Effectiveness of an intervention to facilitate the implementation of healthy eating and physical activity policies and practices in childcare services: a randomised controlled trial

The trial was funded by the Australian National Preventive Health Agency (reference
95WOL2011) and was prospectively registered with the Australian New Zealand Clinical
Trials Registry (reference ACTRN12612000927820). Ethical approval to conduct the study
was obtained from the Hunter New England (reference 12/08/15/5.01) and the University
of Newcastle (reference H-2012-0321) human research ethics committees. The research
is reported in accordance with the requirements of CONSORT Statement 32].

Design and setting

A detailed protocol for the trial has been published elsewhere 33]. A parallel group randomised controlled trial was conducted in 128 centre-based childcare
services in the Hunter region of New South Wales, Australia, from August 2012 to July
2014.

Participants

Centre-based childcare services included pre-schools and long day-care services. Services
in the region were ineligible if they: catered exclusively for children requiring
specialist care (less than 1 % of services), provided all on-site meals to children
(approximately 30 % of services) or were fully government funded (approximately 3 %
of services), as the ethical clearance and intervention design were not appropriate
for such services.

Recruitment procedures

Nominated supervisors (service managers) at all eligible services were contacted by
a research assistant and invited to provide consent: (1) for their service to participate
in the study, (2) for their own participation in a computer-assisted telephone interview
(CATI) survey and (3) for one of their room leaders (head teacher caring for 3 to
5 year-old children) to be contacted and invited to participate in a CATI survey.
A subsample of nominated supervisors were randomly selected by a research assistant
using a random number function and invited to provide consent for their service to
participate in a 1-day, post-intervention observation to assess child dietary intake
and physical activity behaviours.

Randomisation and allocation

Following the completion of baseline data collection, childcare services were randomly
allocated to either the intervention or control condition by a research assistant
using a random number function in a 1:1 (intervention: control) ratio. Services were
not blind to study allocation.

Intervention group

Briefly, the 12 month intervention aimed to increase childcare service implementation
of healthy eating and physical activity policies and practices. The policies and practices
were developed based on best practice Australian healthy eating and physical activity
guidelines for the childcare setting 13] and those shown to be associated with child healthy eating and physical activity
behaviours 16], 17]. The healthy eating and physical activity policies and practices implemented by services
included the following:

1. Development of written nutrition and physical activity policies

2. Staff monitoring of children’s lunchboxes every day against written nutritional
guidelines and provision of feedback to parents when a non-compliant food was packed

3. Provision of water or reduced fat milk (for children over the age of 2 years) only

4. Staff role modelling of physically active play and healthy eating every day

5. Staff provision of prompts and positive comments to children to encourage physical
activity and healthy eating every day

6. Provision of adult-guided fundamental movement skill development activities every
day for at least 75 % of children

7. Restriction of sedentary screen time to less than weekly.

The design of the intervention to support implementation of the policies and practices
utilised Damschroder’s Consolidated Framework for Implementation Research 34]. The Framework integrates 19 theoretical models and is composed of five major domains
identified as influential in successful intervention implementation. The application
of the relevant constructs to the intervention has been published as part of the study
protocol 33]. The intervention consisted of eight evidence-based strategies to facilitate childcare
service implementation of the healthy eating and physical activity policies and practices
35]–39]. The intervention strategies included the following:

1. Implementation support staff 40]—The research team provided each service with a support staff member who provided
on-going implementation support and positive reinforcement via face-to-face visits,
telephone and email contact. Implementation support staff members had tertiary qualifications
in nutrition and dietetics, health education and psychology and had previous experience
in delivering similar initiatives in the childcare setting.

2. Securing executive support 41], 42] – Nominated supervisors were asked to lead the development and implementation of
nutrition and physical activity policies, co-facilitate training workshops with implementation
support staff and communicate expectations regarding the implementation of policies
and practices to childcare service staff during staff meetings.

3. Provision of staff training 43]—A series of three 1-h training workshops which focused on policy and practice implementation
were provided on-site to childcare service staff and included both didactic and interactive
components.

4. Employment of consensus processes 35], 44]— Following each staff training workshop, implementation support staff facilitated
a discussion with nominated supervisors and childcare service staff to reach group
agreement regarding an implementation strategy for the targeted policies and practices.

