Clinical trial NCT04854915: mHealth Biometrics for Young People With Obesity (MOTIVATE- LOOP)
Official title: Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Children and Young People With Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity, Adolescent
Keywords: mobile health technology
physical activity
exercise
exercise prescription/ education
exercise adherence
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
Collaborators: name: Alder Hey Children's NHS Foundation Trust
First posted: 2021-04-22
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pilot, parallel group, randomised controlled trial
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Recruitment rate
timeFrame: Through study completion, an average 16 weeks
measure: Drop out
timeFrame: Through study completion, an average 16 weeks
Secondary outcomes:
measure: Device derived adherence to structured exercise
timeFrame: Up to 12 weeks
measure: Device derived duration of exercise
timeFrame: Up to 12 weeks
measure: Device derived intensity of structured exercise
timeFrame: Up to 12 weeks
measure: Device derived physical activity (GENEActiv)
timeFrame: Baseline and the final 2 weeks of the intervention (weeks 10-12)
measure: Survey reported exercise behaviour
timeFrame: Baseline, 4 and 8 weeks into the intervention and immediately after the intervention
measure: Height
timeFrame: Baseline and immediately after the intervention
measure: Weight (kg)
timeFrame: Baseline and immediately after the intervention
measure: Body composition
timeFrame: Baseline and immediately after the intervention
measure: Blood pressure
timeFrame: Baseline and immediately after the intervention
measure: Concentration of Hba1c
timeFrame: Baseline and immediately after the intervention
measure: Fasted insulin concentration
timeFrame: Baseline and immediately after the intervention
measure: Fasted glucose concentration
timeFrame: Baseline and immediately after the intervention
measure: Glycaemic control
timeFrame: Baseline and the final 2 weeks of the intervention (weeks 10-12)
measure: Blood Lipid concentrations
timeFrame: Baseline and immediately after the intervention
measure: Liver function concentrations
timeFrame: Baseline and immediately after the intervention
measure: C-peptide concentration
timeFrame: Baseline and immediately after the intervention
measure: Health related quality of life as assessed by the PedsQL 4.0
timeFrame: Baseline and immediately after the intervention
measure: Health related quality of life as assessed by the EQ-5D-Y
timeFrame: Baseline and immediately after the intervention
measure: Health related quality of life as assessed by the KIDSCREEN-52
timeFrame: Baseline and immediately after the intervention
measure: Exercise motivation
timeFrame: Baseline and immediately after the intervention
measure: Patient Interview to access intervention acceptability
timeFrame: Within 2 weeks of the end of the intervention
measure: Parent Interview to access intervention acceptability
timeFrame: Within 2 weeks of the end of the intervention
measure: multidisciplinary team focus group to assess intervention acceptability
timeFrame: 1 year
measure: Process evaluation
timeFrame: Within 2 weeks of the end of the intervention
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool John Moores University
city: Liverpool
country: United Kingdom
facility: Alder Hey Childrens NHS Foundation Trust
Study officials:
References: