NCT06409793

Brief Summary

The researchers are investigating whether adding mobile technology to a home-based exercise counselling program makes it easier for youth to begin and maintain regular exercise. Participants who joins the study will receive exercise counselling from an exercise specialist, but half of all participants will receive mobile technology - a fitness watch - that links to a mobile phone App. The mobile App allows the exercise specialist to provide personalized feedback throughout the program via the fitness watch. The investigators are interested to know whether the fitness watch and mobile App will make it easier for youth to achieve their exercise goals. Both groups will be compared to an active control group, who will receive no exercise program.

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

March 4, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 10, 2024

Completed
22 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

March 4, 2024

Last Update Submit

May 7, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Eligibility to participate in the intervention

    1. The number of adolescents approached and reasons for not joining the study 2. Number of participants approached to participate, percentage attending/ dropout throughout the intervention

    Baseline, and follow up at weeks 4,8,12

  • Enrolment in the intervention

    Percentage of adolescents attending at 3-month post and 6-month follow up and reasons for drop-out.

    Baseline, week 12

Secondary Outcomes (5)

  • Adherence

    12 weeks

  • Precision of potential outcome measures of cardiorespiratory fitness

    Baseline, week 12, week 24

  • Precision of potential outcome measures of peripheral vascular function

    Baseline, week 12, week 24

  • Precision of potential outcome measures of cerebrovascular function

    Baseline, week 12, week 24

  • Acceptability of the exercise training program

    baseline, week 6 and week 12

Study Arms (3)

mHealth

EXPERIMENTAL

Participants will undertake a 3-month structured exercise and PA intervention, supported by an exercise specialist. Participants will have 5 exercise consultations. Participants will receive a personalised progressive exercise programme. The aim will be to increase exercise intensity and duration during the first 3-months; aiming to meet the aerobic training guidelines of 3-4 sessions of at least 40 minutes at 85-90% heart rate maximum or of vigorous intensity. During follow-up, the aim will be to at least maintain this level of exercise. Participants will receive 1) a wrist worn fitness watch (Polar Ignite), featuring a 3d accelerometer and optical heart rate monitor, and 2) a smartphone app for participants (Polar Flow - Sync \& Analyse). These will be synced, allowing data to be transferred to the exercise specialist, who will created monitor pre-set exercise sessions.

Behavioral: mHealth

Exercise Counselling

ACTIVE COMPARATOR

Participants will undertake the same 3-month structured exercise and PA intervention, supported by an exercise specialist, but without the use of mHealth technology to support the prescription and adherence to the exercise. Participants will be monitored using a wrist worn fitness watch, but will not receive feedback or have pre-set exercise sessions through the mHealth technology

Behavioral: mHealth

Active control

NO INTERVENTION

Participants will receive no exercise or PA intervention. Participants will continue with regular PA behaviours as an active control comparator. Participants in the control group will be monitored at the start and the end of the 3 months intervention period (2 weeks) to determine habitual PA and exercise levels

Interventions

mHealthBEHAVIORAL

A 3-month structured exercise and PA intervention, supported by an exercise specialist, with a 3-month follow-up

Also known as: Exercise Counselling
Exercise CounsellingmHealth

Eligibility Criteria

Age13 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Male or Female
  • Aged 13-16 years
  • Be comfortable communicating in English

You may not qualify if:

  • Aged \<13 or \>16
  • Inability to increase level of activity or exercise
  • Not owning a smartphone/ or having no data plan or access to Wi-Fi
  • Currently meeting the recommended exercise guidelines
  • Have congenital cardiac abnormalities (e.g., tetralogy of Fallot)
  • Have a known respiratory disease (e.g., asthma)
  • Have a known metabolic disease (e.g., Type 1 diabetes)
  • Are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Kelowna, British Columbia, V1V 1V7, Canada

Location

MeSH Terms

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Alison McManus, PhD

    University of British Columbia- Okanagan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jodie L Koep, PhD

CONTACT

Kate Sansum, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: The proposed intervention will provide one group of adolescents with a combined accelerometer and heart rate monitor, alongside exercise counselling. The accelerometer will be used to support the youngsters achieve a personalised daily PA goal. The heart rate monitor will then be used to support adherence to an individualised and co-created home-based exercise programme. A second group will receive exercise counselling only.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 4, 2024

First Posted

May 10, 2024

Study Start

June 1, 2024

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

May 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

The data collected will be kept by Dr McManus and Dr Koep and written up for publication

Locations