5. Provision of academic detailing visits 45], 46]—Following each staff training workshop, an academic detailing visit was conducted
which involved support staff observing and providing immediate feedback to childcare
service staff as they implemented the practices targeted by the intervention.

6. Provision of tools and resources 40] – All services received an electronic and hardcopy package of tools and resources
to support childcare service staff to implement the healthy eating and physical activity
policies and practices.

7. Performance monitoring and feedback 47], 48]—Verbal and written feedback describing service progress toward implementation of
the targeted policies and practices was delivered at six intervals throughout the
12 month intervention, with feedback based on information collected via the baseline
CATI, telephone contacts and face-to-face visits.

8. Employment of a communications strategy 49]—Services received hard copy and electronic bimonthly newsletters which communicated
key messages relating to the healthy eating and physical activity policies and practices.
Services that implemented all policies and practices received a certificate of recognition,
were acknowledged in newsletters and were used as case study examples.

Control group

Participating services randomised to the control group received three newsletters
at the commencement, mid-point and conclusion of the 12 month intervention. The newsletters
were provided in hard copy and electronic formats and contained information on healthy
eating and physical activity unrelated to the specific policies and practices targeted
by the intervention. Control group services did not receive any other intervention
from the research team during the study period.

Data collection and measures

Surveys administered via CATI were conducted with the nominated supervisor and a room
leader caring for children 3 to 5 years. Baseline data collection occurred between
August and November 2012 and assessed childcare service characteristics and healthy
eating and physical activity policies and practices. Follow-up CATI surveys were conducted
immediately post-intervention between May and July 2014 and assessed healthy eating
and physical activity policies and practices, staff and child injury, and in the intervention
group, the acceptability of the intervention.

Service characteristics

Nominated supervisors were asked to report on the following: service days and hours
of operation, type of service (pre-school or long day-care service), postcode, number
of enrolled and attending children, number of primary contact teaching staff and whether
any Aboriginal and/or Torres Strait Islander children were enrolled. The items used
to assess service characteristics have been used in other Australian surveys of childcare
services conducted by the research team 22], 24], 50].

Primary trial outcome

Healthy eating and physical activity policy and practice implementation

The primary trial outcome was the difference over time between groups in the proportion
of services implementing all seven healthy eating and physical activity policies and
practices. The primary trial outcome represents service achievement of “best practice”,
maximising the potential of the service to support child healthy eating and physical
activity.

Both nominated supervisors and room leaders were asked to report on their service’s
implementation of the seven healthy eating and physical activity policies and practices
using items validated in a previous sample of 42 Australian childcare services 51]. Nominated supervisors were asked to report on the implementation of whole-of-service
policies and practices. Room leaders were asked to report on the implementation of
specific healthy eating and physical activity policies and practices within their
room. Each survey item and its respective percent agreement and Kappa value (K) are listed below in order to provide an indication of the level of agreement between
nominated supervisor report and independent observation 51].

1. Presence of written nutrition (75 %, K?=?0.50) and physical activity policies (79 %, K?=?0.59)

2. Staff monitoring of children’s lunchboxes against written nutritional guidelines
(84 %, K?=?0.69) and provision of feedback to parents when a non-compliant food is packed
(68 %, K?=?0.34)

3. Provision of water (89 %, K?=?0.78) or reduced fat milk only (79 %, K?=?0.57) to children

4. Staff role modelling of physically active play (69 %, K?=?0.39) and healthy eating (94 %, K?=?0.89) every day

5. Staff provision of prompts and positive comments to children to encourage physical
activity (80 %, K?=?0.60) and healthy eating (86 %, K?=?0.71) every day

6. Provision of adult-guided fundamental movement skill development activities (53 %,
K?=?0.06) every day to at least 75 % of children (60 %, K?=?0.20)

7. Restriction of sedentary screen time (58 %, K?=?0.17) to less than weekly.

Secondary trial outcomes

In order to assess if the hypothesised improvements in implementation of the healthy
eating and physical activity policies and practices was sufficient to yield improvements
to child diet and physical activity while attending childcare, observations of child
dietary intake and physical activity levels were undertaken. The 1-day observation
was conducted during core service hours (9 am–3 pm) in a random subsample of intervention
and control group childcare services at follow-up. One of four trained observers attended
each service to observe both child dietary intake and physical activity during the
1-day observation. Observers did not participate in the delivery of the intervention
and were blind to service group allocation.

Child dietary intake

Secondary trial outcomes included the differences between groups at follow-up in the
mean number of serves consumed by children for each food group within the Australian
Guide to Healthy Eating (vegetables, fruit, grains, meat and meat alternatives, milk,
yoghurt and cheese and discretionary foods). Child dietary intake was assessed during
the 1-day observation using a modified version of the Dietary Observation for Child
Care protocol 52]. The Dietary Observation for Child Care is a validated method for recording child-level
dietary intake in 2 to 5 year-olds 52] and has been used extensively in the childcare setting 21], 53], 54]. Dietary intake was assessed in three children per service by an observer who visually
estimated and recorded all types and portions of foods and drinks provided to and
consumed by the children, along with amounts remaining after finishing a meal or snack
52]. This was recorded for every food or drink item supplied by parents in the child’s
lunchbox and offered to the child during the observation period. The children were
randomly selected by asking the room leader at each service to identify the three
children with the most recent birthdays. Following the completion of the observation,
the numbers of serves for each of the Australian Guide to Healthy Eating food groups
was generated by a qualified dietitian. The number of serves consumed for each food
group was calculated using the weight of the food according to a nutrient database
55] and the standard serve size of the food according to the Australian Guide to Healthy
Eating 56]. Discretionary foods were classified using the Australian Guide to Healthy Eating
with reference to the Australian Bureau of Statistics Discretionary Food List where
unclear 57].

Observers were trained according to the Dietary Observation for Child Care protocol
52]. Prior to undertaking the observations, the observers completed a 20-food certification
test. The observer results were compared to the actual measured amounts of foods and
a tolerance level was set for each of the 20 items. The observers correctly described
more than 90 % of items within the test and reached between 75 and 100 % agreement
with actual measured amounts for the 20 food and drink items.

Child physical activity

Secondary trial outcomes included the differences between groups at follow-up in the
proportion of children engaged in sedentary, walking or very active physical activity
during all observations, structured physical activity and outdoor free play sessions.
Child physical activity levels were assessed at the same 1-day observation by the
same observer, using a modified version of the System for Observing Play and Leisure
in Youth (SOPLAY) tool and protocol 58]. SOPLAY is a standardised instrument for assessing physical activity levels in recreational
settings using systematic, momentary time sampling of a predetermined area 58]. SOPLAY has been found to be both valid and reliable in school-aged children 59] and has been previously used to assess physical activity in the childcare setting
60]. The observer coded all structured physical activity and outdoor free play sessions
that occurred between 9 am and 3 pm at each service. Prior to the commencement of
each physical activity session, observers recorded key aspects of the physical environment
including location (inside or outside), type of session (structured physical activity
or free play), scan start time and any equipment available for use. During each scan,
the observers assessed the level of child physical activity by counting the number
of children engaged in sedentary, walking or very active physical activity in 10-min
intervals for the duration of each session.

Observers were trained according to the standardised SOPLAY protocol 58]. The SOPLAY assessment DVD was used to assess each observer’s ability to independently
scan and code physical activity levels quickly and accurately. Of the 28 video clips
in the assessment, observers must have correctly counted the number of people engaged
in either sedentary, walking or very active activity in each clip to receive one point.
Scores ranged between 61 and 71 %.

Other measures

Adverse effects—staff and child injury

Given an increase in child physical activity levels could potentially increase the
risk of child injury 61], nominated supervisors in both the intervention and control groups were asked to
report on the number of staff and children involved in adverse events in their service.
Adverse events were defined as injuries requiring documentation during the previous
12 months.

Acceptability of the intervention

Nominated supervisors and room leaders in the intervention group were asked to respond
on a four-point Likert scale (strongly agree, agree, disagree, strongly disagree)
to a series of statements assessing the acceptability of the intervention resources,
training and support provided to services.

Delivery of the intervention

The delivery of each of the eight intervention strategies was assessed by an independent
research assistant using project records maintained by each implementation support
staff member.

Blinding of CATI interviewers

CATI interviewers did not participate in the delivery of the intervention and were
blind to service group allocation. To assess whether blinding was maintained, after
collection of follow-up data, interviewers were asked to nominate the group to which
they thought the service had been allocated.

Context

For descriptive purposes and to aid an assessment of any external influences on the
trial findings, a systematic search was conducted to describe the context in which
the trial was conducted 62], 63]. Local news archives, websites of national and New South Wales health and education
departments, accreditation standards and national healthy eating and physical activity
guidelines were reviewed to identify the existence of or changes in government policy,
standards, funded programs, or guidelines that may influence the healthy eating and
physical activity environments of childcare services. The search included the 12 months
prior to and during the 12 month intervention.

