Sitting less and moving more for improved metabolic and brain health in type 2 diabetes: 'OPTIMISE your health' trial protocol.

BACKGROUND: Clinical practice guidelines recommend that adults with type 2 diabetes (T2D) sit less and move more throughout the day. The 18-month OPTIMISE Your Health Clinical Trial was developed to support desk-based workers with T2D achieve these recommendations. The two-arm protocol consists of an intervention and control arms. The intervention arm receives 6 months health coaching, a sit-stand desktop workstation and an activity tracker, followed by 6 months of text message support, then 6 months maintenance. The control arm receives a delayed modified intervention after 12 months of usual care. This paper describes the methods of a randomised controlled trial (RCT) evaluating the effectiveness and cost-effectiveness of the intervention, compared to a delayed intervention control. METHODS: This is a two-arm RCT being conducted in Melbourne, Australia. Desk-based workers (≥0.8 full-time equivalent) aged 35-65 years, ambulatory, and with T2D and managed glycaemic control (6.5-10.0% HbA1c), are randomised to the multicomponent intervention (target n = 125) or delayed-intervention control (target n = 125) conditions. All intervention participants receive 6 months of tailored health coaching assisting them to "sit less" and "move more" at work and throughout the day, supported by a sit-stand desktop workstation and an activity tracker (Fitbit). Participants receive text message-based extended care for a further 6-months (6-12 months) followed by 6-months of non-contact (12-18 months: maintenance). Delayed intervention occurs at 12-18 months for the control arm. Assessments are undertaken at baseline, 3, 6, 12, 15 and 18-months. Primary outcomes are activPAL-measured sitting time (h/16 h day), glycosylated haemoglobin (HbA1c; %, mmol/mol) and, cognitive function measures (visual learning and new memory; Paired Associates Learning Total Errors [adjusted]). Secondary, exploratory, and process outcomes will also be collected throughout the trial. DISCUSSION: The OPTIMISE Your Health trial will provide unique insights into the benefits of an intervention aimed at sitting less and moving more in desk-bound office workers with T2D, with outcomes relevant to glycaemic control, and to cardiometabolic and brain health. Findings will contribute new insights to add to the evidence base on initiating and maintaining behaviour change with clinical populations and inform practice in diabetes management. TRIAL REGISTRATION: ANZCTRN12618001159246 .

Prevalence of Undiagnosed Diabetes and Prediabetes in the Dental Setting: A Systematic Review and Meta-Analysis.

BACKGROUND: With the close link between diabetes mellitus (DM) and periodontal disease (PD), dentists have an unrealized opportunity to make a chance discovery of a patient's medical condition. Unlike in the medical setting, information on the point of care (PoC) and opportunistic screening for DM in the dental setting is limited. To make a reliable estimate on the prevalence of undiagnosed type 2 diabetes mellitus (T2DM) and prediabetes among dental patients in the dental setting and to assist healthcare planners in making an informed decision, information on the disease frequency and strategies employed to address this issue is of paramount importance. OBJECTIVES: To summarize the data on the prevalence of undiagnosed T2DM and prediabetes amongst dental patients and further explore the effectiveness of the PoC screening and its implication for use in the dental setting. METHODS: A MEDLINE-PubMed, EMBASE, Web of Science, and Cochrane Library search was conducted with no time specification. Information on study characteristics and diagnostic parameters was retrieved for meta-analysis. All the studies were assessed for methodological quality using the QUADAS-2 tool. Proportions were presented in tables and forest plots. All statistical analysis was performed using the MedCalc software. RESULTS: Nine studies met the inclusion criteria. The proportion of dental patients identified to be at a risk of hyperglycaemia with the PoC screening using random blood glucose (RBG) and HbA1 was 32.47% and 40.10%, whilst the estimated proportion with undiagnosed T2DM and prediabetes was identified as 11.23% and 47.38%. CONCLUSION: A significant proportion of dental patients can be identified as undiagnosed T2DM and prediabetes. Targeted opportunistic screening is a feasible approach and can help reduce the prevalence of undiagnosed T2DM and prediabetes.

Correction: Modelled health benefits of a sugar-sweetened beverage tax across different socioeconomic groups in Australia: A cost-effectiveness and equity analysis.

