Exercise TrainingMOTAFITNCT06409793
Motivating Adolescent Fitness
A study testing mHealth in people with Exercise Training, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Training
- What is being tested?
- mHealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or Female
- Aged 13-16 years
- Be comfortable communicating in English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Kelowna, British Columbia, V1V 1V7
Alison M McManus, PhD, 250 807 8192, ali.mcmanus@ubc.ca
Jodie Koep, PhD, 250 8631621, jodie.koep@ubc.ca
About this study
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.
Read the detailed description
Purpose:
The investigators aim to undertake an experimental trial using exercise training in adolescents, evaluating a theoretical model where mHealth technology, allowing biometric informed feedback and coaching, is incorporated into a structured home-based exercise and physical activity (PA) intervention. The overall objective is to have an evidence-based exercise and PA intervention ready to evaluate in a future randomised controlled trial (RCT).
Hypothesis:
It is hypothesized that this approach will increase both habitual PA and adherence to structured exercise of the appropriate intensity to promote improvements in cardiorespiratory fitness and vascular function.
Justification:
Current physical activity guidelines suggest adolescents should accumulate at least 60 minutes of moderate to vigorous physical activity (MVPA) per day. Yet globally, more than 80% of adolescents fail to achieve the recommended level of daily MVPA, and less than 25% of Canadian adolescents are sufficiently physically active. Adolescence is a time when sedentary habits predominantly manifest. Sedentary time increases by approximately 100 minutes/day between the ages 12 and 16 years, and there is a disproportionate number of inactive adolescent girls (82%) compared to boys (71%). Clearly current strategies to encourage appropriate levels of physical activity in adolescence are inadequate.
It is important to note that the current MVPA guidelines lack the intensity associated with the enhancement of cardiorespiratory fitness in youth (~85-90% of heart rate maximum).Further, the extant data show that habitual physical activity is not related, or at best weakly related to direct laboratory measures of cardiorespiratory fitness in youth.
If we aspire to improve cardiorespiratory or vascular health in our younger population, we need to find ways to engage adolescents in sufficient exercise i.e., 40-60 minutes, 3 to 4 times per week at ~85-90% of heart rate maximum.
Objectives:
Primary Objective
- Determine the number of sedentary adolescents that are eligible to participate, the proportion of these who would be willing to take part in this trial, and their characteristics, and the number of participants retained at 6-months.
Secondary Objectives
- Adherence to the exercise training.
- Estimate precision of potential outcome measures required for sample size estimations for the definitive RCT.
- Intervention acceptability
Research Design:
The study is a randomised controlled intervention, whereby participants will complete pre-randomisation baseline testing (T1) before a 3-month supported PA and exercise intervention is completed. Immediately post-intervention (T2) and 6-months after the intervention is completed
Statistical Analysis:
The proportion of eligible patients who consent to participate in the pilot will be presented, along with the proportions in each intervention group completing each follow up assessment and the reasons for withdrawal. Descriptive characteristics and outcome data will be summarized overall and by intervention group, as mean (standard deviation) for normally distributed continuous variables, median (interquartile range) for non-normally distributed continuous variables, and number (percentage) for categorical variables.
Interview data will be analysed using thematic analysis, which will allow the research team to discuss emerging themes and help the research team to explore the barriers and facilitators to the intervention and refine the theoretical model, assessing which elements of the intervention. are most effective for participants. As this is a pilot study there will be no formal comparisons between groups in the intervention.
- Conditions
- Exercise Training
- Being tested
- mHealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealthBehavioural
Also called Exercise Counselling
A 3-month structured exercise and PA intervention, supported by an exercise specialist, with a 3-month follow-up
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility to participate in the intervention
- The number of adolescents approached and reasons for not joining the study
- Number of participants approached to participate, percentage attending/ dropout throughout the intervention
Measured: 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.
Measured: Baseline, week 12
Secondary outcomes (5)
Adherence
Adherence to the exercise training. Assessed as the number of prescribed sessions completed (as a percentage), and as the percentage of each exercise session spent in desired heart rate zones (80-95% heart rate max).
Measured: 12 weeks
Precision of potential outcome measures of cardiorespiratory fitness
Estimate precision of potential outcome measures required for sample size estimations for the definitive RCT. Maximal oxygen uptake will be assessed on an bike ergometer ramp incremental test to exhaustion. This will be compared from pre compared to post intervention
Measured: Baseline, week 12, week 24
Precision of potential outcome measures of peripheral vascular function
Estimate precision of potential outcome measures required for sample size estimations for the definitive RCT. This is assessed using ultrasound to assess peripheral endothelial function of the brachial artery at baseline compared to post intervention and follow up assessment.
Measured: Baseline, week 12, week 24
Precision of potential outcome measures of cerebrovascular function
Cerebrovascular function will be assessed using ultrasound of the internal carotid artery and vertebral artery for measures of blood flow and shear rate. This will be compared from baseline to post intervention.
Measured: Baseline, week 12, week 24
Acceptability of the exercise training program
This will be assessed using validated PACES 5-point likert scales for enjoyment of exercise sessions, self efficacy, positive and negative affect and perceived behavioural control. These will be assessed on a 5 point scale from 1-5 of participants subjective feelings throughout the intervention, and compared to participants between different arms of the intervention
Measured: baseline, week 6 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise TrainingStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- MOSS ROCK PARK FOUNDATION
- Responsible party
- Principal investigator, Ai McManus, University of British Columbia
- Investigators
- Alison McManus, PhD, Principal investigator, University of British Columbia- Okanagan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409793
- Sponsor's protocol ID
- UBC MOTAFIT
- Acronym
- MOTAFIT
- Status last verified
- May 2024
- First submitted
- 4 Mar 2024
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data collected will be kept by Dr McManus and Dr Koep and written up for publication
Publications
Koep JL, Sansum KM, Low J, Smith KJ, Cocks M, McManus AM. Feasibility of a mobile health intervention to motivate adolescent fitness and high-intensity exercise adherence (Motivating Adolescent Fitness (MOTAFIT)): protocol for a randomised controlled trial. BMJ Open. 2026 Feb 10;16(2):e112546. doi: 10.1136/bmjopen-2025-112546.
