Liverpool John Moores University
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.
Diabetes
Here for Health Only
mHealth technology assisted exercise counselling
Not Applicable
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.
Study Type : | Interventional |
Estimated Enrollment : | 30 participants |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Children and Young People With Diabetes |
Actual Study Start Date : | September 1, 2021 |
Estimated Primary Completion Date : | July 31, 2024 |
Estimated Study Completion Date : | July 31, 2024 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Here for Health only Patients will complete the Here for Health Healthy Lifestyle intervention designed by the Paediatric Diabetes Dietitians at Oxford University Hospitals NHS Foundation Trust. |
Behavioral: Here for Health Only |
Experimental: mHealth technology assisted exercise counselling (mHealth) Patients will complete the Here for Health Healthy Lifestyle intervention before completing a 12 week mHealth technology assisted exercise counselling intervention. Participants will co-develop a 3-month structured exercise and PA programme, with support from an exercise specialist. All participants will have 5 exercise consultations with their exercise specialist. The intervention will be supported by 3 mHealth elements; 1) a wrist worn fitness watch, 2) a smartphone app for patients, and 3) a coaching website for the exercise specialist. The 3 elements will be synced, allowing data to be transferred between platforms. |
Behavioral: mHealth technology assisted exercise counselling |
Ages Eligible for Study: | 12 Years to 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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Not yet recruiting
Liverpool John Moores University
Liverpool, United Kingdom, L33AF
Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom, OX3 9DU