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Trial registered on ANZCTR


Registration number
ACTRN12621001120864
Ethics application status
Approved
Date submitted
6/07/2021
Date registered
23/08/2021
Date last updated
19/10/2023
Date data sharing statement initially provided
23/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness and value-for-money of an intervention supporting healthy food changes in local government food retail outlets
Scientific title
The effectiveness and cost-effectiveness of a capacity-building intervention in local government food retail outlets: a randomised controlled trial
Secondary ID [1] 304600 0
Nil known
Universal Trial Number (UTN)
U1111-1267-0842
Trial acronym
"Promoting CHANGE" (Community Health and Nutrition, and Government Engagement)
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Poor diet 322506 0
Condition category
Condition code
Diet and Nutrition 320143 320143 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multicomponent local government (LG) capacity building intervention (the Intervention):

The Intervention is a 3-year multicomponent intervention to improve the healthiness of the food environment in Victorian LG owned/ managed facilities. The Intervention will include a two-year implementation period followed by a one-year maintenance period. The Intervention will involve 3 to 9 LG managed/owned facilities per LG. The RCT will compare outcomes for non-seasonal sport and recreation facilities (the most common type of council-owned facility that includes a food outlet) only. LGs may also engage other LG owned and/or operated food outlets in facilities such as seasonal sporting facilities, libraries, arts centres and community centres in the Intervention but these won’t be part of the RCT evaluation. The reason for engaging other non RCT sites is to expand LG influence in these novel settings, and to generate learnings for future research in those settings.

The Intervention will involve local government project officers drafting healthy food retail policy and supporting their progress through council. Project officers will also refine and implement changes in facilities in partnership with facility management towards the goal of achieving the Victorian Government Healthy Choices guidelines (‘The Guidelines’). The Guidelines were chosen as the benchmark as many Victorian LGs already use them, and they align well with interstate standards. The Guidelines provide targets relating to the ‘4Ps’ of marketing to discourage customer purchases of less healthy ‘red’ food and drinks and encourage purchases of healthier ‘green’ and ‘amber’ options: Price (e.g. removing meal deals that include ‘red’ options), Promotion (e.g. appealing signage advertising healthier options), Placement (e.g. placing ‘green’ options at eye-level), and Products available (e.g. reducing the range of ‘red’ options and increasing the range of tasty ‘green’ alternatives).

At the facility level, a LG project officer will work with staff and management to progress towards implementing the Guidelines. The project officer will offer support such as changing recipes, sourcing healthier suppliers, training facility staff, developing customer communications material, and conducting in-store audits and sales data collection. Decisions about which aspects of the Guidelines to address, and in what order, will be decided at the LG- and facility-level by the project officer and facility manager, with advice from Nutrition Australia’s Healthy Eating Advisory Service (HEAS) on feasibility, and maintaining customer satisfaction and outlet profitability. These decisions will occur at baseline outlet assessment, and ongoing throughout the project based on Monitoring and Feedback (see below). Planned in-store changes (Intervention ‘targets’) for each facility will be based on a number of factors including sales data in year preceding the Intervention (e.g., to identify high selling ‘red’ items that could be replaced with a ‘green’ or ‘amber’ alternative); baseline in-store food environment assessments using the Store Scout app, including assessment of current progress towards the Guidelines ‘red’, ‘amber’, ‘green’ availability targets; facility resourcing and infrastructure; customer base preferences; and supplier arrangements. A modified version of the Store Scout app (Jaenke et al., 2020) will be used to assess the current use of the 4Ps of marketing to promote ‘red’, ‘amber’, and ‘green’ items in each outlet. It provides a score on the healthiness of the food environment from 0 (least healthy) to 100 (healthiest).

The key elements of the support model which will enable LG policy and facility-level changes include: (1) Human resource support: a LG project officer for three years to assist with implementation, as well as (2) Training; (3) Tools; (4) Technical Assistance; (5) Peer networking; (6) and Monitoring and Feedback. The key actions included in each element are detailed below, but specific elements of each component of the support model will be refined in a series of workshops with recruited LGs and HEAS prior to the beginning of the RCT.

