Physical ActivityNCT03618927
Program Evaluation of an In-school Daily Physical Activity Initiative
A study testing Daily physical activity intervention in people with Physical Activity and Children, Only, run by McMaster University at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Children, Only
- What is being tested?
- Daily physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2016to 31 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Participants not enrolled in one of the participating classes.
- Unable to read and write in English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Physical Activity, Children, Only
- Being tested
- Daily physical activity intervention
- Keywords
- intervention, health policy, psychosocial health, education
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily physical activity interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Daily physical activity intervention | Experimental | 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. Receives: Behavioral: Daily physical activity intervention |
| Control - treatment as usual | No intervention | Participants in control classes completed regular school activities as per the Ontario curriculum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-esteem 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.
Measured: Change from baseline to 20-weeks
Change in grit 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.
Measured: Change from baseline to 20-weeks
Change in Global Happiness 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.
Measured: Change from baseline to 20-weeks
Change in Commitment to School 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.
Measured: Change from baseline to 20-weeks
Change in Sense of Belonging at School 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.
Measured: Change from baseline to 20-weeks
Change in Physical Activity 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.
Measured: Change from baseline to 20-weeks
Change in Self-efficacy 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.
Measured: Change from baseline to 20-weeks
Secondary outcomes (2)
Intervention adherence
Assessed by teacher questionnaire: "On average, how many days per week did your students participate in the program?". A higher score indicates greater adherence.
Measured: 20-weeks
Perceived student behavior
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.
Measured: 20-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start1 Jan 2016
- Primary completion31 May 2016
- Study completion31 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Start2Finish, Hamilton-Wentworth Catholic District School Board
- Responsible party
- Principal investigator, John Cairney, University of Toronto
- Investigators
- John Cairney, PhD, Principal investigator, University of Toronto and McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618927
- Sponsor's protocol ID
- INCH_S2F
- Status last verified
- Aug 2018
- First submitted
- 24 Jul 2018
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared with other researchers
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.
PubMed 20459784Lubans 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.
PubMed 27542849Ahn 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.
PubMed 21227908Allison 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.
PubMed 27502505Pearlin LI, Lieberman MA, Menaghan EG, Mullan JT. The stress process. J Health Soc Behav. 1981 Dec;22(4):337-56. No abstract available.
PubMed 7320473Moilanen 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.
PubMed 12745329Muris 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.
PubMed 15530213Rosenberg 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.
PubMed 19205937Lyubomirsky 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.
PubMed 9346166Bandura 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.
PubMed 30115054
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Program Evaluation of an In-school Daily Physical Activity Initiative for Children and Youth
- ClinicalTrials.gov ID
- NCT03618927
- Acronym / sponsor ID
- INCH_S2F
- Conditions
- Physical Activity, Children, Only
- Keywords
- intervention, health policy, psychosocial health, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Start2Finish, Hamilton-Wentworth Catholic District School Board
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 31 May 2016 (actual)
- First posted
- 7 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily physical activity intervention | Experimental | Behavioral: Daily physical activity interventionThe 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. |
| Control - treatment as usual | No intervention | –Participants in control classes completed regular school activities as per the Ontario curriculum. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Participants not enrolled in one of the participating classes.
- Unable to read and write in English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily physical activity intervention | Behavioural | Daily physical activity intervention |
Primary outcome
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 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 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 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 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 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 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.
2 secondary outcomes
Intervention adherence
Time frame: 20-weeks
Perceived student behavior
Time frame: 20-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Background: PubMed 20459784Janssen 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.
- Background: PubMed 27542849Lubans 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.
- Background: PubMed 21227908Ahn 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.
- Background: PubMed 27502505Allison 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.
- Background: PubMed 7320473Pearlin LI, Lieberman MA, Menaghan EG, Mullan JT. The stress process. J Health Soc Behav. 1981 Dec;22(4):337-56. No abstract available.
- BackgroundMoilanen 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.
- Background: PubMed 12745329Goodman 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.
- Background: PubMed 15530213Muris 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.
- BackgroundRosenberg M. Rosenberg Self-Esteem Scale. Accept Commit Ther. 1965.
- Background: PubMed 19205937Duckworth 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.
- BackgroundLyubomirsky S, Lepper HS. A measure of subjective happiness: Preliminary reliability and construct validation. Soc Indic Res. 1999;46:137-155.
- BackgroundAnderson-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.
- Individual participant dataSharing planned: No. No individual participant data will be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Cairney, PhD principal investigator
University of Toronto and McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily physical activity intervention in people with Physical Activity and Children, Only, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-esteem from baseline to 20-weeks (time frame: Change from baseline to 20-weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03618927, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.