NCT04555746

Brief Summary

The AK-AC study was designed as a two-arm, randomised by ECEC institution, evaluative controlled trial with the overarching aim of increasing the children's PA level and reduce sedentary time.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

8 months

First QC Date

September 9, 2020

Last Update Submit

September 18, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Differences in accelerometer-measured physical activity and sedentary time at 4-month follow-up between intervention and control group

    Free-living PA was assessed using ActiGraph GT1M and GT3X+accelerometers (ActiGraph, LLC, Pensacola, FL, USA). The participants were instructed to wear the accelerometer on the left hip during their stay at the preschool for five consecutive days. The epoch length (sample interval) was set to 15 s. PA data were included if the participant had accumulated a minimum of 6 h of activity data per day for at least two days. The minutes spent in various levels of PA intensity were calculated. Sedentary behavior (sedentary time) was defined as ≤239 counts, light intensity PA was defined as 240 to 2119 counts, moderate intensity PA was defined as 2120 to 4449 counts, and any amount above 4450 was considered vigorous or very vigorous intensity PA.

    5 days on both baseline and posttest

Study Arms (2)

Physical activity

EXPERIMENTAL

Physical activity

Behavioral: Physical activity

Control

NO INTERVENTION

Waiting list

Interventions

Four PA experts (researchers (PhD) within the field of PA and health in children, and physical education teachers) in collaboration with two members of the ECEC staff and two members of the municipality health department (paediatric physiotherapists) developed a frame for the intervention based on COP elements to be further developed, concretized and implemented by the staff. The intervention lasted for four months and contained the following components (Table 1): pre-meetings and follow up meetings in each ECEC institution; start up seminar and two follow up courses with all the staff members; ongoing planning and collective reflections practice in the ECEC institutions; Facebook group; and an equipment-package.

Physical activity

Eligibility Criteria

Age3 Years - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All children attending one of the 11 public ECEC institutions in Sandefjord municipality and born in 2011 (three or four year olds)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Andersen E, Ovreas S, Jorgensen KA, Borch-Jenssen J, Moser T. Children's physical activity level and sedentary behaviour in Norwegian early childhood education and care: effects of a staff-led cluster-randomised controlled trial. BMC Public Health. 2020 Nov 4;20(1):1651. doi: 10.1186/s12889-020-09725-y.

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 9, 2020

First Posted

September 21, 2020

Study Start

September 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 22, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share