Physical ActivityNCT02954614
Active Play in After School Programs
A study testing Active play in after school programs (ASP) in people with Physical Activity and Activity Play, run by Oslo Metropolitan University.
Trial summary
Background: Physical activity (PA) is a key component in health promotion and prevention of overweight. Interventions delivered in after-school programs (ASP) have the potential to become a means of ensuring PA among young schoolchildren. Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Activity Play, Motor Activity
- What is being tested?
- Active play in after school programs (ASP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- No sites listed yet
- Study dates
- May 2016to May 2018
- 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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Attends first grade in one of the ASPs included
Who cannot join
- Does not attend first grade in one of the ASPs included
About this study
Official title: Active Play -an After-school-program Intervention to Promote Physical Activity and Health-related Quality of Life in Young Children
Background: Physical activity (PA) is a key component in health promotion and prevention of overweight. Interventions delivered in after-school programs (ASP) have the potential to become a means of ensuring PA among young schoolchildren. This requires a motivational climate, allowing for self-determination and the intrinsic values of the activity, on the activity's character of play. ASP staff could be trained in stimulating all children in physical activities in their everyday life. Physiotherapists in primary care possess knowledge of motor development and learning, and are important contributors to an ASP-based physical activity intervention.
Aim: To develop a complex intervention that emphasizes physical activity play, and to examine through a cluster-randomized trial the extent to which the intervention promotes PA and health-related quality of life and prevents overweight in a population of young children. We aim to increase the knowledge and autonomy supportive skills among ASP staff members, enabling them to promote physical activity through play among all first graders in ASP.
Read more
In addition to investigate if the children benefit from receiving autonomy support, we aim to study whether the ASP staff themselves benefit from giving autonomy support in terms of increased need satisfaction and autonomous motivation for work.
The intervention: Includes training of ASP-staff members in the fundamental principles of self-determination theory and practical applications for motivating young children in PA through play. Information will be given on the benefits of a physically active lifestyle and the staff will be encouraged to map opportunities for PA in their local ASP and to incorporate strategies to increase PA through play among the children throughout the day.
Methods/design: A complex intervention using a mixed methods approach will be developed and evaluated. A pilot trial will assess the potential of this approach and provide information necessary to perform a cluster-randomized controlled trial (RCT). The cluster-randomized controlled trial (RCT) will together with qualitative interviews and observations, evaluate the effectiveness of the intervention. Outcomes will be measured at baseline (September /October 2016) at the end of the intervention which lasts for 7 months (May 2017), and 1 year after the end of the intervention (May 2018)
- Conditions
- Physical Activity, Activity Play, Motor Activity, Quality of Life, Autonomy, Competence
- Being tested
- Active play in after school programs (ASP)
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active play in after school programs (ASP)Behavioural
- A 15 hour training-program for ASP-staff aimed to increase active play and physical activity among children in ASPs. The program includes lectures, guided discussions and practical tasks focusing on increasing the staffs competence in how to support active play and PA among all children in the ASP
- A 8 hour course for local physiotherapists enabling them to guide ASP-staff during parts of the intervention period
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Active play in after school programs (ASP). Training program for ASP staff. Receives: Behavioral: Active play in after school programs (ASP) |
| Control group | No intervention | ASP as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in minutes spent in moderate to vigorous physical activity in after school programs from baseline to end of intervention (7 months) and 1 year after end of intervention.
Measures at baseline of a cluster randomized controlled intervention study and measures at the end of the 7 month intervention (measures of change) and 1 year after the end of the intervention (long-term effects). Physical activity is measured objectively by accelerometer (ActiGraph GM3X and GM3X+).
Measured: Baseline, end of intervention (7 months), 1 year after intervention
Secondary outcomes (6)
Heath-related quality of life
Parent-reported, measured by KIDSCREEN-27 questionnaire (parent version)
Measured: Baseline, end of intervention (7 months), 1 year after intervention
Leisure time physical activity
Self-reported/parent-reported, measured by UngKan-2 questionnaire
Measured: Baseline, end of intervention (7 months), 1 year after intervention
Active play in the ASP
Self-reported/parent-reported, measured by questionnaire
Measured: Baseline, end of intervention (7 months), 1 year after intervention
Body mass index
kg/(m2), height and weight measured objectively
Measured: Baseline, end of intervention (7 months), 1 year after intervention
Physical activity and play (observations)
Qualitative observations of physical activity and play among children during one day in the ASP (sub sample)
Measured: Baseline or end of intervention (7 months)
Physical activity and play (interviews)
Qualitative interviews with children about active play and physical activity in ASP (sub sample)
Measured: End of intervention (7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy
- Responsible party
- Principal investigator, Kirsti Riiser, Oslo Metropolitan University
- Investigators
- Kirsti Riiser, Phd, Principal investigator, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954614
- Sponsor's protocol ID
- 46008
- Status last verified
- Sep 2018
- First submitted
- 26 Oct 2016
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Riiser K, Richardsen KR, Haugen ALH, Lund S, Londal K. Active play in ASP -a matched-pair cluster-randomized trial investigating the effectiveness of an intervention in after-school programs for supporting children's physical activity. BMC Public Health. 2020 Apr 15;20(1):500. doi: 10.1186/s12889-020-08645-1.
PubMed 32295569Riiser K, Helseth S, Ellingsen H, Fallang B, Londal K. Active Play in After-school Programmes: development of an intervention and description of a matched-pair cluster-randomised trial assessing physical activity play in after-school programmes. BMJ Open. 2017 Aug 4;7(8):e016585. doi: 10.1136/bmjopen-2017-016585.