Sample size calculations

Primary trial outcome

Based on previous research, a 20 % study attrition rate of services was anticipated
50]. Given this, recruitment of 128 services into the trial at baseline would be sufficient
to provide follow-up data from approximately 102 childcare services (51 per group)
and enable the detection of an absolute difference between groups in the proportion
of services implementing all policies and practices of 27 with 80 % power and an alpha
value of 0.05. This was based on an expected prevalence of control group services
implementing all policies and practices at follow-up of 25 %.

Secondary trial outcomes

Assuming a consent rate of 80 %, inviting a random subsample of 42 services to participate
in the post-intervention observations would be sufficient to provide data from approximately
34 childcare services (17 services per group). This would enable the detection of
an absolute difference between groups in very active physical activity of 4.3 % with
80 % power, an alpha of 0.05 and based on an intra-class correlation coefficient (ICC)
of 0.02. This was based on estimations of four physical activity sessions per service,
four 10-min scans per session and 20 children per 10-min scan. This sample was also
sufficient to detect an absolute difference between groups in the mean number of serves
for each food group of 0.3 serves with 80 % power, an alpha of 0.05 and based on an
ICC of 0.02. This was based on estimations of three children being observed at each
service (51 children per group) and a standard deviation of 0.5.

Statistical analyses

All statistical analyses were performed using SAS (version 9.3) statistical software.
All statistical tests were two tailed with an alpha value of 0.05.

Service characteristics

Descriptive statistics were used to describe the service characteristics of intervention
and control group services at baseline. Socioeconomic characteristics were determined
using service postcodes, which were classified as being in the top or bottom 50 %
of New South Wales according to the Socio-economic Indices for Areas (SEIFA). Geographic
characteristics of the service locality were classified as either urban or rural according
to the Australian Statistical Geography Standard.

Healthy eating and physical activity policy and practice implementation

The primary trial outcome was analysed under an intention-to-treat framework using
all available data. A logistic regression model was developed to determine group-by-time
changes in the proportion of services implementing all healthy eating and physical
activity policies and practices from baseline to follow-up. The logistic regression
model included terms for time, group (intervention or control) and group-by-time interaction.
A sensitivity analysis was performed by imputing baseline observations at follow-up
for missing data. The same method of analysis (using six separate logistic regression
models) was used to assess group-by-time changes in the following subgroups: service
type (pre-school or long day-care service), socioeconomic characteristics (top or
bottom 50 % of New South Wales) and geographic characteristics (urban or rural). As
the study was not powered to test any hypotheses relating to such subgroups, these
results are provided for descriptive purposes only. The following post hoc exploratory
analyses were also performed: first, separate logistic regression models were used
to determine group-by-time changes in the proportion of services implementing each
of the individual policies and practices from baseline to follow-up. Second, a linear
regression model was used to assess whether there was a significant difference over
time between groups in the mean number of policies and practices implemented.

Child dietary intake

The amount of food consumed by each child was calculated using the food consumption
equation, defined as: amount served less (amount remaining ± amount wasted or added)
52]. Descriptive statistics were used to assess child dietary intake data according to
each of the Australian Guide to Healthy Eating food groups. A linear regression model
was used to assess whether there was a significant difference between groups at follow-up
in the mean number of serves for each food group (vegetables; fruit; grains; meat
and meat alternatives; milk, yoghurt and cheese and discretionary foods). The model
was adjusted for potential clustering effect.

Child physical activity

Descriptive statistics were used to assess the proportion of observations of the children’s
physical activity levels. A logistic regression model was developed to assess whether
there was a significant difference between groups at follow-up in the proportion of
children engaged in sedentary, walking or very active physical activity. A generalised
estimating equation (GEE) framework was utilised to account for potential clustering
effects of the service (level one) and the SOPLAY session (level two). Analyses were
performed on all observations, as well as on subgroups of the data including the type
of physical activity (structured physical activity or outdoor free play session).

Acceptability of the intervention

Descriptive statistics were used to assess the delivery and acceptability of the intervention.
Acceptability data was calculated using the percentage of nominated supervisors and
room leaders that reported either “strongly agree” or “agree” to each item.