NCT04854915

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Liverpool John Moores University · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity, Adolescent

Interventions

Type	Name	Description
BEHAVIORAL	LOOP + mHealth technology assisted exercise counselling	Participants will complete a 3 month exercise and physical activity intervention supported by mHealth technology
BEHAVIORAL	LOOP Only	Participants will complete the LOOP @ Alder Hey programme

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2021-04-22
• Last updated: 2021-07-16

Locations

2 sites across 1 country: United Kingdom