Clinical trial NCT03970369: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Disease
Child
Adolescent
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
First posted: 2019-05-31
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Estimate the recruitment rates
timeFrame: 10 months
measure: Investigate retention to the trial at the 3-month follow up visit
timeFrame: 3 months
measure: Investigate retention to the trial at 6-month follow up visit.
timeFrame: 6 months
measure: Determine the feasibility of activity monitoring over the first 3 months
timeFrame: 3 months
measure: Determine the feasibility of activity monitoring over 6 months
timeFrame: 6 months
measure: Determine the acceptability of activity monitoring
timeFrame: 6 months
Secondary outcomes:
measure: Change in self-regulation and motivation
timeFrame: baseline, 3- and 6-months
measure: Change in perceived competence in physical activity
timeFrame: baseline, 3- and 6-months
measure: Change in autonomy (supportive vs. controlling)
timeFrame: baseline, 3- and 6-months
measure: Change in physical activity
timeFrame: Baseline, 3- and 6-months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Exercise Medicine Clinic at McMaster Children's Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Joyce Obeid, PhD
role: PRINCIPAL_INVESTIGATOR
References: