- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03618927
Program Evaluation of an In-school Daily Physical Activity Initiative
August 1, 2018 updated by: John Cairney, McMaster University
A Program Evaluation of an In-school Daily Physical Activity Initiative for Children and Youth
The school system is one setting in which children's physical activity levels may be increased through daily physical activity (DPA) policies and initiatives.
Adherence to DPA policies is typically poor and results are limited in regard to the associated benefits for participating children.
Therefore, the purpose of this study was to evaluate a range of psychosocial outcomes following a community-led, in-school DPA initiative for 9-14 year old children and youth.
This program evaluation examined the impact of a DPA program consisting of 20 minutes of teacher-led DPA for 20 consecutive weeks.
Student outcomes were measured using a questionnaire administered at three time points: baseline, mid-intervention, and post-intervention.
A teacher questionnaire regarding program adherence and student behaviour was completed at post-intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
362
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8P 1H6
- David Braley Health Sciences Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants will include males and females between the ages of 9-14.
- Participants must be enrolled in one of 30 elementary school classes across the participating seven elementary schools.
- Participants need to be able to read and write in English
Exclusion Criteria:
- Participants not enrolled in one of the participating classes.
- Unable to read and write in English.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Daily physical activity intervention
The intervention consisted of a DPA program designed by a national organization with expertise in school-based physical activity programming and delivered in school by teachers.
The program was offered to students in grades 4 through 8 and consisted of 20 minutes of structured DPA in school for 20 consecutive weeks.
The DPA activities included jumping jacks, squats, running and other body weight exercises.
|
|
No Intervention: Control - treatment as usual
Participants in control classes completed regular school activities as per the Ontario curriculum.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in self-esteem from baseline to 20-weeks
Time Frame: Change from baseline to 20-weeks
|
Measured using the Rosenberg Self-Esteem Scale.
This is a 10-item measure that has shown to have good construct validity in children.
The scale is scored on a four-point Likert-type scale ranging from 0 (Strongly Disagree) to 3 (Strongly Agree).
An example item is "On the whole, I am satisfied with myself."
Items 2, 5, 6, 8, 9 are reverse scored.
The scores for the 10 items are then summed, with higher scores indicating higher self-esteem.
|
Change from baseline to 20-weeks
|
Change in grit from baseline to 20-weeks
Time Frame: Change from baseline to 20-weeks
|
Assessed with the 8-item Short Grit Scale for Children.
The items are scored on a five-point Likert-type scale ranging from 1 (Not at all like me) to 5 (Very much like me).
An example item is "New ideas and projects sometimes distract me from previous ones."
Items 1,3,5,6 were reversed scored and all items were summed with higher scores indicating better results.
|
Change from baseline to 20-weeks
|
Change in Global Happiness from baseline to 20-weeks
Time Frame: Change from baseline to 20-weeks
|
Measured using the 4-item Subjective Happiness Scale.
The scale is scored on a seven-point Likert-type scale.
Each item has its own stem and anchors ranging from 1 to 7.
An example item stem is "In general I consider myself…" with 1 anchored as Not a very happy person and 7 anchored as A very happy person.
The scale has demonstrated good psychometric properties in children and adolescents.
The sum of scores is divided by four with a higher score indicating a greater level of happiness.
|
Change from baseline to 20-weeks
|
Change in Commitment to School from baseline to 20-weeks
Time Frame: Change from baseline to 20-weeks
|
Assessed with 5 items drawn from the 10-item Commitment to School scale.
The scale consists of 10-items scored on a four-point Likert-type scale ranging from 1 (Strongly Disagree) to 4 (Strongly Agree).
A subset of five-items was selected, scored on a five-point Likert-type ranging from 1 (Not at all true for me) to 5 (Really true for me).
An example item is "You try really hard at school."
The 5 items were summed with higher score indicating greater commitment to school.
|
Change from baseline to 20-weeks
|
Change in Sense of Belonging at School from baseline to 20-weeks
Time Frame: Change from baseline to 20-weeks
|
Measured using the 5-item short form version of the Sense of Belonging Scale.
An example item is "I feel comfortable at my school."
