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

July 15, 2021 updated by: Liverpool John Moores University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Liverpool, United Kingdom
      • Liverpool, United Kingdom, L33AF
        • Not yet recruiting
        • Liverpool John Moores University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Liverpool Overweight and Obesity Programme (LOOP) only
Patients will continue to follow the LOOP@ Alder Hey programme.
Behavioral: LOOP Only
Participants will complete the LOOP @ Alder Hey programme
EXPERIMENTAL: 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.
Behavioral: LOOP + mHealth technology assisted exercise counselling
Participants will complete a 3 month exercise and physical activity intervention supported by mHealth technology

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: Through study completion, an average 16 weeks
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
Drop out
Time Frame: Through study completion, an average 16 weeks
Determine the number of young people retained at 3-months (i.e., participant drop-out).
Through study completion, an average 16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Device derived adherence to structured exercise
Time Frame: Up to 12 weeks
Number of exercise sessions per week
Up to 12 weeks
Device derived duration of exercise
Time Frame: Up to 12 weeks
minutes of exercise completed per session
Up to 12 weeks
Device derived intensity of structured exercise
Time Frame: Up to 12 weeks
intensity of exercise sessions performed (percentage of HR max)
Up to 12 weeks
Device derived physical activity (GENEActiv)
Time Frame: Baseline and the final 2 weeks of the intervention (weeks 10-12)
Minutes of low, moderate and vigorous physical activity
Baseline and the final 2 weeks of the intervention (weeks 10-12)
Survey reported exercise behaviour
Time Frame: Baseline, 4 and 8 weeks into the intervention and immediately after the intervention
Bouts of mild, moderate and strenuous exercise lasting ≥30 minutes
Baseline, 4 and 8 weeks into the intervention and immediately after the intervention
Height
Time Frame: Baseline and immediately after the intervention
Height (m)
Baseline and immediately after the intervention
Weight (kg)
Time Frame: Baseline and immediately after the intervention
Weight (kg)
Baseline and immediately after the intervention
Body composition
Time Frame: Baseline and immediately after the intervention
bioimpedence (fat mass (and lean mass)
Baseline and immediately after the intervention
Blood pressure
Time Frame: Baseline and immediately after the intervention
Blood pressure (systolic and diastolic)
Baseline and immediately after the intervention
Concentration of Hba1c
Time Frame: Baseline and immediately after the intervention
Hba1c
Baseline and immediately after the intervention
Fasted insulin concentration
Time Frame: Baseline and immediately after the intervention
Fasted insulin
Baseline and immediately after the intervention
Fasted glucose concentration
Time Frame: Baseline and immediately after the intervention
Fasted glucose
Baseline and immediately after the intervention
Glycaemic control
Time Frame: Baseline and the final 2 weeks of the intervention (weeks 10-12)
Flash glucose monitoring
Baseline and the final 2 weeks of the intervention (weeks 10-12)
Blood Lipid concentrations
Time Frame: Baseline and immediately after the intervention
Total cholesterol, HDL/LDL, Triglycerides
Baseline and immediately after the intervention
Liver function concentrations
Time Frame: Baseline and immediately after the intervention
AST, ALT, Albumin
Baseline and immediately after the intervention
C-peptide concentration
Time Frame: Baseline and immediately after the intervention
C-peptide
Baseline and immediately after the intervention
Health related quality of life as assessed by the PedsQL 4.0
Time Frame: Baseline and immediately after the intervention
Paediatric Quality of Life Inventory (PedsQL) 4.0 Max score 115, min score 0, high score is better
Baseline and immediately after the intervention
Health related quality of life as assessed by the EQ-5D-Y
Time Frame: Baseline and immediately after the intervention
EuroQol- 5 Dimension Youth version (EQ-5D-Y), Max score 15, min score 5, high score is better
Baseline and immediately after the intervention
Health related quality of life as assessed by the KIDSCREEN-52
Time Frame: Baseline and immediately after the intervention
KIDSCREEN-52. Max score 260, min score 52, high score is better
Baseline and immediately after the intervention
Exercise motivation
Time Frame: Baseline and immediately after the intervention
Behavioural regulation in exercise questionnaire-2 (BREQ-2). Max score 76, min score 0, high score is better
Baseline and immediately after the intervention
Patient Interview to access intervention acceptability
Time Frame: Within 2 weeks of the end of the intervention
Patient interview
Within 2 weeks of the end of the intervention
Parent Interview to access intervention acceptability
Time Frame: Within 2 weeks of the end of the intervention
Parent interview
Within 2 weeks of the end of the intervention
multidisciplinary team focus group to assess intervention acceptability
Time Frame: 1 year
Focus group with multidisciplinary LOOP team
1 year
Process evaluation
Time Frame: Within 2 weeks of the end of the intervention
Participant interview
Within 2 weeks of the end of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Liverpool John Moores University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alder Hey Children's NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MOTIVATE- LOOP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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