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

Primary Purpose

Obesity, Adolescent

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
LOOP + mHealth technology assisted exercise counselling
LOOP Only
Sponsored by
Liverpool John Moores University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity, Adolescent focused on measuring mobile health technology, physical activity, exercise, exercise prescription/ education, exercise adherence

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Liverpool John Moores University
  • Alder Hey Childrens NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Liverpool Overweight and Obesity Programme (LOOP) only

LOOP + mHealth technology assisted exercise counselling

Arm Description

Patients will continue to follow the LOOP@ Alder Hey programme.

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.

Outcomes

Primary Outcome Measures

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
Drop out
Determine the number of young people retained at 3-months (i.e., participant drop-out).

Secondary Outcome Measures

Device derived adherence to structured exercise
Number of exercise sessions per week
Device derived duration of exercise
minutes of exercise completed per session
Device derived intensity of structured exercise
intensity of exercise sessions performed (percentage of HR max)
Device derived physical activity (GENEActiv)
Minutes of low, moderate and vigorous physical activity
Survey reported exercise behaviour
Bouts of mild, moderate and strenuous exercise lasting ≥30 minutes
Height
Height (m)
Weight (kg)
Weight (kg)
Body composition
bioimpedence (fat mass (and lean mass)
Blood pressure
Blood pressure (systolic and diastolic)
Concentration of Hba1c
Hba1c
Fasted insulin concentration
Fasted insulin
Fasted glucose concentration
Fasted glucose
Glycaemic control
Flash glucose monitoring
Blood Lipid concentrations
Total cholesterol, HDL/LDL, Triglycerides
Liver function concentrations
AST, ALT, Albumin
C-peptide concentration
C-peptide
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
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
Health related quality of life as assessed by the KIDSCREEN-52
KIDSCREEN-52. Max score 260, min score 52, high score is better
Exercise motivation
Behavioural regulation in exercise questionnaire-2 (BREQ-2). Max score 76, min score 0, high score is better
Patient Interview to access intervention acceptability
Patient interview
Parent Interview to access intervention acceptability
Parent interview
multidisciplinary team focus group to assess intervention acceptability
Focus group with multidisciplinary LOOP team
Process evaluation
Participant interview

Full Information

First Posted
April 6, 2021
Last Updated
July 15, 2021
Sponsor
Liverpool John Moores University
Collaborators
Alder Hey Children's NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04854915
Brief Title
mHealth Biometrics for Young People With Obesity (MOTIVATE- LOOP)
Acronym
MOTIVATE-L
Official Title
Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Children and Young People With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool John Moores University
Collaborators
Alder Hey Children's NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Adolescent
Keywords
mobile health technology, physical activity, exercise, exercise prescription/ education, exercise adherence

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
pilot, parallel group, randomised controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liverpool Overweight and Obesity Programme (LOOP) only
Arm Type
Active Comparator
Arm Description
Patients will continue to follow the LOOP@ Alder Hey programme.
Arm Title
LOOP + mHealth technology assisted exercise counselling
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
LOOP + mHealth technology assisted exercise counselling
Intervention Description
Participants will complete a 3 month exercise and physical activity intervention supported by mHealth technology
Intervention Type
Behavioral
Intervention Name(s)
LOOP Only
Intervention Description
Participants will complete the LOOP @ Alder Hey programme
Primary Outcome Measure Information:
Title
Recruitment rate
Description
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
Title
Drop out
Description
Determine the number of young people retained at 3-months (i.e., participant drop-out).
Time Frame
Through study completion, an average 16 weeks
Secondary Outcome Measure Information:
Title
Device derived adherence to structured exercise
Description
Number of exercise sessions per week
Time Frame
Up to 12 weeks
Title
Device derived duration of exercise
Description
minutes of exercise completed per session
Time Frame
Up to 12 weeks
Title
Device derived intensity of structured exercise
Description
intensity of exercise sessions performed (percentage of HR max)
Time Frame
Up to 12 weeks
Title
Device derived physical activity (GENEActiv)
Description
Minutes of low, moderate and vigorous physical activity
Time Frame
Baseline and the final 2 weeks of the intervention (weeks 10-12)
Title
Survey reported exercise behaviour
Description
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
Title
Height
Description
Height (m)
Time Frame
Baseline and immediately after the intervention
Title
Weight (kg)
Description
Weight (kg)
Time Frame
Baseline and immediately after the intervention
Title
Body composition
Description
bioimpedence (fat mass (and lean mass)
Time Frame
Baseline and immediately after the intervention
Title
Blood pressure
Description
Blood pressure (systolic and diastolic)
Time Frame
Baseline and immediately after the intervention
Title
Concentration of Hba1c
Description
Hba1c
Time Frame
Baseline and immediately after the intervention
Title
Fasted insulin concentration
Description
Fasted insulin
Time Frame
Baseline and immediately after the intervention
Title
Fasted glucose concentration
Description
Fasted glucose
Time Frame
Baseline and immediately after the intervention
Title
Glycaemic control
Description
Flash glucose monitoring
Time Frame
Baseline and the final 2 weeks of the intervention (weeks 10-12)
Title
Blood Lipid concentrations
Description
Total cholesterol, HDL/LDL, Triglycerides
Time Frame
Baseline and immediately after the intervention
Title
Liver function concentrations
Description
AST, ALT, Albumin
Time Frame
Baseline and immediately after the intervention
Title
C-peptide concentration
Description
C-peptide
Time Frame
Baseline and immediately after the intervention
Title
Health related quality of life as assessed by the PedsQL 4.0
Description
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
Title
Health related quality of life as assessed by the EQ-5D-Y
Description
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
Title
Health related quality of life as assessed by the KIDSCREEN-52
Description
KIDSCREEN-52. Max score 260, min score 52, high score is better
Time Frame
Baseline and immediately after the intervention
Title
Exercise motivation
Description
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
Title
Patient Interview to access intervention acceptability
Description
Patient interview
Time Frame
Within 2 weeks of the end of the intervention
Title
Parent Interview to access intervention acceptability
Description
Parent interview
Time Frame
Within 2 weeks of the end of the intervention
Title
multidisciplinary team focus group to assess intervention acceptability
Description
Focus group with multidisciplinary LOOP team
Time Frame
1 year
Title
Process evaluation
Description
Participant interview
Time Frame
Within 2 weeks of the end of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
matthew Cocks, PhD
Phone
07540191292
Email
m.s.cocks@ljmu.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Katie Hesketh, PhD
Email
K.Hesketh@ljmu.ac.uk
Facility Information:
Facility Name
Liverpool John Moores University
City
Liverpool
ZIP/Postal Code
L33AF
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Cocks, PhD
Phone
07540191292
Email
m.s.cocks@ljmu.ac.uk
Facility Name
Alder Hey Childrens NHS Foundation Trust
City
Liverpool
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Senthil Senniappan, MD
Phone
44+ 151 228 4811
Email
Senthil.Senniappan@alderhey.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share

Learn more about this trial

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

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