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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Adolescent
• Intervention / Treatment: Behavioral: LOOP Only; Behavioral: LOOP + mHealth technology assisted exercise counselling

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Liverpool, United Kingdom
    • Recruiting
    • Alder Hey Childrens Nhs Foundation Trust
    • Contact: Senthil Senniappan, MD; Phone Number: 44+ 151 228 4811; Email: Senthil.Senniappan@alderhey.nhs.uk
  • Liverpool, United Kingdom, L33AF
    • Not yet recruiting
    • Liverpool John Moores University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Liverpool Overweight and Obesity Programme (LOOP) only; Patients will continue to follow the LOOP@ Alder Hey programme.	Behavioral: LOOP Only; Participants will complete the LOOP @ Alder Hey programme
EXPERIMENTAL: LOOP + mHealth technology assisted exercise counselling; 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; Participants will complete a 3 month exercise and physical activity intervention supported by mHealth technology

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Liverpool John Moores University
• Collaborators: Alder Hey Children's NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2021
• Primary Completion (ANTICIPATED): March 1, 2023
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (ACTUAL): April 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: physical activity; exercise; exercise adherence; mobile health technology; exercise prescription/ education
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: MOTIVATE- LOOP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No