Screen Free Time With Friends Feasibility Trial

NCT ID: NCT05480085

Last Updated: 2024-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-19

Study Completion Date

2024-01-19

Brief Summary

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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.

Detailed Description

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Conditions

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Screen Media Use Time With Friends

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Anders Groentved

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anders Grøntved, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Nyborg municipality

Nyborg, , Denmark

Site Status

Odense municipality

Odense, , Denmark

Site Status

Sorø municipality

Sorø, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 38374084 (View on PubMed)

Other Identifiers

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NNF20SH0062965

Identifier Type: -

Identifier Source: org_study_id

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