Screen Free Time With Friends Feasibility Trial

The Screen Free Time with Friends Feasibility Trial is a study designed to inform development of a definitive trial. The feasibility trial aims to 1) examine the feasibility of an intervention aimed to limit recreational screen media use and promote more time with peers after school and during weekends among 10-11 year old children, 2) examine participant recruitment and retention rates, 3) examine the feasibility of the data collection plan and completeness of the compliance and outcome assessment, and 4) obtain baseline and follow-up data on the planned full trial primary outcome. The Screen Free Time with Friends Feasibility Trial will be conducted as a non-randomized single group feasibility trial including children, their parents and school and afterschool personal from 3rd grade school classes from different schools in the Region of Southern Denmark. The goal is to include a representative sample of children and parents in the participating 3rd grades, and thus there will be no individual level inclusion and exclusion criteria. A process evaluation and outcome measurements will be conducted to evaluate the feasibility and acceptability of the intervention, the data collection plan, and compliance. A baseline- and follow-up assessment will be carried out for some measurements, while others will be collected continuously during the intervention period.

Study Overview

• Status: Completed
• Conditions: Screen Media Use; Time With Friends
• Intervention / Treatment: Behavioral: School-based extracurricular intervention focusing on screen media use and time spent with friends

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Nyborg, Denmark
    • Nyborg municipality
  • Odense, Denmark
    • Odense municipality
  • Sorø, Denmark
    • Sorø municipality

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• the distance between the school and the related afterschool club is in walking and cycling distance
• the afterschool club must have potential for improvement (assessed by the municipality)
• the afterschool club personal must have a wish to develop the afterschool club

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: School-based extracurricular intervention focusing on screen media use and time spent with friends

Behavioral: School-based extracurricular intervention focusing on screen media use and time spent with friends; The intervention includes the following components: Within each class parents will engage in two meetings combining education and parent-to-parent communication about 1) the children's leisure time activities, and 2) family and class screen time culture. Parents will engage in a short exercise focusing on screen media dilemmas conducted by the teacher in the beginning of 4th grade.; Children will engage in school hour workshops focusing on the class culture related to screen media use and leisure time activities.; Afterschool club personal will engage in mini actions learning program consisting of three workshops aimed to increase participation rate in the afterschool club.; Local stakeholders, e.g., parents, school- and afterschool club personal and others relevant to children's leisure time (e.g., sports clubs) will engage in workshops to adjust the predetermined intervention components (1-3 above) to fit their local context and to develop a local action plan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the intervention	The feasibility of the intervention is evaluated using process evaluation inspired by the RE-AIM framework. Questionnaires to parents and local workshop participants focusing on the intervention and measurements will be used to assess acceptability.	Baseline
Feasibility of the intervention	The feasibility of the intervention is evaluated using process evaluation inspired by the RE-AIM framework. Questionnaires and interviews with parents, local workshop participants, school and afterschool club personal, municipality and research team focusing on the recruitment process, intervention and measurements will be used to assess acceptability.	After completion of different intervention components

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance to objective physical activity measurement	Proportion of children wearing the accelerometer (Axivity AX3) for at least four out of seven measurements days at baseline and follow-up (at least one day must be a weekend day).	Baseline and 6-month follow-up
Compliance to objective screen media use measurement	Proportion of children and parents with data on objective measured smartphone use.	Baseline and 6-month follow-up
Participant recruitment and retention rate	Proportion of invited municipalities, schools, afterschool clubs and participants included in the study and proportion of municipalities, schools, afterschool clubs and participants completing the study.	Baseline and 6-month follow-up
Compliance to leisure time activities measurement	Proportion of parents answering questions focusing on the child's afterschool club participation and time spent with friends and family during leisure time.	Three times/week for three weeks at baseline and 6-month follow-up
Compliance to subjective screen media use measurement	Proportion of parents answering questions focusing on the child's screen media use during leisure time.	Three times/week for three weeks at baseline and 6-month follow-up
Compliance to wellbeing measurement	Proportion of children answering KIDSCREEN-27 questionnaire focusing on wellbeing.	Baseline and 6-month follow-up
Compliance to a child questionnaire	Proportion of children answering a questionnaire focusing on wellbeing, screen culture in the class and family and children's social relations.	Baseline and 6-month follow-up
Compliance to a parent questionnaire	Proportion of parents answering the parent questionnaire including questions on background informations, their child's and family's physical activity and screen media habits and children's and parents screen media addiction.	Baseline and 6-month follow-up

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: Novo Nordisk A/S
• Investigators: Principal Investigator: Anders Grøntved, PhD, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2022
• Primary Completion (Actual): January 19, 2024
• Study Completion (Actual): January 19, 2024

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: NNF20SH0062965

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No