Clinical trial NCT02954614: Active Play in After School Programs
Official title: Active Play -an After-school-program Intervention to Promote Physical Activity and Health-related Quality of Life in Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Activity Play
Motor Activity
Quality of Life
Autonomy
Competence
Children
After-School Program
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: Norwegian Fund for Postgraduate Training in Physiotherapy
First posted: 2016-11-03
Enrollment: 456
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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)


Eligibility criteria: Inclusion Criteria:

* Attends first grade in one of the ASPs included

Exclusion Criteria:

* Does not attend first grade in one of the ASPs included

Primary outcomes:
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.
timeFrame: Baseline, end of intervention (7 months), 1 year after intervention
Secondary outcomes:
measure: Heath-related quality of life
timeFrame: Baseline, end of intervention (7 months), 1 year after intervention
measure: Leisure time physical activity
timeFrame: Baseline, end of intervention (7 months), 1 year after intervention
measure: Active play in the ASP
timeFrame: Baseline, end of intervention (7 months), 1 year after intervention
measure: Body mass index
timeFrame: Baseline, end of intervention (7 months), 1 year after intervention
measure: Physical activity and play (observations)
timeFrame: Baseline or end of intervention (7 months)
measure: Physical activity and play (interviews)
timeFrame: End of intervention (7 months)
Other outcomes:
measure: Work-related Basic Need Satisfaction among SFP-staff
timeFrame: Baseline, end of intervention (7 months), 1 year after intervention
measure: Work motivation in ASP-staff
timeFrame: Baseline, end of intervention (7 months), 1 year after intervention
measure: Job Satisfaction in ASP-staff
timeFrame: Baseline, end of intervention (7 months), 1 year after intervention
measure: Satisfaction with Life in ASP-staff
timeFrame: Baseline, end of intervention (7 months), 1 year after intervention
measure: ASP-staff's experiences of taking part in the intervention (process outcome)
timeFrame: End of intervention (7 months)
measure: Local physiotherapist's experiences of taking part in the intervention (process outcome)
timeFrame: End of intervention (7 months)
Locations:
Study officials:
affiliation: Oslo Metropolitan University
name: Kirsti Riiser, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.