Effectiveness of a Web-Based Menu-Planning Intervention to Improve Childcare Service Compliance With Dietary Guidelines: Randomized Controlled Trial

Background Foods provided in childcare services are not consistent with dietary guideline recommendations. Web-based systems offer unique opportunities to support the implementation of such guidelines. Objective This study aimed to assess the effectiveness of a Web-based menu planning intervention in increasing the mean number of food groups on childcare service menus that comply with dietary guidelines. Secondary aims were to assess the impact of the intervention on the proportion of service menus compliant with recommendations for (1) all food groups; (2) individual food groups; and (3) mean servings of individual food groups. Childcare service use and acceptability of the Web-based program were also assessed. Methods A single-blind, parallel-group randomized controlled trial was undertaken with 54 childcare services in New South Wales, Australia. Services were randomized to a 12-month intervention or usual care control. Intervention services received access to a Web-based menu planning program linked to their usual childcare management software system. Childcare service compliance with dietary guidelines and servings of food groups were assessed at baseline, 3-month follow-up, and 12-month follow-up. Results No significant differences in the mean number of food groups compliant with dietary guidelines and the proportion of service menus compliant with recommendations for all food groups, or for individual food groups, were found at 3- or 12-month follow-up between the intervention and control groups. Intervention service menus provided significantly more servings of fruit (P<.001), vegetables (P=.03), dairy (P=.03), and meat (P=.003), and reduced their servings of discretionary foods (P=.02) compared with control group at 3 months. This difference was maintained for fruit (P=.03) and discretionary foods (P=.003) at 12 months. Intervention childcare service staff logged into the Web-based program an average of 40.4 (SD 31.8) times and rated the program as highly acceptable. Conclusions Although improvements in childcare service overall menu and individual food group compliance with dietary guidelines were not statistically significant, findings indicate that a Web-based menu planning intervention can improve the servings for some healthy food groups and reduce the provision of discretionary foods. Future research exploring the effectiveness of differing strategies in improving the implementation of dietary guidelines in childcare services is warranted. Trial Registration Australian New Zealand Clinical Trial Registry (ANZCTR): 16000974404; http://www.anzctr.org.au/ACTRN12616000974404.aspx

