- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02954614
Active Play in After School Programs
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Attends first grade in one of the ASPs included
Exclusion Criteria:
- Does not attend first grade in one of the ASPs included
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Active play in after school programs (ASP).
Training program for ASP staff.
|
|
No Intervention: Control group
ASP as usual.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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+).
|
Baseline, end of intervention (7 months), 1 year after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heath-related quality of life
Time Frame: Baseline, end of intervention (7 months), 1 year after intervention
|
Parent-reported, measured by KIDSCREEN-27 questionnaire (parent version)
|
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
|
Self-reported/parent-reported, measured by UngKan-2 questionnaire
|
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
|
Self-reported/parent-reported, measured by questionnaire
|
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
|
kg/(m2), height and weight measured objectively
|
Baseline, end of intervention (7 months), 1 year after intervention
|
Physical activity and play (observations)
Time Frame: Baseline or end of intervention (7 months)
|
Qualitative observations of physical activity and play among children during one day in the ASP (sub sample)
|
Baseline or end of intervention (7 months)
|
Physical activity and play (interviews)
Time Frame: End of intervention (7 months)
|
Qualitative interviews with children about active play and physical activity in ASP (sub sample)
|
End of intervention (7 months)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Work-related Basic Need Satisfaction among SFP-staff
Time Frame: Baseline, end of intervention (7 months), 1 year after intervention
|
Self-reported, measured by the Work-related Basic Need Satisfaction Scale (W-BNS)
|
Baseline, end of intervention (7 months), 1 year after intervention
|
Work motivation in ASP-staff
Time Frame: Baseline, end of intervention (7 months), 1 year after intervention
|
Self-reported, measured by the Multidimensional Work Motivation Scale (MWMS)
|
Baseline, end of intervention (7 months), 1 year after intervention
|
Job Satisfaction in ASP-staff
Time Frame: Baseline, end of intervention (7 months), 1 year after intervention
|
Self-reported, measured by the Job Satisfaction Scale (JSS)
|
Baseline, end of intervention (7 months), 1 year after intervention
|
Satisfaction with Life in ASP-staff
Time Frame: Baseline, end of intervention (7 months), 1 year after intervention
|
Self-reported, measured by the Satisfaction with Life Scale (SWSL)
|
Baseline, end of intervention (7 months), 1 year after intervention
|
ASP-staff's experiences of taking part in the intervention (process outcome)
Time Frame: End of intervention (7 months)
|
Focus group interviews (sub sample)
|
End of intervention (7 months)
|
Local physiotherapist's experiences of taking part in the intervention (process outcome)
Time Frame: End of intervention (7 months)
|
Focus group interviews
|
End of intervention (7 months)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kirsti Riiser, Phd, Oslo Metropolitan University
Publications and helpful links
General 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.
- Riiser 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 46008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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