mHealth Biometrics for Young People With Diabetes

Diabetes Clinical Trial

— MOTIVATE-HfH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04868851
• Other study ID #: MOTIVATE HfH
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: March 2023
• Source: Liverpool John Moores University
• Contact: matthew Cocks, PhD
• Phone: 07540191292
• Email: m.s.cocks[@]ljmu.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

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.
• 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

Locations

Country	Name	City	State
United Kingdom	Liverpool John Moores University	Liverpool
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
Liverpool John Moores University	Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Recruitment rate	The proportion of eligible patients who would be willing to take part in this trial	Through study completion, an average 32 weeks
Primary	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	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
Secondary	Device derived duration of exercise (mHealth technology assisted exercise counselling, Only)	minutes of exercise completed per session	Through study completion, an average 32 weeks
Secondary	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
Secondary	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)
Secondary	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
Secondary	Height	Height (m)	Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Secondary	Weight	Weight (kg)	Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Secondary	Body composition	bioimpedence (fat mass and lean mass)	Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Secondary	Concentration of Hba1c	Hba1c	Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Secondary	Blood Lipid concentrations	Total cholesterol, HDL/LDL, Triglycerides	Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Secondary	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))
Secondary	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))
Secondary	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)
Secondary	Patient survey on intervention acceptability (mHealth technology assisted exercise counselling)	Study specific questionnaire	immediately following intervention 2 (24 weeks)
Secondary	Parent survey on intervention acceptability (mHealth technology assisted exercise counselling)	Study specific questionnaire	immediately following intervention 2 (24 weeks)
Secondary	Patient survey on intervention acceptability (Here for Health)	Study specific questionnaire	immediately following intervention 1 (12 weeks)
Secondary	Parent survey on intervention acceptability (Here for Health)	Study specific questionnaire	immediately following intervention 1 (12 weeks)