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

Chronic Disease Clinical Trial

Official title:

Motivated to Move: A Randomized Pilot Study to Determine the Feasibility of Self-Monitoring on Self-Perceptions Towards Physical Activity in Youth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03970369
• Other study ID #: M2M-5234
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: August 2019
• Source: McMaster University
• Contact: Clinical Research Coordinator
• Phone: 905-521-2100
• Email: proudfna[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent
• Child
• Chronic Disease

Intervention

Behavioral:
• Usual care
Personalized goals and an activity prescription.
• Monitor
Participants wear a step counter to track activity goals.

Locations

Country	Name	City	State
Canada	Exercise Medicine Clinic at McMaster Children's Hospital	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	10 months
Primary	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	3 months
Primary	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.	6 months
Primary	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	3 months
Primary	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	6 months
Primary	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	6 months
Secondary	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.	baseline, 3- and 6-months
Secondary	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.	baseline, 3- and 6-months
Secondary	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.	baseline, 3- and 6-months
Secondary	Change in physical activity	1-week free-living physical activity measured via accelerometry	Baseline, 3- and 6-months