Preschoolers Activity Trial
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this pilot study is to test the efficacy of the physical activity (PA)
      intervention protocol to increase preschoolers overall PA levels and time spent in moderate
      to vigorous PA (MVPA) at the day care setting. The PA intervention includes the Healthy
      Opportunities for Preschoolers manual, a compilation of locomotor, gross motor and movement
      based activities developed for preschoolers and successfully piloted for feasibility in 3 to
      5 year old preschoolers by Drs. Viviene Temple, Justen O'Connor, and Patti-Jean Naylor. As
      well, the PA intervention includes educational workshops for the day care providers, ongoing
      biweekly facilitation and troubleshooting sessions with a Master Trainer, and the equipment
      necessary to implement the program. The study is also evaluating the efficacy of the PA
      intervention to decrease the amount of time spent in sedentary behaviour at the day care
      setting.

      Secondary objectives include evaluating the effects of the PA intervention on preschool
      children's anthropometrics, and fundamental and gross motor skills. In addition, the
      intervention is also assessing the effects of the program on day care provider's attitudes,
      control beliefs, and self-efficacy toward incorporating PA into the day care curriculum.
    

Detailed description: 
      Background & Significance:

      Objective measures of physical activity (PA) using accelerometers (motion sensors worn at the
      hip) reveal that preschoolers level of sedentary behaviour are high, and levels of moderate
      to vigorous physical activity (MVPA) are low (Pate et al., 2004, Reilly et al., 2004, 2006).
      Inquiry into preschoolers daily levels of PA suggest that 2.6% to 4% of waking hours are
      spent in MVPA (Reilly, 2004, 2006;Montgomery et al. 2004), and, during pre-school hours, Pate
      and colleagues found that 3 to 5 year old children engaged in 7.7 minutes of MVPA. A recent
      study of Canadian preschoolers found remarkably similar levels of MVPA (Temple et al., 2009),
      that include 12.3 minutes of MVPA per day and 39.5 minutes of sedentary behaviour per hour.
      Although Pate et al. 2004 found that boys had higher levels of MVPA than girls, they did not
      detect differences in levels of sedentary behaviour, which constituted the vast majority of
      time for boys and girls. The findings suggest that young children are very inactive and
      therefore may be at risk for adverse health consequences related to physical inactivity.

      Opportunities for PA and motor development in early childhood may, over the lifespan,
      influence health behaviours and the potential to maintain a healthy body weight. Fundamental
      movement skills (e.g., catching, throwing, jumping, running, etc.) are the essential building
      blocks for the acquisition of more refined and complicated skills that can be applied later
      in life, such as sporting, recreational and physical activities (Gallahue et al. 2002; Carson
      1994; Seefeldt, 1979). However, movement skills will not develop to their potential without
      opportunities to practice in environments that are stimulating and supportive (Kelly et al.,
      1989; Taggart & Keegan, 1997). Butcher & Eaton found that preschoolers movement competence
      already influenced their PA choices and levels. It is the mastery of motor skills and the
      ability of children to incorporate these skills into games, dances, and sports of one's
      culture that provides the stimulus for movement which contributes to long-term health
      (Seefeldt & Vogel, 1987).

      There is a paucity of information on current trends in PA of preschool aged children, and on
      the relationship between the ability of children to perform fundamental movement skills and
      prediction of PA (Mackenzie et al 2003). The few studies noted above indicate that preschool
      aged children do not come close to being physically active enough to accrue health benefits.
      In fact, although the evidence of how much and what type of PA is necessary to optimize
      health and development of preschool-aged children is somewhat unclear (Timmons et al., 2007),
      expert consensus suggests that preschool-aged children should not be sedentary for more than
      60 minutes at a time, except when sleeping, and they should engage in at least 60 minutes
      (and up to several hours) of structured (facilitated by day care providers, parents, etc. )
      and 60 minutes of unstructured PA daily, as well as 180 mins of total PA (National
      Association for Sport & Physical Education, NASPE, 2002).

      In keeping with the settings-based approach to health promotion, which acknowledges the
      influence of place on behaviour (Dooris et al. 2007), it is believed that powerful influences
      on children's PA levels are the social and physical environments in which they spend time
      (Bower et al., 2008; Dowda et al., 2004; Finn eta l., 2002). Over half of all Canadian
      children aged 6 months to 5 years were in some form of nonparental/guardian care in
      2002-2003, and children spent an average of 29 hours a week in these day care settings
      (Bushnik , 2006; Silver 2000). The majority of Canadian children in both two parent and
      single parent families fall into this category as 77% of two parent families and 75% of
      single parent families rely on day care for their children. As such, the paid child day care
      setting provides an ideal opportunity to examine and enhance the movement skills and PA
      behaviours of preschool-aged children. There is a small body of evidence that suggests that
      group preschool and child care settings, policies and practices strongly influence children's
      PA (Finn et al., 2002; Pate et al., 2004; Bower et al., 2008), but the efficacy of
      interventions in day care centre settings on preschool children's PA and inactivity
      behaviours has not yet been determined.

