Chronic DiseaseNCT03970369
Motivated to Move: A Study to Determine the Feasibility of Self-Monitoring Physical Activity in Youth
A study testing Monitor in people with Chronic Disease and Child, run by McMaster University at 1 site in Canada.
Trial summary
Children with a medical condition don't get enough exercise, which can lead to even more health problems in childhood and adulthood. To help patients be more active, the McMaster Children's Hospital has an Exercise Medicine Clinic, where kids with any medical condition can get help from doctors and exercise… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Chronic Disease, Child, Adolescent
- What is being tested?
- Monitor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jun 2019to 30 Dec 2020
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newly referred patients to the Exercise Medicine Clinic (i.e. either first or second visit)
- 8-17 years old
Who cannot join
- Inability to communicate in English
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Exercise Medicine Clinic at McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5
Clinical Research Coordinator
About this study
Official title: Motivated to Move: A Randomized Pilot Study to Determine the Feasibility of Self-Monitoring on Self-Perceptions Towards Physical Activity in Youth
Children with a medical condition don't get enough exercise, which can lead to even more health problems in childhood and adulthood. To help patients be more active, the McMaster Children's Hospital has an Exercise Medicine Clinic, where kids with any medical condition can get help from doctors and exercise specialists to safely become more active. The Exercise Medicine Clinic works with kids that have arthritis, inflammatory bowel disease, cystic fibrosis, cerebral palsy, cancer, diabetes, and a lot of other conditions. So far, most of the kids that go to the Exercise Medicine Clinic show improved fitness levels, but other kids don't seem to improve at all. These differences in improvements probably relate to how much physical activity the patients do on a regular basis. What is not known is exactly how to motivate the patients to be more active. In the Motivated to Move study, the investigators are going to learn more about how technology can be used to help kids feel more motivated to be active. The purpose of the Motivated to Move study is to see if it's feasible for patients to use step trackers over a 6-month period as part of the care patients receive at the Exercise Medicine Clinic. The results from the study will be used to see how the step tracking worked and to design a larger study that compares motivation to be physically active between children who wear and don't wear step trackers.
Read the detailed description
The Motivated to Move study is a single-centre, pilot randomized controlled trial that has been designed based on experience to be minimally intrusive to the busy lives of patients and families. As part of a typical Exercise Medicine Clinic (EXMED) visit, children receive an individualized physical activity prescription to follow for the next three months. Participants of Motivated to Move will receive this prescription and be randomized to either a MONITOR group or USUAL CARE. The monitor group will wear a step counter to track if participants are meeting the activity prescription. This study will determine if this step counter affects the participants' motivation, self regulation, and perceived competence with respect to physical activity, which will be measured with questionnaires.
Participants enrolled in the Motivated to Move study will undergo a total of 3 study visits over the course of 6 months. All study visits will take place as part of the patient's EXMED clinic visits, which are scheduled every 3 months. Eligible patients will be identified by a member of the EXMED team and be invited to learn more about the Motivated to Move study. All interested patients will have the opportunity to speak with the study research coordinator about the study. Consent and/or assent (as appropriate) will be obtained from patients who would like to participate in the Motivated to Move study. Upon providing consent, all participants will undergo a similar protocol, which includes a total of 3 study visits that coincide with a clinic appointment:
At the baseline study visit all participants will be asked to complete a series of questionnaires related to motivation, self-regulation, and perceived competence with respect to physical activity. Participants will then meet with the Exercise Physiologist to perform a fitness assessment. Next, participants will discuss the results of the fitness assessment and develop goals with the Kinesiologist. Participants will also receive a detailed, individualized physical activity prescription for the next three months. At the end of the clinic visit, the research assistant will randomize each participant into one of two groups: no activity monitoring (USUAL CARE) or activity monitoring with feedback (MONITOR). All participants, regardless of group, will be given an accelerometer (research-grade physical activity monitor), which is worn around the waist for 7 days. This protocol (with the exception of randomization) will be repeated at the participant's 3-month and 6-month study visits. Upon completion of the 3 study visits, participants will complete a brief questionnaire to assess the acceptability of the activity monitoring and questionnaires.
- Conditions
- Chronic Disease, Child, Adolescent
- Being tested
- Usual care, Monitor
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careBehavioural
Personalized goals and an activity prescription.