Human Resourcing:
At the LG-level, the project officer will co-ordinate and draft policies to embed long-term changes, e.g., updating facility lease agreements to provide food consistent with the Guidelines. In the first two years, salary support will assume a 4 hours/ week base (time for administration, evaluation, policy development, and training and other capacity-building exercises) + 4 hours/ week per facility (total funding 3 to 5 days per week depending on number of engaged facilities).
In the third year of the RCT (maintenance period), human resourcing support will be halved to 2 hours/ week per facility (total 2 to 3 days per week). During the maintenance year, training and other intervention components will continue at the same frequency and intensity as described below.

Training:
HEAS will provide training for project officers and other relevant LG staff, with assistance from researchers and other partners. Training will include data collection, council cross-sectoral planning, stakeholder engagement, policy development, health promotion and business skills and in-store marketing. Training will include a variety of modes including online and in-person seminars, short videos, worksheets, and group discussions. Training will be delivered at staggered intervals, e.g., 4 hours every 6 months during the three-year Intervention. Number of training sessions attended by each participant will be recorded.

Tools and technical assistance:
HEAS will provide LGs with technical assistance including their FoodChecker classification tool (used to classify food and drinks according to the Guidelines) and six-monthly telephone check-ins on progress. LGs will also be provided with access to additional implementation tools, example policies, marketing materials, and additional evaluation tools that may be of interest to LGs or facilities such as customer survey templates and case studies. We will survey project officers in the Intervention group at the end of the RCT (end of third maintenance year), to collect data on which tools were used and how useful participants found them.

Peer networking:
HEAS will facilitate face-to-face and online project officer communities of practice between study project officers meeting and sharing ideas, at least every 6 months. The face-to-face meetings are likely to be linked to the training sessions, i.e. approximately 4 hours every 6 months. Face-to-face will be the preferred method of networking but may need to be online subject to COVID-19 travel restrictions or participants’ convenience. The online peer support (e.g. via Facebook group) will be approximately 30mins per week. Number of peer networking sessions attended by each participant will be recorded.

Monitoring and feedback (and fidelity assessment):
Six-monthly feedback on sales and in-store audit data (collected by LG project officers with assistance from the research team) will be provided to Intervention LGs to demonstrate how they are tracking towards intervention targets, and change in display and sales of ‘red’, ‘amber’ and ‘green’ items to indicate if the intervention is working to change consumer behaviour, as well as financial outcomes to indicate the impact on the business of changes. This will allow sites to make iterative changes to improve Intervention effectiveness and reduce unintended consequences (e.g., profit loss). The reconsideration of facility targets and tailored Interventions is expected to occur at six-monthly timepoints.

The Intervention sample size will involve a target of 6 local governments (20 local government facilities).

Stakeholder interviews:
Semi-structured stakeholder interviews will be conducted by the research project manager and/or PhD student at the end of the 3-year RCT. Interviews will be up to 1 hour in length and will include the first 20 willing participants to comprise a purposive sample of Intervention local government retail outlet staff, local government project officers and managers, and other stakeholders.

Interviews will ask stakeholders about perceived Intervention costs, benefits, acceptability, implementation infrastructure required for scale-up, and perceived ability of the Intervention to be sustained long-term. Interview questions and analysis will be guided by the Intervention Scalability Assessment Tool (Lee at al., 2020).

References
Jaenke R, Van Den Boogaard C, McMahon E, Brimblecombe J. Development and pilot of a tool to measure the healthiness of the in-store food environment. Public Health Nutr. 2021 Feb;24(2):243-52.

