NCT02954614

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)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
456

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 3, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

September 25, 2018

Status Verified

September 1, 2018

Enrollment Period

2 years

First QC Date

October 26, 2016

Last Update Submit

September 21, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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+).

    Baseline, end of intervention (7 months), 1 year after intervention

Secondary Outcomes (6)

  • Heath-related quality of life

    Baseline, end of intervention (7 months), 1 year after intervention

  • Leisure time physical activity

    Baseline, end of intervention (7 months), 1 year after intervention

  • Active play in the ASP

    Baseline, end of intervention (7 months), 1 year after intervention

  • Body mass index

    Baseline, end of intervention (7 months), 1 year after intervention

  • Physical activity and play (observations)

    Baseline or end of intervention (7 months)

  • +1 more secondary outcomes

Other Outcomes (6)

  • Work-related Basic Need Satisfaction among SFP-staff

    Baseline, end of intervention (7 months), 1 year after intervention

  • Work motivation in ASP-staff

    Baseline, end of intervention (7 months), 1 year after intervention

  • Job Satisfaction in ASP-staff

    Baseline, end of intervention (7 months), 1 year after intervention

  • +3 more other outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Active play in after school programs (ASP). Training program for ASP staff.

Behavioral: Active play in after school programs (ASP)

Control group

NO INTERVENTION

ASP as usual.

Interventions

* 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

Intervention group

Eligibility Criteria

Age5 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Attends first grade in one of the ASPs included

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Kirsti Riiser, Phd

    Oslo Metropolitan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

October 26, 2016

First Posted

November 3, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

September 25, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share