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Completed

NCT Number: NCT05480085

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.

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Key information

Conditions

Screen Media Use Time With Friends

Age range

8 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nyborg municipality, Nyborg, Denmark

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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.

Primary outcomes

  1. Feasibility of the intervention

    Time frame: Baseline

    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.

  2. Feasibility of the intervention

    Time frame: After completion of different intervention components

    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.

Secondary outcomes

  1. Participant recruitment and retention rate

    Time frame: Baseline and 6-month follow-up

    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.

  2. Compliance to leisure time activities measurement

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

    Proportion of parents answering questions focusing on the child's afterschool club participation and time spent with friends and family during leisure time.

  3. Compliance to objective screen media use measurement

    Time frame: Baseline and 6-month follow-up

    Proportion of children and parents with data on objective measured smartphone use.

  4. Compliance to subjective screen media use measurement

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

    Proportion of parents answering questions focusing on the child's screen media use during leisure time.

  5. Compliance to objective physical activity measurement

    Time frame: Baseline and 6-month follow-up

    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).

  6. Compliance to wellbeing measurement

    Time frame: Baseline and 6-month follow-up

    Proportion of children answering KIDSCREEN-27 questionnaire focusing on wellbeing.

  7. Compliance to a child questionnaire

    Time frame: Baseline and 6-month follow-up

    Proportion of children answering a questionnaire focusing on wellbeing, screen culture in the class and family and children's social relations.

  8. Compliance to a parent questionnaire

    Time frame: Baseline and 6-month follow-up

    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.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 29, 2022
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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