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

Liverpool John Moores University

Status: Unknown

Conditions: Obesity, Adolescent

Treatments: Behavioral: LOOP + mHealth technology assisted exercise counselling; Behavioral: LOOP Only

Study type: Interventional

Funder types: Other

Identifiers

NCT04854915

MOTIVATE- LOOP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Liverpool Overweight and Obesity Programme (LOOP) only

Active Comparator group

Description:

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

Treatment:

Behavioral: LOOP Only

LOOP + mHealth technology assisted exercise counselling

Experimental group

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.

Treatment:

Behavioral: LOOP + mHealth technology assisted exercise counselling