      The current PA intervention program is based upon the Healthy Opportunities for Preschoolers
      manual and program which were developed and successfully piloted for feasibility in 3 to 5
      year old preschoolers by Drs. Viviene Temple, Justen O'Connor, and Patti-Jean Naylor. Drs
      Temple and Naylor are researchers from the University of Victoria, and are co-investigators
      on this study (Temple et al., 2009). We are using a randomized controlled trial design to
      build on their previous work to evaluate the efficacy of the physical activity intervention
      training manual and program to increase PA (with slight modifications and editing of the
      Healthy Opportunities for Preschoolers training manual).

      The Preschoolers Activity Trial was developed from a socio-ecological perspective recognizing
      that behaviour is affected by multiple levels of influence: intrapersonal, interpersonal,
      organizational/environmental, community and policy levels. (Burkman & Kawachi, 2000). The
      program is an environmentally-based intervention and focuses on child care as a setting of
      influence in children's lives. Recent research has demonstrated the potential of focusing on
      settings to modify health promoting behaviours such as eating, PA and tobacco use (Snyder et
      al., 1992; Moore et al., 2001; McKenzie et al., 1994) Theoretically, the focus on the setting
      is underpinned by the work of community psychologists Barker (1968) and Bronfenbrenner
      (1999). Behaviour settings are stable units that affect more than one individual and
      substantially influence the behaviour that occurs within them (Barker, 1968). Barker's
      research showed that some attributes varied less across children within settings than between
      settings. Bronfenbrenner's (1999) bio-ecological model expanded this, highlighting the
      importance of reciprocal interactions in children's development; and the need for children to
      engage in activities regularly over extended periods of time.

      Ultimately, the effectiveness of the PA intervention will rest in our ability to transfer
      knowledge to the day care-providers which would motivate them to change the child care
      programming and environment in which children spend time. Despite varying definitions, the
      measure of effective knowledge transfer or exchange is knowledge utilization (Cousins &
      Leithwood, 1993); the uptake and implementation of innovation to the curriculum
      (evidence-based practices) by decision-makers and practitioners.

      Study Design and Methodology:

      A Cluster randomized controlled trial design will be used with day care centres as the unit
      of measurement (clusters), though analysis will also be at the individual subjects level
      given the few number of day cares targeted in this study. Several large (non-home based) day
      care centres in Ottawa that represent ethnic diversity and varying levels of socio-economic
      status (SES) have been invited to participate. We sent out a letter to a few daycares that
      expressed interest, outlining the objectives and procedures of the project, as well as the
      chance of being randomly assigned to either Intervention or Control Group. The current
      intervention is designed for 3-5 year old children attending day care. Of the interested day
      care centres, 3 have been randomly assigned to intervention and 3 to the control group. Day
      care providers in centres randomized to the control group will receive the educational
      workshops and the resource manual after their involvement with the study is completed (6
      months post-treatment), however the children in the control day care centres will not be
      evaluated after the providers receive the training.

      The PA intervention designed to increase PA and reduce sedentary behaviour consists of 2,
      three-hour workshop training sessions conducted by a master trainer with experience in
      promoting PA in preschoolers. The training workshops target the day care providers of 3 to 5
      year old children assigned to the intervention group. The first workshop focuses on the
      importance of PA and movement skills for pre-school-aged children, understanding structured
      and unstructured play, how to implement HOP in day care centres, and practical activities
      related to movement skills. The second workshop focuses on overcoming barriers to
      facilitating PA; understanding the range of movement skills; and using everyday materials to
      facilitate PA and active play. Each provider in the intervention group is provided with the
      Healthy Opportunities for Preschoolers resource training manual, a recommended program
      outlining which activities to participate in and how often, and a starter kit of equipment
      that forms the basis of training for the day care providers and the intervention. The manual
      is full of various ways providers can get children active in structured and unstructured
      physical activities, some of which target motor skill development. The aim of the
      intervention is based on the aforementioned NASPE (2002) guidelines of not having children
      sedentary more than 60 minutes at a time, and that children accumulate at least 60 minutes in
      structured PA and at least 60 minutes of unstructured (active play) each day at moderate
      intensity or higher.

      Participation and Consent:

      The parents of children aged 3-5 years, in participating day cares, were given informed
      consent forms to take home to read. The letter made it clear that the care provider's
      participation was not dependent on all of the children participating and that their
      participation was completely voluntary. Participating children receive a randomized
      identification number, which is used for all data collection, as the information is
      confidential. This information is linked to a master sheet that is locked in a secure
      location. Data is collected solely on children who have parental consent.

