Obesity, AdolescentMOTIVATE-LNCT04854915
mHealth Biometrics for Young People With Obesity (MOTIVATE- LOOP)
A study testing LOOP + mHealth technology assisted exercise counselling and LOOP Only in people with Obesity, Adolescent, 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 incorporated into the existing Liverpool Overweight and Obesity Programme (LOOP) at Alder Hey Children's Hospital. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Adolescent
- What is being tested?
- LOOP + mHealth technology assisted exercise counselling and LOOP Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Jul 2021to 1 Mar 2023
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients within the Liverpool Overweight and Obesity Programme aged 12-18 years
- BMI>30
- Receiving input from members of LOOP clinic at Alder Hey for weight management
- For those prescribed Metformin: Stable dose for 3-months or more
Who cannot join
- Severe learning/behaviour difficulties
- Severe autism
- Secondary causes of obesity like Cushing's disease
- Syndromic causes of obesity
- Patients on GLP-1 analogues for obesity
- Type 2 diabetes mellitus
- Require an interpreter
Trial locations and contacts
2 sites in 1 country.
Katie Hesketh, PhD contact
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Liverpool John Moores University
Liverpool, L33AF
Matthew Cocks, PhD, 07540191292, m.s.cocks@ljmu.ac.uk
- Recruiting
Alder Hey Childrens NHS Foundation Trust
Liverpool
Senthil Senniappan, MD, 44+ 151 228 4811, Senthil.Senniappan@alderhey.nhs.uk
About this study
Official title: Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Children and Young People With Obesity
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 incorporated into the existing Liverpool Overweight and Obesity Programme (LOOP) at Alder Hey Children's Hospital. The overall objective is to have an evidence-based exercise and PA intervention ready to evaluate in a future RCT.
Read the detailed description
The study will recruit patients from the Liverpool Overweight and Obesity Programme at Alder Hey Children's Hospital (LOOP@ Alder Hey). 40 participants will be recruited and randomly assigned to one of two groups (Control n=20, Intervention n=20). Patients in the control group will continue to follow the LOOP@ Alder Hey programme but physical activity sessions will be monitored during the 12-week intervention using a heart rate monitor. Importantly, the heart rate monitor will not provide any feedback to the patient. 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. Before and after the 3-month supported interventions, volunteers will participate in testing to assess changes in physical activity, blood pressure, glycaemia control, body composition and health related quality of life. Interviews with participants, parents and the LOOP Clinic multidisciplinary team will form the basis for a review of the pilot randomised control trial. Participants will also fill out 6 validated questionnaires about motivations, the impact of their condition on daily life and their typical exercise levels.
- Conditions
- Obesity, Adolescent
- Being tested
- LOOP + mHealth technology assisted exercise counselling, LOOP Only
- Keywords
- mobile health technology, physical activity, exercise, exercise prescription/ education, exercise adherence
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOOP + mHealth technology assisted exercise counsellingBehavioural
Participants will complete a 3 month exercise and physical activity intervention supported by mHealth technology
LOOP OnlyBehavioural
Participants will complete the LOOP @ Alder Hey programme
| Study group | Role | What they receive |
|---|---|---|
| Liverpool Overweight and Obesity Programme (LOOP) only | Active comparator | Patients will continue to follow the LOOP@ Alder Hey programme. Receives: Behavioral: LOOP Only |
| LOOP + mHealth technology assisted exercise counselling | Experimental | Patients will continue to work with the LOOP MDT. However, exercise and physical activity advise will be taken over by an exercise specialist. 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: LOOP + mHealth technology assisted exercise counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Determine the number of young people referred to the LOOP that are eligible to participate, the proportion of these who would be willing to take part in this trial (i.e., recruitment rate), and their characteristics
Measured: Through study completion, an average 16 weeks
Drop out
Determine the number of young people retained at 3-months (i.e., participant drop-out).
Measured: Through study completion, an average 16 weeks
Secondary outcomes (24)
Device derived adherence to structured exercise
Number of exercise sessions per week
Measured: Up to 12 weeks
Device derived duration of exercise
minutes of exercise completed per session
Measured: Up to 12 weeks
Device derived intensity of structured exercise
intensity of exercise sessions performed (percentage of HR max)
Measured: Up to 12 weeks
Device derived physical activity (GENEActiv)
Minutes of low, moderate and vigorous physical activity
Measured: Baseline and the final 2 weeks of the intervention (weeks 10-12)
Survey reported exercise behaviour
Bouts of mild, moderate and strenuous exercise lasting ≥30 minutes
Measured: Baseline, 4 and 8 weeks into the intervention and immediately after the intervention
Height
Height (m)
Measured: Baseline and immediately after the intervention
Weight (kg)
Weight (kg)
Measured: Baseline and immediately after the intervention
Body composition
bioimpedence (fat mass (and lean mass)
Measured: Baseline and immediately after the intervention
Blood pressure
Blood pressure (systolic and diastolic)
Measured: Baseline and immediately after the intervention
Concentration of Hba1c
Hba1c
Measured: Baseline and immediately after the intervention
Fasted insulin concentration
Fasted insulin
Measured: Baseline and immediately after the intervention
Fasted glucose concentration
Fasted glucose
Measured: Baseline and immediately after the intervention
Glycaemic control
Flash glucose monitoring
Measured: Baseline and the final 2 weeks of the intervention (weeks 10-12)
Blood Lipid concentrations
Total cholesterol, HDL/LDL, Triglycerides
Measured: Baseline and immediately after the intervention
Liver function concentrations
AST, ALT, Albumin
Measured: Baseline and immediately after the intervention
C-peptide concentration
C-peptide
Measured: Baseline and immediately after the intervention
Health related quality of life as assessed by the PedsQL 4.0
Paediatric Quality of Life Inventory (PedsQL) 4.0 Max score 115, min score 0, high score is better
Measured: Baseline and immediately after the intervention
Health related quality of life as assessed by the EQ-5D-Y
EuroQol- 5 Dimension Youth version (EQ-5D-Y), Max score 15, min score 5, high score is better
Measured: Baseline and immediately after the intervention
Health related quality of life as assessed by the KIDSCREEN-52
KIDSCREEN-52. Max score 260, min score 52, high score is better
Measured: Baseline and immediately after the intervention
Exercise motivation
Behavioural regulation in exercise questionnaire-2 (BREQ-2). Max score 76, min score 0, high score is better
Measured: Baseline and immediately after the intervention
Patient Interview to access intervention acceptability
Patient interview
Measured: Within 2 weeks of the end of the intervention
Parent Interview to access intervention acceptability
Parent interview
Measured: Within 2 weeks of the end of the intervention
multidisciplinary team focus group to assess intervention acceptability
Focus group with multidisciplinary LOOP team
Measured: 1 year
Process evaluation
Participant interview
Measured: Within 2 weeks of the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start1 Jul 2021
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, AdolescentStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- Alder Hey Children's NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854915
- Sponsor's protocol ID
- MOTIVATE- LOOP
- Acronym
- MOTIVATE-L
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share
Publications
Davies AP, Hesketh KL, Apperley LJ, Clarke E, Crozier A, Russon C, Sprung VS, Jones H, Kinnafick F, Senniappan S, Cocks M. Integrating an exercise specialist supported by mHealth technology to increase exercise and physical activity adherence in a paediatric Complications from Excess Weight Service (MOTIVATE-CEW): a feasibility study. Arch Dis Child. 2026 May 18;111(6):532-538. doi: 10.1136/archdischild-2025-329092.
PubMed 41735047
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. 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 Obesity
- ClinicalTrials.gov ID
- NCT04854915
- Acronym / sponsor ID
- MOTIVATE-L / MOTIVATE- LOOP
- Conditions
- Obesity, Adolescent
- Keywords
- mobile health technology, physical activity, exercise, exercise prescription/ education, exercise adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- Alder Hey Children's NHS Foundation Trust
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 22 Apr 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 incorporated into the existing Liverpool Overweight and Obesity Programme (LOOP) at Alder Hey Children's Hospital. The overall objective is to have an evidence-based exercise and PA intervention ready to evaluate in a future RCT.
Detailed description
The study will recruit patients from the Liverpool Overweight and Obesity Programme at Alder Hey Children's Hospital (LOOP@ Alder Hey). 40 participants will be recruited and randomly assigned to one of two groups (Control n=20, Intervention n=20). Patients in the control group will continue to follow the LOOP@ Alder Hey programme but physical activity sessions will be monitored during the 12-week intervention using a heart rate monitor. Importantly, the heart rate monitor will not provide any feedback to the patient. 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. Before and after the 3-month supported interventions, volunteers will participate in testing to assess changes in physical activity, blood pressure, glycaemia control, body composition and health related quality of life. Interviews with participants, parents and the LOOP Clinic multidisciplinary team will form the basis for a review of the pilot randomised control trial. Participants will also fill out 6 validated questionnaires about motivations, the impact of their condition on daily life and their typical exercise levels.
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 |
|---|---|---|
| Liverpool Overweight and Obesity Programme (LOOP) only | Active comparator | Behavioral: LOOP OnlyPatients will continue to follow the LOOP@ Alder Hey programme. |
| LOOP + mHealth technology assisted exercise counselling | Experimental | Behavioral: LOOP + mHealth technology assisted exercise counsellingPatients will continue to work with the LOOP MDT. However, exercise and physical activity advise will be taken over by an exercise specialist. 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
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients within the Liverpool Overweight and Obesity Programme aged 12-18 years
- BMI>30
- Receiving input from members of LOOP clinic at Alder Hey for weight management
- For those prescribed Metformin: Stable dose for 3-months or more
Key exclusion criteria (7 listed)
- Severe learning/behaviour difficulties
- Severe autism
- Secondary causes of obesity like Cushing's disease
- Syndromic causes of obesity
- Patients on GLP-1 analogues for obesity
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 |
|---|---|---|
| LOOP + mHealth technology assisted exercise counsellingParticipants will complete a 3 month exercise and physical activity intervention supported by mHealth technology | Behavioural | LOOP + mHealth technology assisted exercise counselling |
| LOOP OnlyParticipants will complete the LOOP @ Alder Hey programme | Behavioural | Liverpool Overweight and Obesity Programme (LOOP) only |
Primary outcome
Recruitment rate
Time frame: Through study completion, an average 16 weeks
Determine the number of young people referred to the LOOP that are eligible to participate, the proportion of these who would be willing to take part in this trial (i.e., recruitment rate), and their characteristics
Drop out
Time frame: Through study completion, an average 16 weeks
Determine the number of young people retained at 3-months (i.e., participant drop-out).
24 secondary outcomes
Device derived adherence to structured exercise
Time frame: Up to 12 weeks
Device derived duration of exercise
Time frame: Up to 12 weeks
Device derived intensity of structured exercise
Time frame: Up to 12 weeks
Device derived physical activity (GENEActiv)
Time frame: Baseline and the final 2 weeks of the intervention (weeks 10-12)
Survey reported exercise behaviour
Time frame: Baseline, 4 and 8 weeks into the intervention and immediately after the intervention
Height
Time frame: Baseline and immediately after the intervention
Weight (kg)
Time frame: Baseline and immediately after the intervention
Body composition
Time frame: Baseline and immediately after the intervention
Blood pressure
Time frame: Baseline and immediately after the intervention
Concentration of Hba1c
Time frame: Baseline and immediately after the intervention
Fasted insulin concentration
Time frame: Baseline and immediately after the intervention
Fasted glucose concentration
Time frame: Baseline and immediately after the intervention
Glycaemic control
Time frame: Baseline and the final 2 weeks of the intervention (weeks 10-12)
Blood Lipid concentrations
Time frame: Baseline and immediately after the intervention
Liver function concentrations
Time frame: Baseline and immediately after the intervention
C-peptide concentration
Time frame: Baseline and immediately after the intervention
Health related quality of life as assessed by the PedsQL 4.0
Time frame: Baseline and immediately after the intervention
Health related quality of life as assessed by the EQ-5D-Y
Time frame: Baseline and immediately after the intervention
Health related quality of life as assessed by the KIDSCREEN-52
Time frame: Baseline and immediately after the intervention
Exercise motivation
Time frame: Baseline and immediately after the intervention
Patient Interview to access intervention acceptability
Time frame: Within 2 weeks of the end of the intervention
Parent Interview to access intervention acceptability
Time frame: Within 2 weeks of the end of the intervention
multidisciplinary team focus group to assess intervention acceptability
Time frame: 1 year
Process evaluation
Time frame: Within 2 weeks of the end of the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Derived from this study: PubMed 41735047Davies AP, Hesketh KL, Apperley LJ, Clarke E, Crozier A, Russon C, Sprung VS, Jones H, Kinnafick F, Senniappan S, Cocks M. Integrating an exercise specialist supported by mHealth technology to increase exercise and physical activity adherence in a paediatric Complications from Excess Weight Service (MOTIVATE-CEW): a feasibility study. Arch Dis Child. 2026 May 18;111(6):532-538. doi: 10.1136/archdischild-2025-329092.
- Individual participant dataSharing planned: No. No plan to share
Related trials for Obesity, Adolescent
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
Overweight Adolescents, Sleep
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.
Katie Hesketh, PhD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LOOP + mHealth technology assisted exercise counselling and LOOP Only in people with Obesity, Adolescent, 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 16 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact matthew Cocks, PhD (07540191292, m.s.cocks@ljmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Through study completion, an average 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04854915, which also lists 1 linked publication.
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 16 Jul 2021.