PubMed 41667175
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivating Adolescent Fitness
- ClinicalTrials.gov ID
- NCT06409793
- Acronym / sponsor ID
- MOTAFIT / UBC MOTAFIT
- Conditions
- Exercise Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- MOSS ROCK PARK FOUNDATION
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose:
The investigators aim to undertake an experimental trial using exercise training in adolescents, evaluating a theoretical model where mHealth technology, allowing biometric informed feedback and coaching, is incorporated into a structured home-based exercise and physical activity (PA) intervention. The overall objective is to have an evidence-based exercise and PA intervention ready to evaluate in a future randomised controlled trial (RCT).
Hypothesis:
It is hypothesized that this approach will increase both habitual PA and adherence to structured exercise of the appropriate intensity to promote improvements in cardiorespiratory fitness and vascular function.
Justification:
Current physical activity guidelines suggest adolescents should accumulate at least 60 minutes of moderate to vigorous physical activity (MVPA) per day. Yet globally, more than 80% of adolescents fail to achieve the recommended level of daily MVPA, and less than 25% of Canadian adolescents are sufficiently physically active. Adolescence is a time when sedentary habits predominantly manifest. Sedentary time increases by approximately 100 minutes/day between the ages 12 and 16 years, and there is a disproportionate number of inactive adolescent girls (82%) compared to boys (71%). Clearly current strategies to encourage appropriate levels of physical activity in adolescence are inadequate.
It is important to note that the current MVPA guidelines lack the intensity associated with the enhancement of cardiorespiratory fitness in youth (~85-90% of heart rate maximum).Further, the extant data show that habitual physical activity is not related, or at best weakly related to direct laboratory measures of cardiorespiratory fitness in youth.
If we aspire to improve cardiorespiratory or vascular health in our younger population, we need to find ways to engage adolescents in sufficient exercise i.e., 40-60 minutes, 3 to 4 times per week at ~85-90% of heart rate maximum.
Objectives:
Primary Objective
- Determine the number of sedentary adolescents that are eligible to participate, the proportion of these who would be willing to take part in this trial, and their characteristics, and the number of participants retained at 6-months.
Secondary Objectives
- Adherence to the exercise training.
- Estimate precision of potential outcome measures required for sample size estimations for the definitive RCT.
- Intervention acceptability
Research Design:
The study is a randomised controlled intervention, whereby participants will complete pre-randomisation baseline testing (T1) before a 3-month supported PA and exercise intervention is completed. Immediately post-intervention (T2) and 6-months after the intervention is completed
Statistical Analysis:
The proportion of eligible patients who consent to participate in the pilot will be presented, along with the proportions in each intervention group completing each follow up assessment and the reasons for withdrawal. Descriptive characteristics and outcome data will be summarized overall and by intervention group, as mean (standard deviation) for normally distributed continuous variables, median (interquartile range) for non-normally distributed continuous variables, and number (percentage) for categorical variables.
Interview data will be analysed using thematic analysis, which will allow the research team to discuss emerging themes and help the research team to explore the barriers and facilitators to the intervention and refine the theoretical model, assessing which elements of the intervention. are most effective for participants. As this is a pilot study there will be no formal comparisons between groups in the intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| mHealth | Experimental | Behavioral: mHealthParticipants 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. |
| Exercise Counselling | Active comparator | Behavioral: mHealthParticipants 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 |
| 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 |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male or Female
- Aged 13-16 years
- Be comfortable communicating in English
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealthAlso: Exercise CounsellingA 3-month structured exercise and PA intervention, supported by an exercise specialist, with a 3-month follow-up | Behavioural | Exercise Counselling, mHealth |
Primary outcome
Eligibility to participate in the intervention
Time frame: Baseline, and follow up at weeks 4,8,12
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
Enrolment in the intervention
Time frame: Baseline, week 12
Percentage of adolescents attending at 3-month post and 6-month follow up and reasons for drop-out.
5 secondary outcomes
Adherence
Time frame: 12 weeks
Precision of potential outcome measures of cardiorespiratory fitness
Time frame: Baseline, week 12, week 24
Precision of potential outcome measures of peripheral vascular function
Time frame: Baseline, week 12, week 24
Precision of potential outcome measures of cerebrovascular function
Time frame: Baseline, week 12, week 24
Acceptability of the exercise training program
Time frame: baseline, week 6 and week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Derived from this study: PubMed 41667175Koep JL, Sansum KM, Low J, Smith KJ, Cocks M, McManus AM. Feasibility of a mobile health intervention to motivate adolescent fitness and high-intensity exercise adherence (Motivating Adolescent Fitness (MOTAFIT)): protocol for a randomised controlled trial. BMJ Open. 2026 Feb 10;16(2):e112546. doi: 10.1136/bmjopen-2025-112546.
- Individual participant dataSharing planned: No. The data collected will be kept by Dr McManus and Dr Koep and written up for publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison McManus, PhD principal investigator
University of British Columbia- Okanagan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth in people with Exercise Training, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jodie L Koep, PhD (1-250-807-9873, jodie.koep@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility to participate in the intervention (time frame: Baseline, and follow up at weeks 4,8,12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06409793, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.