mHealth Biometrics for Young People With Obesity (MOTIVATE- LOOP)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Children and Young People With Obesity

Conditions
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Obesity, Adolescent

Intervention / Treatment
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* Behavioral: LOOP + mHealth technology assisted exercise counselling
* Behavioral: LOOP Only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: pilot, parallel group, randomised controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liverpool Overweight and Obesity Programme (LOOP) only<br>Patients will continue to follow the LOOP@ Alder Hey programme. | Behavioral: LOOP Only<br>* Participants will complete the LOOP @ Alder Hey programme<br>|
| Experimental: LOOP + mHealth technology assisted exercise counselling<br>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. | Behavioral: LOOP + mHealth technology assisted exercise counselling<br>* Participants will complete a 3 month exercise and physical activity intervention supported by mHealth technology<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Through study completion, an average 16 weeks | 
| Drop out | Determine the number of young people retained at 3-months (i.e., participant drop-out). | Through study completion, an average 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device derived adherence to structured exercise | Number of exercise sessions per week | Up to 12 weeks | 
| Device derived duration of exercise | minutes of exercise completed per session | Up to 12 weeks | 
| Device derived intensity of structured exercise | intensity of exercise sessions performed (percentage of HR max) | Up to 12 weeks | 
| Device derived physical activity (GENEActiv) | Minutes of low, moderate and vigorous physical activity | 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 | Baseline, 4 and 8 weeks into the intervention and immediately after the intervention | 
| Height | Height (m) | Baseline and immediately after the intervention | 
| Weight (kg) | Weight (kg) | Baseline and immediately after the intervention | 
| Body composition | bioimpedence (fat mass (and lean mass) | Baseline and immediately after the intervention | 
| Blood pressure | Blood pressure (systolic and diastolic) | Baseline and immediately after the intervention | 
| Concentration of Hba1c | Hba1c | Baseline and immediately after the intervention | 
| Fasted insulin concentration | Fasted insulin | Baseline and immediately after the intervention | 
| Fasted glucose concentration | Fasted glucose | Baseline and immediately after the intervention | 
| Glycaemic control | Flash glucose monitoring | Baseline and the final 2 weeks of the intervention (weeks 10-12) | 
| Blood Lipid concentrations | Total cholesterol, HDL/LDL, Triglycerides | Baseline and immediately after the intervention | 
| Liver function concentrations | AST, ALT, Albumin | Baseline and immediately after the intervention | 
| C-peptide concentration | C-peptide | 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 | 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 | 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 | 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 | Baseline and immediately after the intervention | 
| Patient Interview to access intervention acceptability | Patient interview | Within 2 weeks of the end of the intervention | 
| Parent Interview to access intervention acceptability | Parent interview | Within 2 weeks of the end of the intervention | 
| multidisciplinary team focus group to assess intervention acceptability | Focus group with multidisciplinary LOOP team | 1 year | 
| Process evaluation | Participant interview | Within 2 weeks of the end of the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, mobile health technology, physical activity, exercise prescription/ education, exercise adherence