MonitorBehavioural
Participants wear a step counter to track activity goals.
| Study group | Role | What they receive |
|---|---|---|
| Monitor | Experimental | Activity monitoring with feedback. Participants in the Monitor group will wear a step counter to track if the activity prescription is being met. Receives: Behavioral: Usual care; Behavioral: Monitor |
| Usual care | Active comparator | All children will receive the usual care, which includes personalized goals and an activity prescription. Participants in the usual care group will not receive a step counter. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the recruitment rates
The recruitment rate will be determined by calculating the proportion of eligible children who enroll in the study over the estimated 10-month recruitment period
Measured: 10 months
Investigate retention to the trial at the 3-month follow up visit
Proportion of participants who remained enrolled in the study (regardless of data completeness) at 3-months
Measured: 3 months
Investigate retention to the trial at 6-month follow up visit.
Proportion of participants who remained enrolled in the study (regardless of data completeness) at 6-months.
Measured: 6 months
Determine the feasibility of activity monitoring over the first 3 months
The participants' compliance wearing the activity monitor will be measured by determining the % of days participants wore the monitor over the first 3 months
Measured: 3 months
Determine the feasibility of activity monitoring over 6 months
The participants' compliance wearing the activity monitor will be measured by determining the % of days participants wore the monitor over 6 months
Measured: 6 months
Determine the acceptability of activity monitoring
A brief survey will be used at the final visit (6-mo) to assess the acceptability of activity monitoring
Measured: 6 months
Secondary outcomes (4)
Change in self-regulation and motivation
Measured using Behavioural Regulation in Exercise Questionnaire 3 (BREQ-3). The BREQ-3 includes 4 items (responses 0-4) for each of the following 6 dimensions: amotivation, external regulation, introjected regulation, identified regulation, integrated regulation, intrinsic regulation. Dimensions are calculated by the average score on the 4 corresponding items.
Measured: baseline, 3- and 6-months
Change in perceived competence in physical activity
Measured using the Self-Perceived Competence in Physical Education Scale. Responses (1-7) of 4 items will be averaged. A higher score indicates greater perceived competence.
Measured: baseline, 3- and 6-months
Change in autonomy (supportive vs. controlling)
Patients' perceptions of the degree to which their health care providers are autonomy supportive vs. controlling. Measured using the Health Care Climate questionnaire. Responses (1-7) on 6 items are averaged. A higher score indicates higher perception of supportive autonomy.
Measured: baseline, 3- and 6-months
Change in physical activity
1-week free-living physical activity measured via accelerometry
Measured: Baseline, 3- and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start20 Jun 2019
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Joyce Obeid, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970369
- Sponsor's protocol ID
- M2M-5234
- Status last verified
- Aug 2019
- First submitted
- 16 May 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivated to Move: A Randomized Pilot Study to Determine the Feasibility of Self-Monitoring on Self-Perceptions Towards Physical Activity in Youth
- ClinicalTrials.gov ID
- NCT03970369
- Acronym / sponsor ID
- M2M-5234
- Conditions
- Chronic Disease, Child, Adolescent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 31 May 2019 (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.
Children with a medical condition don't get enough exercise, which can lead to even more health problems in childhood and adulthood. To help patients be more active, the McMaster Children's Hospital has an Exercise Medicine Clinic, where kids with any medical condition can get help from doctors and exercise specialists to safely become more active. The Exercise Medicine Clinic works with kids that have arthritis, inflammatory bowel disease, cystic fibrosis, cerebral palsy, cancer, diabetes, and a lot of other conditions. So far, most of the kids that go to the Exercise Medicine Clinic show improved fitness levels, but other kids don't seem to improve at all. These differences in improvements probably relate to how much physical activity the patients do on a regular basis. What is not known is exactly how to motivate the patients to be more active. In the Motivated to Move study, the investigators are going to learn more about how technology can be used to help kids feel more motivated to be active. The purpose of the Motivated to Move study is to see if it's feasible for patients to use step trackers over a 6-month period as part of the care patients receive at the Exercise Medicine Clinic. The results from the study will be used to see how the step tracking worked and to design a larger study that compares motivation to be physically active between children who wear and don't wear step trackers.
