Childhood ObesityAPPLE SchoolsNCT01914185
Alberta Project Promoting Active Living and Healthy Eating in Schools
A study testing Comprehensive School Health (CSH) in people with Childhood Obesity, run by University of Alberta at 1 site in Canada.
Trial summary
The objectives were to 1) make students eat healthier and be more active; and 2) prevent overweight and obesity. Children will therefore be less likely overweight or obese. Beginning in January 2008, the Alberta Project Promoting active Living and healthy Eating in Schools (APPLE Schools) was implemented in 10 schools… Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Comprehensive School Health (CSH)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,663 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to Jun 2011
- 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 5 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Intervention Schools:
- school located in a socioeconomically disadvantaged neighbourhood and a demonstrated need for health promotion
- Grade five students with parent consent, who also assented to participate were included in annual evaluations
- Control Schools:
- Grade five students with parent consent, who also assented to participate were included in annual evaluations
Who cannot join
- Intervention \& Control Schools:
- Schools that did not receive jurisdictional approval to participate
- Grade five students who did not receive parent consent or did not provide their assent were not included in annual evaluations
Trial locations and contacts
1 site in 1 country.
Canada1 site
Population Health Intervention Research Unit
Edmonton, Alberta, T6G2T4
About this study
Official title: The Effectiveness of a Comprehensive School Health Intervention in Improving Healthy Eating and Physical Activity and Preventing Childhood Obesity
The objectives were to 1) make students eat healthier and be more active; and 2) prevent overweight and obesity. Children will therefore be less likely overweight or obese. Beginning in January 2008, the Alberta Project Promoting active Living and healthy Eating in Schools (APPLE Schools) was implemented in 10 schools throughout the Canadian Province, Alberta. Full-time School Health Facilitators were placed in each of the schools to implement what is know in Canada as Comprehensive School Health (CSH). In the United States, CSH is more commonly referred to as "Coordinated School Health", while the synonymous term "Health Promoting Schools" is often used in Australia and Europe. The project was evaluated annually in the spring from 2008 to 2011 and as of 2009 evaluations included the use of time-stamped pedometers. The comparison group included approximately 150 schools that were randomly selected to reflect the population of Alberta, Canada. Twenty of these randomly selected schools also participated in data collection which involved the use of time-stamped pedometers.
Read the detailed description
The Alberta Project Promoting active Living and healthy Eating in Schools (APPLE Schools) is a quasi-experimental pre-post trial with a non-equivalent parallel control group. The intervention began in January 2008 and lasted through June 2011 and was implemented school-wide. As out primary interest is to reduce the prevalence of overweight and obesity in schools, the essential comparisons were across grade five students in differing calendar years. At each survey all grade five students were invited to participate. The current design allowed intervention effects to be assessed over time at the school-level. Surveys were administered in the spring of 2008, 2009, 2010, and 2011 in intervention schools. And in the spring of 2008 and 2011 in control schools.
- Conditions
- Childhood Obesity
- Being tested
- Comprehensive School Health (CSH)
- Keywords
- Childhood, Physical activity, Nutrition, Health Promotion
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive School Health (CSH)Other
APPLE Schools uses a CSH approach to health promotion which addresses health through four inter-related pillars 1) positive social and physical environments 2) teaching and learning 3) healthy school policy 4) partnerships and services. A key component of the APPLE Schools intervention was the placement of a full-time School Health Facilitator in each school. Their role was to facilitate the development and implementation of the project, to ensure that it met the schools' unique needs for health promotion, and that it aligned with the core principles of CSH.
| Study group | Role | What they receive |
|---|---|---|
| Comparison Schools | No intervention | Regular health promotion activities |
| Comprehensive School Health (CSH) | Experimental | Full time School Health Facilitator present in each school on a day-to-day basis for 3.5 years responsible for facilitating implementation of Comprehensive School Health Receives: Other: Comprehensive School Health (CSH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overweight and obesity
Students' body weight was measured to the nearest 0.1kg using calibrated digital scales and height was measured to the nearest 0.1cm. BMI was calculated as weight divided by height^2 (kg/m^2). Overweight and obesity were defined using the International Obesity Task Force age and sex specific body mass index (BMI) cut-off points.
