What is the economic and social return on investment for telephone cancer information and support services in Australia? An evaluative social return on investment study protocol.

INTRODUCTION: Over 50% of people affected by cancer report unmet support needs. To address unmet information and psychological needs, non-government organisations such as Cancer Councils (Australia) have developed state-based telephone cancer information and support services. Due to competing demands, evidence of the value of these services is needed to ensure that future investment makes the best use of scarce resources. This research aims to determine the costs and broader economic and social value of a telephone support service, to inform future funding and service provision. METHODS AND ANALYSIS: A codesigned, evaluative social return on investment analysis (SROI) will be conducted to estimate and compare the costs and monetised benefits of Cancer Council Victoria's (CCV) telephone support line, 13 11 20, over 1-year and 3-year benefit periods. Nine studies will empirically estimate the parameters to inform the SROI and calculate the ratio (economic and social value to value invested): step 1 mapping outcomes (in-depth analysis of CCV's 13 11 20 recorded call data; focus groups and interviews); step 2 providing evidence of outcomes (comparative survey of people affected by cancer who do and do not call CCV's 13 11 20; general public survey); step 3 valuing the outcomes (financial proxies, value games); step 4 establishing the impact (Delphi); step 5 calculating the net benefit and step 6 service improvement (discrete choice experiment (DCE), 'what if' analysis). Qualitative (focus groups, interviews) and quantitative studies (natural language processing, cross-sectional studies, Delphi) and economic techniques (willingness-to-pay, financial proxies, value games, DCE) will be applied. ETHICS AND DISSEMINATION: Ethics approval for each of the studies will be sought independently as the project progresses. So far, ethics approval has been granted for the first two studies. As each study analysis is completed, results will be disseminated through presentation, conferences, publications and reports to the partner organisations.

iCare - a self-directed, interactive online program to improve health and wellbeing for people living with upper gastrointestinal or hepato-pancreato-biliary cancers, and their informal carers: the study protocol for a Phase II randomised controlled trial.

BACKGROUND: Up to 70% of people diagnosed with upper gastrointestinal (GI) tract or hepato-pancreato-biliary (HPB) cancers experience substantial reductions in quality of life (QoL), including high distress levels, pain, fatigue, sleep disturbances, weight loss and difficulty swallowing. With few advocacy groups and support systems for adults with upper GI or HPB cancers (i.e. pancreas, liver, stomach, bile duct and oesophageal) and their carers, online supportive care programs may represent an alternate cost-effective mechanism to support this patient group and carers. iCare is a self-directed, interactive, online program that provides information, resources, and psychological packages to patients and their carers from the treatment phase of their condition. The inception and development of iCare has been driven by consumers, advocacy groups, government and health professionals. The aims of this study are to determine the feasibility and acceptability of iCare, examine preliminary efficacy on health-related QoL and carer burden at 3- and 6-months post enrolment, and the potential cost-effectiveness of iCare, from health and societal perspectives, for both patients and carers. METHODS AND ANALYSIS: A Phase II randomised controlled trial. Overall, 162 people with newly diagnosed upper GI or HPB cancers and 162 carers will be recruited via the Upper GI Cancer Registry, online advertisements, or hospital clinics. Patients and carers will be randomly allocated (1:1) to the iCare program or usual care. Participant assessments will be at enrolment, 3- and 6-months later. The primary outcomes are i) feasibility, measured by eligibility, recruitment, response and attrition rates, and ii) acceptability, measured by engagement with iCare (frequency of logins, time spent using iCare, and use of features over the intervention period). Secondary outcomes are patient changes in QoL and unmet needs, and carer burden, unmet needs and QoL. Linear mixed models will be fitted to obtain preliminary estimates of efficacy and variability for secondary outcomes. The economic analysis will include a cost-consequences analysis where all outcomes will be compared with costs. DISCUSSION: iCare provides a potential model of supportive care to improve QoL, unmet needs and burden of disease among people living with upper GI or HPB cancers and their carers. AUSTRALIAN AND NEW ZEALAND CLINICAL TRIALS REGISTRY: ACTRN12623001185651. This protocol reflects Version #1 26 April 2023.

Reflexive Evidence and Systems interventions to Prevention Obesity and Non-communicable Disease (RESPOND): protocol and baseline outcomes for a stepped-wedge cluster-randomised prevention trial.

