Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes: A Pilot Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Determine the number of adults with newly diagnosed T2D that are eligible to participate in the trial
研究概览
简要总结
Being physically active and exercising is important for the treatment of Type 2 diabetes as it helps control blood sugar and improve physical function. Lots of people find it hard to be physically active and sticking with exercise is difficult for most people. In this project we will investigate two strategies to support people with Type 2 diabetes to increase and then maintain a physically active lifestyle, which includes exercising regularly. Participants in one group (Exercise Counselling) will complete a 6-month structured exercise and physical activity programme supported by regular (virtual) contact with an exercise specialist. Participants in the second group (Mobile health technology (mHealth)) will receive the same 6-month exercise and physical activity programme supported by an exercise specialist, but participants in this group will also receive a fitness watch that links to a mobile phone application (App). The fitness watch and mobile App will allow the exercise specialist to provide greater support and feedback throughout the programme.
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
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with T2D within the previous 5-24 months
- •Male or Female
- •Aged 40-75
- •Treat diabetes with only Metformin or lifestyle modifications (diet and exercise)
- •For those prescribed Metformin: have used a stable dose for 3-months or more
排除标准
- •Aged under 40 or over 75
- •Glycated hemoglobin level (HbA1c) more than 10% (>86mmol/mol)
- •Blood pressure higher than 160/110 mmHg
- •Treat diabetes with an antidiabetic drug other than Metformin (Sulfonylureas, Thiazolidinedione, dipeptidylpeptidase-4 inhibitors, sodium glucose co-transporter 2 inhibitors, glucagon-like peptide-1 receptor agonist, Acarbose, meglitinides)
- •Prescription of Insulin
- •Unstable angina (frequent chest pain)
- •Myocardial infarction (heart attack) within the previous 3 months
- •Transient ischemic attack (TIA) within the previous 6 months
- •Heart failure ≥class 2
- •Arrhythmia
- •Inability to increase activity
- •Pregnancy or planning to become pregnant
- •Less than 6 months post childbirth or stopped breastfeeding less than 1 month ago
- •Not owning a smartphone/ or having no data plan or access to WiFi
- •currently meeting the recommended exercise guidelines (150 min of moderate intensity exercise per week).
结局指标
主要结局
Determine the number of adults with newly diagnosed T2D that are eligible to participate in the trial
时间窗: 0-12 months
Information will be collected on: - The number of patients approached and reasons for not joining the study
The characteristics of these adults with newly diagnosed T2D who are willing to take part in the trial
时间窗: 0-12 months
Information will be collected on: - Patient gender, age, and how patients are currently treating their T2D
The number of these adults with newly diagnosed T2D who would be willing to take part in this trial
时间窗: 0-12 months
Information will be collected on: - The number of patients who actually enroll
The number and percentage of participants retained at 12-months.
时间窗: 0-12 months
Information will be collected on: - Number and percentage of patients attending at 12-month follow up and reasons for drop-out.
次要结局
- Change in glycaemic control(0 months, 0-6 months, 0-12 months)
- Adherence to exercise(0 months, 0-6 months, 0-12 months)
- Change in body composition(0 months, 0-6 months, 0-12 months)
- Change in weight(0 months, 0-6 months, 0-12 months)
- Change in waist circumference(0 months, 0-6 months, 0-12 months)
- Change in blood pressure(0 months, 0-6 months, 0-12 months)
- Change in blood lipids(0 months, 0-6 months, 0-12 months)
- Diabetes related quality of life(0 months, 0-6 months, 0-12 months)
- Behavioural regulation in exercise(0 months, 0-6 months, 0-12 months)
- Patient rapport with counsellor(0 months, 0-6 months, 0-12 months)
研究者
Jonathan Little
associate professor
University of British Columbia