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

NCT03970369 | Unknown

• 1 other identifier: M2M-5234
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Disease; Child; Adolescent

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• Change in self-regulation and motivation

  baseline, 3- and 6-months

• Change in perceived competence in physical activity

  baseline, 3- and 6-months

• Change in autonomy (supportive vs. controlling)

  baseline, 3- and 6-months

• Change in physical activity

  Baseline, 3- and 6-months

Study Arms (2)

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.

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.

Behavioral: Usual care

Interventions

Usual care BEHAVIORAL

Personalized goals and an activity prescription.

Monitor; Usual care

Monitor BEHAVIORAL

Participants wear a step counter to track activity goals.

Monitor

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newly referred patients to the Exercise Medicine Clinic (i.e. either first or second visit)
• years old

You may not qualify if:

• Inability to communicate in English

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

Exercise Medicine Clinic at McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joyce Obeid, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Coordinator

CONTACT

905-521-2100; proudfna@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 31, 2019
• Study Start: June 20, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: August 21, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)