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| Name | Class |
|---|---|
| Oxford University Hospitals NHS Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Here for Health only | Active Comparator | Patients will complete the Here for Health Healthy Lifestyle intervention designed by the Paediatric Diabetes Dietitians at Oxford University Hospitals NHS Foundation Trust. |
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| mHealth technology assisted exercise counselling (mHealth) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Here for Health Only | Behavioral | Patients will complete the Here for Health Healthy Lifestyle intervention designed by the Paediatric Diabetes Dietitians at Oxford University Hospitals NHS Foundation Trust. |
| Measure | Description | Time Frame |
|---|---|---|
| Eligibility Rate | Determine the number of young people referred to the paediatric diabetes team that are eligible to participate | Through study completion, an average 32 weeks |
| Recruitment rate | The proportion of eligible patients who would be willing to take part in this trial | Through study completion, an average 32 weeks |
| Drop out | Determine the number of young people retained at study completion (i.e., participant drop-out). | Through study completion, an average 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Device derived adherence to structured exercise (mHealth technology assisted exercise counselling, Only) | Number of exercise sessions per week | Through study completion, an average 32 weeks |
| Device derived duration of exercise (mHealth technology assisted exercise counselling, Only) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Cocks, PhD | Liverpool John Moore University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool John Moores University | Liverpool | L33AF | United Kingdom | |||
| Oxford University Hospitals NHS Foundation Trust |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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pilot, parallel group, randomised controlled trial
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| mHealth technology assisted exercise counselling | Behavioral | Patients will complete the Here for Health intervention before completing a 3 month exercise and physical activity intervention supported by mHealth technology |
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minutes of exercise completed per session |
| Through study completion, an average 32 weeks |
| Device derived intensity of structured exercise (mHealth technology assisted exercise counselling, Only) | intensity of exercise sessions performed (% of HR max) | Through study completion, an average 32 weeks |
| Device derived physical activity (GENEActiv) | Minutes of low, moderate and vigorous physical activity | 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)) | Bouts of mild, moderate and strenuous exercise lasting ≥30 minutes | Baseline, 4, 8 12,16, 20, 24 weeks |
| Height | Height (m) | Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks) |
| Weight | Weight (kg) | Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks) |
| Body composition | bioimpedence (fat mass and lean mass) | Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks) |
| Concentration of Hba1c | Hba1c | Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks) |
| Blood Lipid concentrations | Total cholesterol, HDL/LDL, Triglycerides | Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks) |
| Glycaemic control | Flash glucose monitoring | Baseline, immediately following intervention period 1 (12 weeks) and the final 2 weeks of intervention period 2 (weeks 22-24)) |
| Insulin dose | Insulin dose log | Baseline, immediately following intervention period 1 (12 weeks) and the final 2 weeks of intervention period 2 (weeks 22-24)) |
| Diet | Patients will be asked to complete The UK Diabetes and Diet Questionnaire (UKDDQ) | Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks) |
| Patient survey on intervention acceptability (mHealth technology assisted exercise counselling) | Study specific questionnaire | immediately following intervention 2 (24 weeks) |
| Parent survey on intervention acceptability (mHealth technology assisted exercise counselling) | Study specific questionnaire | immediately following intervention 2 (24 weeks) |
| Patient survey on intervention acceptability (Here for Health) | Study specific questionnaire | immediately following intervention 1 (12 weeks) |
| Parent survey on intervention acceptability (Here for Health) | Study specific questionnaire | immediately following intervention 1 (12 weeks) |
| Oxford |
| OX3 9DU |
| United Kingdom |
| D001519 | Behavior |