An interventional study of Here for Health Only and mHealth technology assisted exercise counselling in Diabetes, sponsored by Liverpool John Moores University. Completed at 2 sites in United Kingdom. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-10-02.
Sponsored by Liverpool John Moores University · Not applicable, Interventional, and Supportive care
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.
11,090 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 18 is below the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Liverpool John Moores University is the lead sponsor of 74 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
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
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
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
Eligibility Rate
Determine the number of young people referred to the paediatric diabetes team that are eligible to participate
Time frame: Through study completion, an average 32 weeks
Recruitment rate
The proportion of eligible patients who would be willing to take part in this trial
Time frame: Through study completion, an average 32 weeks
Drop out
Determine the number of young people retained at study completion (i.e., participant drop-out).
Time frame: Through study completion, an average 32 weeks
Device derived adherence to structured exercise (mHealth technology assisted exercise counselling, Only)
Number of exercise sessions per week
Time frame: Through study completion, an average 32 weeks
Device derived duration of exercise (mHealth technology assisted exercise counselling, Only)
minutes of exercise completed per session
Time frame: 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)
Time frame: Through study completion, an average 32 weeks
Device derived physical activity (GENEActiv)
Minutes of low, moderate and vigorous physical activity
Time frame: 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
Time frame: Baseline, 4, 8 12,16, 20, 24 weeks
Height
Height (m)
Time frame: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Weight
Weight (kg)
Time frame: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Body composition
bioimpedence (fat mass and lean mass)
Time frame: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Concentration of Hba1c
Hba1c
Time frame: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Blood Lipid concentrations
Total cholesterol, HDL/LDL, Triglycerides
Time frame: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Glycaemic control
Flash glucose monitoring
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: immediately following intervention 2 (24 weeks)
Parent survey on intervention acceptability (mHealth technology assisted exercise counselling)
Study specific questionnaire
Time frame: immediately following intervention 2 (24 weeks)
Patient survey on intervention acceptability (Here for Health)
Study specific questionnaire
Time frame: immediately following intervention 1 (12 weeks)
Parent survey on intervention acceptability (Here for Health)
Study specific questionnaire
Time frame: immediately following intervention 1 (12 weeks)
Plan to share: No — No plan to share
No publications or documents are linked to this record.
Ran from Sep 2021 to primary completion in Jul 2024, 34 months.
Of 2,196 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's 34 months is above that.
Counting every sponsor, half of 2,388 studies reached it within 20 months; a quarter within 9 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Liverpool John Moores University