Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Children and Young People with Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Eligibility Rate
研究概览
简要总结
The investigators aim to undertake a feasibility randomised controlled trial (RCT) to investigate whether mHealth technology, allowing biometric informed feedback and coaching on exercise and PA, can be effective in children with diabetes. The overall objective is to have an evidence-based exercise and PA intervention ready to evaluate in a future RCT.
详细描述
Staff from the Children's Diabetes team at Oxford University Hospitals NHS Foundation Trust will identify patients during routine multidisciplinary team (MDT) clinics. 30 young people with diabetes will be recruited and randomly assigned to one of two groups (Active control n=15, Intervention n=15). Following baseline measures all patients will then complete the 12 week Here for Health (HfH) Healthy lifestyle programme designed by the Diabetes team at Oxford University Hospitals NHS Foundation Trust. Following the initial HfH intervention period assessments will be repeated (T2) before a second 12 week intervention period is completed. Active control patients will receive no further input. The intervention group will be provided with exercise counselling and to support this they will also be provide with a wristwatch that can monitor everyday activity and their heart rate, a smartphone app and access to a website. The intervention group will also participate in 5 consultations with an exercise specialist to plan their exercise programme and be updated on their progress towards physical activity targets. Weekly text message updates will also provide feedback to the intervention group with participants able to respond to these updates. Following the second intervention period assessments will be repeated for a final time (T3). Testing at baseline and following the 2 interventions will include changes in physical activity, blood pressure, glycaemia control, body composition and diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving input from the Here for Health Healthy Lifestyle Programme
- •Aged 12-18 years
- •Diagnosed with type 1 diabetes
- •Type 1 diabetes diagnosis more than 1 year ago
- •Hypoglycaemic aware or on a continuous glucose monitor (CGM) with alarms
- •Willing to attend additional education on managing blood glucose and exercise
- •Diagnosed with type 2 diabetes and on a stable metformin dose for 3-months or more
- •BMI centile > 91st
- •Access to internet-enabled device for video calling
排除标准
- •Severe learning/behaviour difficulties
- •Severe autism
- •Unstable blood glucose levels
- •Glucose lowering medications other than metformin
- •Underlying medical conditions that contraindicate physical activity
结局指标
主要结局
Eligibility Rate
时间窗: Through study completion, an average 32 weeks
Determine the number of young people referred to the paediatric diabetes team that are eligible to participate
Recruitment rate
时间窗: Through study completion, an average 32 weeks
The proportion of eligible patients who would be willing to take part in this trial
Drop out
时间窗: Through study completion, an average 32 weeks
Determine the number of young people retained at study completion (i.e., participant drop-out).
次要结局
- Height(Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks))
- Body composition(Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks))
- Diet(Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks))
- Device derived intensity of structured exercise (mHealth technology assisted exercise counselling, Only)(Through study completion, an average 32 weeks)
- Concentration of Hba1c(Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks))
- Insulin dose(Baseline, immediately following intervention period 1 (12 weeks) and the final 2 weeks of intervention period 2 (weeks 22-24)))
- Device derived adherence to structured exercise (mHealth technology assisted exercise counselling, Only)(Through study completion, an average 32 weeks)
- Device derived duration of exercise (mHealth technology assisted exercise counselling, Only)(Through study completion, an average 32 weeks)
- Blood Lipid concentrations(Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks))
- Parent survey on intervention acceptability (Here for Health)(immediately following intervention 1 (12 weeks))
- Device derived physical activity (GENEActiv)(Baseline, the final 2 weeks of intervention period 1 (weeks 10-12), and the final 2 weeks of intervention period 2 (weeks 22-24))
- Survey reported exercise behaviour (Godin Leisure Time Exercise Questionnaire (GLTEQ))(Baseline, 4, 8 12,16, 20, 24 weeks)
- Weight(Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks))
- Patient survey on intervention acceptability (Here for Health)(immediately following intervention 1 (12 weeks))
- Glycaemic control(Baseline, immediately following intervention period 1 (12 weeks) and the final 2 weeks of intervention period 2 (weeks 22-24)))
- Patient survey on intervention acceptability (mHealth technology assisted exercise counselling)(immediately following intervention 2 (24 weeks))
- Parent survey on intervention acceptability (mHealth technology assisted exercise counselling)(immediately following intervention 2 (24 weeks))