Measured: 24 months
Secondary outcomes (2)
physical activity
Children's physical activity was measured using time-stamped pedometers which were worn for 9 consecutive days.
The Physical Activity Questionnaire for Older Children (PAQ-C) was also used to assess children's physical activity levels
Measured: 24 months
Diet Quality
Students' diet quality was assessed through the use of the Harvard Youth/Adolescent Food Frequency Questionnaire.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startJan 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- 8,663 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul J Veugelers, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914185
- Sponsor's protocol ID
- Pro00003800
- Acronym
- APPLE Schools
- Status last verified
- Jul 2013
- First submitted
- 31 Jul 2013
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Fung C, Kuhle S, Lu C, Purcell M, Schwartz M, Storey K, Veugelers PJ. From "best practice" to "next practice": the effectiveness of school-based health promotion in improving healthy eating and physical activity and preventing childhood obesity. Int J Behav Nutr Phys Act. 2012 Mar 13;9:27. doi: 10.1186/1479-5868-9-27.
PubMed 22413778Bastian KA, Maximova K, McGavock J, Veugelers P. Does School-Based Health Promotion Affect Physical Activity on Weekends? And, Does It Reach Those Students Most in Need of Health Promotion? PLoS One. 2015 Oct 21;10(10):e0137987. doi: 10.1371/journal.pone.0137987. eCollection 2015.
PubMed 26488168Vander Ploeg KA, McGavock J, Maximova K, Veugelers PJ. School-based health promotion and physical activity during and after school hours. Pediatrics. 2014 Feb;133(2):e371-8. doi: 10.1542/peds.2013-2383. Epub 2014 Jan 13.
PubMed 24420806Vander Ploeg KA, Maximova K, McGavock J, Davis W, Veugelers P. Do school-based physical activity interventions increase or reduce inequalities in health? Soc Sci Med. 2014 Jul;112:80-7. doi: 10.1016/j.socscimed.2014.04.032. Epub 2014 Apr 29.
PubMed 24820223Dube N, Khan K, Loehr S, Chu Y, Veugelers P. The use of entertainment and communication technologies before sleep could affect sleep and weight status: a population-based study among children. Int J Behav Nutr Phys Act. 2017 Jul 19;14(1):97. doi: 10.1186/s12966-017-0547-2.
PubMed 28724380
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Comprehensive School Health Intervention in Improving Healthy Eating and Physical Activity and Preventing Childhood Obesity
- ClinicalTrials.gov ID
- NCT01914185
- Acronym / sponsor ID
- APPLE Schools / Pro00003800
- Conditions
- Childhood Obesity
- Keywords
- Childhood, Physical activity, Nutrition, Health Promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,663 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Aug 2013 (estimated)
- 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 objectives were to 1) make students eat healthier and be more active; and 2) prevent overweight and obesity. Children will therefore be less likely overweight or obese. Beginning in January 2008, the Alberta Project Promoting active Living and healthy Eating in Schools (APPLE Schools) was implemented in 10 schools throughout the Canadian Province, Alberta. Full-time School Health Facilitators were placed in each of the schools to implement what is know in Canada as Comprehensive School Health (CSH). In the United States, CSH is more commonly referred to as "Coordinated School Health", while the synonymous term "Health Promoting Schools" is often used in Australia and Europe. The project was evaluated annually in the spring from 2008 to 2011 and as of 2009 evaluations included the use of time-stamped pedometers. The comparison group included approximately 150 schools that were randomly selected to reflect the population of Alberta, Canada. Twenty of these randomly selected schools also participated in data collection which involved the use of time-stamped pedometers.
Detailed description
The Alberta Project Promoting active Living and healthy Eating in Schools (APPLE Schools) is a quasi-experimental pre-post trial with a non-equivalent parallel control group. The intervention began in January 2008 and lasted through June 2011 and was implemented school-wide. As out primary interest is to reduce the prevalence of overweight and obesity in schools, the essential comparisons were across grade five students in differing calendar years. At each survey all grade five students were invited to participate. The current design allowed intervention effects to be assessed over time at the school-level. Surveys were administered in the spring of 2008, 2009, 2010, and 2011 in intervention schools. And in the spring of 2008 and 2011 in control schools.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison Schools | No intervention | –Regular health promotion activities |
| Comprehensive School Health (CSH) | Experimental | Other: Comprehensive School Health (CSH)Full time School Health Facilitator present in each school on a day-to-day basis for 3.5 years responsible for facilitating implementation of Comprehensive School Health |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- school located in a socioeconomically disadvantaged neighbourhood and a demonstrated need for health promotion
- Grade five students with parent consent, who also assented to participate were included in annual evaluations
- Grade five students with parent consent, who also assented to participate were included in annual evaluations
Key exclusion criteria (3 listed)
- Schools that did not receive jurisdictional approval to participate
- Grade five students who did not receive parent consent or did not provide their assent were not included in annual evaluations
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 |
|---|---|---|
| Comprehensive School Health (CSH)APPLE Schools uses a CSH approach to health promotion which addresses health through four inter-related pillars 1) positive social and physical environments 2) teaching and learning 3) healthy school policy 4) partnerships and services. A key component of the APPLE Schools intervention was the placement of a full-time School Health Facilitator in each school. Their role was to facilitate the development and implementation of the project, to ensure that it met the schools' unique needs for health promotion, and that it aligned with the core principles of CSH. | Other | Comprehensive School Health (CSH) |
Primary outcome
Overweight and obesity
Time frame: 24 months
Students' body weight was measured to the nearest 0.1kg using calibrated digital scales and height was measured to the nearest 0.1cm. BMI was calculated as weight divided by height^2 (kg/m^2). Overweight and obesity were defined using the International Obesity Task Force age and sex specific body mass index (BMI) cut-off points.
2 secondary outcomes
physical activity
Time frame: 24 months
Diet Quality
Time frame: 24 months
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 25 Mar 2020.
- Results publication: PubMed 22413778Fung C, Kuhle S, Lu C, Purcell M, Schwartz M, Storey K, Veugelers PJ. From "best practice" to "next practice": the effectiveness of school-based health promotion in improving healthy eating and physical activity and preventing childhood obesity. Int J Behav Nutr Phys Act. 2012 Mar 13;9:27. doi: 10.1186/1479-5868-9-27.
- Results publication: PubMed 26488168Bastian KA, Maximova K, McGavock J, Veugelers P. Does School-Based Health Promotion Affect Physical Activity on Weekends? And, Does It Reach Those Students Most in Need of Health Promotion? PLoS One. 2015 Oct 21;10(10):e0137987. doi: 10.1371/journal.pone.0137987. eCollection 2015.
- Results publication: PubMed 24420806Vander Ploeg KA, McGavock J, Maximova K, Veugelers PJ. School-based health promotion and physical activity during and after school hours. Pediatrics. 2014 Feb;133(2):e371-8. doi: 10.1542/peds.2013-2383. Epub 2014 Jan 13.
- Results publication: PubMed 24820223Vander Ploeg KA, Maximova K, McGavock J, Davis W, Veugelers P. Do school-based physical activity interventions increase or reduce inequalities in health? Soc Sci Med. 2014 Jul;112:80-7. doi: 10.1016/j.socscimed.2014.04.032. Epub 2014 Apr 29.
- Derived from this study: PubMed 28724380Dube N, Khan K, Loehr S, Chu Y, Veugelers P. The use of entertainment and communication technologies before sleep could affect sleep and weight status: a population-based study among children. Int J Behav Nutr Phys Act. 2017 Jul 19;14(1):97. doi: 10.1186/s12966-017-0547-2.
- Related InfoLink provided by the sponsor.
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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.
Paul J Veugelers, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive School Health (CSH) in people with Childhood Obesity, run by University of Alberta 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 5 inclusion and 3 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 25 Mar 2020. 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?
Overweight and obesity (time frame: 24 months). 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 NCT01914185, which also lists 5 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 25 Mar 2020.