Effectiveness of Integrating Motivational Instant Messaging Into an E-diabetes Prevention Programme in People at High Risk of Type 2 Diabetes: a Prospective, Parallel-group, Randomised Controlled Trial (Diabetes Stopwatch)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Physical activity (average steps per day)
研究概览
简要总结
The overall aim of this feasibility trial is to assess the effectiveness of a wearable technology and an e-diabetes prevention programme delivered via a smartphone application, including motivational messaging, in reducing weight and increasing physical activity in people at risk of developing type 2 diabetes.
详细描述
The study will examine whether a wearable technology, combined with biofeedback, motivational messaging and an e-diabetes prevention programme, is effective in reducing weight and increasing physical activity after 12 months.
The intervention will consist of a wearable technology and a smartphone application made available for a 12 month period. 22 online multimedia sessions targeting diet, physical activity and mental resilience delivered via the smartphone application. Motivational messaging based on the diabetes prevention module content and biofeedback will be sent to participants via the application.
The control group will receive the wearable technology and will have access to a smartphone application detailing their activity. Participants will be directed to the same educational material as is made available via the multimedia sessions, but will not receive motivational messages.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HbA1c between 42 and 47 mmol/mol
- •BMI≥25 kg/m²
- •Fluent in conversational English
- •Permanent resident in Lambeth, Southwark or Lewisham
- •Ownership of a smartphone (iPhone or Android only) for communication defined as logging on at least once/day to the internet
- •Ambulatory.
排除标准
- •Known diabetes
- •Pregnancy or planning pregnancy during the duration of the study
- •Severe mental illness (severe depression, psychosis, bipolar affective disorder, dementia, learning difficulties, substance problem use or dependence)
- •Severe physical disability e.g. that would prevent any increased uptake of physical exercise
- •Advanced active disease such as cancer or heart failure
- •Any other condition which requires glucose altering drugs
- •Morbid obesity (BMI ≥50 kg/m²)
- •Current participation in a weight loss programme.
- •When in doubt the investigators will seek the GP opinion and approval.
研究组 & 干预措施
Intervention
If participants are allocated to the intervention group, participants will receive the wearable technology and access to the smartphone application. Motivational messages based on diabetes prevention programme content, and biofeedback messages based on physical activity data provided via the wearable technology, will be received by participants via the application. The diabetes prevention programme educational material will be available via the application.
干预措施: Diabetes Prevention Programme educational material (Behavioral)
Intervention
If participants are allocated to the intervention group, participants will receive the wearable technology and access to the smartphone application. Motivational messages based on diabetes prevention programme content, and biofeedback messages based on physical activity data provided via the wearable technology, will be received by participants via the application. The diabetes prevention programme educational material will be available via the application.
干预措施: Wearable technology (Device)
Intervention
If participants are allocated to the intervention group, participants will receive the wearable technology and access to the smartphone application. Motivational messages based on diabetes prevention programme content, and biofeedback messages based on physical activity data provided via the wearable technology, will be received by participants via the application. The diabetes prevention programme educational material will be available via the application.
干预措施: Motivational messaging (Behavioral)
Control
If participants are allocated to the control group, participants will receive the wearable technology and will be able to access their activity data via the smartphone application. Participants will also have have access to the diabetes prevention programme educational material via the application. Participants will not receive motivational messages related to the education content or activity data.
干预措施: Wearable technology (Device)
Control
If participants are allocated to the control group, participants will receive the wearable technology and will be able to access their activity data via the smartphone application. Participants will also have have access to the diabetes prevention programme educational material via the application. Participants will not receive motivational messages related to the education content or activity data.
干预措施: Diabetes Prevention Programme educational material (Behavioral)
结局指标
主要结局
Physical activity (average steps per day)
时间窗: 7 days
Average steps taken per day from 7 days wear measured using the Buddi wearable technology, which will be worn 24 hours per day for 7 days
Weight (kg)
时间窗: At 12 month follow-up appointment
Measured in light clothing, without shoes, on the a Class 3 Tanita SC240 weighing digital scale to 0.01 kg for weight
次要结局
- HbA1c (mmol/mol)(At 12 month follow-up appointment)
- Height (cm)(At 12 month follow-up appointment)
- BMI (kg/m^2)(At 12 month follow-up appointment)
- Waist circumference (cm)(At 12 month follow-up appointment)
- Hip circumference (cm)(At 12 month follow-up appointment)
- Total cholesterol (mmol/L)(At 12 month follow-up appointment)
- High density lipoprotein cholesterol (mmol/L)(At 12 month follow-up appointment)
- Low density lipoprotein cholesterol (mmol/L)(At 12 month follow-up appointment)
- Systolic blood pressure (mmHg)(At 12 month follow-up appointment)
- Diastolic blood pressure (mmHg)(At 12 month follow-up appointment)
- Sleep duration (average hours per night)(7 days)