Walking Away From Type 2 Diabetes: a Cluster Randomized Controlled Trial to Investigate the Effect of Structured Education on Walking Activity in Those With a High Risk of Developing Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 833
- 试验地点
- 2
- 主要终点
- Change in ambulatory activity (walking)
研究概览
简要总结
Diabetes is a debilitating chronic disease reaching epidemic proportions. Lack of physical activity is a key factor driving this epidemic and it is therefore vital that workable methods of encouraging people to exercise and reducing inactivity are developed and tested if we are to stem the rising tide of diabetes.
This cluster randomised controlled trial will investigate whether a person-centred group educational programme can increase walking activity and reduce the risk of developing diabetes in high-risk individuals identified in primary care settings. In total 804 patients will be recruited to the study. Physical activity levels, glucose control, incidence of type 2 diabetes and anthropometric measurements (e.g. weight) will be tested on an annual basis over three years.
This trial will be the first to test the feasibility, efficacy and value for money of a physical activity intervention aimed at reducing the risk of diabetes in a community setting in a multi-ethnic population in the UK.
Primary research hypothesis: A pragmatic structured education programme aimed at promoting walking activity initiates long-term increases in physical activity in individuals identified through a risk score as having an increased risk of developing type 2 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High risk of developing type 2 diabetes as identified through a risk score
排除标准
- •Diagnosed diabetes
- •Taking steroid medication
- •Serious chronic illness preventing participation in trial
- •Unable to speak English
结局指标
主要结局
Change in ambulatory activity (walking)
时间窗: 12 months
次要结局
- Health related quality of life(12 months; 24 months; 36 months)
- Change in ambulatory activity (walking)(24 months; 36 months)
- Depression(12 months; 24 months; 36 months)
- Light-, moderate- and vigorous-intensity physical activity(12 months; 24 months; 36 months)
- Time spent in sedentary activities(12 months; 24 months; 36 months)
- Fasting and 2-hour post-challenge plasma glucose(12 months; 24 months; 36 months)
- Standard anthropometric variables(12 months; 24 months; 36 months)
- Visceral adiposity (sub-set of participants)(12 months; 24 months; 36 months)
- Muscle mass (sub-set of participants)(12 months; 24 months; 36 months)
- Glycosylated hemoglobin (HbA1c)(12 months; 24 months; 36 months)
- Advanced glycation end products(12 months; 24 months; 36 months)
- Fasting and 2-hour post-challange plasma insulin(12 months; 24 months; 36 months)
- Adipokines (leptin, interleukin 6 and tumor necrosis factor alpha)(12 months; 24 months; 36 months)
- C-reactive protein(12 months; 24 months; 36 months)
- Illness perceptions and efficacy beliefs(12 months; 24 months; 36 months)