DiabetesMOTIVATE-HfHNCT04868851
MHealth Biometrics for Young People with Diabetes
A study testing Here for Health Only and mHealth technology assisted exercise counselling in people with Diabetes, run by Liverpool John Moores University at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Here for Health Only and mHealth technology assisted exercise counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Sep 2021to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Severe learning/behaviour difficulties
- Severe autism
- Unstable blood glucose levels
- Glucose lowering medications other than metformin
- Underlying medical conditions that contraindicate physical activity
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Liverpool John Moores University
Liverpool, L33AF
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 9DU
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Here for Health Only, mHealth technology assisted exercise counselling
- Keywords
- mobile health technology, physical activity, exercise, exercise prescription/ education, exercise adherence
- Medical subject headings
- Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Here for Health OnlyBehavioural
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 counsellingBehavioural
Patients will complete the Here for Health intervention before completing a 3 month exercise and physical activity intervention supported by mHealth technology
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: mHealth technology assisted exercise counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility Rate
Determine the number of young people referred to the paediatric diabetes team that are eligible to participate
Measured: Through study completion, an average 32 weeks
Recruitment rate
The proportion of eligible patients who would be willing to take part in this trial
Measured: Through study completion, an average 32 weeks
Drop out
Determine the number of young people retained at study completion (i.e., participant drop-out).
Measured: Through study completion, an average 32 weeks
Secondary outcomes (17)
Device derived adherence to structured exercise (mHealth technology assisted exercise counselling, Only)
Number of exercise sessions per week
Measured: Through study completion, an average 32 weeks
Device derived duration of exercise (mHealth technology assisted exercise counselling, Only)
minutes of exercise completed per session
Measured: 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)
Measured: Through study completion, an average 32 weeks
Device derived physical activity (GENEActiv)
Minutes of low, moderate and vigorous physical activity
Measured: 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
Measured: Baseline, 4, 8 12,16, 20, 24 weeks
Height
Height (m)
Measured: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Weight
Weight (kg)
Measured: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Body composition
bioimpedence (fat mass and lean mass)
Measured: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Concentration of Hba1c
Hba1c
Measured: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Blood Lipid concentrations
Total cholesterol, HDL/LDL, Triglycerides
Measured: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Glycaemic control
Flash glucose monitoring
Measured: 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
Measured: 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)
Measured: 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
Measured: immediately following intervention 2 (24 weeks)
Parent survey on intervention acceptability (mHealth technology assisted exercise counselling)
Study specific questionnaire
Measured: immediately following intervention 2 (24 weeks)
Patient survey on intervention acceptability (Here for Health)
Study specific questionnaire
Measured: immediately following intervention 1 (12 weeks)
Parent survey on intervention acceptability (Here for Health)
Study specific questionnaire
Measured: immediately following intervention 1 (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Sep 2021
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pilot, parallel group, randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Matthew Cocks, PhD, Principal investigator, Liverpool John Moore University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868851
- Sponsor's protocol ID
- MOTIVATE HfH
- Acronym
- MOTIVATE-HfH
- Status last verified
- Mar 2023
- First submitted
- 22 Apr 2021
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Children and Young People with Diabetes
- ClinicalTrials.gov ID
- NCT04868851
- Acronym / sponsor ID
- MOTIVATE-HfH / MOTIVATE HfH
- Conditions
- Diabetes
- Keywords
- mobile health technology, physical activity, exercise, exercise prescription/ education, exercise adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pilot, parallel group, randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Here for Health only | Active comparator | Behavioral: Here for Health OnlyPatients 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 (mHealth) | Experimental | Behavioral: mHealth technology assisted exercise counsellingPatients 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- Severe learning/behaviour difficulties
- Severe autism
- Unstable blood glucose levels
- Glucose lowering medications other than metformin
- Underlying medical conditions that contraindicate physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Here for Health OnlyPatients will complete the Here for Health Healthy Lifestyle intervention designed by the Paediatric Diabetes Dietitians at Oxford University Hospitals NHS Foundation Trust. | Behavioural | Here for Health only |
| mHealth technology assisted exercise counsellingPatients will complete the Here for Health intervention before completing a 3 month exercise and physical activity intervention supported by mHealth technology | Behavioural | mHealth technology assisted exercise counselling (mHealth) |
Primary outcome
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
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
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).
17 secondary outcomes
Device derived adherence to structured exercise (mHealth technology assisted exercise counselling, Only)
Time frame: Through study completion, an average 32 weeks
Device derived duration of exercise (mHealth technology assisted exercise counselling, Only)
Time frame: Through study completion, an average 32 weeks
Device derived intensity of structured exercise (mHealth technology assisted exercise counselling, Only)
Time frame: Through study completion, an average 32 weeks
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)
Survey reported exercise behaviour (Godin Leisure Time Exercise Questionnaire (GLTEQ))
Time frame: Baseline, 4, 8 12,16, 20, 24 weeks
Height
Time frame: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Weight
Time frame: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Body composition
Time frame: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Concentration of Hba1c
Time frame: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Blood Lipid concentrations
Time frame: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Glycaemic control
Time frame: Baseline, immediately following intervention period 1 (12 weeks) and the final 2 weeks of intervention period 2 (weeks 22-24))
Insulin dose
Time frame: Baseline, immediately following intervention period 1 (12 weeks) and the final 2 weeks of intervention period 2 (weeks 22-24))
Diet
Time frame: Baseline and immediately following intervention 1 (12 weeks) and 2 (24 weeks)
Patient survey on intervention acceptability (mHealth technology assisted exercise counselling)
Time frame: immediately following intervention 2 (24 weeks)
Parent survey on intervention acceptability (mHealth technology assisted exercise counselling)
Time frame: immediately following intervention 2 (24 weeks)
Patient survey on intervention acceptability (Here for Health)
Time frame: immediately following intervention 1 (12 weeks)
Parent survey on intervention acceptability (Here for Health)
Time frame: immediately following intervention 1 (12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No. No plan to share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Cocks, PhD principal investigator
Liverpool John Moore University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Here for Health Only and mHealth technology assisted exercise counselling in people with Diabetes, run by Liverpool John Moores University at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility Rate (time frame: Through study completion, an average 32 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.