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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 27 August 2018
Main ID:  ISRCTN70604107
Date of registration: 08/10/2014
Prospective Registration: Yes
Primary sponsor: Canadian Institutes of Health Research (Canada)
Public title: The supporting physical activity in childcare environments (SPACE) study
Scientific title: The Supporting Physical Activity in Childcare Environments (SPACE) study: a randomized controlled trial
Date of first enrolment: 01/01/2015
Target sample size: 348
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN70604107
Study type:  Interventional
Study design:  Parallel clustered randomized controlled trial with a single-blinded design (single-centre) (Quality of life)  
Phase:  Not Applicable
Countries of recruitment
Canada
Contacts
Name: Patricia    Tucker
Address:  1201 Western Rd Elborn College, Rm 2547 University of Western Ontario N6G 1H1 London Canada
Telephone: -
Email: ttucker2@uwo.ca
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Childcare centres will be invited to participate if they have one or more full-day preschool-aged classrooms at their facility. A sample of male and female preschoolers (aged 2.5-4 years) will be drawn from these centre-based childcare facilities in London Ontario.

Inclusion criteria for childcare centres include:
1. Must provide childcare in London, Ontario from a centre-based facility
2. Must have at least one preschool classroom
3. Must have childcare providers in the preschool classroom who are willing to participate
4. Must speak/read English

Inclusion criteria for pre-schooler participants include:
1. Must be enrolled in the preschool classroom of a participating centre
2. Must between the ages of 2.5 and 4 years of age at baseline
3. Must be expected to remain in childcare for the next 12 months
4. Must have a parent/guardian that can read and write English
5. Must speak and understand English
6. Must receive parental consent

Exclusion criteria: Exclusion criteria for childcare centres include:
1. Not located in London, Ontario
2. Do not have a preschool classroom
3. Do not have childcare providers in the classroom who are willing to participate
4. Not an English-speaking facility.

Inclusion criteria for pre-schooler participants include:
1. Not between the ages of 2.5 and 4 years at baseline
2. Not expected to remain in childcare for the next 12 months
3. Not enrolled in a preschool classroom of a participating centre
4. Do not speak English
5. Parent/guardian does not read/write in English


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
An evidence-based health promotion intervention aimed at improving the physical activity levels of preschoolers in centre-based childcare
Not Applicable
Intervention(s)
The following is a description of our planned trial interventions (of which will take place over an 8-week period during the spring and summer months):

