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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02954614
Other study ID # 46008
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2016
Est. completion date May 2018

Study information

Verified date September 2018
Source Oslo and Akershus University College of Applied Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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)


Recruitment information / eligibility

Status Completed
Enrollment 456
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 6 Years
Eligibility 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 Design


Intervention

Behavioral:
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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Oslo and Akershus University College of Applied Sciences Norwegian Fund for Postgraduate Training in Physiotherapy

Outcome

Type Measure Description Time frame Safety issue
Other Work-related Basic Need Satisfaction among SFP-staff Self-reported, measured by the Work-related Basic Need Satisfaction Scale (W-BNS) Baseline, end of intervention (7 months), 1 year after intervention
Other Work motivation in ASP-staff Self-reported, measured by the Multidimensional Work Motivation Scale (MWMS) Baseline, end of intervention (7 months), 1 year after intervention
Other Job Satisfaction in ASP-staff Self-reported, measured by the Job Satisfaction Scale (JSS) Baseline, end of intervention (7 months), 1 year after intervention
Other Satisfaction with Life in ASP-staff Self-reported, measured by the Satisfaction with Life Scale (SWSL) Baseline, end of intervention (7 months), 1 year after intervention
Other ASP-staff's experiences of taking part in the intervention (process outcome) Focus group interviews (sub sample) End of intervention (7 months)
Other Local physiotherapist's experiences of taking part in the intervention (process outcome) Focus group interviews End of intervention (7 months)
Primary 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 Heath-related quality of life Parent-reported, measured by KIDSCREEN-27 questionnaire (parent version) Baseline, end of intervention (7 months), 1 year after intervention
Secondary Leisure time physical activity Self-reported/parent-reported, measured by UngKan-2 questionnaire Baseline, end of intervention (7 months), 1 year after intervention
Secondary Active play in the ASP Self-reported/parent-reported, measured by questionnaire Baseline, end of intervention (7 months), 1 year after intervention
Secondary Body mass index kg/(m2), height and weight measured objectively Baseline, end of intervention (7 months), 1 year after intervention
Secondary Physical activity and play (observations) Qualitative observations of physical activity and play among children during one day in the ASP (sub sample) Baseline or end of intervention (7 months)
Secondary Physical activity and play (interviews) Qualitative interviews with children about active play and physical activity in ASP (sub sample) End of intervention (7 months)
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