INTRODUCTION: Systems science methodologies have been used in attempts to address the complex and dynamic causes of childhood obesity with varied results. This paper presents a protocol for the Reflexive Evidence and Systems interventions to Prevention Obesity and Non-communicable Disease (RESPOND) trial. RESPOND represents a significant advance on previous approaches by identifying and operationalising a clear systems methodology and building skills and knowledge in the design and implementation of this approach among community stakeholders. METHODS AND ANALYSIS: RESPOND is a 4-year cluster-randomised stepped-wedge trial in 10 local government areas in Victoria, Australia. The intervention comprises four stages: catalyse and set up, monitoring, community engagement and implementation. The trial will be evaluated for individuals, community settings and context, cost-effectiveness, and systems and implementation processes. Individual-level data including weight status, diet and activity behaviours will be collected every 2 years from school children in grades 2, 4 and 6 using an opt-out consent process. Community-level data will include knowledge and engagement, collaboration networks, economic costs and shifts in mental models aligned with systems training. Baseline prevalence data were collected between March and June 2019 among >3700 children from 91 primary schools. ETHICS AND DISSEMINATION: Ethics approval: Deakin University Human Research Ethics Committee (HREC 2018-381) or Deakin University's Faculty of Health Ethics Advisory Committee (HEAG-H_2019-1; HEAG-H 37_2019; HEAG-H 173_2018; HEAG-H 12_2019); Victorian Government Department of Education and Training (2019_003943); Catholic Archdiocese of Melbourne (Catholic Education Melbourne, 2019-0872) and Diocese of Sandhurst (24 May 2019). The results of RESPOND, including primary and secondary outcomes, and emerging studies developed throughout the intervention, will be published in the academic literature, presented at national and international conferences, community newsletters, newspapers, infographics and relevant social media. TRIAL REGISTRATION NUMBER: ACTRN12618001986268p.

Healthy weight, health behaviours and quality of life among Aboriginal children living in regional Victoria.

OBJECTIVE: To report the prevalence of healthy weight and related behaviours among Victorian Aboriginal and non-Aboriginal children and explore associations between these factors and health-related quality of life (HRQoL). METHODS: Analysis of cross-sectional data from two cluster randomised controlled trials using logistic and linear mixed models. The sample included Aboriginal (n=303) and non-Aboriginal (n=3,026) children aged 8-13 years. RESULTS: More than two-thirds of Aboriginal children met guidelines for fruit (75.9%), sweetened drinks (66.7%), sleep (73.1%), screen time (67.7%) and objectively measured physical activity (83.6%); and 79.1% reported consuming take-away foods less than once per week. Aboriginal children were more likely to meet vegetable consumption guidelines (OR=1.42, 95%CI: 1.05, 1.93), but less likely to have a healthy weight (OR=0.66, 95%CI: 0.52, 0.85) than non-Aboriginal children. Mean HRQoL scores were significantly higher among non-Aboriginal children and both Aboriginal and non-Aboriginal children meeting health guidelines. CONCLUSIONS: Most Aboriginal children in this study met guidelines for fruit, physical activity, screen time and sleep, and those meeting these guidelines had significantly higher HRQoL. IMPLICATIONS FOR PUBLIC HEALTH: Promoting nutrition, physical activity and sleep is likely to benefit all children. Aboriginal community-controlled organisations can use these data to design culturally-specific programs that may improve disparities in healthy weight and HRQoL.

Cost-Benefit and Cost-Utility Analyses to Demonstrate the Potential Value-for-Money of Supermarket Shelf Tags Promoting Healthier Packaged Products in Australia.

The supermarket environment impacts the healthiness of food purchased and consumed. Shelf tags that alert customers to healthier packaged products can improve the healthiness of overall purchases. This study assessed the potential value-for-money of implementing a three-year shelf tag intervention across all major supermarket chains in Australia. Cost-benefit analyses (CBA) and cost-utility analyses (CUA) were conducted based on results of a 12-week non-randomised controlled trial of a shelf tag intervention in seven Australian supermarkets. The change in energy density of all packaged foods purchased during the trial was used to estimate population-level changes in mean daily energy intake. A multi-state, multiple-cohort Markov model estimated the subsequent obesity-related health and healthcare cost outcomes over the lifetime of the 2019 Australian population. The CBA and CUA took societal and healthcare sector perspectives, respectively. The intervention was estimated to produce a mean reduction in population body weight of 1.09 kg. The net present value of the intervention was approximately AUD 17 billion (B). Over 98% of the intervention costs were borne by supermarkets. CUA findings were consistent with the CBA-the intervention was dominant, producing both health benefits and cost-savings. Shelf tags are likely to offer excellent value-for-money from societal and healthcare sector perspectives.

The Sleep-Obesity Nexus: Assessment of Multiple Sleep Dimensions and Weight Status Among Victorian Primary School Children.

