Alberta Project Promoting Active Living and Healthy Eating in Schools (APPLE Schools)

March 23, 2020 updated by: University of Alberta

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8663

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2T4
        • Population Health Intervention Research Unit

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Comparison Schools
Regular health promotion activities
Experimental: 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
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
physical activity
Time Frame: 24 months

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
24 months
Diet Quality
Time Frame: 24 months
Students' diet quality was assessed through the use of the Harvard Youth/Adolescent Food Frequency Questionnaire.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alberta

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paul J Veugelers, PhD, University of Alberta

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

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00003800

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.

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