[This corrects the article DOI: 10.1371/journal.pmed.1002326.].

Cost comparison of five Australasian obesity prevention interventions for children aged from birth to two years.

BACKGROUND: In the absence of rigorous evidence of cost-effectiveness for early childhood obesity prevention interventions, the next-best option may be for decision-makers to consider the relevant costs of interventions when allocating resources. OBJECTIVES: This study aimed to estimate systematically the cost of five obesity prevention interventions in children aged 0-2 years, undertaken in research settings in Australia and New Zealand. METHODS: A standardised costing protocol informed the costing methodology, ensuring comparability of results across interventions. Micro-costing was undertaken, with intervention costs defined from the funder perspective and valued in 2018 Australian dollars using unit costs from the trials or market rates. RESULTS: Interventions varied widely in their resource use. The total cost per participant ranged from $80 for the CHAT SMS intervention arm (95% UI $77-$82) to $1135 for the Healthy Beginnings intervention (95% UI $1059-$1189). Time costs of personnel delivering interventions contributed >50% of total intervention costs for all included studies. CONCLUSIONS: An understanding of the costs associated with intervention delivery modes is important, alongside effectiveness. Telephone delivery may include unexpected costs associated with connection to intervention participants at convenient times. A SMS-based intervention had the lowest delivery cost in this study.

Supporting Workers to Sit Less and Move More Through the Web-Based BeUpstanding Program: Protocol for a Single-Arm, Repeated Measures Implementation Study.

BACKGROUND: The web-based BeUpstanding Champion Toolkit was developed to support work teams in addressing the emergent work health and safety issue of excessive sitting. It provides a step-by-step guide and associated resources that equip a workplace representative-the champion-to adopt and deliver the 8-week intervention program (BeUpstanding) to their work team. The evidence-informed program is designed to raise awareness of the benefits of sitting less and moving more, build a supportive culture for change, and encourage staff to take action to achieve this change. Work teams collectively choose the strategies they want to implement and promote to stand up, sit less, and move more, with this bespoke and participative approach ensuring the strategies are aligned with the team's needs and existing culture. BeUpstanding has been iteratively developed and optimized through a multiphase process to ensure that it is fit for purpose for wide-scale implementation. OBJECTIVE: The study aimed to describe the current version of BeUpstanding, and the methods and protocol for a national implementation trial. METHODS: The trial will be conducted in collaboration with five Australian workplace health and safety policy and practice partners. Desk-based work teams from a variety of industries will be recruited from across Australia via partner-led referral pathways. Recruitment will target sectors (small business, rural or regional, call center, blue collar, and government) that are of priority to the policy and practice partners. A minimum of 50 work teams will be recruited per priority sector with a minimum of 10,000 employees exposed to the program. A single-arm, repeated-measures design will assess the short-term (end of program) and long-term (9 months postprogram) impacts. Data will be collected on the web via surveys and toolkit analytics and by the research team via telephone calls with champions. The Reach, Effectiveness, Adoption, Implementation, and Maintenance Framework will guide the evaluation, with assessment of the adoption/reach of the program (the number and characteristics of work teams and participating staff), program implementation (completion by the champion of core program components), effectiveness (on workplace sitting, standing, and moving), and maintenance (sustainability of changes). There will be an economic evaluation of the costs and outcomes of scaling up to national implementation, including intervention affordability and sustainability. RESULTS: The study received funding in June 2018 and the original protocol was approved by institutional review board on January 9, 2017, with national implementation trial consent and protocol amendment approved March 12, 2019. The trial started on June 12, 2019, with 48 teams recruited as of December 2019. CONCLUSIONS: The implementation and multimethod evaluation of BeUpstanding will provide the practice-based evidence needed for informing the potential broader dissemination of the program. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12617000682347; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372843&isReview=true. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15756.

Diabetes Related Knowledge, Attitudes and Practice - A Survey Among Oral Health Professionals in Victoria, Australia.