Purpose: To examine the association between sleep and weight status across multiple dimensions of sleep (duration, efficiency, quality and timing) and assess the cumulative influence of these dimensions on the overall sleep-obesity association. Participants and Methods: Cross-sectional data from 2253 students aged 8.8 to 13.5 years participating in two monitoring studies across regional Victoria was analyzed. Students were invited to have measures of height and weight taken and to complete a self-report electronic questionnaire on demographic characteristics and health behaviors. Logistic regression models were used to assess association between sleep dimensions and BMI z-scores. Results: Beyond sleep duration, poor perceived sleep quality, delayed sleep initiation, later bed times and sleep-wake timing, all significantly increased the odds of overweight/obesity (OR 1.47, 95% CI: 1.07-2.01; OR 1.25, 95% CI: 1.02-1.55; and OR 1.70. 95% CI: 1.28-2.28, respectively). Additionally, a cumulative effect of having multiple poorly scored sleep dimensions was found, where four or more poorly scored sleep dimensions more than doubled the odds of overweight/obesity among children (OR 2.25, 95% CI: 1.41-3.58). Conclusion: This study highlights the importance of measuring and considering multiple dimensions of sleep, along with the individual and additive influence of the sleep dimension on the sleep-obesity nexus.

Assessment of the triangle test methodology for determining umami discrimination status.

The prototypical stimuli for umami taste is monosodium glutamate (MSG), which is the sodium salt form of glutamic acid. A proportion of the population has a reduced or complete inability to taste l-glutamate independent to the sodium ion. To determine individuals' umami discrimination status, many studies use a series of triangle tests containing isomolar (29 mM) sodium chloride (NaCl) and MSG, requiring participants to correctly identify the odd sample. Across studies, inconsistent categorization criteria have been applied. The aim of this study was to determine the optimal classification criterion based on the number of tests assessed to ascertain an individual's ability to discriminate between MSG and NaCl. Thirty-eight participants attended 3 taste assessment sessions, each involving 24 triangle tests (2 blocks of 12 tests) containing 29 mM NaCl and 29 mM MSG, detection and recognition threshold were measured for MSG, monopotassium glutamate (MPG), and sweet (sucrose) tastes. There was no learning, or fatigue trend over n = 24 (P = 0.228), and n = 12 (P = 0.940) triangle tests across each testing session. Twenty-four triangle tests produced the most consistent categorization of tasters across sessions (68.4%). The test-retest correlation across each testing session was highest for n = 24 triangle tests (ICC = 0.50), in comparison to 12 (ICC = 0.37). Overall, conducting n = 24 compared with n = 12 triangle tests provided the optimal classification to determine an individual's ability to discriminate l-glutamate from NaCl and thus their umami discrimination status, based on the number of tests assessed in this study.

Protocol for the Let's Grow randomised controlled trial: examining efficacy, cost-effectiveness and scalability of a m-Health intervention for movement behaviours in toddlers.

INTRODUCTION: Despite being an important period for the development of movement behaviours (physical activity, sedentary behaviour and sleep), few interventions commencing prior to preschool have been trialled. The primary aim of this trial is to assess the 12-month efficacy of the Let's Grow mHealth intervention, designed to improve the composition of movement behaviours in children from 2 years of age. Let's Grow is novel in considering composition of movement behaviours as the primary outcome, using non-linear dynamical approaches for intervention delivery, and incorporating planning for real-world implementation and scale-up from its inception. METHODS AND ANALYSIS: A randomised controlled trial will test the effects of the 12-month parental support mHealth intervention, Let's Grow, compared with a control group that will receive usual care plus electronic newsletters on unrelated topics for cohort retention. Let's Grow will be delivered via a purpose-designed mobile web application with linked SMS notifications. Intervention content includes general and movement-behaviour specific parenting advice and incorporates established behaviour change techniques. Intervention adherence will be monitored by app usage data. Data will be collected from participants using 24-hour monitoring of movement behaviours and parent report at baseline (T0), mid-intervention (T1; 6 months post baseline), at intervention conclusion (T2; 12 months post baseline) and 1-year post intervention (T3; 2 years post baseline). The trial aims to recruit 1100 families from across Australia during 2021. In addition to assessment of efficacy, an economic evaluation and prospective scalability evaluation will be conducted. ETHICS AND DISSEMINATION: The study was approved by the Deakin University Human Ethics Committee (2020-077). Study findings will be disseminated through publication in peer-reviewed journals, presentation at scientific and professional conferences, and via social and traditional media. TRIAL REGISTRATION NUMBER: ACTRN12620001280998; U1111-1252-0599.

