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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| School-based extracurricular intervention focusing on screen media use and time spent with friends | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| School-based extracurricular intervention focusing on screen media use and time spent with friends | Behavioral | The intervention includes the following components:
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Grøntved, PhD | University of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nyborg municipality | Nyborg | Denmark | ||||
| Odense municipality |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38374084 | Derived | 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. |
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|
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 objective screen media use measurement | Proportion of children and parents with data on objective measured smartphone use. | 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 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 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 |
| Odense |
| Denmark |
| Sorø municipality | Sorø | Denmark |