Screen Free Time With Friends Feasibility Trial

NCT05480085 | Completed

• 1 other identifier: NNF20SH0062965
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Screen Media Use; Time With Friends

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Participant recruitment and retention rate

  Baseline and 6-month follow-up

• Compliance to leisure time activities measurement

  Three times/week for three weeks at baseline and 6-month follow-up

• Compliance to objective screen media use measurement

  Baseline and 6-month follow-up

• Compliance to subjective screen media use measurement

  Three times/week for three weeks at baseline and 6-month follow-up

• Compliance to objective physical activity measurement

  Baseline and 6-month follow-up

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

The intervention includes the following components: 1. 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. 2. Children will engage in school hour workshops focusing on the class culture related to screen media use and leisure time activities. 3. Afterschool club personal will engage in mini actions learning program consisting of three workshops aimed to increase participation rate in the afterschool club. 4. 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.

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

Eligibility Criteria

• Age: 8 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead
• Novo Nordisk A/S: collaborator

Study Sites (3)

Nyborg municipality

Nyborg, Denmark

Location

Odense municipality

Odense, Denmark

Location

Sorø municipality

Sorø, Denmark

Location

Related Publications (1)

• Sorensen SO, Larsen KT, Hoy TV, Hansen ABG, Jago R, Kristensen PL, Toftager M, Grontved A, Gejl AK. Study protocol for the Screen-Free Time with Friends Feasibility Trial. Pilot Feasibility Stud. 2024 Feb 19;10(1):33. doi: 10.1186/s40814-024-01462-y.

  PMID: 38374084 DERIVED

Study Officials

• Anders Grøntved, PhD

  Department of Sports Science and Clinical Biomechanics, University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 29, 2022
• Study Start: August 19, 2022
• Primary Completion: January 19, 2024
• Study Completion: January 19, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)