Efficacy and cost-effectiveness of an online mindfulness program (MindOnLine) to reduce fear of recurrence among people with cancer: study protocol for a randomised controlled trial.

INTRODUCTION: Fear of cancer recurrence (FCR) is a common condition among cancer survivors that can lead to significant levels of distress, anxiety and depression. Online mindfulness programmes may provide the mechanism to support cancer survivors manage FCR and distress, and improve people's well-being over the short, medium and long term. The primary aim of this study is to determine the potential efficacy of MindOnLine, a 9 session mindfulness-based programme for survivors of breast, prostate and colorectal cancer. A formal economic programme will also be conducted. METHODS AND ANALYSIS: A single-blind randomised controlled trial to determine the efficacy and cost-efficacy of a MindOnLine programme for cancer survivors. A total of 400 people living with cancer will be recruited via online advertisements on social media platforms, peak consumer advocacy groups or through outpatient services at healthcare providers across Victoria, Australia. People will be randomly allocated to either the MindOnLine programme (n=200) or waitlist control (n=200). Participant assessments will occur at baseline, at 9 weeks and 9-month follow-up. The primary outcome is change in Fear of Recurrence Index Score total score between baseline and 9 weeks; secondary outcomes are changes in depression and anxiety, quality of life and mindfulness. The economic analysis comprises a cost-consequences analysis where all outcomes will be compared with costs. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Peter MacCallum Cancer Centre (20-53) and Deakin University (2020-284). All participants will be required to provide written informed consent. Findings will be disseminated in peer reviewed journals and among key stakeholder organisations including hospitals, cancer and community organisations and Government. If successful the project will be rolled out nationally with a formal implementation plan. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (12620000645954); Pre-results. Registered 6 June 2020, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379520&isReview=true.

Price promotions offered by quick service restaurants in Australia: analysis from an obesity prevention perspective.

OBJECTIVE: To assess the price promotions offered by major quick service restaurant (QSR) chains in Australia from an obesity prevention perspective. DESIGN: Cross-sectional audit of ten of the largest QSR chains in Australia. We collected information regarding temporary price promotions and 'combination deals' offered by each chain over thirteen consecutive weeks in 2019-2020. We assessed the type of promotions, the magnitude of discount, and the energy content and healthiness of items promoted (based on Victorian Government criteria). SETTING: Melbourne, Australia. PARTICIPANTS: Ten major QSR chains. RESULTS: Temporary price promotions (n 196) and combination deals (n 537 on regular menus, n 36 on children's menus) were observed across the ten selected QSR chains. In relation to temporary price promotions, the mean magnitude of discount for main menu items (n 75) was 41·7 %. The price reductions and energy content of combination deals varied substantially the by chain, the meal size and the sides/drinks selected as part of the 'deal'. When the lowest-energy options (e.g. small chips, small sugar-free drink) were included as part of each combination deal, the mean energy content was 2935 kJ, compared to 5764 kJ when the highest-energy options (e.g. large fries, large sugar-sweetened drink) were included. Almost all available products were classified as unhealthy. CONCLUSION: Price promotions are ubiquitous in major QSR chains in Australia and provide incentives to consume high levels of energy. The action to restrict price promotions on unhealthy foods and ensure lower-energy default items as part of combination deals should be included as part of efforts to improve population diets and address obesity in Australia.

The impact of a community-based intervention on weight, weight-related behaviours and health-related quality of life in primary school children in Victoria, Australia, according to socio-economic position.

BACKGROUND: Approximately a quarter of Australian children are classified as overweight or obese. In high-income countries, childhood obesity follows a socio-economic gradient, with greater prevalence amongst the most socio-economically disadvantaged children. Community-based interventions (CBI), particularly those using a systems approach, have been shown to be effective on weight and weight-related behaviours. They are also thought to have an equitable impacts, however there is limited evidence of their effectiveness in achieving this goal. METHODS: Secondary analysis was conducted on data collected from primary school children (aged 6-13 years) residing in ten communities (five intervention, five control) involved in the Whole of Systems Trial of Prevention Strategies for Childhood Obesity (WHO STOPS) cluster randomised trial in Victoria, Australia. Outcomes included Body Mass Index z-score (BMI-z) derived from measured height and weight, self-reported physical activity and dietary behaviours and health related quality of life (HRQoL). Repeat cross-sectional data from 2015 (n = 1790) and 2019 (n = 2137) were analysed, stratified by high or low socio-economic position (SEP). Multilevel linear models and generalised estimating equations were fitted to assess whether SEP modified the intervention effect on the outcomes. RESULTS: There were no overall changes in BMI-z for either SEP strata. For behavioural outcomes, the intervention resulted in a 22.5% (95% CI 5.1, 39.9) point greater improvement in high-SEP compared to low-SEP intervention schools for meeting physical activity guidelines. There were also positive dietary intervention effects for high SEP students, reducing takeaway and packaged snack consumption, although there was no significant difference in effect between high and low SEP students. There were positive intervention effects for HRQoL, whereby scores declined in control communities with no change in intervention communities, and this did not differ by SEP. CONCLUSION: The WHO STOPS intervention had differential effects on several weight-related behaviours according to SEP, including physical activity. Similar impacts on HRQoL outcomes were found between high and low SEP groups. Importantly, the trial evaluation was not powered to detect subgroup differences. Future evaluations of CBIs should be designed with an equity lens, to understand if and how these types of interventions can benefit all community members, regardless of their social and economic resources.