Despite the potential, the effectiveness of a web-based intervention to improve childcare service implementation of dietary guidelines has not yet been evaluated [32]. As such, the primary aim of the study was to assess, compared to usual care, the effectiveness of a web-based menu planning intervention in increasing the mean number of food groups on childcare service menus that comply with dietary guidelines. Secondary aims include assessment of the impact of the intervention on: the proportion of service menus compliant with i) all food groups; ii) individual food groups; and iii) the mean servings of individual food groups. Childcare service use and acceptability of the webbased program was also assessed." 2a-ii) Scientific background, rationale: What is known about the (type of) system Does your paper address subitem 2a-ii? * "Online interventions offer an opportunity to provide implementation support that has the potential to be effective in enhancing childcare service implementation of dietary guidelines. Firstly, childcare services have existing infrastructure (computer and internet access) to support an online intervention [27]; and staff are willing to use such an intervention to support their implementation of healthy eating policies and practices [27]. Secondly, specific programming within online systems [28] has the potential to integrate active behaviour change strategies [29] to target primary barriers to guideline implementation, including audit and feedback for menus, automated calculation of menu compliance, eliminating the need for manual calculations by service staff, and online resources. Thirdly, online interventions can be tailored to a particular service's needs, and delivered with high fidelity, at low end-user cost, and are able to address equity issues related to access to dietetic support, in particular for childcare services in rural and remote areas [30,31]. Finally, online systems have the potential to minimise the need for ongoing investment in implementation support (e.g. the provision of training and resources) in order for practice improvements to be sustained." METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 2b? * "As such, the primary aim of the study was to assess, compared to usual care, the effectiveness of a web-based menu planning intervention in increasing the mean number of food groups on childcare service menus that comply with dietary guidelines. Secondary aims include assessment of the impact of the intervention on: the proportion of service menus compliant with i) all food groups; ii) individual food groups; and iii) the mean servings of individual food groups. Childcare service use and acceptability of the web-based program was also assessed." Does your paper address CONSORT subitem 3a? * "a parallel group randomised controlled trial" "Following the completion of baseline data collection, services were allocated to the intervention or control group in a 1:1 ratio, stratified by socioeconomic status (as determined by service postcode) [37] by an independent statistician using a random number function in Microsoft Excel 2010." Does your paper address CONSORT subitem 3b? * 4a) Eligibility criteria for participants Does your paper address subitem 3b-i? Does your paper address CONSORT subitem 4a? * "Eligible childcare services were required to: i) be open for ≥8 hours each weekday; ii) prepare and provide at least one main meal and two snacks to children onsite each weekday; iii) have service staff make menu planning decisions; and iv) have a menu planner with sufficient English to engage with the intervention. Services that outsourced menu planning, did not cater for children aged 3-6 years, catered exclusively for special needs children, or were run by the NSW Department of Education were excluded due to differing administrative characteristics." 4a-i) Computer / Internet literacy Does your paper address subitem 4a-i? 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Does your paper address subitem 4a-ii? * "All services in the sampling frame were posted an invitation letter and information statements about the study in random order, approximately two weeks prior to receiving a call from a research assistant to assess eligibility and obtain service consent to participate (August -December 2017). Recruitment of services was conducted in random order as a sub-sample of services also participated in a nested evaluation [34]. The CCMS provider also displayed an invitation for services to participate in the trial via their online access portal." Does your paper address subitem 5-vii? * "Services received a 12 month implementation intervention consisting of access to a web-based menu planning tool, in addition to training and support to use the program (Table 1). The menu planning intervention was not embedded within the CCMS platform already used by the childcare services as originally planned due to changes in national regulatory requirements for CCMS. Rather, the menu planning program was developed as a stand-alone program, allowing childcare services to access the intervention outside of CCMS. The program was linked to the online web-based CCMS platform to allow communication between the two systems." Participants did not pay to use the program. 5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework Does your paper address subitem 5-viii? * "Services received a 12 month implementation intervention consisting of access to a web-based menu planning tool, in addition to training and support to use the program (Table 1). The menu planning intervention was not embedded within the CCMS platform already used by the childcare services as originally planned due to changes in national regulatory requirements for CCMS. Rather, the menu planning program was developed as a stand-alone program, allowing childcare services to access the intervention outside of CCMS. The program was linked to the web-based CCMS platform to allow communication between the two systems. The intervention was co-developed and overseen by an experienced multi-disciplinary expert advisory group consisting of health promotion practitioners, implementation and behavioural scientists, policy makers, and public health nutritionists with experience working in the setting. To ensure uptake and enhance use of the web-based program, the menu planning program was developed using the Technology Acceptance Model [38], with implementation support strategies identified through barriers assessment using the Theoretical Domains Framework [39]. Further details regarding the theoretical underpinnings and development of the intervention are reported elsewhere [34]. " 5-ix) Describe use parameters Does your paper address subitem 5-ix?

5-x) Clarify the level of human involvement
Does your paper address subitem 5-x? 5-xi) Report any prompts/reminders used Does your paper address subitem 5-xi? * Table 1 "Online Reminders: [42] Remind providers: Develop reminder systems designed to help childcare providers to recall information and/or prompt them to implement the guidelines Actor: Web-based program Action: Fortnightly prompts to access the web-based program were displayed to services on their CCMS dashboard when: their current menu was not compliant with guidelines; insufficient information was entered into the program to calculate compliance; or their new menu cycle was due to be entered.

Targets: Menu planners, Supervisors
Temporality: Immediate commencement within intervention period Dose: Fortnightly over the intervention period" Table 1 "Training and support to use the program: [38] Conduct educational outreach visits: A trained person (health promotion officer with nutrition and dietetic qualifications) meet with childcare providers in their practice settings with the intent of changing their behaviour to implement the guideline.
Provide ongoing consultation: Provide ongoing consultation with one or more experts in the strategies used to support implementing the guidelines.
Centralise technical assistance: Develop and use a centralised system to deliver technical assistance focused on implementation issues.
Actor: Health promotion officer with nutrition and dietetic qualifications Action: A face-to-face training session with a health promotion officer, with nutrition and dietetic qualifications and with extensive experience using the program, was provided to supervisors and menu planners. Training included information regarding the dietary guidelines for the sector, a demonstration of the web-based program and supporting resources, and an opportunity to answer any queries. Action planning and goal setting with staff was undertaken with the goal of facilitating integration of the program into existing roles and service procedures [44,45].
Services received telephone support calls by a health promotion officer, tailored to their engagement with the program and menu compliance with guidelines.
Services were sent one newsletter via email and within the CCMS program, containing ideas to increase menu compliance, and tips for using the program.
Services without a current menu entered in the program and those who had not improved in menu compliance were offered an online booster training session [46].
Online support was also available from the technical and nutritional support teams of the CCMS provider via an online portal (help desk) already used by the services for all other IT queries.

Targets: Menu planners, Supervisors
Temporality: 3 hour face-to-face training session within 4 weeks of intervention commencement; 5-30 minute telephone support calls provided at 2 weeks, 8 weeks, 6 months, and 8 months; newsletter provided at 4 months;15-60 minute online booster training sessions provided at 6 months Dose: Tailored to service needs -one-off face-to-face training session; up to 4 telephone support calls over 8 months; one-off newsletter; one-off online booster training session" Table 1 "Additional resources (portable computer tablet): Change equipment: Evaluate current configurations and adapt, as needed, the equipment (e.g. adding equipment) to best accommodate the targeted innovation Actor: Health promotion officer with nutrition and dietetic qualifications Action: Services were provided with a wifi-enabled computer tablet (Samsung Galaxy) to maximise integration of the online program into usual practice and provide the menu planner with portable access.

Targets: Menu planners, Supervisors
Temporality: Computer tablet provided at initial training session Dose: One-off computer tablet" 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Does your paper address CONSORT subitem 6a? * As a summary indicator of childcare service menu compliance, the primary outcome was the mean number of food groups on the menu that were compliant with dietary guidelines for the sector [15], at 12 months follow-up.
The majority of childcare services in NSW typically plan their menus in cycles of two -six weeks [18]. As such, at baseline, 3 and 12 month follow-ups, a dietitian or nutritionist blinded to service allocation randomly selected one week of each services' current menu cycle for review to eliminate selection bias, using the random number function in Microsoft Excel 2010. Menus were assessed using best practice protocols [47] to calculate the number of serves of each food group that the menu provided per child, per day.
Dietary guidelines for the setting [15] recommend services provide the following serves of each of the following Australian Guide to Healthy Eating (AGHE) [14] food groups on a daily basis: (i) vegetables and legumes/bean (two serves); (ii) fruit (one serve); (iii) wholegrain cereals, foods and breads (two serves); (iv) lean meat and poultry, fish, eggs, tofu, seeds and legumes (3/4 serve); (v) milk, yoghurt, cheese and alternatives (one serve); and (vi) no 'discretionary' foods that are high in energy and low in nutrients (zero serves). A food group was only considered compliant when the recommended number of serves, and no discretionary foods, were provided for every child, every day over a one-week period. A menu was only considered compliant when the recommended number of serves of all food groups, and no discretionary foods, were provided for every child, every day over a one-week period.
Secondary outcomes: i) Compliance with guidelines for all food groups: To identify absolute compliance with dietary guidelines, the proportion of services compliant for all of the six AGHE food groups was assessed via one-week menu review at baseline, 3 months and 12 months follow-up.
ii) Individual food group compliance with dietary guidelines: To identify variation in compliance with dietary guidelines for individual food groups, the proportion of services compliant with dietary guidelines for each of the six AGHE food groups individually was compared between the intervention and control group as assessed via one-week menu review at baseline, 3 months and 12 months follow-up. " 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed 6b) Any changes to trial outcomes after the trial commenced, with reasons 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed Does your paper address subitem 6a-i? 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Does your paper address subitem 6a-ii? 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Does your paper address subitem 6a-iii?
Does your paper address CONSORT subitem 6b? * "iii) Mean servings of individual food groups: To identify any changes in the quantities or times an individual food group was provided on the menu, an additional exploratory outcome was included. This measure was not prospectively registered: The mean number of serves for each of 5 AGHE food groups (vegetables, fruit, breads and cereals, meat and dairy) and the number of times discretionary foods were provided on the menu daily was compared between the intervention and control groups as assessed via one-week menu review (resulting in 5 days of data per service) at baseline, 3 months and 12 months follow-up." 7b) When applicable, explanation of any interim analyses and stopping guidelines 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Does your paper address subitem 7a-i? Does your paper address CONSORT subitem 7b? * NA Does your paper address CONSORT subitem 8a? * "Following the completion of baseline data collection, services were allocated to the intervention or control group in a 1:1 ratio, stratified by socioeconomic status (as determined by service postcode) [37] by an independent statistician using a random number function in Microsoft Excel 2010." Does your paper address CONSORT subitem 8b? * "Following the completion of baseline data collection, services were allocated to the intervention or control group in a 1:1 ratio, stratified by socioeconomic status (as determined by service postcode) [37] by an independent statistician using a random number function in Microsoft Excel 2010." 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment Does your paper address CONSORT subitem 9? * "Following the completion of baseline data collection, services were allocated to the intervention or control group in a 1:1 ratio, stratified by socioeconomic status (as determined by service postcode) [37] by an independent statistician using a random number function in Microsoft Excel 2010." Does your paper address CONSORT subitem 10? * "All services in the sampling frame were posted an invitation letter and information statements about the study in random order, approximately two weeks prior to receiving a call from a research assistant to assess eligibility and obtain service consent to participate (August -December 2017)." "Following the completion of baseline data collection, services were allocated to the intervention or control group in a 1:1 ratio, stratified by socioeconomic status (as determined by service postcode) [37] by an independent statistician using a random number function in Microsoft Excel 2010." 11a-i) Specify who was blinded, and who wasn't Does your paper address subitem 11a-i? * "All outcome data assessors were blind to group allocation; however due to the nature of the trial childcare staff and health promotion officers delivering the intervention were aware of group allocation." 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" 11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address subitem 11a-ii?
Does your paper address CONSORT subitem 11b? * NA "Services randomly allocated to the control group did not receive access to the web-based menu planning program or other implementation support strategies." Does your paper address CONSORT subitem 12a? * "All statistical analysis was undertaken using SAS 9.3 [49] by a statistician blinded to group allocation. All statistical analyses were two-tailed with an α value of 0·05. Service postcodes ranked in the top 50% of NSW according to the 2016 Socioeconomic Indices for Areas were classified as higher socioeconomic status [37]. Chi-square and t-test analyses were used to compare service and menu planner characteristics between intervention and control groups at baseline. The primary (mean number of food groups compliant with guidelines) and secondary menu outcomes (individual and all food group compliance with guidelines, and mean daily servings of individual food groups) were analysed with generalised linear mixed models, to account for repeated measures at the service level, as well as potential service level clustering effects for the mean daily servings of food groups analysis. The model included a random effect for service, as well as a group by time interaction to assess intervention effectiveness over the three time points." 12a-i) Imputation techniques to deal with attrition / missing values 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item) Does your paper address subitem 12a-i? * "For the primary and secondary outcomes, under an intention to treat framework, a complete case analysis was performed using all available data based on group allocation (without imputation), in addition to analysis using multiple imputation for missing data at follow-up undertaken using the MI procedure in SAS." Does your paper address CONSORT subitem 12b? * NA X26-i) Comment on ethics committee approval Does your paper address subitem X26-i? x26-ii) Outline informed consent procedures Does your paper address subitem X26-ii? X26-iii) Safety and security procedures RESULTS 13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center 13b) For each group, losses and exclusions after randomisation, together with reasons 14a) Dates defining the periods of recruitment and follow-up Does your paper address subitem X26-iii?
Does your paper address CONSORT subitem 13a? * "Twenty-seven services were randomised to intervention, and 27 services to the control. Two intervention services withdrew from the study prior to 12 months follow-up; one no longer prepared and provided meals, the other no longer Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * "Twenty-seven services were randomised to intervention, and 27 services to the control. Two intervention services withdrew from the study prior to 12 months follow-up; one no longer prepared and provided meals, the other no longer wished to participate." See Figure 1.

13b-i) Attrition diagram
Does your paper address subitem 13b-i?
14b) Why the trial ended or was stopped (early) 15) A table showing baseline demographic and clinical characteristics for each group NPT: When applicable, a description of care providers (case volume, qualification, expertise, etc.) and centers (volume) in each group Does your paper address CONSORT subitem 14a? * "All services in the sampling frame were posted an invitation letter and information statements about the study in random order, approximately two weeks prior to receiving a call from a research assistant to assess eligibility and obtain service consent to participate (August -December 2016)." 14a-i) Indicate if critical "secular events" fell into the study period Does your paper address subitem 14a-i? Does your paper address CONSORT subitem 14b? * NA Does your paper address CONSORT subitem 15? * See Table 2 "Services in the control arm had a significantly higher proportion of menu planners with a university qualification (19%) compared to services in the intervention (0%) (P=.02)." 15-i) Report demographics associated with digital divide issues 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory Does your paper address CONSORT subitem 17a? * See Tables 3 and 4 "Primary outcome: Mean number of food groups compliant with dietary guidelines. Whilst an increase in the mean number of food groups compliant with dietary guidelines from baseline to follow-up was found for both intervention and control services, no significant differences between the groups were found at 3 months (ES 0.52; 95% CI -0.35 to 1.39; P=.24) ( Table 3) or 12 months follow-up (ES 0.26; 95% CI -0.61 to 1.14; P=.55).

