- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07521878
Moving Kindergartens Feasibility Study
Objective of the study: The primary aim of this study is to evaluate the feasibility of a proposed intervention designed to support the daily movement practices and fostering joy of movement in Danish kindergartens, as well as the implementation strategies intended to facilitate adoption. Additionally, the feasibility of the planned measurement and procedures for a future effectiveness study will be examined.
Methods: The study uses a mixed-methods design to examine the feasibility of the intervention and the future evaluation design. The planned duration of the intervention period is 10 weeks. The intervention consists of multiple integrated components co-designed with pedagogical staff, leaders, experts in kindergarten movement culture, and a team of researchers, to collectively support the daily movement practice in kindergartens. Alongside the intervention components, tailored strategies are developed to facilitate adoption and implementation. The intervention elements are categorized into four main types: 1) Formal establishment of the project; 2) Components of physical activity integrated in existing structures in the kindergarten; 3) Organizational and staff training; 4) Inspirational materials, tools and exemplary plans.
The use of a co-design approach in close collaboration between kindergartens, experts, and a team of researchers will ensure contextual relevance and shared ownership. This approach is expected to enhance acceptability, feasibility, and sustainability of the intervention. The mixed-methods evaluation design, use of theoretical implementation frameworks, and tailored strategies further strengthen the study. The findings from this feasibility study will inform the refinement of the final intervention and guide the planning of a forthcoming effectiveness study.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anna Bugge, PhD
- Phone Number: +45 51632509
- Email: abug@kp.dk
Study Contact Backup
- Name: Elisabeth Bandak, PhD
- Phone Number: +45 24793991
- Email: elib@kp.dk
Study Locations
-
-
-
Copenhagen, Denmark, 2200
- Recruiting
- University College Copenhagen
-
Contact:
- Daria Staghøj
- Phone Number: +45 23491711
- Email: dari@kp.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pedagogical staff/leaders in included kindergartens
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Moving Kindergarten Intervention
In the feasibility study, the intervention period spans 10 weeks.
The intervention consists of multiple integrated components designed to collectively support the daily movement practice in the kindergartens.
Alongside the intervention components, tailored strategies are developed to facilitate adoption and implementation.
|
The intervention elements can be categorized into four main types :
Children will be exposed to multiple daily opportunities for physical activity and active play - including child group gatherings integrating movement, play, storytelling and language development, structured active play sessions during outdoor periods, and a weekly session led by the movement agent focusing on fundamental movement skills. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of the intervention - interviews
Time Frame: The last three weeks of the 10-week intervention (week 8 to 10)
|
Semi-structured group interviews (pedagogical staff) and individual interviews (leaders).
|
The last three weeks of the 10-week intervention (week 8 to 10)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of the intervention - survey
Time Frame: The last three weeks of the 10-week intervention (week 8 to 10)
|
Assesed by the questionnaire "Feasibility of Intervention Measure (FIM)"(Weiner, et al., 2017.
https://doi.org/10.1186/s13012-017-0635-3)
answered by the pedagogical staff
|
The last three weeks of the 10-week intervention (week 8 to 10)
|
|
Acceptability of the intervention - interviews
Time Frame: The last three weeks of the 10-week intervention (week 8 to 10)
|
Semi-structured group Interviews (pedagogical staff) and individual interviews (leaders).
|
The last three weeks of the 10-week intervention (week 8 to 10)
|
|
Acceptability of the intervention - survey
Time Frame: The last three weeks of the 10-week intervention (week 8 to 10)
|
Assessed by the questionnaire Acceptability of Intervention Measure (AIM) (Weiner, et al., 2017.
https://doi.org/10.1186/s13012-017-0635-3)
answered by pedagogical staff.
|
The last three weeks of the 10-week intervention (week 8 to 10)
|
|
Feasibility of recruitment strategy - enrollment rate
Time Frame: Prior to the intervention start
|
Number of included kindergartens.
|
Prior to the intervention start
|
|
Feasibility of recruitment strategy - interviews
Time Frame: The last three weeks of the 10-week intervention (week 8 to 10).
|
Semi-structured individual interviews with leaders
|
The last three weeks of the 10-week intervention (week 8 to 10).
|
|
Feasibility of data collection on child level - descriptive data
Time Frame: The last four weeks of the 10-week intervention (week 6 to 9).
|
Number of completed tests and time required for assessing physical activity (accelerometry), fundamental movement skills, and anthropometrics in selected kindergartens.
|
The last four weeks of the 10-week intervention (week 6 to 9).
|
|
Feasibility of data collection on staff level - descriptive data
Time Frame: The last three weeks of the 10-week intervention (week 8 to 10).
|
Response rate on "Children's general movement engagement and social participation in physical activity and active play" (10-items staff-rated questionnaire)
|
The last three weeks of the 10-week intervention (week 8 to 10).
|
|
Appropriateness of the intervention - interviews
Time Frame: The last three weeks of the 10-week intervention (week 8 to 10).
|
Semi-structured group interviews (pedagogical staff) and individual interviews (leaders)
|
The last three weeks of the 10-week intervention (week 8 to 10).
|
|
Appropriateness of the intervention - survey
Time Frame: The last three weeks of the 10-week intervention (week 8 to 10).
|
Assessed by the survey: "Intervention Appropriatness Measure (IAM)" (Weiner et al., 2017 et al. https://doi.org/10.1186/s13012-017-0635-3)
|
The last three weeks of the 10-week intervention (week 8 to 10).
|
|
Appropriateness of the intervention - observations
Time Frame: The last three weeks of the 10-week intervention (week 8 to 10).
|
Participatory field observations in kindergartens
|
The last three weeks of the 10-week intervention (week 8 to 10).
|
|
Adoption of the intervention - interviews
Time Frame: The last three weeks of the 10-week intervention (week 8 to 10)
|
Semi-structured group interviews (pedagogical staff) and individual interviews (leaders)
|
The last three weeks of the 10-week intervention (week 8 to 10)
|
|
Adoption of the intervention - survey
Time Frame: The last two weeks of the 10-week intervention (week 8 to 10)
|
Survey (pedagogical staff)
|
The last two weeks of the 10-week intervention (week 8 to 10)
|
|
Adoption of the intervention - log book
Time Frame: The last three weeks of the 10-week intervention (week 8 to 10)
|
Daily completion of check boxes on poster
|
The last three weeks of the 10-week intervention (week 8 to 10)
|
|
Adoption of the intervention - observations
Time Frame: The last three weeks of the 10-week intervention (week 8 to 10)
|
Participatory field observations
|
The last three weeks of the 10-week intervention (week 8 to 10)
|
|
Fidelity to the intervention - interviews
Time Frame: The last three weeks of the 10-weeks of the intervention (week 8 to 10)
|
Semi-structured group interviews (pedagogical staff) and individual interviews (leaders).
|
The last three weeks of the 10-weeks of the intervention (week 8 to 10)
|
|
Fidelity to the intervention - log book
Time Frame: The last three weeks of the 10-weeks of the intervention (week 8 to 10)
|
Daily completion of check boxes on poster
|
The last three weeks of the 10-weeks of the intervention (week 8 to 10)
|
|
Fidelity to the intervention - observations
Time Frame: The last three weeks of the 10-weeks of the intervention (week 8 to 10)
|
Participatory field observations.
|
The last three weeks of the 10-weeks of the intervention (week 8 to 10)
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-14029
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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