Inequalities in early childhood body-mass index Z scores in Victoria, Australia: a 15-year observational study.

BACKGROUND: Early childhood overweight and obesity increased substantially in high-income countries throughout the 1980s and 1990s. The flattening or reversal of this trend since the early 2000s might conceal widening inequalities. This study aimed to identify trends in body-mass index Z score (BMIz) among children aged 1-3·5 years in Victoria (Australia), by socioeconomic status and geographical location. METHODS: This repeated, cross-sectional study used deidentified records of height, weight, and demographic information from electronic databases in the Victorian Maternal and Child Health system. Data from the consultations for children aged 1, 2, and 3·5 years were included in this analysis. We removed duplicate records; records with missing data for sex, age, weight, height, or postcode; and records with postcodes that were outside of Victoria. The coprimary outcomes were trends in mean BMIz (continuous linear models) and prevalence of high BMIz (>+1; generalised linear models), estimated for six independent age-sex groups. Secondary analysis was done for the prevalence of BMIz greater than 2. Effect modification by socioeconomic status and remoteness was evaluated. FINDINGS: Electronic data were available for 48 local government areas collected between Jan 1, 2003, and Dec 31, 2017, representing approximately 63% of the Victorian population. Overall, 1 329 520 measurements from 675 991 children were included in the analysis. There were small, significantly decreasing trends in mean BMIz across all six age-sex groups, overall and in major cities. Similar patterns were observed for some subgroups in prevalence of high BMIz. These decreasing trends appear to be partly explained by migration. Conversely, in regional areas the trends in BMIz were consistently increasing in all age-sex groups and across socioeconomic strata, although not all groups were statistically significant. Inequalities in BMIz according to socioeconomic status persisted throughout the study period, such that the children from more advantaged areas had lower mean BMIz. INTERPRETATION: This study showed that at a state level, mean BMIz and prevalence of high BMIz decreased in children aged 1, 2, and 3·5 years in Victoria between 2003 and 2017. We found metropolitan-regional differences to be key source of inequality in early childhood BMIz trends, alongside area-level socioeconomic status. These findings highlight the risk that analysis of overall trends in childhood BMIz might obscure important inequalities according to, for example, remoteness, socioeconomic status, and ethnicity. Future research requires monitoring data with large population samples to adequately examine differences in prevalence and trends between population subgroups. FUNDING: None.

The 'Eat Well @ IGA' healthy supermarket randomised controlled trial: process evaluation.

BACKGROUND: Successful implementation and long-term maintenance of healthy supermarkets initiatives are crucial to achieving potential population health benefits. Understanding barriers and enablers of implementation of real-world trials will enhance wide-scale implementation. This process evaluation of a healthy supermarket intervention sought to describe (i) customer, retailer and stakeholder perspectives on the intervention; (ii) intervention implementation; and (iii) implementation barriers and enablers. METHODS: Eat Well @ IGA was a 12-month randomised controlled trial conducted in 11 Independent Grocers of Australia (IGA) chain supermarkets in regional Victoria, Australia (5 intervention and 6 wait-listed control stores). Intervention components included trolley and basket signage, local area and in-store promotion, and shelf tags highlighting the healthiest packaged foods. A sequential mixed-methods process evaluation was undertaken. Customer exit surveys investigated demographics, and intervention recall and perceptions. Logistic mixed-models estimated associations between customer responses and demographics, with store as random effect. Supermarket staff surveys investigated staff demographics, interactions with customers, and intervention component feedback. Semi-structured stakeholder interviews with local government, retail and academic partners explored intervention perceptions, and factors which enabled or inhibited implementation, maintenance and scalability. Interviews were inductively coded to identify key themes. RESULTS: Of 500 customers surveyed, 33%[95%CI:23,44] recalled the Eat Well @ IGA brand and 97%[95%CI:93,99] agreed that IGA should continue its efforts to encourage healthy eating. The 82 staff surveyed demonstrated very favourable intervention perceptions. Themes from 19 interviews included that business models favour sales of unhealthy foods, and that stakeholder collaboration was crucial to intervention design and implementation. Staff surveys and interviews highlighted the need to minimise staff time for project maintenance and to regularly refresh intervention materials to increase and maintain salience among customers. CONCLUSIONS: This process evaluation found that interventions to promote healthy diets in supermarkets can be perceived as beneficial by retailers, customers, and government partners provided that barriers including staff time and intervention salience are addressed. Collaborative partnerships in intervention design and implementation, including retailers, governments, and academics, show potential for encouraging long-term sustainability of interventions. TRIAL REGISTRATION: ISRCTN, ISRCTN37395231 Registered 4 May 2017.