PURPOSE: Until now, little is known as to how well the evidence supporting the link between periodontal disease and diabetes is incorporated in the dental practice, in Australia. This study aims to explore Oral health Professionals (OHP) knowledge, attitudes, and practice (KAP) towards diabetes screening in the dental setting. METHODS: The survey questionnaire consisted of sociodemographic, practice characteristics and Likert scaled questions categorised in different domains of KAP and one additional domain as barriers. A Mann-Whitney and Kruskal-Wallis test was performed to determine differences in the OHP response. To predict if practice behavior was influenced by knowledge and attitudes, a multiple linear regression was conducted. RESULTS: A total of 197 respondents were included in the analysis of the results. General dentists constituted 64.6% of the response. For chairside screening of diabetes, 58% felt it was essential and 70% felt it was appropriate. More public sector OHP (79%) felt it is important to conduct chairside screening for T2DM. Patient willingness was identified as the most important and insurance coverage as the least important (43%) consideration for T2DM screening. CONCLUSION: Overall, knowledge, attitude and practice towards DM were positive, but a significant proportion of the OHP felt chairside screening may not be appropriate or important.

Are Office-Based Workplace Interventions Designed to Reduce Sitting Time Cost-Effective Primary Prevention Measures for Cardiovascular Disease? A Systematic Review and Modelled Economic Evaluation.

OBJECTIVES: To assess the cost-effectiveness of workplace-delivered interventions designed to reduce sitting time as primary prevention measures for cardiovascular disease (CVD) in Australia. METHODS: A Markov model was developed to simulate the lifetime cost-effectiveness of a workplace intervention for the primary prevention of CVD amongst office-based workers. An updated systematic review and a meta-analysis of workplace interventions that aim to reduce sitting time was conducted to inform the intervention effect. The primary outcome was workplace standing time. An incremental cost-effectiveness ratio (ICER) was calculated for this intervention measured against current practice. Costs (in Australia dollars) and benefits were discounted at 3% annually. Both deterministic (DSA) and probabilistic (PSA) sensitivity analyses were performed. RESULTS: The updated systematic review identified only one new study. Only the multicomponent intervention that included a sit-and-stand workstation showed statistically significant changes in the standing time compared to the control. The intervention was associated with both higher costs ($6820 versus $6524) and benefits (23.28 versus 23.27, quality-adjusted life year, QALYs), generating an ICER of $43,825/QALY. The DSA showed that target age group for the intervention, relative risk of CVD relative to the control and intervention cost were the key determinants of the ICER. The base case results were within the range of the 95% confidence interval and the intervention had a 85.2% probability of being cost-effective. CONCLUSIONS: A workplace-delivered intervention in the office-based setting including a sit-and-stand desk component is a cost-effective strategy for the primary prevention of CVD. It offers a new option and location when considering interventions to target the growing CVD burden.

Equity Weights for Socioeconomic Position: Two Methods-Survey of Stated Preferences and Epidemiological Data.

BACKGROUND: There is an implicit equity approach in cost-effectiveness analysis that values health gains of socioeconomic position groups equally. An alternative approach is to integrate equity by weighting quality-adjusted life-years according to the socioeconomic position group. OBJECTIVES: To use two approaches to derive equity weights for use in cost-effectiveness analysis in Australia, in contexts in which the use of the traditional nonweighted quality-adjusted life-years could increase health inequalities between already disadvantaged groups. METHODS: Equity weights derived using epidemiological data used burden of disease and mortality data by Socio-Economic Indexes for Areas quintiles from the Australian Institute of Health and Welfare. Two ratios were calculated comparing quintile 1 (lowest) to the total Australian population, and comparing quintile 1 to quintile 5 (highest). Preference-based weights were derived using a discrete choice experiment survey (n = 710). Respondents chose between two programs, with varying gains in life expectancy going to a low- or a high-income group. A probit model incorporating nominal values of the difference in life expectancy was estimated to calculate the equity weights. RESULTS: The epidemiological weights ranged from 1.2 to 1.5, with larger weights when quintile 5 was the denominator. The preference-based weights ranged from 1.3 (95% confidence interval 1.2-1.4) to 1.8 (95% confidence interval 1.6-2.0), with a tendency for increasing weights as the gains to the low-income group increased. CONCLUSIONS: Both methods derived plausible and consistent weights. Using weights of different magnitudes in sensitivity analysis would allow the appropriate weight to be considered by decision makers and stakeholders to reflect policy objectives.

Health-Promoting Food Pricing Policies and Decision-Making in Very Remote Aboriginal and Torres Strait Islander Community Stores in Australia.

Aboriginal and Torres Strait Islander people living in remote communities in Australia experience a disproportionate burden of diet-related chronic disease. This occurs in an environment where the cost of store-purchased food is high and cash incomes are low, factors that affect both food insecurity and health outcomes. Aboriginal and Torres Strait Islander storeowners and the retailers who work with them implement local policies with the aim of improving food affordability and health outcomes. This paper describes health-promoting food pricing policies, their alignment with evidence, and the decision-making processes entailed in their development in community stores across very remote Australia. Semi-structured interviews were conducted with a purposive sample of retailers and health professionals identified through the snowball method, September 2015 to October 2016. Data were complemented through review of documents describing food pricing policies. A content analysis of the types and design of policies was undertaken, while the decision-making process was considered through a deductive, thematic analysis. Fifteen retailers and 32 health professionals providing services to stores participated. Subsidies and subsidy/price increase combinations dominated. Magnitude of price changes ranged from 5% to 25% on fruit, vegetables, bottled water, artificially sweetened and sugar sweetened carbonated beverages, and broadly used 'healthy/essential' and 'unhealthy' food classifications. Feasibility and sustainability were considered during policy development. Greater consideration of acceptability, importance, effectiveness and unintended consequences of policies guided by evidence were deemed important, as were increased involvement of Aboriginal and Torres Strait Islander storeowners and nutritionists in policy development. A range of locally developed health-promoting food pricing policies exist and partially align with research-evidence. The decision-making processes identified offer an opportunity to incorporate evidence, based on consideration of the local context.

Is there an association between early weight status and utility-based health-related quality of life in young children?

PURPOSE: Few studies focus on the health-related quality of life (HRQoL) of preschool children with overweight or obesity. This is relevant for evaluation of obesity prevention trials using a quality-adjusted life year (QALY) framework. This study examined the association between weight status in the preschool years and HRQoL at age 5 years, using a preference-based instrument. METHODS: HRQoL [based on parent proxy version of the Health Utilities Index Mark 3 (HUI3)] and weight status were measured in children born in Australia between 2007 and 2009. Children's health status was scored across eight attributes of the HUI3-vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain, and these were used to calculate a multi-attribute utility score. Ordinary least squares (OLS), Tobit and two-part regressions were used to model the association between weight status and multi-attribute utility. RESULTS: Of the 368 children for whom weight status and HUI3 data were available, around 40% had overweight/obesity. After adjusting for child's sex, maternal education, marital status and household income, no significant association between weight status in the preschool years and multi-attribute utility scores at 5 years was found. CONCLUSIONS: Alternative approaches for capturing the effects of weight status in the preschool years on preference-based HRQoL outcomes should be tested. The application of the QALY framework to economic evaluations of obesity-related interventions in young children should also consider longitudinal effects over the life-course. Clinical Trial Registration The Healthy Beginnings Trial was registered with the Australian Clinical Trial Registry (ACTRNO12607000168459).

The Potential Cost-Effectiveness and Equity Impacts of Restricting Television Advertising of Unhealthy Food and Beverages to Australian Children.

Television (TV) advertising of food and beverages high in fat, sugar and salt (HFSS) influences food preferences and consumption. Children from lower socioeconomic position (SEP) have higher exposure to TV advertising due to more time spent watching TV. This paper sought to estimate the cost-effectiveness of legislation to restrict HFSS TV advertising until 9:30 pm, and to examine how health benefits and healthcare cost-savings differ by SEP. Cost-effectiveness modelling was undertaken (i) at the population level, and (ii) by area-level SEP. A multi-state multiple-cohort lifetable model was used to estimate obesity-related health outcomes and healthcare cost-savings over the lifetime of the 2010 Australian population. Incremental cost-effectiveness ratios (ICERs) were reported, with assumptions tested through sensitivity analyses. An intervention restricting HFSS TV advertising would cost AUD5.9M (95% UI AUD5.8M⁻AUD7M), resulting in modelled reductions in energy intake (mean 115 kJ/day) and body mass index (BMI) (mean 0.352 kg/m²). The intervention is likely to be cost-saving, with 1.4 times higher total cost-savings and 1.5 times higher health benefits in the most disadvantaged socioeconomic group (17,512 HALYs saved (95% UI 10,372⁻25,155); total cost-savings AUD126.3M (95% UI AUD58.7M⁻196.9M) over the lifetime) compared to the least disadvantaged socioeconomic group (11,321 HALYs saved (95% UI 6812⁻15,679); total cost-savings AUD90.9M (95% UI AUD44.3M⁻136.3M)). Legislation to restrict HFSS TV advertising is likely to be cost-effective, with greater health benefits and healthcare cost-savings for children with low SEP.

