Effectiveness of Behavioural Economics-based Incentives on Glycaemic Control and Lifestyle in Adults With Newly Diagnosed Type 2 Diabetes: a Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Glycaemic control
研究概览
简要总结
A randomised control trial of adults with newly diagnosed type 2 diabetes to assess the effectiveness of behavioural economics-based incentives on healthy lifestyle behaviour, using a pragmatic trial approach.
详细描述
This is a randomised control trial of adults aged 30-70 with newly diagnosed type 2 diabetes within a year in Hong Kong to compare the effectiveness of financial incentives and combined financial and social incentives against a control group receiving standard care. We plan to recruit 261 participants and follow them for 9-months (6-month intervention period and a 3-month post-intervention follow-up period) to assess glycemic control and other health indicators. Participants will be randomly assigned to one of three groups (in ratio 1:1:1): arm A (financial incentives in addition to standard care), arm B (financial and social incentives in addition to standard care), and arm C (control arm receiving standard care). Financial incentives will be framed around loss aversion and the endowment effect. Social incentives will include peer competition, and social support. Financial and social incentives are to encourage increased physical activity and participants will use a pedometer to track activity. Participants are followed for an additional 3-months after the cessation of incentives to assess the sustainability of lifestyle changes.
This trial adopts a pragmatic study design based on the PRECIS-2 tool and RE-AIM frameworks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese adults aged 30-70 years
- •Capable of providing informed consent
- •Resident in Hong Kong
- •Able to communicate in English or Chinese
- •Diagnosed with type 2 diabetes within past year
- •6.5% ≤ HbA1c ≤ 9.0%
- •Willing to take blood tests
- •Access to a phone to track physical activity and receive text messages
- •Physically mobile for duration of the trial
排除标准
- •Planned surgery in the next 6 months
- •Biological impairment or health condition affecting the ability to walk, such as blindness, physical immobility, and paralysis
- •Pregnant or breastfeeding
- •On insulin for diabetes control
结局指标
主要结局
Glycaemic control
时间窗: Baseline, 6-months, and 9-months
The change in HbA1c levels
次要结局
- Walking performance(Weekly)
- Changes in lipid profile(Baseline, 6-months, and 9-months)
- Change in blood pressure(Baseline, 6-months, and 9-months)
- Body weight control(Baseline, 6-months, and 9-months)
- Glycaemic control(6-months and 9-months)
- Glycaemic control (addition of medications)(6-months and 9-months)
- Level of physical activity(Baseline, 6-months and 9-months)
- Diabetes control(Baseline, 6-months, and 9-months)