1. Experimental condition:
Randomly selected childcare centres (i.e., clusters) will be assigned to the experimental condition. Centres will participate in the SPACE study, which entails environmental modifications, staff training, and curriculum changes to their preschooler classrooms; all of which are designed to encourage physical activity participation among preschoolers. The intervention period will last 8 weeks (weekdays only; Monday-Friday), after which the intervention will cease.
The specific components of the intervention will be guided by the steering committee and are discussed below:
(a) Environmental modifications will involve the addition of portable play equipment (for use indoors and outdoors) shown to predict physical activity levels among preschoolers (Bower et al., 2008; Vanderloo et al., 2012).The equipment provided will be available for the full 8-week duration of the intervention, and will be rotated on a daily basis (e.g., on Mondays, tricycles will be added to their typical equipment offerings, on Tuesdays, hula hoops will be provided, etc., in addition to pavement markings that will be added to the outdoor play area). Each participating childcare centre will keep the equipment provided to them.
(b) Physical activity-related staff training will involve lunch time or evening sessions with childcare providers and directors assigned to this condition. Staff training will be led by members of the research team. These sessions, four in total, will provide childcare staff with information regarding:
1. Physical activity recommendations for preschoolers
2. Resources available to improve activity participation in the childcare centre (e.g., Hop, Skip, Munch)
3. The need for shorter bouts of activity
4. The need to incorporate physical activity into their indoor curriculum.
(c) Curriculum modifi
Primary Outcome(s)
Physical activity levels, to know if our research program has been effective if we see an increase in minutes of moderate-to-vigorous physical activity and total physical activity (MVPA and TPA, respectively). This outcome will be measured using accelerometers, which have been acknowledged in research as the most favourable tool for assessing young children?s (i.e., 0-5 years) habitual activity patterns (Cliff et al., 2009; Oliver et al., 2007; Pate et al., 2010). Specific to this study, preschooler?s physical activity and sedentary behaviours will be measured using Actical accelerometers (MiniMitter, Bend, Oregon). These lightweight omnidirectional motion sensors (which do not record the children?s location) will provide detailed data on the duration (summed into minutes of physical activity), intensity, and frequency of the children?s movements (Van Cauwenberghe et al., 2011) as well as step counts. A 15-second epoch length will be applied to capture the sporadic activity and intermittent periods of rest of the young participants (Cliff et al., 2009; Colley et al., 2010; Pate et al., 2010; Pfeiffer et al., 2006). The Acticals will be secured to the participants? right hip using an adjustable neoprene belt and will be programmed to begin collecting activity data on the morning of the first day of data collection. Wear-time of the accelerometers will be recorded in a daily log.
Physical activity assessments using accelerometers will last one week for each classroom during childcare hours; Monday-Friday only, for each of the four assessment points (i.e., baseline, post-intervention, 6- and 12-month follow-up). The 6- and 12-month follow-up time points will allow us to determine the long-term impact of the intervention and to identify if changes in physical activity levels can be maintained.
Secondary Outcome(s)
The secondary outcome measures for preschoolers include sedentary behaviour (decreased time) and BMI (decreased score). Secondary outcome measures also include childcare providers? physical activity levels, knowledge, and self-efficacy.
1. Demographics: Parents of preschoolers will be asked to complete a demographic questionnaire at baseline to gather information regarding potential correlates of preschoolers? physical activity (e.g., their preschooler?s age, sex, ethnic origin, family income, parent education levels, parent activity levels, as well as the child?s physical activity participation outside of childcare [e.g., swimming lessons, soccer]). This tool will also capture parent/guardian physical activity levels along with their height and weight (for BMI calculations). Such data will be entered as predictors of physical activity in our analyses.
2. Anthropometric measures: A number of anthropometric measures will be taken from the children at pre-, post-intervention, and at 6- and 12-month follow-up. These measures are: height (using a Seca 214 'Road Rod' Portable Stadiometer; nearest 0.1 cm); weight (using a Tanita 700-TBF300GS Body Fat Analyzer w/Goal Setter scale; nearest 0.1 kg); and waist circumference (using a measuring tape; nearest 0.1 cm). The data collected will be used to calculate the child?s standardized body mass index score (BMI-z). All of these data will be recorded in a separate tracking sheet for each participant.
3. Childcare Provider Physical Activity Questionnaire: This questionnaire, comprising the validated Adapted Godin Leisure Time Physical Activity Questionnaire (Irwin, 2007) along with questions devoted to activity knowledge and practice, will be administered to childcare providers prior to the onset of the intervention to examine their current physical activity levels, knowledge, and practice within their childcare centres. Childcare providers have acknowledged their influence on preschoolers? activity levels, as such, it is important to examine their own knowledge and practice (Copeland et al., 2012). This questionnaire will be re-administered post- intervention and at 6- and 12-month follow-up to determine if any changes in their physical activity-related knowledge and behaviours occurred and were sustained after the intervention.
4. Childcare Provider Physical Activity Self-Efficacy Questionnaire: Self-efficacy, an individual?s confidence in his/her ability to perform a particular behaviour, represents a major component of social cognitive theory and is arguably one of the most important determinants of behaviour (Bandura, 1989). Childcare providers have noted lack of self-efficacy as a barrier to facilitating physical activity engagement in early learning environments (Copeland et al., 2012; Froelich Chow et al., 2011). A physical activity self-efficacy questionnaire, developed for the purpose of the present study (based on Bandura?s Guide for Constructing Self-Efficacy Scales; Bandura, 2006), will be administered both pre- and post-intervention, 6- and 12-month follow-up to assess whether a significant change occurred in providers? confidence to engage preschoolers in physical activity while in childcare (as well as whether this change was maintained after the intervention).
5. Quality of Life Questionnaire: The Pediatric Quality of Life Inventory (PedsQL) 4.0 (Varni et al., 1993), a reliable and valid inventory for the preschool population (aged 2-4 years), will be used (Varni et al., 2007). Specifically, the parent report for children of PedsQL 4.0 Generic Core Scales questionnaire will be administered .
6. Child Temperament Questionnaire: Previous research has acknowledged preschoolers? temperament as influencing their engagement in physical activity within childcare (Tucker et al., 2011). As such, the Children?s Behaviour Questionnaire (CBQ; very short form; Putnam et al., 2006; Rothbart et al., 2001) will be administered. Used with children aged 3 to 7 years old, this tool will be employed to determine temperament across the dimensions of effortful control, surgency extraversion, and affectivity (all via parent-report).
7. Program Evaluation Survey: Questions regarding the intervention?s feasibility and acceptability will be asked post-intervention as part of the process evaluation (to ensure we receive feedback from all childcare providers assigned to the experimental condition). This tool will be developed with the steering committee and pilot-tested with a sample of childcare staff to ensure the appropriateness of questions.
8. Focus Groups with Childcare Providers: Focus groups with childcare providers from the experimental condition will be undertaken to gather their perspectives regarding the appropriateness of the SPACE study, the feasibility of implementation, and suggestions for improvement. These qualitative discussions will allow us to gather rich data regarding the logistical challenges and the strengths and weaknesses of the SPACE study that cannot be captured on a questionnaire. A semi-structured interview guide will be used to conduct four focus groups (anticipating between 20-30 participants in total). All focus groups will be completed at participating childcare centres and will be led by an experienced moderator and co-moderator. If after four focus groups saturation has not been reached, additional focus groups will be completed.
Secondary ID(s)
Grant Award # R4368A10; ROLA # 0000033871
Source(s) of Monetary Support
Canadian Institutes of Health Research - Grant Award # R4368A10; ROLA # 0000033871
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
University of Western Ontario?s Health Sciences Research Ethics Board (full board review), 30/10/2014, ref: 105779
Results
Results available: Yes
Date Posted:
Date Completed: 31/08/2017
URL:
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