Detailed description
The Motivated to Move study is a single-centre, pilot randomized controlled trial that has been designed based on experience to be minimally intrusive to the busy lives of patients and families. As part of a typical Exercise Medicine Clinic (EXMED) visit, children receive an individualized physical activity prescription to follow for the next three months. Participants of Motivated to Move will receive this prescription and be randomized to either a MONITOR group or USUAL CARE. The monitor group will wear a step counter to track if participants are meeting the activity prescription. This study will determine if this step counter affects the participants' motivation, self regulation, and perceived competence with respect to physical activity, which will be measured with questionnaires.
Participants enrolled in the Motivated to Move study will undergo a total of 3 study visits over the course of 6 months. All study visits will take place as part of the patient's EXMED clinic visits, which are scheduled every 3 months. Eligible patients will be identified by a member of the EXMED team and be invited to learn more about the Motivated to Move study. All interested patients will have the opportunity to speak with the study research coordinator about the study. Consent and/or assent (as appropriate) will be obtained from patients who would like to participate in the Motivated to Move study. Upon providing consent, all participants will undergo a similar protocol, which includes a total of 3 study visits that coincide with a clinic appointment:
At the baseline study visit all participants will be asked to complete a series of questionnaires related to motivation, self-regulation, and perceived competence with respect to physical activity. Participants will then meet with the Exercise Physiologist to perform a fitness assessment. Next, participants will discuss the results of the fitness assessment and develop goals with the Kinesiologist. Participants will also receive a detailed, individualized physical activity prescription for the next three months. At the end of the clinic visit, the research assistant will randomize each participant into one of two groups: no activity monitoring (USUAL CARE) or activity monitoring with feedback (MONITOR). All participants, regardless of group, will be given an accelerometer (research-grade physical activity monitor), which is worn around the waist for 7 days. This protocol (with the exception of randomization) will be repeated at the participant's 3-month and 6-month study visits. Upon completion of the 3 study visits, participants will complete a brief questionnaire to assess the acceptability of the activity monitoring and questionnaires.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitor | Experimental | Behavioral: Usual care, Behavioral: MonitorActivity monitoring with feedback. Participants in the Monitor group will wear a step counter to track if the activity prescription is being met. |
| Usual care | Active comparator | Behavioral: Usual careAll children will receive the usual care, which includes personalized goals and an activity prescription. Participants in the usual care group will not receive a step counter. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Newly referred patients to the Exercise Medicine Clinic (i.e. either first or second visit)
- 8-17 years old
Key exclusion criteria (1 listed)
- Inability to communicate in English
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 |
|---|---|---|
| Usual carePersonalized goals and an activity prescription. | Behavioural | Monitor, Usual care |
| MonitorParticipants wear a step counter to track activity goals. | Behavioural | Monitor |
Primary outcome
Estimate the recruitment rates
Time frame: 10 months
The recruitment rate will be determined by calculating the proportion of eligible children who enroll in the study over the estimated 10-month recruitment period
Investigate retention to the trial at the 3-month follow up visit
Time frame: 3 months
Proportion of participants who remained enrolled in the study (regardless of data completeness) at 3-months
Investigate retention to the trial at 6-month follow up visit.
Time frame: 6 months
Proportion of participants who remained enrolled in the study (regardless of data completeness) at 6-months.
Determine the feasibility of activity monitoring over the first 3 months
Time frame: 3 months
The participants' compliance wearing the activity monitor will be measured by determining the % of days participants wore the monitor over the first 3 months
Determine the feasibility of activity monitoring over 6 months
Time frame: 6 months
The participants' compliance wearing the activity monitor will be measured by determining the % of days participants wore the monitor over 6 months
Determine the acceptability of activity monitoring
Time frame: 6 months
A brief survey will be used at the final visit (6-mo) to assess the acceptability of activity monitoring
4 secondary outcomes
Change in self-regulation and motivation
Time frame: baseline, 3- and 6-months
Change in perceived competence in physical activity
Time frame: baseline, 3- and 6-months
Change in autonomy (supportive vs. controlling)
Time frame: baseline, 3- and 6-months
Change in physical activity
Time frame: Baseline, 3- and 6-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Joyce Obeid, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitor in people with Chronic Disease and Child, run by McMaster University 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 2 inclusion and 1 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 21 Aug 2019. 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 Clinical Research Coordinator (905-521-2100 ext. 75620, proudfna@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate the recruitment rates (time frame: 10 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2019.