Retailer-led healthy pricing interventions: a pilot study within aquatic and recreation centres in Victoria, Australia.

This study aimed to pilot the feasibility, acceptability and effectiveness of three co-developed healthy food and beverage pricing interventions in a community retail setting. Aquatic and recreation centres in Victoria, Australia were recruited to co-develop and pilot pricing interventions within their onsite cafés, for 15 weeks from January 2019. A mixed method intervention evaluation was conducted. Interviews were conducted with food retail managers to understand the factors perceived to influence implementation, maintenance and effectiveness. Customer surveys assessed support for, and awareness of, interventions. Interrupted time series analysis estimated the impact of pricing interventions on food and beverage sales. Three centres each implemented a unique intervention: (i) discounted healthy bundles ('healthy combination deals'), (ii) offering deals at specific times of the day ('healthy happy hours') and (iii) increasing the prices of selected unhealthy options and reducing the prices of selected healthier options ('everyday pricing changes'). Café team leaders did not identify any significant challenges to implementation or maintenance of interventions, though low staff engagement was identified as potentially influencing the null effect on sales for healthy combination deals and healthy happy hours interventions. Customers reported low levels of awareness and high levels of support for interventions. Everyday pricing changes resulted in a significant decrease in sales of unhealthy items during the intervention period, though also resulted in a decrease in café revenue. Co-developed healthy food and beverage pricing interventions can be readily implemented with broad customer support. Everyday pricing changes have demonstrated potential effectiveness at reducing unhealthy purchases.

Protocol for an Effectiveness-Implementation Hybrid Trial to Evaluate Scale up of an Evidence-Based Intervention Addressing Lifestyle Behaviours From the Start of Life: INFANT.

Introduction: Promoting healthy eating and active play in early life is critical, however few interventions have been delivered or sustained at scale. The evaluation of interventions at scale is a crucial, yet under-researched aspect of modifying population-level health behaviours. INFANT is an evidence-based early childhood healthy lifestyle intervention that aims to improve parents' knowledge and skills around promoting optimal energy balance-related behaviours that, in turn, influence children's diet, activity and adiposity. It consists of: 1) Four group sessions delivered via first time parent groups across the first 12 months of life; 2) access to the My Baby Now app from birth to 18 months of age. This research aims to assess real-world implementation, effectiveness and cost-effectiveness of INFANT when delivered at scale across Victoria, Australia. Methods and Analysis: A hybrid type II implementation-effectiveness trial applying a mixed methods design will be conducted. INFANT will be implemented in collaboration with practice and policy partners including maternal and child health services, population health and Aboriginal health, targeting all local government areas (n=79) in Victoria, Australia. Evaluation is based on criteria from the 'Outcomes for Implementation Research' and 'RE-AIM' frameworks. Implementation outcomes will be assessed using descriptive quantitative surveys and qualitative interviews with those involved in implementation, and include intervention reach, organisational acceptability, adoption, appropriateness, cost, feasibility, penetration and sustainability. Process measures include organizational readiness, fidelity, and adaptation. Effectiveness outcomes will be assessed using a sample of INFANT participants and a non-randomized comparison group receiving usual care (1,500 infants in each group), recruited within the same communities. Eligible participants will be first time primary caregivers of an infant aged 0-3 months, owning a personal mobile phone and able to communicate in English. Effectiveness outcomes include infant lifestyle behaviours and BMIz at 12 and 18 months of age. Impact: This is the first known study to evaluate the scale up of an evidence based early childhood obesity prevention intervention under real world conditions. This study has the potential to provide generalisable implementation, effectiveness and cost-effectiveness evidence to inform the future scale up of public health interventions both in Australia and internationally. Clinical Trial Registration: Australian and New Zealand Clinical Trial Registry https://www.anzctr.org.au/, identifier ACTRN12620000670976.