Lee K, Milat A, Grunseit A, Conte K, Wolfenden L, Bauman A. The Intervention Scalability Assessment Tool: a pilot study assessing five interventions for scalability. Public Health Res Pract. 2020;30(2):e3022011.
Intervention code [1] 320950 0
Behaviour
Comparator / control treatment
The Control group of 4 local governments (approximately 20 seasonal and non-seasonal facilities) will be expected to continue with their current practice during the RCT period (i.e. standard care). The Control group will receive in-store food environment and sales data monitoring support only during the RCT. Local governments will be provided with funding to monitor the in-store food environment using the Store Scout app, and collect sales data every 6 months. Following the RCT, the Control group will be offered a shortened one-year version of the Intervention. This will be equivalent to the human resourcing support received by the Intervention group in year one of the RCT.
Control group
Active

Outcomes
Primary outcome [1] 328020 0
Rate of change in the proportion of ‘red’ drink item volume (L) sold weekly in Intervention compared to Control facilities, as measured using electronic sales data for each participating facility. All food and drink items will be matched to the Victorian Government FoodChecker database (to identify traffic light classification according to the Guidelines).
Timepoint [1] 328020 0
Mean weekly rate of change from baseline to 2 years (end of implementation), and from 2 years to 3 years (end of maintenance period) after intervention commencement. To be measured at 2 years post-implementation and 3-years post-implementation.
Primary outcome [2] 328434 0
Rate of change in the proportion of ‘red’ food item volume (kg) sold weekly in Intervention compared to Control facilities, as measured using electronic sales data for each participating facility. All food and drink items will be matched to the Victorian Government FoodChecker database (to identify traffic light classification according to the Guidelines).
Timepoint [2] 328434 0
Mean weekly rate of change from baseline to 2 years (end of implementation), and from 2 years to 3 years (end of maintenance period) after intervention commencement. To be measured at 2 years post-implementation and 3-years post-implementation.
Secondary outcome [1] 397250 0
Rate of change in the proportion of ‘amber’ drink item volume (L) sold weekly in Intervention compared to Control facilities, as measured using electronic sales data for each participating facility. All food and drink items will be matched to the Victorian Government FoodChecker database (to identify traffic light classification according to the Guidelines).
Timepoint [1] 397250 0
Mean weekly rate of change from baseline to 2 years (end of implementation), and from 2 years to 3 years (end of maintenance period) after intervention commencement. To be measured at 2 years post-implementation and 3-years post-implementation.
Secondary outcome [2] 397251 0
Rate of change in the proportion of ‘amber’ food item volume (kg) sold weekly in Intervention compared to Control facilities, as measured using electronic sales data for each participating facility. All food and drink items will be matched to the Victorian Government FoodChecker database (to identify traffic light classification according to the Guidelines).
Timepoint [2] 397251 0
Mean weekly rate of change from baseline to 2 years (end of implementation), and from 2 years to 3 years (end of maintenance period) after intervention commencement. To be measured at 2 years post-implementation and 3-years post-implementation.
Secondary outcome [3] 397252 0
Rate of change in the proportion of ‘green’ drink item volume (L) sold weekly in Intervention compared to Control facilities, as measured using electronic sales data for each participating facility. All food and drink items will be matched to the Victorian Government FoodChecker database (to identify traffic light classification according to the Guidelines).
Timepoint [3] 397252 0
Mean weekly rate of change from baseline to 2 years (end of implementation), and from 2 years to 3 years (end of maintenance period) after intervention commencement. To be measured at 2 years post-implementation and 3-years post-implementation.
Secondary outcome [4] 397325 0
Rate of change in the proportion of ‘green’ food item volume (kg) sold weekly in Intervention compared to Control facilities, as measured using electronic sales data for each participating facility. All food and drink items will be matched to the Victorian Government FoodChecker database (to identify traffic light classification according to the Guidelines).
Timepoint [4] 397325 0
Mean weekly rate of change from baseline to 2 years (end of implementation), and from 2 years to 3 years (end of maintenance period) after intervention commencement. To be measured at 2 years post-implementation and 3-years post-implementation.
Secondary outcome [5] 398936 0
Rate of change in energy content (kJ per 100g) of combined food and drink sold weekly in Intervention compared to Control facilities, as measured using electronic sales data for each participating facility. All food items will be matched to the AUSNUT database (to identify nutritional content).
