Clinical trial NCT05480085: Screen Free Time With Friends Feasibility Trial
Official title: Screen Free Time With Friends Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Screen Media Use
Time With Friends
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2022-07-29
Enrollment: 204
Sex: ALL
Minimum age (years): 8
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the intervention
timeFrame: Baseline
measure: Feasibility of the intervention
timeFrame: After completion of different intervention components
Secondary outcomes:
measure: Participant recruitment and retention rate
timeFrame: Baseline and 6-month follow-up
measure: Compliance to leisure time activities measurement
timeFrame: Three times/week for three weeks at baseline and 6-month follow-up
measure: Compliance to objective screen media use measurement
timeFrame: Baseline and 6-month follow-up
measure: Compliance to subjective screen media use measurement
timeFrame: Three times/week for three weeks at baseline and 6-month follow-up
measure: Compliance to objective physical activity measurement
timeFrame: Baseline and 6-month follow-up
measure: Compliance to wellbeing measurement
timeFrame: Baseline and 6-month follow-up
measure: Compliance to a child questionnaire
timeFrame: Baseline and 6-month follow-up
measure: Compliance to a parent questionnaire
timeFrame: Baseline and 6-month follow-up
Other outcomes:
Locations:
city: Nyborg
country: Denmark
facility: Nyborg municipality
city: Odense
country: Denmark
facility: Odense municipality
city: Sorø
country: Denmark
facility: Sorø municipality
Study officials:
affiliation: Department of Sports Science and Clinical Biomechanics, University of Southern Denmark
name: Anders Grøntved, PhD
role: PRINCIPAL_INVESTIGATOR
References: