NCT04854915

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

July 16, 2021

Status Verified

April 1, 2021

Enrollment Period

1.7 years

First QC Date

April 6, 2021

Last Update Submit

July 15, 2021

Conditions

Obesity, Adolescent

Keywords

mobile health technologyphysical activityexerciseexercise prescription/ educationexercise adherence

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (24)

  • Device derived adherence to structured exercise

    Up to 12 weeks

  • Device derived duration of exercise

    Up to 12 weeks

  • Device derived intensity of structured exercise

    Up to 12 weeks

  • Device derived physical activity (GENEActiv)

    Baseline and the final 2 weeks of the intervention (weeks 10-12)

  • Survey reported exercise behaviour

    Baseline, 4 and 8 weeks into the intervention and immediately after the intervention

  • +19 more secondary outcomes

Study Arms (2)

Liverpool Overweight and Obesity Programme (LOOP) only

ACTIVE COMPARATOR

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

Behavioral: LOOP Only

LOOP + mHealth technology assisted exercise counselling

EXPERIMENTAL

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

Interventions

LOOP + mHealth technology assisted exercise counsellingBEHAVIORAL

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

LOOP + mHealth technology assisted exercise counselling
LOOP OnlyBEHAVIORAL

Participants will complete the LOOP @ Alder Hey programme

Liverpool Overweight and Obesity Programme (LOOP) only

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Liverpool John Moores University

Liverpool, L33AF, United Kingdom

NOT YET RECRUITING

Alder Hey Childrens NHS Foundation Trust

Liverpool, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pediatric ObesityMotor Activity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Central Study Contacts

matthew Cocks, PhD

CONTACT

07540191292m.s.cocks@ljmu.ac.uk

Katie Hesketh, PhD

CONTACT

K.Hesketh@ljmu.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: pilot, parallel group, randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2021

First Posted

April 22, 2021

Study Start

July 1, 2021

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

July 16, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

No plan to share

Locations

GB(2)