Secondary outcomes
Compliance with guidelines for all food groups At 3 months, only one service in the intervention arm was compliant with dietary guideline recommendations for all 6 food groups (Table 3). At 12 months followup, no services in either group were compliant with dietary guidelines for all 6 food groups. Statistical analysis was unable to be performed given inadequate values in all cells.
Individual food group compliance with dietary guidelines An increase in the proportion of services compliant with individual food groups from baseline to follow-up was found for both intervention and control services, for the majority of food groups (4 out of 6), however no significant differences between groups were found at 3 or 12 months follow-up for any individual food group (Table 3).
No changes to the statistical significance of any outcomes were observed in the multiple imputation analyses, and as such these results are not reported." 17a-i) Presentation of process outcomes such as metrics of use and intensity of use Does your paper address subitem 17a-i? Does your paper address CONSORT subitem 17b? * See Tables 3 and 4 for relative effect sizes.

19) All important harms or unintended effects in each group
(for specific guidance see CONSORT for harms) Does your paper address CONSORT subitem 18? * "Mean servings of individual food groups At 3 months follow-up, menus from services in the intervention group provided significantly more mean daily servings of fruit, vegetables, dairy, meat, and reduced the number of times discretionary foods were provided compared to control (Table 4). At 12 months follow-up, menus from intervention services provided significantly more mean daily servings of fruit and significantly less discretionary foods compared to control service menus."

18-i) Subgroup analysis of comparing only users
Does your paper address subitem 18-i? NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group Does your paper address subitem 19-ii? 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Does your paper address subitem 22-i? * "This study is the first RCT measuring the effectiveness of a web-based menu planning program, linked to childcare management software systems, in improving childcare service compliance with dietary guidelines. The study found that, despite being considered acceptable by childcare service staff, the intervention did not significantly improve childcare service menu compliance with dietary guidelines, relative to control. However, significant increases in the servings of fruit, vegetables, dairy and meat on the menu, and a reduction in the times discretionary foods were provided were observed at 3 months. In addition, an increase in servings of fruit and reduction in the provision of discretionary foods at 12 months were found. Such findings suggest that while the webbased intervention did not improve menu compliance with guidelines, it increased the quantity of healthy foods, and decreased unhealthy foods provided on childcare service menus." "Among intervention services, there were high levels of acceptability, and variable levels of use of the web-based program (as evidenced by the large SDs and IQR in program use data). "

22-ii) Highlight unanswered new questions, suggest future research
Does your paper address subitem 22-ii? 20) Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses 21) Generalisability (external validity, applicability) of the trial findings NPT: External validity of the trial findings according to the intervention, comparators, patients, and care providers or centers involved in the trial

20-i) Typical limitations in ehealth trials
Does your paper address subitem 20-i? * "The study had notable strengths including the design (RCT), rigorous evaluation approaches, and inclusion of theory-driven and evidence-based intervention and implementation support strategies. Limitations, however were also present. Similar to previous trials within childcare services [56], the study yielded a moderate consent rate (47.4%). Whilst there were no significant differences in socioeconomic status for consenters and non-consenters, given the study was conducted within one state in Australia (NSW) with few indigenous services, it is unclear whether these findings are generalisable nationally or internationally. Furthermore, despite randomisation, services in the control arm had a significantly higher proportion of menu planners with a university qualification compared to intervention services. It is possible that this may account for the improvement in menu compliance observed in the control arm. While the menu planning program was linked to a CCMS platform to increase uptake and integration into daily routines, the program was not viewable on the main child enrolments page that is accessed on a daily basis by childcare service staff. Integrating the onlinethe web-based menu planning program into the main CCMS platform of the software may reduce variability in service's use of the program use. Finally, the outcome relating to servings of individual food groups provided on the menu was was not prospectively registered, and should be interpreted with caution."