Weighting Health Outcomes by Socioeconomic Position Using Stated Preferences.

BACKGROUND: The trade-off that society is willing to make to promote a more equitable distribution of health can be represented as a social welfare function (SWF). SWFs are an economic construct that can be used to illustrate concerns for total health with aversion to inequalities between socioeconomic groups. OBJECTIVE: This study used people's preferences to estimate the shapes of health-related SWFs (HRSWFs). We tested the suitability of this method to derive equity weights. METHODS: A questionnaire was used to elicit preferences concerning trade-offs between the total level of health and its distribution among two socioeconomic groups. The participant group was a sample of convenience that included a mix of health researchers, academics, clinicians, managers, public servants and research students. The data collected were used to develop HRSWFs with a constant elasticity of substitution. The weight was calculated using the marginal rate of substitution. RESULTS: A marginal health gain to the lowest socioeconomic position (SEP) group was valued 14.1-81.4 times more than a marginal health gain to the high SEP group. CONCLUSIONS: Our results provide evidence to support the idea that the public may be willing to make trade-offs between efficiency and equity, and that they value health gains differently depending on which socioeconomic group receives the health gain. Further evidence is required before such indicative weights have practical value.

Inclusion of equity in economic analyses of public health policies: systematic review and future directions.

OBJECTIVES: To assess current approaches to inclusion of equity in economic analysis of public health interventions and to recommend best approaches and future directions. METHODS: We conducted a systematic review of studies that have used socioeconomic position (SEP) in cost-effectiveness analyses. Studies were identified using MedLine, EconLit and HEED and were evaluated based on their SEP specific inputs and methods of quantification of the health and financial inequalities. RESULTS: Twenty-nine relevant studies were identified. The majority of studies comparing two or more interventions left interpretation of the size of the health and financial inequality differences to the reader. Newer approaches include: i) use of health inequality measures to quantify health inequalities; ii) inclusion of financial impacts, such as out-of-pocket expenditures; and iii) use of equity weights. The challenge with these approaches is presenting results that policy makers can easily interpret. CONCLUSIONS: Using CEA techniques to generate new information about the health equity implications of alternative policy options has not been widely used, but should be considered to inform future decision making. Implications for public health: Inclusion of equity in economic analysis would facilitate a more nuanced comparison of interventions in relation to efficiency, equity and financial impact.

Modelled health benefits of a sugar-sweetened beverage tax across different socioeconomic groups in Australia: A cost-effectiveness and equity analysis.

BACKGROUND: A sugar-sweetened beverage (SSB) tax in Mexico has been effective in reducing consumption of SSBs, with larger decreases for low-income households. The health and financial effects across socioeconomic groups are important considerations for policy-makers. From a societal perspective, we assessed the potential cost-effectiveness, health gains, and financial impacts by socioeconomic position (SEP) of a 20% SSB tax for Australia. METHODS AND FINDINGS: Australia-specific price elasticities were used to predict decreases in SSB consumption for each Socio-Economic Indexes for Areas (SEIFA) quintile. Changes in body mass index (BMI) were based on SSB consumption, BMI from the Australian Health Survey 2011-12, and energy balance equations. Markov cohort models were used to estimate the health impact for the Australian population, taking into account obesity-related diseases. Health-adjusted life years (HALYs) gained, healthcare costs saved, and out-of-pocket costs were estimated for each SEIFA quintile. Loss of economic welfare was calculated as the amount of deadweight loss in excess of taxation revenue. A 20% SSB tax would lead to HALY gains of 175,300 (95% CI: 68,700; 277,800) and healthcare cost savings of AU$1,733 million (m) (95% CI: $650m; $2,744m) over the lifetime of the population, with 49.5% of the total health gains accruing to the 2 lowest quintiles. We estimated the increase in annual expenditure on SSBs to be AU$35.40/capita (0.54% of expenditure on food and non-alcoholic drinks) in the lowest SEIFA quintile, a difference of AU$3.80/capita (0.32%) compared to the highest quintile. Annual tax revenue was estimated at AU$642.9m (95% CI: $348.2m; $1,117.2m). The main limitations of this study, as with all simulation models, is that the results represent only the best estimate of a potential effect in the absence of stronger direct evidence. CONCLUSIONS: This study demonstrates that from a 20% tax on SSBs, the most HALYs gained and healthcare costs saved would accrue to the most disadvantaged quintiles in Australia. Whilst those in more disadvantaged areas would pay more SSB tax, the difference between areas is small. The equity of the tax could be further improved if the tax revenue were used to fund initiatives benefiting those with greater disadvantage.

