Jones 2015.
Study characteristics | ||
Methods |
Study design: cluster‐RCT Length of follow‐up from baseline: 12 months Unit of allocation: centre Unit of analysis: child |
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Participants |
Service type: centre‐based (preschools and long‐day care) Operation: were not 100% government‐funded services. 90%‐98% of services operated 5 d/week Country (region): Australia (Hunter region, New South Wales) Country income classification: high Low‐SES sample: yes Population description: the study took place in the Hunter region of New South Wales, Australia. The region encompasses non‐metropolitan ‘major cities’ and ‘inner regional’ areas as described by the Australian Statistical Geography Standard. There are 586,000 people residing in the area, of whom 23,000 are children aged 3–5 years. Approximately 3% of residents are of Aboriginal or Torres Strait Islander origin and 4% speak languages other than English. The Hunter region has lower indices of SES than the New South Wales state average. Inclusion criteria: not reported Exclusion criteria: services in the region were ineligible if they: catered exclusively for children requiring specialist care (< 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. Number of services randomised: 128 (64 intervention, 64 control) Number of children randomised: not reported (3 children from each service randomly selected for dietary outcome assessment) Characteristics Children Age: not reported Gender (% female): not reported Ethnicity: not reported Parents Age (years): not reported Gender (% female): not reported Ethnicity: not reported Parent/family SES: not reported Service Ethnicity: Children of Aboriginal or Torres Strait Islander background enrolled: Intervention: 68% Control: 78% Service socioeconomic area: Top 50% of New South Wales: Intervention: 30% Control: 27% Method of recruitment: Phone and mail Missing data/dropout: 6 child‐care services with baseline data declined to participate in the trial. 62 services were retained in the intervention group, and 60 in the control. But observational data were collected from 17 intervention centres and 19 control centres. Reasons for dropout: not reported Characteristics of dropouts: not reported |
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Interventions |
Programme name: not reported Number of conditions: 1 intervention, 1 control Intervention duration: 12 months Intervention setting: ECEC Intervention strategies: Ethos and environment Children Exposure: provision of adult‐guided fundamental movement skills for at least 75% of children daily. Restriction of sedentary screen time to less than weekly. Role modelling: staff role modelling of physical activity and healthy eating to children Prompts and feedback: staff provision of prompts and positive feedback to encourage child healthy eating ECEC staff Training: a series of 3 x 1‐h training workshops which focused on policy and practice implementation. Support: following each staff training workshop, implementation support staff facilitated a discussion with nominated supervisors and ECEC service staff to reach group agreement regarding an implementation strategy for the targeted policies and practices. Engagement: 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 ECEC service staff during staff meetings. Service Policy: development and implementation of written nutrition and physical activity policies Monitoring: daily staff monitoring of children's lunch boxes against written nutritional guidelines and provision of feedback to parents when a non‐compliant food was packed. Provision of water or reduced‐fat milk only. Resources: all services received an electronic and hardcopy package of tools and resources to support ECEC service staff to implement the healthy eating and physical activity policies and practices. 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. Feedback: verbal and written feedback describing service progress toward implementation of the targeted policies and practices was delivered at 6 intervals throughout the 12‐month intervention. Partnerships Healthcare Support: health promotion officers provided each service with a support staff member who provided ongoing implementation support and positive reinforcement via in‐person visits, telephone and email contact. Intensity of intervention: 3 x 1‐h staff training workshops; bimonthly newsletters. The frequency and duration of the following strategies were not reported: ongoing implementation support; face‐to‐face meetings; telephone and email contact; executive support; consensus process with staff; academic detailing visits; provision of tools and resources; performance monitoring and feedback. Intervention delivered by: research team, ECEC staff, healthcare staff Modality: face‐to‐face, telephone, online, written Theoretical basis: Damschroder’s Consolidated Framework for Implementation Research Description of control: usual care, plus services received 3 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. |
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Outcomes |
