MHealth Biometrics for Young People with Diabetes (MOTIVATE-HfH)

Liverpool John Moores University

Status: Completed

Conditions: Diabetes

Treatments: Behavioral: mHealth technology assisted exercise counselling; Behavioral: Here for Health Only

Study type: Interventional

Funder types: Other

Identifiers

NCT04868851

MOTIVATE HfH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Here for Health only

Active Comparator group

Description:

Patients will complete the Here for Health Healthy Lifestyle intervention designed by the Paediatric Diabetes Dietitians at Oxford University Hospitals NHS Foundation Trust.

Treatment:

Behavioral: Here for Health Only

mHealth technology assisted exercise counselling (mHealth)

Experimental group

Description:

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.

Treatment:

Behavioral: mHealth technology assisted exercise counselling