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Motivated to Move: A Study to Determine the Feasibility of Self-Monitoring Physical Activity in Youth

Primary Purpose

Chronic Disease, Child, Adolescent

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Usual care
Monitor
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Disease

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Exercise Medicine Clinic at McMaster Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Monitor

Usual care

Arm Description

Activity monitoring with feedback. Participants in the Monitor group will wear a step counter to track if the activity prescription is being met.

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.

Outcomes

Primary Outcome Measures

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
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
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.
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
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
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

Secondary Outcome Measures

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.
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.
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.
Change in physical activity
1-week free-living physical activity measured via accelerometry

Full Information

First Posted
May 16, 2019
Last Updated
August 20, 2019
Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03970369
Brief Title
Motivated to Move: A Study to Determine the Feasibility of Self-Monitoring Physical Activity in Youth
Official Title
Motivated to Move: A Randomized Pilot Study to Determine the Feasibility of Self-Monitoring on Self-Perceptions Towards Physical Activity in Youth
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 20, 2019 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Child, Adolescent

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monitor
Arm Type
Experimental
Arm Description
Activity monitoring with feedback. Participants in the Monitor group will wear a step counter to track if the activity prescription is being met.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Personalized goals and an activity prescription.
Intervention Type
Behavioral
Intervention Name(s)
Monitor
Intervention Description
Participants wear a step counter to track activity goals.
Primary Outcome Measure Information:
Title
Estimate the recruitment rates
Description
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
Time Frame
10 months
Title
Investigate retention to the trial at the 3-month follow up visit
Description
Proportion of participants who remained enrolled in the study (regardless of data completeness) at 3-months
Time Frame
3 months
Title
Investigate retention to the trial at 6-month follow up visit.
Description
Proportion of participants who remained enrolled in the study (regardless of data completeness) at 6-months.
Time Frame
6 months
Title
Determine the feasibility of activity monitoring over the first 3 months
Description
The participants' compliance wearing the activity monitor will be measured by determining the % of days participants wore the monitor over the first 3 months
Time Frame
3 months
Title
Determine the feasibility of activity monitoring over 6 months
Description
The participants' compliance wearing the activity monitor will be measured by determining the % of days participants wore the monitor over 6 months
Time Frame
6 months
Title
Determine the acceptability of activity monitoring
Description
A brief survey will be used at the final visit (6-mo) to assess the acceptability of activity monitoring
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in self-regulation and motivation
Description
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.
Time Frame
baseline, 3- and 6-months
Title
Change in perceived competence in physical activity
Description
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.
Time Frame
baseline, 3- and 6-months
Title
Change in autonomy (supportive vs. controlling)
Description
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.
Time Frame
baseline, 3- and 6-months
Title
Change in physical activity
Description
1-week free-living physical activity measured via accelerometry
Time Frame
Baseline, 3- and 6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Research Coordinator
Phone
905-521-2100
Ext
75620
Email
proudfna@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joyce Obeid, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise Medicine Clinic at McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Research Coordinator

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Motivated to Move: A Study to Determine the Feasibility of Self-Monitoring Physical Activity in Youth

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