Outcomes relating to child dietary intake: Fruit intake, vegetable intake, grains (breads and cereals) intake, meat and meat alternatives intake, milk/yoghurt/cheese intake, discretionary food intake Number of participants analysed: Intervention baseline: not reported Intervention follow‐up: 41 Control baseline: not reported Control follow‐up: 49 Data collection measure: in‐care observations Data collector: trained research observers Validity of measures used: validated Outcomes relating to child physical measures: not reported Outcome relating to child language and cognitive performance: not reported Outcome relating to child social/emotional measures: not reported Outcome relating to child quality of life: not reported Outcome relating to cost: not reported Outcome relating to adverse consequences: Increased occurrence of injury among staff or children Number of participants analysed: not reported Data collection measure: nominated supervisors were asked to report on the number of staff and children involved in adverse events in their service Data collector: nominated supervisors Validity of measures used: not reported |
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Notes | Funding source: Australian National Preventive Health Agency (reference 95WOL2011), Hunter New England Population Health and Hunter Medical Research Institute. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | After the completion of baseline data collection, ECEC 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. |
Allocation concealment (selection bias) | Low risk | After baseline data were collected, a statistician not involved in the trial allocated the services to groups using a random number function. |
Blinding of participants and personnel (performance bias) Diet outcomes | High risk | Services were not blind to study allocation, and the outcome is likely to be influenced by lack of blinding. |
Blinding of participants and personnel (performance bias) Adverse consequences | Unclear risk | Services were not blind to study allocation. It is unclear whether the outcome is likely to be influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) Diet outcomes | Low risk | Children's dietary intake was observed by a trained observer who did not participate in the intervention delivery and who was blind to service group allocation. |
Blinding of outcome assessment (detection bias) Adverse consequences | Unclear risk | Services were not blind to study allocation. It is unclear whether the outcome is likely to be influenced by lack of blinding. |
Incomplete outcome data (attrition bias) Diet outcomes | Unclear risk | Data analysed for 17/62 (27%) of intervention services and 19/60 (32%) of control services. Dietary observations were conducted in a random subsample of intervention and control services at follow‐up, however there is no information on how the random sample was determined or if there was loss to follow‐up in the random subsample. Risk of attrition bias is unclear. |
Incomplete outcome data (attrition bias) Adverse consequences | Unclear risk | The number of services that reported on this outcome at follow‐up is unclear. |
Selective reporting (reporting bias) | High risk | Observation data and adverse events, the data of interest for the review, are not mentioned in the available protocol. These outcomes appear to have been added in post‐hoc with no reasoning provided. |
Recruitment bias | Low risk | ECEC services were recruited prior to randomisation, and no ECEC services were recruited after randomisation. |
Baseline imbalance | Unclear risk | No information provided on individual participants. Data only provided at the service level |
Loss of clusters | Low risk | 2 of the 64 intervention clusters and 4 of the 64 control clusters were lost. However, this is a small percentage (< 5%) of the overall sample. Study authors stated that "There were no differences between the characteristics of services that provided follow‐up data and those that did not (p = 0.22‐1.00)." |
Incorrect analysis | Low risk | Study authors stated that "The model was adjusted for potential clustering effect." |
Contamination | Unclear risk | No evidence to make assessment |
Other bias | Unclear risk | Intervention and control groups showed baseline imbalance in terms of extraneous training. Study authors stated that "Project records show that 80% of intervention group services and 12% of control group services attended training in healthy eating and physical activity provided by the 'Munch & Move' program during the study period." and "Project records provided by the program show 45% of intervention group services and 52% of control group services attended training in healthy eating and physical activity provided by the 'Good for Kids. Good for Life' program during the period from 2006 to 2011." There were also baseline differences in the implementation of policies and practices between groups. Study authors stated that "However, five of the seven policies and practices were being implemented by 80% or more of intervention group services at baseline, limiting scope for further improvements. Second, the trial did not exclude services who were already implementing all policies and practices at baseline (24% of intervention services)." Children who were randomly selected for observation were chosen based on their birth date. There is insufficient information to assess whether an important risk of bias exists. |