MHealth Biometrics for Young People with Diabetes

NCT ID: NCT04868851

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2024-07-31

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Here for Health only

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

Group Type: ACTIVE_COMPARATOR

Here for Health Only

Intervention Type: BEHAVIORAL

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

mHealth technology assisted exercise counselling (mHealth)

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.

Group Type: EXPERIMENTAL

mHealth technology assisted exercise counselling

Intervention Type: BEHAVIORAL

Patients will complete the Here for Health intervention before completing a 3 month exercise and physical activity intervention supported by mHealth technology

Interventions

Here for Health Only

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

Intervention Type: BEHAVIORAL

mHealth technology assisted exercise counselling

Patients will complete the Here for Health intervention before completing a 3 month exercise and physical activity intervention supported by mHealth technology

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

Liverpool John Moores University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Cocks, PhD

Role: PRINCIPAL_INVESTIGATOR

Liverpool John Moore University

Locations

Liverpool John Moores University

Liverpool, , United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, , United Kingdom

Countries

United Kingdom

Other Identifiers

MOTIVATE HfH

Identifier Type: -

Identifier Source: org_study_id