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Effects of reduced sitting on toddlers’ cognitive development: a cluster randomised controlled trial.

Effects of reduced sitting on toddlers’ cognitive development: a cluster randomised controlled trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000471482
Acronym
GET UP
Enrollment
338
Registered
2016-04-11
Start date
2016-03-01
Completion date
2016-07-25
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Our primary aim is to assess the effects of reducing sitting time during childcare on Executive Functions in a cluster randomised controlled trial in Australian toddlers from low socio-economic families. We hypothesise that at 15-month follow-up, toddlers in centres allocated to the intervention group will have improved their cognitive development by 0.5 SD more than toddlers in childcare centres randomly allocated to the control group. The secondary aims are to examine the effects of the intervention (i) on time spent in total sitting and bouts of sitting (ii) on time spent in total physical activity and moderate-to-vigorous physical activity (iii) on bone mineral density and (iv) and on cardiovascular health.

Interventions

Our primary aim is to assess the effects of a 12 months intervention reducing sitting time during childcare on Executive Functions in a cluster randomised controlled trial in Australian toddlers from low socio-economic families. We hypothesise that at follow-up, toddlers in centres allocated to the intervention group will have improved their cognitive development by 0.5 SD more than toddlers in childcare centres randomly allocated to the control group. The secondary aims are to examine the effe

Our primary aim is to assess the effects of a 12 months intervention reducing sitting time during childcare on Executive Functions in a cluster randomised controlled trial in Australian toddlers from low socio-economic families. We hypothesise that at follow-up, toddlers in centres allocated to the intervention group will have improved their cognitive development by 0.5 SD more than toddlers in childcare centres randomly allocated to the control group. The secondary aims are to examine the effects of the intervention (i) on time spent in total sitting and bouts of sitting (ii) on time spent in total physical activity and moderate-to-vigorous physical activity (iii) on bone mineral density and (iv) and on cardiovascular health. We will implement a 2-arm parallel group cluster randomised controlled trial comparing a reduced sitting time intervention with usual childcare practice (control group). The sampling frame will comprise 16 childcare services, selected using recognised indexes for socioeconomic disadvantage and early development. We will ensure that the centres we approach are ones that do not have any current research projects with this age group to ensure they are not overburdened. In Early Start, we have a comprehensive database that contains the names of all the centres where research is currently being conducted, the nature of this research, timeframes, and ages of children who are involved. This database will be consulted prior to approaching any centres. The intervention has been designed in response to formative research conducted by ESRI within similar childcare services in disadvantaged locations. In 2013, 12 focus groups were held with educators from 11 services. Educators were provided with data on how much time children in their service spent sitting and asked to identify by how much they would like to reduce this proportion of time. The most common reduction was 50% of the time currently spent sitting. Based on the proportions presented above, this would result in reducing a “typical” day (50% or half of the time in childcare spent sitting) to 25% of the time spent sitting. Educators were then asked to complete a daily routine for their service, which described the modifications that would take place to allow the halving of time spent sitting. Researchers then provided further ideas. The ideas provided by educators largely focused on changes to practices and modifications to the physical environment. Included in these ideas were ways to ensure no bouts of sitting exceeded 15 minutes. These example schedules will be used by each of the intervention childcare services to design their own daily schedule to reduce total sitting time by 50% and to reduce bouts of sitting to <15 minutes. Exemples of practice and environmental changes include: removing the chairs way from the tables for painting activities, action time stories (children can role-play the story), settling the play/learning equipment/areas near the wall of the room to create an open space in the centre of the room, remove chairs and tables from the outdoor space. Educators from the intervention centres will attend a 6 hours professional development workshop. The workshop will begin by introducing the rationale and aims of the study (1 hour). Educators will then be asked to think about ways to (i) modify routine activities to reduce the total amount of sitting time and reduce bouts of sitting to less than 15 min and (ii) to change indoor and outdoor environment to reduce the total amount of sitting time and the length of the sitting bouts. (1 hour). After this activity, the educators will be able to rehearsal some of the proposed activities in our laboratory (2 hour and 30 min).Finally, educators will be given further ideas on how to reduce toddlers’ total sitting time and reduce bouts of sitting to less than 15 min. Perceived barriers for the implementation of the program and possible solutions to overcome these barriers will be discussed (1 hour and 30 minutes). All educators will receive training on the same day to ensure standardization of content delivery. After the professional development workshop we will provide educators with supporting written materials with the rationale, aims and strategies/activities to reduce toddler’s sitting time. We will provide them with posters to be displayed in their classroom as a reminder of the need to reduce sitting time. A video demonstrating the proposed activities and desired routine changes will also be provided. During the intervention period the educators will receive monthly on-site visits from the research team, to revise key activities and behavioural strategies to reduce toddlers’ total sitting time and to follow up on the activities that are being undertaken. Three months and six months after the start of the intervention educators will attend an interactive online webinar to follow-up on the intervention, to share ideas and perceived barriers of the intervention implementation and to address possible solutions to overcome those barriers. During the intervention period educators will also receive regular emails and telephone calls. During the monthly visits the research staff will collect objective information on the total sitting time and sitting bouts (by accelerometry) in a random small sample of toddlers (10%) to monitor the implementation of the intervention. This performance will be delivered to the educators, providing feedback on the intervention implementation.

Sponsors

Rute Santos
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
12 Months to 26 Months
Healthy volunteers
Yes

Inclusion criteria

Apparently healthy toddlers aged 12 to 26-months at baseline will be eligible to participate if they attend the childcare service at least twice per week. All ethical consents will be obtained from the children’s parents or guardians.

Exclusion criteria

Children will be considered ineligible if they have a learning or physical disability, born very preterm (<29 weeks of gestation) or have a diagnosed medical or psychological condition that would affect the results of this study.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 11, 2026