PubMed 28780558
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Play -an After-school-program Intervention to Promote Physical Activity and Health-related Quality of Life in Young Children
- ClinicalTrials.gov ID
- NCT02954614
- Acronym / sponsor ID
- 46008
- Conditions
- Physical Activity, Activity Play, Motor Activity, Quality of Life, Autonomy, Competence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy
- Study start
- May 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 3 Nov 2016 (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.
Background: Physical activity (PA) is a key component in health promotion and prevention of overweight. Interventions delivered in after-school programs (ASP) have the potential to become a means of ensuring PA among young schoolchildren. This requires a motivational climate, allowing for self-determination and the intrinsic values of the activity, on the activity's character of play. ASP staff could be trained in stimulating all children in physical activities in their everyday life. Physiotherapists in primary care possess knowledge of motor development and learning, and are important contributors to an ASP-based physical activity intervention.
Aim: To develop a complex intervention that emphasizes physical activity play, and to examine through a cluster-randomized trial the extent to which the intervention promotes PA and health-related quality of life and prevents overweight in a population of young children. We aim to increase the knowledge and autonomy supportive skills among ASP staff members, enabling them to promote physical activity through play among all first graders in ASP.
In addition to investigate if the children benefit from receiving autonomy support, we aim to study whether the ASP staff themselves benefit from giving autonomy support in terms of increased need satisfaction and autonomous motivation for work.
The intervention: Includes training of ASP-staff members in the fundamental principles of self-determination theory and practical applications for motivating young children in PA through play. Information will be given on the benefits of a physically active lifestyle and the staff will be encouraged to map opportunities for PA in their local ASP and to incorporate strategies to increase PA through play among the children throughout the day.
Methods/design: A complex intervention using a mixed methods approach will be developed and evaluated. A pilot trial will assess the potential of this approach and provide information necessary to perform a cluster-randomized controlled trial (RCT). The cluster-randomized controlled trial (RCT) will together with qualitative interviews and observations, evaluate the effectiveness of the intervention. Outcomes will be measured at baseline (September /October 2016) at the end of the intervention which lasts for 7 months (May 2017), and 1 year after the end of the intervention (May 2018)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Active play in after school programs (ASP)Active play in after school programs (ASP). Training program for ASP staff. |
| Control group | No intervention | –ASP as usual. |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Attends first grade in one of the ASPs included
Key exclusion criteria (1 listed)
- Does not attend first grade in one of the ASPs included
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 |
|---|---|---|
| Active play in after school programs (ASP)* A 15 hour training-program for ASP-staff aimed to increase active play and physical activity among children in ASPs. The program includes lectures, guided discussions and practical tasks focusing on increasing the staffs competence in how to support active play and PA among all children in the ASP * A 8 hour course for local physiotherapists enabling them to guide ASP-staff during parts of the intervention period | Behavioural | Intervention group |
Primary outcome
Change in minutes spent in moderate to vigorous physical activity in after school programs from baseline to end of intervention (7 months) and 1 year after end of intervention.
Time frame: Baseline, end of intervention (7 months), 1 year after intervention
Measures at baseline of a cluster randomized controlled intervention study and measures at the end of the 7 month intervention (measures of change) and 1 year after the end of the intervention (long-term effects). Physical activity is measured objectively by accelerometer (ActiGraph GM3X and GM3X+).
6 secondary outcomes
Heath-related quality of life
Time frame: Baseline, end of intervention (7 months), 1 year after intervention
Leisure time physical activity
Time frame: Baseline, end of intervention (7 months), 1 year after intervention
Active play in the ASP
Time frame: Baseline, end of intervention (7 months), 1 year after intervention
Body mass index
Time frame: Baseline, end of intervention (7 months), 1 year after intervention
Physical activity and play (observations)
Time frame: Baseline or end of intervention (7 months)
Physical activity and play (interviews)
Time frame: End of intervention (7 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 Sep 2018.
- Derived from this study: PubMed 32295569Riiser K, Richardsen KR, Haugen ALH, Lund S, Londal K. Active play in ASP -a matched-pair cluster-randomized trial investigating the effectiveness of an intervention in after-school programs for supporting children's physical activity. BMC Public Health. 2020 Apr 15;20(1):500. doi: 10.1186/s12889-020-08645-1.
- Derived from this study: PubMed 28780558Riiser K, Helseth S, Ellingsen H, Fallang B, Londal K. Active Play in After-school Programmes: development of an intervention and description of a matched-pair cluster-randomised trial assessing physical activity play in after-school programmes. BMJ Open. 2017 Aug 4;7(8):e016585. doi: 10.1136/bmjopen-2017-016585.
- Individual participant dataSharing planned: No
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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.
Kirsti Riiser, Phd principal investigator
Oslo Metropolitan University
Questions about this trial
What is this clinical trial studying?
A study testing Active play in after school programs (ASP) in people with Physical Activity and Activity Play, run by Oslo Metropolitan University.
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 1 inclusion and 1 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 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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 minutes spent in moderate to vigorous physical activity in after school programs from baseline to end of intervention (7 months) and 1 year after end of intervention. (time frame: Baseline, end of intervention (7 months), 1 year after intervention). 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 NCT02954614, which also lists 2 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 Sep 2018; AzTrials last refreshed its copy on 29 Oct 2026.