline)
- Fasting insulin(Changes of fasting insulin to 12-months from baseline)
- 2hr post OGTT glucose (2hr PP)(Changes of 2hr PP at 12-months from baseline)
- Fasting blood glucose (FG)(Changes of FG at 12-months from baseline)
- Health-related quality of life (HRQOL) as assessed by SF12(Changes in HRQOL from baseline to 4 and 12-months)
- Smartphone apps user engagement(At 12-months follow-up)
- Dietary intake as assessed by 24-hour recall(Changes in dietary intake from baseline to 4 and 12-months)
- Central obesity(Changes of waist circumference at 12-months from baseline)
- User feedback as assessed by an online exit questionnaire(At 12-months follow-up)
- Physical activity as assessed by IPAQ(Change in levels of physical activity from baseline to 4 and 12-months)
- Percentage body fat as assessed by BIA(Changes of body fat at 12-months from baseline)
研究者
Dr. Mandy M. Ho
Assistant Professor
The University of Hong Kong