      Questionnaire data:

      Day care providers in both groups will be surveyed about their understanding of the Central
      Health Messages (CHM) associated with Healthy Opportunities for Preschoolers manual, as well
      as physical facilities in the day care environments that may promote or restrict PA. The
      questionnaire also assesses providers attitudes, control beliefs, intentions, and support for
      PA based on the Theory of Planned Behaviour (TPB). Providers will complete these
      questionnaires at baseline and after the 2 training workshops. This information can then be
      used to evaluate how well it predicts changes in children's PA and sedentary behaviour. This
      questionnaire was specifically developed and successfully used in the feasibility and
      collection of preliminary outcome data in the HOP trial conducted by Drs. Temple and Naylor
      (co-investigators).

      Parents of participating children are sent a socio-demographics questionnaire asking details
      on parent's age, sex, highest level of education achieved, total parental/family income,
      height and weight.

      Anthropometry and Body Composition Data is collected at each measurement period (baseline, 3
      months and 6 months post-intervention workshops):

        -  Height

        -  Body weight

        -  Body mass index (kg/m2)(calculated)

        -  Body composition (lean body mass, fat mass, and percent body fat) using Bioelctrical
           impedance analysis validated for the preschool population.

      Physical Activity: Self-reported or care provided reports of PA are fraught with difficulties
      and subject to considerable bias in young children (Adamo et al. 2008). Thus, we are
      measuring PA objectively using the Actical (mini Mitter Co., Inc., Bend, Ore.) accelerometer
      which is a small unobtrusive device worn on the right hip by using belts around the waist (in
      young children), and is an omni-directional sensor to monitor the occurrence and intensity of
      motion. At each measurement period (baseline, 3- and 6- months post workshop intervention),
      children wear these activity monitors from the time of awakening (except showering/bathing as
      they are not waterproof) until the time they go to bed from Monday to Friday, thus providing
      each subject with a minimum of 4 days of PA monitoring. Parents keep a log to verify times
      when accelerometers were on and taken off, and whether children napped. To account for the
      possibility that not all children will wear the Acticals every day, and the length of time
      that children spend in day care differs, the proportion of PA and sedentary behaviour per
      hour of wear time will be computed, as done previously in a group of preschool children
      (Temple et al. 2009). Pfeiffer et al's (2006) cut points for preschool-aged children's
      moderate and vigorous (MVPA) will be applied. The cut-points will be 715 counts with a 15
      second epoch sampling for MVPA,1411 counts using the same 15 second epoch sampling for
      vigorous PA, and less than 50 counts per hour for sedentary behaviour using a 15 second epoch
      sampling. For ease of comprehension and comparison with other studies, activity data will be
      summarized and reported as activity minutes per hour, computed from tallied counts for each
      activity level average across wear time. Only children with 4 or more hours of accelerometer
      data per day will be included in the dataset. Acticals will be used to assess overall levels
      of PA, PA intensity, and energy expenditure at baseline, 3- and 6- months post-intervention.

      Fundamental/Gross Motor Skills: We are using the Test of Gross Motor Development -2 (TGMD-2)
      to evaluate the effects of the intervention on children's movement skills (Ulrich, 2000). The
      TGMD-2 is a validated standardized norm-referenced measure of 12 common gross motor skills of
      children ages 3 to 11 years (Evaggelinou et al., 2002). Reliability of the Gross Motor
      composite index in our targeted age range of children is 0.91 (Ulrich, 2000). Since this test
      takes about 30-40 minutes, it is conducted on a sub-group (about 50%) of children in both
      groups to provide pilot data on trends in motor skill development that can inform a larger
      and more definitive RCT test of HOP. Children in each group are randomly selected to do the
      TGMD-2 at each measurement time period (baseline, 3- months and 6-months).
    

Intervention name(s): Physical Activity Intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention consists of 2, 3-hour workshops conducted by a master trainer with experience in promoting PA in preschoolers. The workshops focus on the importance of PA and movement skills for preschool-aged children, understanding structured and unstructured play, practical activities related to movement skills, how to overcome barriers in facilitating PA, and using everyday materials to facilitate PA and active play. Each provider in the intervention group is given the Healthy Opportunities for Preschoolers resource training manual, suggested implementation, and a starter kit of equipment. Master Trainers facilitated biweekly PA sessions throughout the intervention. The intervention is based on NASPE (2002) guidelines of not having children sedentary more than 60 mins at a time, having children accumulate 60 mins in structured and unstructured PA (active play) each day at MVPA, as well as 180 mins of total PA as recommended by the Canadian PA Guidelines for preschoolers.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: MVPA; sedentary behaviour; PA intervention; preschool; gross motor; anthropometrics; day care