mHealth Biometrics for Young People With Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Children and Young People With Diabetes

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: Here for Health Only
* Behavioral: mHealth technology assisted exercise counselling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: pilot, parallel group, randomised controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Here for Health only<br>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<br>* Patients will complete the Here for Health Healthy Lifestyle intervention designed by the Paediatric Diabetes Dietitians at Oxford University Hospitals NHS Foundation Trust.<br>|
| Experimental: mHealth technology assisted exercise counselling (mHealth)<br>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<br>* Patients will complete the Here for Health intervention before completing a 3 month exercise and physical activity intervention supported by mHealth technology<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobile health technology, physical activity, exercise, exercise prescription/ education, exercise adherence