- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03970369
Motivated to Move: A Study to Determine the Feasibility of Self-Monitoring Physical Activity in Youth
Motivated to Move: A Randomized Pilot Study to Determine the Feasibility of Self-Monitoring on Self-Perceptions Towards Physical Activity in Youth
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Clinical Research Coordinator
- Phone Number: 75620 905-521-2100
- Email: proudfna@mcmaster.ca
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 3Z5
- Recruiting
- Exercise Medicine Clinic at McMaster Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Newly referred patients to the Exercise Medicine Clinic (i.e. either first or second visit)
- 8-17 years old
Exclusion Criteria:
- Inability to communicate in English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Monitor
Activity monitoring with feedback.
Participants in the Monitor group will wear a step counter to track if the activity prescription is being met.
|
Personalized goals and an activity prescription.
Participants wear a step counter to track activity goals.
|
Active Comparator: Usual care
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.
|
Personalized goals and an activity prescription.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
10 months
|
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
|
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.
|
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
|
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
|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in self-regulation and motivation
Time Frame: baseline, 3- and 6-months
|
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.
|
baseline, 3- and 6-months
|
Change in perceived competence in physical activity
Time Frame: baseline, 3- and 6-months
|
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.
|
baseline, 3- and 6-months
|
Change in autonomy (supportive vs. controlling)
Time Frame: baseline, 3- and 6-months
|
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.
|
baseline, 3- and 6-months
|
Change in physical activity
Time Frame: Baseline, 3- and 6-months
|
1-week free-living physical activity measured via accelerometry
|
Baseline, 3- and 6-months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joyce Obeid, PhD, McMaster University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M2M-5234
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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