Timepoint [5] 398936 0
Mean weekly rate of change from baseline to 2 years (end of implementation), and from 2 years to 3 years (end of maintenance period) after intervention commencement. To be measured at 2 years post-implementation and 3-years post-implementation.
Secondary outcome [6] 398937 0
Rate of change in free sugar content (g per 100g) of combined food and drink sold weekly in Intervention compared to Control facilities, as measured using electronic sales data for each participating facility. All food items will be matched to the AUSNUT database (to identify nutritional content).
Timepoint [6] 398937 0
Mean weekly rate of change from baseline to 2 years (end of implementation), and from 2 years to 3 years (end of maintenance period) after intervention commencement. To be measured at 2 years post-implementation and 3-years post-implementation.
Secondary outcome [7] 398938 0
Rate of change in combined food and drink revenue ($) sold weekly in Intervention compared to Control facilities, as measured using electronic sales data for each participating facility
Timepoint [7] 398938 0
Mean weekly rate of change from baseline to 2 years (end of implementation), and from 2 years to 3 years (end of maintenance period) after intervention commencement. To be measured at 2 years post-implementation and 3-years post-implementation.
Secondary outcome [8] 398939 0
Change in proportion 'red' combined food and drink products available at each food outlet in Intervention compared to Control facilities. All food items will be matched to the Victorian Government FoodChecker database (to identify traffic light classification according to the Guidelines).
Timepoint [8] 398939 0
At baseline and then every six months during 3-year RCT
Secondary outcome [9] 398998 0
Change in proportion 'amber' combined food and drink products available at each food outlet in Intervention compared to Control facilities. All food items will be matched to the Victorian Government FoodChecker database (to identify traffic light classification according to the Guidelines).
Timepoint [9] 398998 0
At baseline and then every six months during 3-year RCT
Secondary outcome [10] 398999 0
Change in proportion 'green' combined food and drink products available at each food outlet in Intervention compared to Control facilities. All food items will be matched to the Victorian Government FoodChecker database (to identify traffic light classification according to the Guidelines).
Timepoint [10] 398999 0
At baseline and then every six months during 3-year RCT
Secondary outcome [11] 399000 0
Stakeholder perceived Intervention costs. Measured via semi-structured interviews (~20) conducted with a purposive sample of retail outlet staff, local government project officers and managers, and other stakeholders. Interviews will be guided by the Intervention Scalability Assessment Tool (Lee at al., 2020).
Timepoint [11] 399000 0
End of 3-year RCT
Secondary outcome [12] 399001 0
Stakeholder perceived Intervention benefits. Measured via semi-structured interviews (~20) conducted with a purposive sample of retail outlet staff, local government project officers and managers, and other stakeholders. Interviews will be guided by the Intervention Scalability Assessment Tool (Lee at al., 2020).
Timepoint [12] 399001 0
End of 3-year RCT
Secondary outcome [13] 399002 0
Stakeholder perceived Intervention acceptability. Measured via semi-structured interviews (~20) conducted with a purposive sample of retail outlet staff, local government project officers and managers, and other stakeholders. Interviews will be guided by the Intervention Scalability Assessment Tool (Lee at al., 2020).
Timepoint [13] 399002 0
End of 3-year RCT
Secondary outcome [14] 399003 0
Stakeholder perceived implementation infrastructure required for scale-up. Measured via semi-structured interviews (~20) conducted with a purposive sample of retail outlet staff, local government project officers and managers, and other stakeholders. Interviews will be guided by the Intervention Scalability Assessment Tool (Lee at al., 2020).
Timepoint [14] 399003 0
End of 3-year RCT
Secondary outcome [15] 399004 0
Stakeholder perceived ability of the Intervention to be sustained long-term. Measured via semi-structured interviews (~20) conducted with a purposive sample of retail outlet staff, local government project officers and managers, and other stakeholders. Interviews will be guided by the Intervention Scalability Assessment Tool (Lee at al., 2020).
Timepoint [15] 399004 0
End of 3-year RCT
Secondary outcome [16] 399005 0
Policy ‘Implementation’. Determined via strength of council and site-level food policies as assessed using the Food-EPI tool for Australian local governments (tool currently under development).
Timepoint [16] 399005 0
End of 3-year RCT

Eligibility
Key inclusion criteria
Human participants will be those who utilise food outlets in local government facilities in the course of this study. We do not plan any direct contact with or data collection from humans who use these sites.

We plan to conduct a cluster randomised trial, with the local government areas randomised and all participating facilities in each local government area assigned to the same treatment group. Prior to the Intervention, eligible Victorian LGs must have engaged at least three non-seasonal sport and recreation facilities. Non-seasonal facilities are those open at least 10 months of the year. Engagement is defined as in-principle agreement from facility management to meet eligibility criteria as described below. Eligible LGs must have also agreed to provide: (i) sales and environmental audit data; and (ii) in-kind commitment of at least one day per week of project officer time over intervention period.

Eligible facilities must have (i) food and/or drinks available for sale ‘over-the-counter’ (not just vending machines or catering); (ii) agreed to make food retail environment changes; (iii) not fully implemented the Victorian Healthy Choices Guidelines; and (iv) itemised sales data.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All LGs and facilities will be assessed for eligibility and enrolled in the study before treatment allocation. At the end of recruitment, the researcher will contact the holder of the allocation schedule, an independent statistician based in the Biostatistics Unit at Deakin University, who will be blind to the names of the LGs and facilities recruited and randomise LGs to treatment groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Pairs of LGs will be matched on location (regional/metropolitan) and the Local Government Area socioeconomic index for areas (SEIFA). After they are matched, one LG will be randomised to the Intervention group. Simple randomisation will be used with a randomisation table created using the statistical package Stata.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
POWER CALCULATION
Power calculations were based on the number of non-seasonal facilities which will be used to evaluate the sales outcomes, and performed in PASS (v.16) using estimates from our Water in Sport study (Blake et al, 2022). The trial involves 4 LGs per arm, with 21 non-seasonal sites in the Intervention and 14 in the Control group (mean n=5 & n=4 sites per LG, respectively). Primary implementation outcome: The trial will have 80% power to detect a mean difference between groups of =18.8% in the percentage of ‘red’ drinks available at the end of the 3-year RCT (intraclass correlation coefficient 0.05, cluster size variation coefficient 0.37, SD=17.8, a=0.05, 2-sided test). This effect size is similar to the Water in Sport study (-18.9% at 18-months) (Blake et al, 2022).
Primary effectiveness outcome: With 156 weeks of sales data, the trial will have 80% power to detect a difference between groups of = 9% in percentage of ‘red’ drink weekly drink sales at the end of the 3-year RCT, using a GEE model assuming linear trends (Anh et al, 2015) (AR(1) correlation structure, ?=0.73, SD=13.7). This effect size is smaller than in Water in Sport (-11% at 2-years) (Blake et al, 2022).

ANALYSIS:
Sales data:
We will conduct an intention-to-treat analysis of the outcome measures using generalized estimating equations to allow for the autocorrelation between weekly sales within each facility. Linear regression models will compare the rates of change in the outcome variable between treatment groups. Analyses will be conducted initially controlling for factors used in the matching: location (urban/rural), and Socio-Economic Indexes for Areas; and then further adjusted for other potential confounders: outlet type (canteen, kiosk, café); size of facility; and weekly mean daily temperature from the Australian Bureau of Meteorology.

Economic evaluation:
The primary analysis will be a ‘trial-based evaluation’. Implementation cost will be estimated using project invoices and detailed resource-use surveys completed by LGs and Intervention facility managers every six months. To determine short-term Intervention impact, we will calculate the cost per percentage reduction in ‘red’ items sold. To assess the longer-term impact, we will use validated ACE-Obesity models (Ananthapavan et al. 2020) to predict the cost-effectiveness of rolling out the Intervention across Australia. Outputs will estimate the long-term costs, Health-Adjusted Life Years gained, healthcare cost-savings, and incremental cost-effectiveness ratios for the Australian population from a societal perspective.

Implementation:
‘Adoption’ will be defined as the number of LG sites that have made any changes to in-store environments since baseline, assessed using the Store Scout in-store auditing app. ‘Implementation’ and ‘Maintenance’ will be defined as changes in the proportion of ‘red’, ‘amber’, and ‘green’ food and drink item availability using a modified version of the Store Scout in-store auditing app. Linear regression models will compare the change in the outcome variable between treatment groups. Analyses will be conducted initially controlling for factors used in the matching: location (urban/rural), and Socio-Economic Indexes for Areas; and then further adjusted for other potential confounders: outlet type (canteen, kiosk, café); and size of facility.

Process evaluation:
Policy ‘Implementation’ will be determined via strength of council and site-level food policies. Semi-structured interviews (~20) will be conducted with a purposive sample of retail outlet staff, LG project officers and managers, and other stakeholders at the end of the RCT. Interviews will be guided by the Intervention Scalability Assessment Tool (Lee at al., 2020) to assess Intervention scalability including costs and benefits, acceptability, implementation infrastructure required for scale-up and perceptions of ability to be sustained long-term.

References:
Ahn, C., Heo, M., and Zhang, S. 2015. Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research. CRC Press. New York.

Ananthapavan J, Sacks G, Brown V, Moodie M, Nguyen P, Veerman L, Mantilla Herrera AM, Lal A, Peeters A, Carter R. Priority-setting for obesity prevention—The Assessing Cost-Effectiveness of obesity prevention policies in Australia (ACE-Obesity Policy) study. PloS one. 2020 Jun 19;15(6):e0234804.

Blake MR, Romaniuk H, Riesenberg D, Boelsen-Robinson T, Cameron AJ, Orellana L, Peeters A. Implementation and sales impact of a capacity building intervention in Australian sporting facility food outlets: a longitudinal observational study. BMJ Nutrition, Prevention & Health. 2022 Dec;5(2):171.

Lee K, Milat A, Grunseit A, Conte K, Wolfenden L, Bauman A. The Intervention Scalability Assessment Tool: a pilot study assessing five interventions for scalability. Public Health Res Pract. 2020;30(2):e3022011.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2023
Actual
1/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
26
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 308963 0
University
Name [1] 308963 0
Deakin University
Country [1] 308963 0
Australia
Funding source category [2] 315068 0
Government body
Name [2] 315068 0
National Health and Medical Research Council
Country [2] 315068 0
Australia
Primary sponsor type
Individual
Name
Dr Miranda Blake
Address
Deakin University
221 Burwood Highway, Burwood, VIC 3125
Country
Australia
Secondary sponsor category [1] 309893 0
Individual
Name [1] 309893 0
A/Prof Adrian Cameron
Address [1] 309893 0
Deakin University
221 Burwood Highway
Victoria Australia 3125
Country [1] 309893 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308850 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 308850 0
Ethics committee country [1] 308850 0
Australia
Date submitted for ethics approval [1] 308850 0
31/08/2022
Approval date [1] 308850 0
25/07/2023
Ethics approval number [1] 308850 0
HEAG-H 92_2023

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112114 0
Dr Miranda Blake
Address 112114 0
Deakin University
221 Burwood Highway, Burwood, VIC 3125
Country 112114 0
Australia
Phone 112114 0
+61 3 9246 8487
Fax 112114 0
Email 112114 0
miranda.blake@deakin.edu.au
Contact person for public queries
Name 112115 0
Miranda Blake
Address 112115 0
Deakin University
221 Burwood Highway, Burwood, VIC 3125
Country 112115 0
Australia
Phone 112115 0
+61 3 9246 8487
Fax 112115 0
Email 112115 0
miranda.blake@deakin.edu.au
Contact person for scientific queries
Name 112116 0
Miranda Blake
Address 112116 0
Deakin University
221 Burwood Highway, Burwood, VIC 3125
Country 112116 0
Australia
Phone 112116 0
+61 3 9246 8487
Fax 112116 0
Email 112116 0
miranda.blake@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This data including sales data will be provided to the researchers by the local governments and facilities under a commercial-in-confidence agreement.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.