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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
Participants will complete a 3 month exercise and physical activity intervention supported by mHealth technology
Participants will complete the LOOP @ Alder Hey programme
Liverpool John Moores University
Liverpool, United Kingdom
NOT_YET_RECRUITINGAlder Hey Childrens NHS Foundation Trust
Liverpool, United Kingdom
RECRUITINGRecruitment 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
Time frame: Through study completion, an average 16 weeks
Drop out
Determine the number of young people retained at 3-months (i.e., participant drop-out).
Time frame: Through study completion, an average 16 weeks
Device derived adherence to structured exercise
Number of exercise sessions per week
Time frame: Up to 12 weeks
Device derived duration of exercise
minutes of exercise completed per session
Time frame: Up to 12 weeks
Device derived intensity of structured exercise
intensity of exercise sessions performed (percentage of HR max)
Time frame: Up to 12 weeks
Device derived physical activity (GENEActiv)
Minutes of low, moderate and vigorous physical activity
Time frame: 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
Time frame: Baseline, 4 and 8 weeks into the intervention and immediately after the intervention
Height
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Height (m)
Time frame: Baseline and immediately after the intervention
Weight (kg)
Weight (kg)
Time frame: Baseline and immediately after the intervention
Body composition
bioimpedence (fat mass (and lean mass)
Time frame: Baseline and immediately after the intervention
Blood pressure
Blood pressure (systolic and diastolic)
Time frame: Baseline and immediately after the intervention
Concentration of Hba1c
Hba1c
Time frame: Baseline and immediately after the intervention
Fasted insulin concentration
Fasted insulin
Time frame: Baseline and immediately after the intervention
Fasted glucose concentration
Fasted glucose
Time frame: Baseline and immediately after the intervention
Glycaemic control
Flash glucose monitoring
Time frame: Baseline and the final 2 weeks of the intervention (weeks 10-12)
Blood Lipid concentrations
Total cholesterol, HDL/LDL, Triglycerides
Time frame: Baseline and immediately after the intervention
Liver function concentrations
AST, ALT, Albumin
Time frame: Baseline and immediately after the intervention
C-peptide concentration
C-peptide
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and immediately after the intervention
Patient Interview to access intervention acceptability
Patient interview
Time frame: Within 2 weeks of the end of the intervention
Parent Interview to access intervention acceptability
Parent interview
Time frame: Within 2 weeks of the end of the intervention
multidisciplinary team focus group to assess intervention acceptability
Focus group with multidisciplinary LOOP team
Time frame: 1 year
Process evaluation
Participant interview
Time frame: Within 2 weeks of the end of the intervention