Two items were reverse scored, and the items were summed with higher scores indicating a greater sense of belonging at school.
|
Change from baseline to 20-weeks
|
Change in Physical Activity from baseline to 20-weeks
Time Frame: Change from baseline to 20-weeks
|
Assessed with the Physical Activity Questionnaire for Older Children (PAQ-C).
The PAQ-C was designed for children in grades 4-8 who have recess as a regular part of their school week.
The PAQ-C is a 9-item 7-day recall instrument that has been shown to have good psychometric properties.
We omitted the first item from this questionnaire because it asked about the types of physical activity performed, and we were interested only in overall levels of participation.
An example item is "In the last 7 days, what did you do most of the time at recess?"
The items were averaged together to generate a total score, with higher scores indicating higher levels of participation in physical activity.
|
Change from baseline to 20-weeks
|
Change in Self-efficacy from baseline to 20-weeks
Time Frame: Change from baseline to 20-weeks
|
Self-efficacy for engaging in physical activity, sports, and active play was assessed using a three-item scale adhering to recommendations by Bandura for assessing self-efficacy.
Each item was prefaced with the stem "I am confident in my ability to engage in…" The individual items were "Physical activity (e.g., running, yoga, skating)," "Sports (e.g., soccer, baseball, ultimate Frisbee)," and "Activity play (e.g., playing with friends at recess or after school)."
Following guidelines provided by Bandura, participants rated their confidence for each item using an 11-point scale (0=not confident, 10=totally confident).
A generalized task self-efficacy overall score was computed by averaging the ratings for each item to produce a scale value out of 10.
Higher scores indicate more favorable self-efficacy.
|
Change from baseline to 20-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention adherence
Time Frame: 20-weeks
|
Assessed by teacher questionnaire: "On average, how many days per week did your students participate in the program?".
A higher score indicates greater adherence.
|
20-weeks
|
Perceived student behavior
Time Frame: 20-weeks
|
Assessed by teacher questionnaire on a 10-point scale from "No improvement" to "A great deal of improvement."
Questions were averaged and higher scores indicated greater perceived student behavior.
|
20-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John Cairney, PhD, University of Toronto and McMaster University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Janssen I, Leblanc AG. Systematic review of the health benefits of physical activity and fitness in school-aged children and youth. Int J Behav Nutr Phys Act. 2010 May 11;7:40. doi: 10.1186/1479-5868-7-40.
- Lubans D, Richards J, Hillman C, Faulkner G, Beauchamp M, Nilsson M, Kelly P, Smith J, Raine L, Biddle S. Physical Activity for Cognitive and Mental Health in Youth: A Systematic Review of Mechanisms. Pediatrics. 2016 Sep;138(3):e20161642. doi: 10.1542/peds.2016-1642. Epub 2016 Aug 19.
- Ahn S, Fedewa AL. A meta-analysis of the relationship between children's physical activity and mental health. J Pediatr Psychol. 2011 May;36(4):385-97. doi: 10.1093/jpepsy/jsq107. Epub 2011 Jan 11.
- Allison KR, Vu-Nguyen K, Ng B, Schoueri-Mychasiw N, Dwyer JJ, Manson H, Hobin E, Manske S, Robertson J. Evaluation of Daily Physical Activity (DPA) policy implementation in Ontario: surveys of elementary school administrators and teachers. BMC Public Health. 2016 Aug 8;16:746. doi: 10.1186/s12889-016-3423-0.
- Pearlin LI, Lieberman MA, Menaghan EG, Mullan JT. The stress process. J Health Soc Behav. 1981 Dec;22(4):337-56. No abstract available.
- Moilanen KL. The Adolescent Self-Regulatory Inventory: The development and validation of a questionnaire of short-term and long-term self-regulation. J Youth Adolesc. 2007;36:835-48.
- Goodman R, Meltzer H, Bailey V. The Strengths and Difficulties Questionnaire: a pilot study on the validity of the self-report version. Int Rev Psychiatry. 2003 Feb-May;15(1-2):173-7. doi: 10.1080/0954026021000046137.
- Muris P, Meesters C, Eijkelenboom A, Vincken M. The self-report version of the Strengths and Difficulties Questionnaire: its psychometric properties in 8- to 13-year-old non-clinical children. Br J Clin Psychol. 2004 Nov;43(Pt 4):437-48. doi: 10.1348/0144665042388982.
- Rosenberg M. Rosenberg Self-Esteem Scale. Accept Commit Ther. 1965.
- Duckworth AL, Quinn PD. Development and validation of the short grit scale (grit-s). J Pers Assess. 2009 Mar;91(2):166-74. doi: 10.1080/00223890802634290.
- Lyubomirsky S, Lepper HS. A measure of subjective happiness: Preliminary reliability and construct validation. Soc Indic Res. 1999;46:137-155.
- Anderson-Butcher D, Conroy DE. Factorial and Criterion Validity of Scores of a Measure of Belonging in Youth Development Programs. Educ Psychol Meas. 2002;62:857-76.
- Crocker PR, Bailey DA, Faulkner RA, Kowalski KC, McGrath R. Measuring general levels of physical activity: preliminary evidence for the Physical Activity Questionnaire for Older Children. Med Sci Sports Exerc. 1997 Oct;29(10):1344-9. doi: 10.1097/00005768-199710000-00011.
- Bandura A. Guide for constructing self-efficacy scales. Self-Effic Beliefs Adolesc. 2006;5.
- Bremer E, Graham JD, Veldhuizen S, Cairney J. A program evaluation of an in-school daily physical activity initiative for children and youth. BMC Public Health. 2018 Aug 16;18(1):1023. doi: 10.1186/s12889-018-5943-2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
May 31, 2016
Study Completion (Actual)
May 31, 2016
Study Registration Dates
First Submitted
July 24, 2018
First Submitted That Met QC Criteria
August 1, 2018
First Posted (Actual)
August 7, 2018
Study Record Updates
Last Update Posted (Actual)
August 7, 2018
Last Update Submitted That Met QC Criteria
August 1, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- INCH_S2F
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
No individual participant data will be shared with other researchers
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Physical Activity
-
Istinye UniversityCompletedPhysical Activity | Youth | Physical Activity Barriers | Physical Activity FacilitatorsTurkey
-
Istanbul Kültür UniversityWithdrawnPhysical Activity Level | Physical Activity Awareness
-
Georgetown UniversityUniversity of PennsylvaniaCompletedPhysical Activity | Motor ActivityUnited States
-
Assistance Publique - Hôpitaux de ParisTerminatedPhysical Activity | Physical DisabilityFrance
-
University of Colorado, DenverCompletedPhysical Activity | Physical ImpairmentUnited States
-
PXL University CollegeHasselt UniversityNot yet recruitingPhysical Activity - Digital Phenotyping - Activity Tracking
-
University of ExtremaduraThe Spanish Ministry of Science, Innovation and UniversitiesRecruitingPhysical Activity | Cognition | Physical Fitness | AdolescentsSpain
-
Universitaet InnsbruckRecruiting
-
AdventHealth Translational Research InstituteWake Forest UniversityRecruiting
-
Wake Forest University Health SciencesMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases... and other collaboratorsRecruitingPhysical ActivityUnited States
Clinical Trials on Daily physical activity intervention
-
Hannover Medical SchoolCompletedHeart FailureGermany
-
Medical University of GrazKristiania University CollegeRecruitingPhysical Activity | Cardiometabolic HealthAustria
-
Brown UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
University of ConnecticutNational Institutes of Health (NIH); National Center for Complementary and...RecruitingChronic Low Back PainUnited States
-
University GhentBOFCompleted
-
Institut Català d'OncologiaUnknownRecurrence | Breast NeoplasmsSpain
-
Centre Leon BerardNational Cancer Institute, FranceNot yet recruitingMetastatic Testicular CancerFrance
-
University of California, DavisActive, not recruitingBehavior, HealthUnited States
-
Jamie JacksonNational Heart, Lung, and Blood Institute (NHLBI)CompletedPhysical Activity | Cardiovascular Disease OtherUnited States
-
Brown UniversityNational Cancer Institute (NCI)Not yet recruiting