Seward 2018.
Study characteristics | ||
Methods |
Study design: cluster‐RCT Length of follow‐up from baseline: 6 months Unit of allocation: centre Unit of analysis: service |
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Participants |
Service type: centre‐based (long day care) Operation: not reported Country (region): Australia (New South Wales) Country income classification: high Low‐SES sample: no Population description: not reported Inclusion criteria: centres were eligible to participate in the trial if they had an onsite cook who prepared and provided at least 1 main meal and 2 mid‐meals to children attending the centre; were open ≥ 8 h each day; and the individual centre played a role in planning their own menu. Exclusion criteria: centres that did not prepare meals onsite or those catering exclusively for children requiring specialist care, mobile preschools, and family day care centres were excluded. Number of services randomised: 54 (26 intervention, 28 control) Number of children randomised: 395 (220 intervention, 175 control) Characteristics Children Age: Intervention: 3.5 years (SD 1.0) Control: 3.6 years (SD: 1.0) Gender (% female): Intervention: 47.7% Control: 47.6% Ethnicity: Children of Aboriginal or Torres Strait Islander background enrolled in service Intervention: 66.7% Control: 61.5% Parents Age (years): not reported Gender (% female): not reported Ethnicity: not reported Parent/family SES: not reported ECEC staff (service cook) Age (years): Intervention: 43.0 (SD 10.2) Control: 45.2 (SD 11.7) Gender (% female): Intervention: 100% Control: 92.3% Ethnicity: not reported Service/ECEC staff SES: not reported Method of recruitment: mailed recruitment with follow‐up telephone invitation Missing data/dropout: of the 54 services in the study, 9 services (intervention, n = 1; control, n = 8) withdrew consent prior to baseline data collection and without knowledge of group allocation. Only 1 service did not complete follow‐up data collection. 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: 6 months Intervention setting: ECEC Intervention strategies: Ethos and environment ECEC staff Training: 1 d face‐to‐face menu planning workshop provided to service managers and cooks to improve staff knowledge and skills in the application of nutrition guidelines to child‐care food service. The workshop incorporated both didactic and interactive components, including small group discussions, case studies, review of existing menu items, facilitator feedback, and opportunities to practise new skills. Service Resources: services received a resource pack to support the implementation of nutrition guidelines, which includes the Caring for Children resource, menu planning checklists, recipe ideas and budgeting fact sheets. 2 x newsletters were also distributed. Support: services were allocated an implementation support officer to provide expert advice and assistance to facilitate guideline implementation. Each intervention service received 2 face‐to‐face contacts, following the menu planning workshop. Support contacts were provided to service managers and cooks. Audit and feedback: service menus were audited by a dietitian and feedback was provided at 2 time points (baseline and mid‐intervention). Intervention service cooks and service managers received written (email) and verbal (service visit) feedback following each menu assessment via their implementation support officer. Policy: the implementation support officer, the service manager and cook signed a memorandum of understanding outlining each party’s responsibilities in working to improve food service. Service managers were asked to communicate support and endorsement of adhering to nutrition guidelines to other staff and update the service nutrition policy accordingly. Partnerships Healthcare Delivery: experienced implementation support staff and dietitian facilitated staff training and policy support. Intensity of intervention: 1 x 6‐h training session; 1 x resource pack; 2 x newsletters; 2 x rounds of audit and feedback; 2 x face‐to‐face visits; 1 x written commitment for supervisors and cooks to implement the intervention. Intervention delivered by: research team, ECEC staff, healthcare staff Modality: face‐to‐face, telephone, online, written Theoretical basis: Theoretical Domains Framework Description of control: usual care |
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Outcomes |
Outcomes relating to child dietary intake: Vegetable intake, fruit intake, breads and cereals intake, meat, dairy intake, discretionary food intake, diet quality (total, vegetable intake, fruit intake, breads and cereals intake, meat, dairy intake, discretionary food intake, water intake, variety intake, healthy fats intake) Number of participants analysed: Intervention baseline: 15‐220 Intervention follow‐up: 13‐259 Control baseline: 13‐175 Control follow‐up: 12‐216 Data collection measure: plate waste and educator‐reported short‐food survey Data collector: researchers and educator Validity of measures used: not reported 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: Negative feedbacks, % of meal waste Number of participants analysed: Intervention baseline: 22 services Intervention follow‐up: 22 services Control baseline: 16 services Control follow‐up: 16 services Data collection measure: cooks’ pen‐and‐paper questionnaire Data collector: service cook Validity of measures used: not reported |
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Notes | Funding source: priority Research Centre for Health Behaviour and received infrastructure funding from Hunter New England Population Health and the University of Newcastle. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The randomisation schedule for the main trial was prepared a priori by an independent statistician. Centres were randomised to the intervention or control group via block randomisation (block size ranged between 2 and 6), using a central conceal random allocation process. Of these, 25 centres were approached in random order using a random number list generated in Microsoft Excel and invited to participate in the nested study. |
Allocation concealment (selection bias) | Low risk | Allocation was conducted by an independent statistician after recruitment. |
Blinding of participants and personnel (performance bias) Diet outcomes | High risk | The study was conducted as an open trial as it was not possible to blind the ECEC centre staff receiving the intervention. The outcome is likely to be influenced by the lack of blinding. |
Blinding of participants and personnel (performance bias) Adverse consequences | Unclear risk | The study was conducted as an open trial as it was not possible to blind the ECEC centre staff receiving the intervention. It is unclear whether the outcome is likely to be influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) Diet outcomes | High risk | Children's dietary intake (outcomes which were included in meta‐analysis) was assessed via questionnaire by centre educators who were not blinded to group allocation. Study authors state that, "While educators were not specifically targeted by the intervention, this could have resulted in detection bias where centres were more likely to report favorable outcomes due to receipt of the intervention." |
Blinding of outcome assessment (detection bias) Adverse consequences | Unclear risk | The study was conducted as an open trial as it was not possible to blind the ECEC centre staff receiving the intervention. It is unclear whether the outcome is likely to be influenced by lack of blinding. |
Incomplete outcome data (attrition bias) Diet outcomes | Unclear risk | Study authors stated that "there was a significant amount of missing data for the questionnaire with approximately 21% of children at baseline or follow‐up, missing at least one item on the record. However, no significant differences in child age or gender were found among children with and without missing data and multiple imputation and intention to treat analysis did not result in any changes to statistical significance of trial outcomes." Risk of attrition bias is unclear. |
Incomplete outcome data (attrition bias) Cost | Low risk | Data were available for 38 of the 45 (84%) participating services. |
Selective reporting (reporting bias) | Low risk | The outcomes reported in the paper were prespecified in the protocol paper. |
Recruitment bias | Unclear risk | Baseline data collection occurred after randomisation of centres, however it is unclear whether individual recruitment occurred before or after randomisation. |
Baseline imbalance | Unclear risk | There were no differences in age or sex between groups, but these are the only 2 individual‐level variables measured. |
Loss of clusters | High risk | One intervention cluster lost to follow‐up, and 2 intervention clusters and 1‐2 control clusters did not provide questionnaire data at baseline and/or follow‐up |
Incorrect analysis | Low risk | Study authors stated that "Group differences for all outcome data were assessed through a group by time interaction using generalized linear mixed models, adjusting for clustering within centres." |
Contamination | Unclear risk | No evidence to make assessment |
Other bias | Unclear risk | Study authors stated that "Additionally, the self‐reported dietary measure required childcare educators to recall child diet over the past month and as such is subject to recall bias." There is insufficient information to assess whether an important risk of bias exists. |