Diabetes
Conditions
Keywords
mobile health technology, physical activity, exercise, exercise prescription/ education, exercise adherence
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALHere 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.
Patients will complete the Here for Health intervention before completing a 3 month exercise and physical activity intervention supported by mHealth technology
Sponsors
Oxford University Hospitals NHS Trust
Liverpool John Moores University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
pilot, parallel group, randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Severe learning/behaviour difficulties * Severe autism * Unstable blood glucose levels * Glucose lowering medications other than metformin * Underlying medical conditions that contraindicate physical activity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eligibility Rate | 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 | Through study completion, an average 32 weeks | The proportion of eligible patients who would be willing to take part in this trial |
| Drop out | Through study completion, an average 32 weeks | Determine the number of young people retained at study completion (i.e., participant drop-out). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Minutes of low, moderate and vigorous physical activity |
| Survey reported exercise behaviour (Godin Leisure Time Exercise Questionnaire (GLTEQ)) | Baseline, 4, 8 12,16, 20, 24 weeks | Bouts of mild, moderate and strenuous exercise lasting ≥30 minutes |
| Height | Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks) | Height (m) |
| Weight | Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks) | Weight (kg) |
| Body composition | Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks) | bioimpedence (fat mass and lean mass) |
| Concentration of Hba1c | Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks) | Hba1c |
| Blood Lipid concentrations | Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks) | Total cholesterol, HDL/LDL, Triglycerides |
| Device derived adherence to structured exercise (mHealth technology assisted exercise counselling, Only) | Through study completion, an average 32 weeks | Number of exercise sessions per week |
| Insulin dose | Baseline, immediately following intervention period 1 (12 weeks) and the final 2 weeks of intervention period 2 (weeks 22-24)) | Insulin dose log |
| Diet | Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks) | Patients will be asked to complete The UK Diabetes and Diet Questionnaire (UKDDQ) |
| Patient survey on intervention acceptability (mHealth technology assisted exercise counselling) | immediately following intervention 2 (24 weeks) | Study specific questionnaire |
| Parent survey on intervention acceptability (mHealth technology assisted exercise counselling) | immediately following intervention 2 (24 weeks) | Study specific questionnaire |
| Patient survey on intervention acceptability (Here for Health) | immediately following intervention 1 (12 weeks) | Study specific questionnaire |
| Parent survey on intervention acceptability (Here for Health) | immediately following intervention 1 (12 weeks) | Study specific questionnaire |
| Glycaemic control | Baseline, immediately following intervention period 1 (12 weeks) and the final 2 weeks of intervention period 2 (weeks 22-24)) | Flash glucose monitoring |
| Device derived duration of exercise (mHealth technology assisted exercise counselling, Only) | Through study completion, an average 32 weeks | minutes of exercise completed per session |
| Device derived intensity of structured exercise (mHealth technology assisted exercise counselling, Only) | Through study completion, an average 32 weeks | intensity of exercise sessions performed (% of HR max) |
Countries
United Kingdom
Outcome results
None listed