Spanish Adaptation of the Pediatric Memorial Symptom Assessment Scale for Children, Teens, and Caregivers.

CONTEXT: There are no validated Spanish tools to assess symptom burden in pediatric cancer. The Pediatric Memorial Symptom Assessment Scale (Pediatric-MSAS) is an English valid multidimensional and comprehensive instrument. OBJECTIVES: To validate Pediatric-MSAS-Spanish (MSAS-Child, MSAS-Teen, and MSAS-Caregiver versions) in patients with cancer treated in two public hospitals in Buenos Aires, Argentina. METHODS: Cross-sectional study, classical psychometric theory. We recruited a convenience sample of 148 caregivers of children ≥ two years, 51 young children (seven to 12 years), and 48 adolescents (≥13 years). We assessed feasibility, comprehensibility, internal consistency, and convergent and known-groups validity. RESULTS: Pediatric-MSAS-Spanish was feasible, acceptable, and comprehensible. Reliability of MSAS-total and subscale scores was satisfactory (Cronbach alpha: 0.90, 0.89, 0.71, respectively, for caregiver, teen, and child MSAS-total score). MSAS-total caregiver, teen, and child scores met a priori criteria for convergent validity correlating with Pediatric Quality of Life Inventory total scores (Spearman correlation (rs) = -0.59, -0.66, and -0.32, respectively) and visual -analogue well-being scores (rs = -0.63, -0.46, and -0.4, respectively). Caregiver-teen correlation was strong for total (rs = 0.78) and physical (rs = 0.85) scores, and moderate for global distress index (rs = 0.64) and psychological (rs = 0.45) scores. MSAS-total caregiver-child correlation was moderate (rs = 0.30) and Kappa analysis showed poor agreement. All MSAS-Caregiver scores and MSAS-Teen total and physical scores differentiated inpatients/outpatients and patients on/off-treatment, while MSAS-Teen psychological and global distress index subscales or MSAS-Child scores did not. CONCLUSION: Pediatric-MSAS-Spanish is feasible and reliable for assessing symptom burden in children with cancer. Validity of MSAS-Caregiver and MSAS-Teen was largely supported. Further work on MSAS-Child is warranted.

Availability and placement of healthy and discretionary food in Australian supermarkets by chain and level of socio-economic disadvantage.

OBJECTIVE: The current study aimed to investigate availability and placement of healthy and discretionary (less healthy) food in supermarkets in Victoria, Australia, and examine variation by supermarket chain and area-level socio-economic disadvantage. DESIGN: Cross-sectional supermarket audit. Measures included: (i) proportion of shelf space (in square metres) allocated to selected healthy and discretionary food and beverages; (ii) proportion of end-of-aisle, checkout and island bin displays containing discretionary food and beverages and (iii) proportion of space within end-of-aisle, checkout and island bin displays devoted to discretionary food and beverages. SETTING: Metropolitan areas of Melbourne and Geelong, Australia. Assessment: June-July 2019. PARTICIPANTS: Random sample of 104 stores, with equal numbers from each supermarket group (Coles, Woolworths, Aldi and Independent stores) within strata of area-level socio-economic position. RESULTS: Proportion of shelf space devoted to selected discretionary foods was greater for Independent stores (72·7 %) compared with Woolworths (65·7 %), Coles (64·8 %) and Aldi (63·2 %) (all P < 0·001). Proportion of shelf space devoted to selected discretionary food for all Coles, Woolworths and Aldi stores was 9·7 % higher in the most compared with the least disadvantaged areas (P = 0·002). Across all stores, 90 % of staff-assisted checkout displays and 50 % of end-of-aisle displays included discretionary food. Aldi was less likely to feature discretionary food in end-of-aisle and checkout displays compared with other supermarket groups. CONCLUSIONS: Extensive marketing of discretionary food in all Australian supermarket chains was observed, which is likely to strongly influence purchasing patterns and population diets. Findings should be used to inform private and public sector policies to reduce marketing of discretionary food in supermarkets.

The Healthiness of Food and Beverages on Price Promotion at Promotional Displays: A Cross-Sectional Audit of Australian Supermarkets.

