Obesity, Adolescent
Conditions
Keywords
mobile health technology, physical activity, exercise, exercise prescription/ education, exercise adherence
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.
Interventions
BEHAVIORALLOOP + mHealth technology assisted exercise counselling
Participants will complete a 3 month exercise and physical activity intervention supported by mHealth technology
BEHAVIORALLOOP Only
Participants will complete the LOOP @ Alder Hey programme
Sponsors
Alder Hey Children's NHS Foundation Trust
Liverpool John Moores University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
pilot, parallel group, randomised controlled trial
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 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 | Through study completion, an average 16 weeks | Determine the number of young people retained at 3-months (i.e., participant drop-out). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device derived duration of exercise | Up to 12 weeks | minutes of exercise completed per session |
| Device derived physical activity (GENEActiv) | Baseline and the final 2 weeks of the intervention (weeks 10-12) | Minutes of low, moderate and vigorous physical activity |
| Survey reported exercise behaviour | Baseline, 4 and 8 weeks into the intervention and immediately after the intervention | Bouts of mild, moderate and strenuous exercise lasting ≥30 minutes |
| Height | Baseline and immediately after the intervention | Height (m) |
| Weight (kg) | Baseline and immediately after the intervention | Weight (kg) |
| Body composition | Baseline and immediately after the intervention | bioimpedence (fat mass (and lean mass) |
| Blood pressure | Baseline and immediately after the intervention | Blood pressure (systolic and diastolic) |
| Concentration of Hba1c | Baseline and immediately after the intervention | Hba1c |
| Fasted insulin concentration | Baseline and immediately after the intervention | Fasted insulin |
| Fasted glucose concentration | Baseline and immediately after the intervention | Fasted glucose |
| Glycaemic control | Baseline and the final 2 weeks of the intervention (weeks 10-12) | Flash glucose monitoring |
| Device derived intensity of structured exercise | Up to 12 weeks | intensity of exercise sessions performed (percentage of HR max) |
| Liver function concentrations | Baseline and immediately after the intervention | AST, ALT, Albumin |
| C-peptide concentration | Baseline and immediately after the intervention | C-peptide |
| Health related quality of life as assessed by the PedsQL 4.0 | Baseline and immediately after the intervention | Paediatric Quality of Life Inventory (PedsQL) 4.0 Max score 115, min score 0, high score is better |
| Health related quality of life as assessed by the EQ-5D-Y | Baseline and immediately after the intervention | EuroQol- 5 Dimension Youth version (EQ-5D-Y), Max score 15, min score 5, high score is better |
| Health related quality of life as assessed by the KIDSCREEN-52 | Baseline and immediately after the intervention | KIDSCREEN-52. Max score 260, min score 52, high score is better |
| Exercise motivation | Baseline and immediately after the intervention | Behavioural regulation in exercise questionnaire-2 (BREQ-2). Max score 76, min score 0, high score is better |
| Patient Interview to access intervention acceptability | Within 2 weeks of the end of the intervention | Patient interview |
| Parent Interview to access intervention acceptability | Within 2 weeks of the end of the intervention | Parent interview |
| multidisciplinary team focus group to assess intervention acceptability | 1 year | Focus group with multidisciplinary LOOP team |
| Process evaluation | Within 2 weeks of the end of the intervention | Participant interview |
| Blood Lipid concentrations | Baseline and immediately after the intervention | Total cholesterol, HDL/LDL, Triglycerides |
| Device derived adherence to structured exercise | Up to 12 weeks | Number of exercise sessions per week |
Countries
United Kingdom
Contacts
Primary Contactmatthew Cocks, PhD
Backup ContactKatie Hesketh, PhD
Outcome results
None listed