Effects of a Community-based Weight Loss Programme Targetting Chinese Overweight Adults With Pre-diabetes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 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. Pre-diabetes is a prevalent and potentially reversible condition, 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 a community setting to reduce diabetes risks in Hong Kong Chinese people with pre-diabetes .
详细描述
Type 2 diabetes (T2DM) is a major non-communicable disease and one of the world's fastest growing health problem. It is associated with significant morbidity, including increased risk of heart disease and stroke, hypertension, retinopathy and blindness, renal failure and leg amputation, which place an enormous burden on individuals, society and the healthcare system. The T2DM trend in Hong Kong mirrors the global trend. It is a major cause of mortality and morbidity with approximately 700,000 people diagnosed with diabetes, representing 10% of Hong Kong's total population.
T2DM is a non-reversible, yet a preventable condition. The onset of T2DM is gradual, with most individuals progressing through a state of 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.
International clinical trials demonstrated that lifestyle interventions targeting at least 5% weight loss in individuals with pre-diabetes can be cost-effective in preventing T2DM. Lifestyle intervention (which includes diet, physical activity and behavioural modification components) and self-management of pre-diabetes has been listed as an effective means of decreasing the incidence of T2DM in the international guidelines on management of pre-diabetes.
The aim of this study is to translate preventive research into effective community-based intervention by setting up a culturally appropriate lifestyle intervention programme for the prevention of T2DM in Hong Kong Chinese adults with pre-diabetes.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 30 to 65 years
- •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%
- •have a mobile phone
- •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 (e.g. Metformin) or long-term use of medications known to influence glucose metabolism (e.g. corticosteroids)
结局指标
主要结局
Percent weight change
时间窗: % weight change from baseline at 6-month and 12-months
% weight change from baseline
次要结局
- Haemoglobin A1C (HbA1C)(Changes from baseline HbA1Cat 6-month and 12-months)
- Diabetes status(6-month and 12-months follow-up)
- Systolic and diastolic blood pressure (SBP, DBP)(Changes from baseline SBP and DBP at 6-month and 12-months)
- Carotid artery intima-media thickness (cIMT)(Change in cIMT from baseline to 6-month and 12-months)
- Fasting insulin(Changes from baseline fasting insulin at 6-month and 12-months)
- Dietary intake(Changes in dietary intake from baseline to 6-month and 12-months)
- Health-related quality of life (HRQOL)(Changes in HRQOL from baseline to 6-month and 12-months)
- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)(Changes from baseline insulin sensitivity at 6-month and 12-months)
- Fasting blood glucose (FG)(Changes from baseline FG at 6-month and 12-months)
- Blood lipid profile(Changes from baseline blood lipid to 6-month and 12-months)
- Physical activity(Change in levels of physical activity from baseline to 6-month and 12-months)
研究者
Dr. Mandy M. Ho
Assistant Professor
The University of Hong Kong