Supermarket environments can strongly influence purchasing decisions. Price promotions are recognised as a particularly persuasive tactic, but the healthiness of price promotions in prominent in-store locations is understudied. This study compared the prevalence and magnitude of price promotions on healthy and unhealthy food and beverages (foods) displayed at prominent in-store locations within Australian supermarkets, including analyses by supermarket group and area-level socio-economic position. A cross-sectional in-store audit of price promotions on foods at key display areas was undertaken in 104 randomly selected stores from major Australian supermarket groups (Woolworths, Coles, Aldi and independents) in Victoria, Australia. Of the display space dedicated to foods with price promotions, three of the four supermarket groups had a greater proportion of display space devoted to unhealthy (compared to healthy) foods at each promotional location measured (end of aisles: 66%; island bins: 53%; checkouts: 88%). Aldi offered very few price promotions. Few measures varied by area-level socio-economic position. This study demonstrated that price promotions at prominent in-store locations in Australian supermarkets favoured unhealthy foods. Marketing of this nature is likely to encourage the purchase of unhealthy foods, highlighting the need for retailers and policy-makers to consider addressing in-store pricing and placement strategies to encourage healthier food environments.

Protocol for economic evaluation alongside the SHINE (Supporting Healthy Image, Nutrition and Exercise) cluster randomised controlled trial.

INTRODUCTION: Limited evidence exists on the cost-effectiveness of interventions to prevent obesity and promote healthy body image in adolescents. The SHINE (Supporting Healthy Image, Nutrition and Exercise) study is a cluster randomised control trial (cRCT) aiming to deliver universal education about healthy nutrition and physical activity to adolescents, as well as targeted advice to young people with body image concerns who are at risk of developing disordered eating behaviours. This paper describes the methods for the economic evaluation of the SHINE cRCT, to determine whether the intervention is cost-effective as an obesity prevention measure. METHODS AND ANALYSIS: A public payer perspective will be adopted, with intervention costs collected prospectively. Within-trial cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) will quantify the incremental costs and health gains of the intervention as compared with usual practice (ie, teacher-delivered curriculum). CEA will present results as cost per body mass index unit saved. CUA will present results as cost per quality-adjusted life year gained. A modelled CUA will extend the target population, time horizon and decision context to provide valuable information to policymakers on the potential for incremental cost offsets attributable to disease prevention arising from intervention. Intervention costs and effects will be extrapolated to the population of Australian adolescents in Grade 7 of secondary school (approximate age 13 years) and modelled over the cohort's lifetime. Modelled CUA results will be presented as health-adjusted life years saved and healthcare cost-savings of diseases averted. Incremental cost-effectiveness ratios will be calculated as the difference in costs between the intervention and comparator divided by the difference in benefit. Semi-structured interviews with key intervention stakeholders will explore the potential impact of scalability on cost-effectiveness. These data will be thematically analysed to inform sensitivity analysis of the base case economic evaluation, such that cost-effectiveness evidence is reflective of the potential for scalability. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Deakin University Human Research Ethics Committee (#2017-269) and the Victorian Department of Education and Training (#2018_003630). Study findings will be disseminated through peer-reviewed academic papers and participating schools will receive annual reports over the 3 years of data collection. TRIAL REGISTRATION NUMBER: ACTRN 12618000330246; Pre-results.

Change in drink purchases in 16 Australian recreation centres following a sugar-sweetened beverage reduction initiative: an observational study.

OBJECTIVE: To assess the impact of a sugar-sweetened beverage (SSB) reduction initiative on customer purchasing patterns, including volume sales of healthy and unhealthy packaged drinks and sales value of all packaged drinks, in a major Australian aquatic and recreation provider, YMCA Victoria. DESIGN: Prospective SETTING: 16 aquatic and recreation centres in Victoria, Australia. INTERVENTIONS: The SSB-reduction initiative aimed to remove all SSBs (excluding sports drinks) and increase healthier drink availability over a 1-year period. PRIMARY AND SECONDARY OUTCOME MEASURES: Itemised monthly drink sales data were collected for 16 centres, over 4 years (2 years preimplementation, 1 year implementation and 1 year postimplementation). Drinks were classified as 'green' (best choice), 'amber' (choose carefully) or 'red' (limit). Interrupted time series analysis was conducted for each centre to determine the impact on volume sales of 'red' and 'green' drinks, and overall sales value. A novel meta-analysis approach was conducted to estimate the mean changes across centres. RESULTS: Following implementation, volume sales of 'red' drinks reduced by 46.2% across centres (95% CI: -53.2% to -39.2%), 'green' drink volume did not change (0.0%, 95% CI: -13.3% to 13.2%) and total drink sales value decreased by 24.3% (95% CI: -32.0% to -16.6%). CONCLUSIONS: The reduction of SSBs in health-promoting settings such as recreation centres is a feasible, effective public health policy that is likely to be transferable to other high-income countries with similarly unhealthy beverage offerings. However, complementary strategies should be considered to encourage customers to switch to healthier alternatives, particularly when translating policies to organisations with less flexible income streams.