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

Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Children and Young People with Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Behavioral: Here for Health Only; Behavioral: mHealth technology assisted exercise counselling

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Liverpool, United Kingdom, L33AF
    • Liverpool John Moores University
  • Oxford, United Kingdom, OX3 9DU
    • Oxford University Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: 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.
Experimental: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device derived adherence to structured exercise (mHealth technology assisted exercise counselling, Only)	Number of exercise sessions per week	Through study completion, an average 32 weeks
Device derived duration of exercise (mHealth technology assisted exercise counselling, Only)	minutes of exercise completed per session	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)	Through study completion, an average 32 weeks
Device derived physical activity (GENEActiv)	Minutes of low, moderate and vigorous physical activity	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	Baseline, 4, 8 12,16, 20, 24 weeks
Height	Height (m)	Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Weight	Weight (kg)	Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Body composition	bioimpedence (fat mass and lean mass)	Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Concentration of Hba1c	Hba1c	Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Blood Lipid concentrations	Total cholesterol, HDL/LDL, Triglycerides	Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Glycaemic control	Flash glucose monitoring	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	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)	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	immediately following intervention 2 (24 weeks)
Parent survey on intervention acceptability (mHealth technology assisted exercise counselling)	Study specific questionnaire	immediately following intervention 2 (24 weeks)
Patient survey on intervention acceptability (Here for Health)	Study specific questionnaire	immediately following intervention 1 (12 weeks)
Parent survey on intervention acceptability (Here for Health)	Study specific questionnaire	immediately following intervention 1 (12 weeks)

Collaborators and Investigators

• Sponsor: Liverpool John Moores University
• Collaborators: Oxford University Hospitals NHS Trust
• Investigators: Principal Investigator: Matthew Cocks, PhD, Liverpool John Moore University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; exercise; exercise adherence; mobile health technology; exercise prescription/ education
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: MOTIVATE HfH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No