MHealth Biometrics for Young People with Diabetes

NCT04868851 | Completed

• 1 other identifier: MOTIVATE HfH
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes

Keywords

mobile health technology; physical activity; exercise; exercise prescription/ education; exercise adherence

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (17)

• Device derived adherence to structured exercise (mHealth technology assisted exercise counselling, Only)

  Through study completion, an average 32 weeks

• Device derived duration of exercise (mHealth technology assisted exercise counselling, Only)

  Through study completion, an average 32 weeks

• Device derived intensity of structured exercise (mHealth technology assisted exercise counselling, Only)

  Through study completion, an average 32 weeks

• Device derived physical activity (GENEActiv)

  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))

  Baseline, 4, 8 12,16, 20, 24 weeks

Study Arms (2)

Here for Health only

ACTIVE COMPARATOR

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

mHealth technology assisted exercise counselling (mHealth)

EXPERIMENTAL

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

Interventions

Here for Health Only BEHAVIORAL

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

Here for Health only

mHealth technology assisted exercise counselling BEHAVIORAL

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

mHealth technology assisted exercise counselling (mHealth)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Severe learning/behaviour difficulties
• Severe autism
• Unstable blood glucose levels
• Glucose lowering medications other than metformin
• Underlying medical conditions that contraindicate physical activity

Sponsors & Collaborators

• Liverpool John Moores University: lead
• Oxford University Hospitals NHS Trust: collaborator

Study Sites (2)

Liverpool John Moores University

Liverpool, L33AF, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Matthew Cocks, PhD

  Liverpool John Moore University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pilot, parallel group, randomised controlled trial

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: May 3, 2021
• Study Start: September 1, 2021
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: October 2, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)