Clinical trial NCT04868851: MHealth Biometrics for Young People with Diabetes
Official title: Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Children and Young People with Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: mobile health technology
physical activity
exercise
exercise prescription/ education
exercise adherence
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
Collaborators: name: Oxford University Hospitals NHS Trust
First posted: 2021-05-03
Enrollment: 18
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pilot, parallel group, randomised controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Eligibility Rate
timeFrame: Through study completion, an average 32 weeks
measure: Recruitment rate
timeFrame: Through study completion, an average 32 weeks
measure: Drop out
timeFrame: Through study completion, an average 32 weeks
Secondary outcomes:
measure: Device derived adherence to structured exercise (mHealth technology assisted exercise counselling, Only)
timeFrame: Through study completion, an average 32 weeks
measure: Device derived duration of exercise (mHealth technology assisted exercise counselling, Only)
timeFrame: Through study completion, an average 32 weeks
measure: Device derived intensity of structured exercise (mHealth technology assisted exercise counselling, Only)
timeFrame: Through study completion, an average 32 weeks
measure: Device derived physical activity (GENEActiv)
timeFrame: Baseline, the final 2 weeks of intervention period 1 (weeks 10-12), and the final 2 weeks of intervention period 2 (weeks 22-24)
measure: Survey reported exercise behaviour (Godin Leisure Time Exercise Questionnaire (GLTEQ))
timeFrame: Baseline, 4, 8 12,16, 20, 24 weeks
measure: Height
timeFrame: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
measure: Weight
timeFrame: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
measure: Body composition
timeFrame: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
measure: Concentration of Hba1c
timeFrame: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
measure: Blood Lipid concentrations
timeFrame: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
measure: Glycaemic control
timeFrame: Baseline, immediately following intervention period 1 (12 weeks) and the final 2 weeks of intervention period 2 (weeks 22-24))
measure: Insulin dose
timeFrame: Baseline, immediately following intervention period 1 (12 weeks) and the final 2 weeks of intervention period 2 (weeks 22-24))
measure: Diet
timeFrame: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
measure: Patient survey on intervention acceptability (mHealth technology assisted exercise counselling)
timeFrame: immediately following intervention 2 (24 weeks)
measure: Parent survey on intervention acceptability (mHealth technology assisted exercise counselling)
timeFrame: immediately following intervention 2 (24 weeks)
measure: Patient survey on intervention acceptability (Here for Health)
timeFrame: immediately following intervention 1 (12 weeks)
measure: Parent survey on intervention acceptability (Here for Health)
timeFrame: immediately following intervention 1 (12 weeks)
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool John Moores University
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
Study officials:
affiliation: Liverpool John Moore University
name: Matthew Cocks, PhD
role: PRINCIPAL_INVESTIGATOR
References: