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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-03-01

Brief Summary

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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.

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Detailed Description

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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

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Obesity, Adolescent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

pilot, parallel group, randomised controlled trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Liverpool Overweight and Obesity Programme (LOOP) only

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

Group Type ACTIVE_COMPARATOR

LOOP Only

Intervention Type BEHAVIORAL

Participants will complete the LOOP @ Alder Hey programme

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.

Group Type EXPERIMENTAL

LOOP + mHealth technology assisted exercise counselling

Intervention Type BEHAVIORAL

Participants will complete a 3 month exercise and physical activity intervention supported by mHealth technology

Interventions

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LOOP + mHealth technology assisted exercise counselling

Participants will complete a 3 month exercise and physical activity intervention supported by mHealth technology

Intervention Type BEHAVIORAL

LOOP Only

Participants will complete the LOOP @ Alder Hey programme

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes