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mHealth Biometrics for Young People With Diabetes (MOTIVATE-HfH)

Primary Purpose

Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Here for Health Only
mHealth technology assisted exercise counselling
Sponsored by
Liverpool John Moores University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes focused on measuring mobile health technology, physical activity, exercise, exercise prescription/ education, exercise adherence

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Liverpool John Moores University
  • Oxford University Hospitals NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Here for Health only

mHealth technology assisted exercise counselling (mHealth)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Eligibility Rate
Determine the number of young people referred to the paediatric diabetes team that are eligible to participate
Recruitment rate
The proportion of eligible patients who would be willing to take part in this trial
Drop out
Determine the number of young people retained at study completion (i.e., participant drop-out).

Secondary Outcome Measures

Device derived adherence to structured exercise (mHealth technology assisted exercise counselling, Only)
Number of exercise sessions per week
Device derived duration of exercise (mHealth technology assisted exercise counselling, Only)
minutes of exercise completed per session
Device derived intensity of structured exercise (mHealth technology assisted exercise counselling, Only)
intensity of exercise sessions performed (% of HR max)
Device derived physical activity (GENEActiv)
Minutes of low, moderate and vigorous physical activity
Survey reported exercise behaviour (Godin Leisure Time Exercise Questionnaire (GLTEQ))
Bouts of mild, moderate and strenuous exercise lasting ≥30 minutes
Height
Height (m)
Weight
Weight (kg)
Body composition
bioimpedence (fat mass and lean mass)
Concentration of Hba1c
Hba1c
Blood Lipid concentrations
Total cholesterol, HDL/LDL, Triglycerides
Glycaemic control
Flash glucose monitoring
Insulin dose
Insulin dose log
Diet
Patients will be asked to complete The UK Diabetes and Diet Questionnaire (UKDDQ)
Patient survey on intervention acceptability (mHealth technology assisted exercise counselling)
Study specific questionnaire
Parent survey on intervention acceptability (mHealth technology assisted exercise counselling)
Study specific questionnaire
Patient survey on intervention acceptability (Here for Health)
Study specific questionnaire
Parent survey on intervention acceptability (Here for Health)
Study specific questionnaire

Full Information

First Posted
April 22, 2021
Last Updated
March 17, 2023
Sponsor
Liverpool John Moores University
Collaborators
Oxford University Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04868851
Brief Title
mHealth Biometrics for Young People With Diabetes
Acronym
MOTIVATE-HfH
Official Title
Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Children and Young People With Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool John Moores University
Collaborators
Oxford University Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
Keywords
mobile health technology, physical activity, exercise, exercise prescription/ education, exercise adherence

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
pilot, parallel group, randomised controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Here for Health only
Arm Type
Active Comparator
Arm Description
Patients will complete the Here for Health Healthy Lifestyle intervention designed by the Paediatric Diabetes Dietitians at Oxford University Hospitals NHS Foundation Trust.
Arm Title
mHealth technology assisted exercise counselling (mHealth)
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Here for Health Only
Intervention Description
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
Intervention Name(s)
mHealth technology assisted exercise counselling
Intervention Description
Patients will complete the Here for Health intervention before completing a 3 month exercise and physical activity intervention supported by mHealth technology
Primary Outcome Measure Information:
Title
Eligibility Rate
Description
Determine the number of young people referred to the paediatric diabetes team that are eligible to participate
Time Frame
Through study completion, an average 32 weeks
Title
Recruitment rate
Description
The proportion of eligible patients who would be willing to take part in this trial
Time Frame
Through study completion, an average 32 weeks
Title
Drop out
Description
Determine the number of young people retained at study completion (i.e., participant drop-out).
Time Frame
Through study completion, an average 32 weeks
Secondary Outcome Measure Information:
Title
Device derived adherence to structured exercise (mHealth technology assisted exercise counselling, Only)
Description
Number of exercise sessions per week
Time Frame
Through study completion, an average 32 weeks
Title
Device derived duration of exercise (mHealth technology assisted exercise counselling, Only)
Description
minutes of exercise completed per session
Time Frame
Through study completion, an average 32 weeks
Title
Device derived intensity of structured exercise (mHealth technology assisted exercise counselling, Only)
Description
intensity of exercise sessions performed (% of HR max)
Time Frame
Through study completion, an average 32 weeks
Title
Device derived physical activity (GENEActiv)
Description
Minutes of low, moderate and vigorous physical activity
Time Frame
Baseline, the final 2 weeks of intervention period 1 (weeks 10-12), and the final 2 weeks of intervention period 2 (weeks 22-24)
Title
Survey reported exercise behaviour (Godin Leisure Time Exercise Questionnaire (GLTEQ))
Description
Bouts of mild, moderate and strenuous exercise lasting ≥30 minutes
Time Frame
Baseline, 4, 8 12,16, 20, 24 weeks
Title
Height
Description
Height (m)
Time Frame
Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Title
Weight
Description
Weight (kg)
Time Frame
Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Title
Body composition
Description
bioimpedence (fat mass and lean mass)
Time Frame
Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Title
Concentration of Hba1c
Description
Hba1c
Time Frame
Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Title
Blood Lipid concentrations
Description
Total cholesterol, HDL/LDL, Triglycerides
Time Frame
Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Title
Glycaemic control
Description
Flash glucose monitoring
Time Frame
Baseline, immediately following intervention period 1 (12 weeks) and the final 2 weeks of intervention period 2 (weeks 22-24))
Title
Insulin dose
Description
Insulin dose log
Time Frame
Baseline, immediately following intervention period 1 (12 weeks) and the final 2 weeks of intervention period 2 (weeks 22-24))
Title
Diet
Description
Patients will be asked to complete The UK Diabetes and Diet Questionnaire (UKDDQ)
Time Frame
Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Title
Patient survey on intervention acceptability (mHealth technology assisted exercise counselling)
Description
Study specific questionnaire
Time Frame
immediately following intervention 2 (24 weeks)
Title
Parent survey on intervention acceptability (mHealth technology assisted exercise counselling)
Description
Study specific questionnaire
Time Frame
immediately following intervention 2 (24 weeks)
Title
Patient survey on intervention acceptability (Here for Health)
Description
Study specific questionnaire
Time Frame
immediately following intervention 1 (12 weeks)
Title
Parent survey on intervention acceptability (Here for Health)
Description
Study specific questionnaire
Time Frame
immediately following intervention 1 (12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
matthew Cocks, PhD
Phone
07540191292
Email
m.s.cocks@ljmu.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Katie Hesketh, PhD
Email
K.Hesketh@ljmu.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Cocks, PhD
Organizational Affiliation
Liverpool John Moore University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liverpool John Moores University
City
Liverpool
ZIP/Postal Code
L33AF
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Cocks, PhD
Phone
07540191292
Email
m.s.cocks@ljmu.ac.uk
Facility Name
Oxford University Hospitals NHS Foundation Trust
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Marie Frohock
Phone
01865231227
Email
anne-marie.frohock@ouh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Megan Holland
Phone
01865 231227
Email
Megan.Holland@ouh.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share

Learn more about this trial

mHealth Biometrics for Young People With Diabetes

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