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Completed

NCT Number: NCT04868851

MHealth Biometrics for 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.

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Key information

Conditions

Diabetes Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liverpool John Moores University, Liverpool, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Eligibility Rate

    Time frame: Through study completion, an average 32 weeks

    Determine the number of young people referred to the paediatric diabetes team that are eligible to participate

  2. Recruitment rate

    Time frame: Through study completion, an average 32 weeks

    The proportion of eligible patients who would be willing to take part in this trial

  3. Drop out

    Time frame: Through study completion, an average 32 weeks

    Determine the number of young people retained at study completion (i.e., participant drop-out).

Secondary outcomes

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

    Time frame: Through study completion, an average 32 weeks

    Number of exercise sessions per week

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

    Time frame: Through study completion, an average 32 weeks

    minutes of exercise completed per session

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

    Time frame: Through study completion, an average 32 weeks

    intensity of exercise sessions performed (% of HR max)

  4. Device derived physical activity (GENEActiv)

    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)

    Minutes of low, moderate and vigorous physical activity

  5. Survey reported exercise behaviour (Godin Leisure Time Exercise Questionnaire (GLTEQ))

    Time frame: Baseline, 4, 8 12,16, 20, 24 weeks

    Bouts of mild, moderate and strenuous exercise lasting ≥30 minutes

  6. Height

    Time frame: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)

    Height (m)

  7. Weight

    Time frame: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)

    Weight (kg)

  8. Body composition

    Time frame: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)

    bioimpedence (fat mass and lean mass)

  9. Concentration of Hba1c

    Time frame: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)

    Hba1c

  10. Blood Lipid concentrations

    Time frame: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)

    Total cholesterol, HDL/LDL, Triglycerides

  11. Glycaemic control

    Time frame: Baseline, immediately following intervention period 1 (12 weeks) and the final 2 weeks of intervention period 2 (weeks 22-24))

    Flash glucose monitoring

  12. Insulin dose

    Time frame: Baseline, immediately following intervention period 1 (12 weeks) and the final 2 weeks of intervention period 2 (weeks 22-24))

    Insulin dose log

  13. Diet

    Time frame: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)

    Patients will be asked to complete The UK Diabetes and Diet Questionnaire (UKDDQ)

  14. Patient survey on intervention acceptability (mHealth technology assisted exercise counselling)

    Time frame: immediately following intervention 2 (24 weeks)

    Study specific questionnaire

  15. Parent survey on intervention acceptability (mHealth technology assisted exercise counselling)

    Time frame: immediately following intervention 2 (24 weeks)

    Study specific questionnaire

  16. Patient survey on intervention acceptability (Here for Health)

    Time frame: immediately following intervention 1 (12 weeks)

    Study specific questionnaire

  17. Parent survey on intervention acceptability (Here for Health)

    Time frame: immediately following intervention 1 (12 weeks)

    Study specific questionnaire

Sponsors and collaborators

Lead sponsor

Liverpool John Moores University

Other

Collaborators

  • Oxford University Hospitals NHS Trust

Registry information

Official study title

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

Acronym: MOTIVATE-HfH

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 3, 2021
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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