Knowledge-exchange in the Pacific: outcomes of the TROPIC (translational research for obesity prevention in communities) project.

BACKGROUND: The Pacific TROPIC (Translational Research for Obesity Prevention in Communities) project aimed to design, implement and evaluate a knowledge-broking approach to evidence-informed policy making to address obesity in Fiji. This paper reports on the quantitative evaluation of the knowledge-broking intervention through assessment of participants' perceptions of evidence use and development of policy/advocacy briefs. METHODS: Selected staff from six organizations - four government Ministries and two nongovernment organizations (NGOs) - participated in the project. The intervention comprised workshops and supported development of policy/advocacy briefs. Workshops addressed obesity and policy cycles and developing participants' skills in accessing, assessing, adapting and applying relevant evidence. A knowledge-broking team supported participants individually and/or in small groups to develop evidence-informed policy/advocacy briefs. A questionnaire survey that included workplace and demographic items and the self-assessment tool "Is Research Working for You?" (IRWFY) was administered pre- and post-intervention. RESULTS: Forty nine individuals (55% female, 69% 21-40 years, 69% middle-senior managers) participated in the study. The duration and level of participant engagement with the intervention activities varied - just over half participated for 10+ months, just under half attended most workshops and approximately one third produced one or more policy briefs. There were few reliable changes on the IRWFY scales following the intervention; while positive changes were found on several scales, these effects were small (d < .2) and only one individual scale (assess) was statistically significant (p < .05). Follow up (N = 1) analyses of individual-level change indicated that while 63% of participants reported increased research utilization post-intervention, this proportion was not different to chance levels. Similar analysis using scores aggregated by organization also revealed no organizational-level change post-intervention. CONCLUSIONS: This study empirically evaluated a knowledge-broking program that aimed to extend evidence-informed policy making skills and development of a suite of national policy briefs designed to increase the enactment of obesity-related policies. The findings failed to indicate reliable improvements in research utilization at either the individual or organizational level. Factors associated with fidelity and intervention dose as well as challenges related to organizational support and the measurement of research utilization, are discussed and recommendations for future research presented.

The comparative cost of food and beverages at remote Indigenous communities, Northern Territory, Australia.

OBJECTIVE: To determine the average price difference between foods and beverages in remote Indigenous community stores and capital city supermarkets and explore differences across products. METHODS: A cross-sectional survey compared prices derived from point-of-sale data in 20 remote Northern Territory stores with supermarkets in capital cities of the Northern Territory and South Australia for groceries commonly purchased in remote stores. Average price differences for products, supply categories and food groups were examined. RESULTS: The 443 products examined represented 63% of food and beverage expenditure in remote stores. Remote products were, on average, 60% and 68% more expensive than advertised prices for Darwin and Adelaide supermarkets, respectively. The average price difference for fresh products was half that of packaged groceries for Darwin supermarkets and more than 50% for food groups that contributed most to purchasing. CONCLUSIONS: Strategies employed by manufacturers and supermarkets, such as promotional pricing, and supermarkets' generic products lead to lower prices. These opportunities are not equally available to remote customers and are a major driver of price disparity. IMPLICATIONS: Food affordability for already disadvantaged residents of remote communities could be improved by policies targeted at manufacturers, wholesalers and/or major supermarket chains.

