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

Obesity, Adolescent Clinical Trial

— MOTIVATE-L  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04854915
• Other study ID #: MOTIVATE- LOOP
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: April 2021
• Source: Liverpool John Moores University
• Contact: matthew Cocks, PhD
• Phone: 07540191292
• Email: m.s.cocks[@]ljmu.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Adolescent
• Pediatric Obesity

Intervention

Behavioral:
• LOOP + mHealth technology assisted exercise counselling
Participants will complete a 3 month exercise and physical activity intervention supported by mHealth technology
• LOOP Only
Participants will complete the LOOP @ Alder Hey programme

Locations

Country	Name	City	State
United Kingdom	Alder Hey Childrens NHS Foundation Trust	Liverpool
United Kingdom	Liverpool John Moores University	Liverpool

Sponsors (2)

Lead Sponsor	Collaborator
Liverpool John Moores University	Alder Hey Children's NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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