AVERT2 (a very early rehabilitation trial, a very effective reproductive trigger): retrospective observational analysis of the number of babies born to trial staff.

OBJECTIVE: To report the number of participants needed to recruit per baby born to trial staff during AVERT, a large international trial on acute stroke, and to describe trial management consequences. DESIGN: Retrospective observational analysis. SETTING: 56 acute stroke hospitals in eight countries. PARTICIPANTS: 1074 trial physiotherapists, nurses, and other clinicians. OUTCOME MEASURES: Number of babies born during trial recruitment per trial participant recruited. RESULTS: With 198 site recruitment years and 2104 patients recruited during AVERT, 120 babies were born to trial staff. Births led to an estimated 10% loss in time to achieve recruitment. Parental leave was linked to six trial site closures. The number of participants needed to recruit per baby born was 17.5 (95% confidence interval 14.7 to 21.0); additional trial costs associated with each birth were estimated at 5736 Australian dollars on average. CONCLUSION: The staff absences registered in AVERT owing to parental leave led to delayed trial recruitment and increased costs, and should be considered by trial investigators when planning research and estimating budgets. However, the celebration of new life became a highlight of the annual AVERT collaborators' meetings and helped maintain a cohesive collaborative group. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry no 12606000185561. DISCLAIMER: Participation in a rehabilitation trial does not guarantee successful reproductive activity.

Child and adolescent obesity: part of a bigger picture.

The prevalence of childhood overweight and obesity has risen substantially worldwide in less than one generation. In the USA, the average weight of a child has risen by more than 5 kg within three decades, to a point where a third of the country's children are overweight or obese. Some low-income and middle-income countries have reported similar or more rapid rises in child obesity, despite continuing high levels of undernutrition. Nutrition policies to tackle child obesity need to promote healthy growth and household nutrition security and protect children from inducements to be inactive or to overconsume foods of poor nutritional quality. The promotion of energy-rich and nutrient-poor products will encourage rapid weight gain in early childhood and exacerbate risk factors for chronic disease in all children, especially those showing poor linear growth. Whereas much public health effort has been expended to restrict the adverse marketing of breastmilk substitutes, similar effort now needs to be expanded and strengthened to protect older children from increasingly sophisticated marketing of sedentary activities and energy-dense, nutrient-poor foods and beverages. To meet this challenge, the governance of food supply and food markets should be improved and commercial activities subordinated to protect and promote children's health.

Low health-related quality of life in school-aged children in Tonga, a lower-middle income country in the South Pacific.

BACKGROUND: Ensuring a good life for all parts of the population, including children, is high on the public health agenda in most countries around the world. Information about children's perception of their health-related quality of life (HRQoL) and its socio-demographic distribution is, however, limited and almost exclusively reliant on data from Western higher income countries. OBJECTIVES: To investigate HRQoL in schoolchildren in Tonga, a lower income South Pacific Island country, and to compare this to HRQoL of children in other countries, including Tongan children living in New Zealand, a high-income country in the same region. DESIGN: A cross-sectional study from Tonga addressing all secondary schoolchildren (11-18 years old) on the outer island of Vava'u and in three districts of the main island of Tongatapu (2,164 participants). A comparison group drawn from the literature comprised children in 18 higher income and one lower income country (Fiji). A specific New Zealand comparison group involved all children of Tongan descendent at six South Auckland secondary schools (830 participants). HRQoL was assessed by the self-report Pediatric Quality of Life Inventory 4.0. RESULTS: HRQoL in Tonga was overall similar in girls and boys, but somewhat lower in children below 15 years of age. The children in Tonga experienced lower HRQoL than the children in all of the 19 comparison countries, with a large difference between children in Tonga and the higher income countries (Cohen's d 1.0) and a small difference between Tonga and the lower income country Fiji (Cohen's d 0.3). The children in Tonga also experienced lower HRQoL than Tongan children living in New Zealand (Cohen's d 0.6). CONCLUSION: The results reveal worrisome low HRQoL in children in Tonga and point towards a potential general pattern of low HRQoL in children living in lower income countries, or, alternatively, in the South Pacific Island countries.