Associations between diet quality and mental health in socially disadvantaged New Zealand adolescents.

BACKGROUND/OBJECTIVES: To examine the relationship between diet quality and mental health in an ethnically diverse adolescent population in New Zealand. SUBJECTS/METHODS: Cross-sectional, population-based study design. Data were available at baseline for 4249 students. Responses from self-reported dietary questionnaires were used to assess diet quality; healthy eating and unhealthy eating were assessed as two separate scales. Mental health was assessed by the emotional subscale of the PedsQL instrument. RESULTS: Eating a healthy diet was significantly associated with better emotional health (P<0.001) and eating an unhealthy diet was significantly associated with greater emotional distress (P<0.001), after controlling for age, ethnicity and gender. The healthy and unhealthy eating scales were independently related to mental health scores. CONCLUSIONS: These findings contribute to a growing body of literature that diet quality is associated with mental health in adolescents. Further research is warranted to determine whether improvements to the diets of adolescents can have meaningful improvements to mental well-being.

Pharmaceutical utilisation and costs before and after bariatric surgery.

OBJECTIVE: To determine whether pharmaceutical utilisation and costs change after bariatric surgery. SUBJECTS: Total population of Australians receiving Medicare-subsidised laparoscopic adjustable gastric banding (LAGB) in 2007 (n=9542). DESIGN: Computerised data linkage with Medicare, Australia's universal tax-funded health insurance scheme. Pharmaceuticals relating to obesity-related disease and postsurgical management were assigned to therapeutic categories and analysed. The mean annual numbers of pharmaceutical prescriptions for each category were compared over the 4-year period from the year before LAGB (2006) to 2 years after LAGB (2009) using utilisation incidence rate ratios (IRRs). RESULTS: The population was mainly female (77.7%) and age was normally distributed with the majority (60.7%) of subjects aged between 35-54 years. Utilisation rates decreased significantly after LAGB in the following therapeutic categories: diabetes (IRR 0.51, IRR 95% CI 0.50-0.53, mean annual cost differences per person $30), cardiovascular (0.81, 0.80-0.82, $29), psychiatric (0.95, 0.93-0.97, $13), rheumatic and inflammatory disorders (0.51, 0.49-0.53, $10) and asthma (0.78, 0.75-0.81, $9). In contrast, significantly greater utilisation was observed in the pain (1.28, 1.23-1.32, $12), gastrointestinal tract disorder (1.04, 1.02-1.07, $5) and anaemia/vitamins (2.34, 2.01-2.73, $4) therapeutic categories. When the defined categories were combined, a net reduction in pharmaceutical utilisation was observed, from 10.5 to 9.6 pharmaceuticals prescribed per person/year, and costs decreased from $AUD517 to $AUD435 per year in 2009 prices. CONCLUSION: Relative to the year before LAGB, overall pharmaceutical utilisation was reduced in the 2 years after the year of LAGB surgery, demonstrating that bariatric surgery can lead to reductions in pharmaceutical utilisation in the 'real world' setting. The greatest absolute cost reductions were observed in the therapies to treat diabetes and cardiovascular disease.

The possibility of regulating for obesity prevention--understanding regulation in the Commonwealth Government.

A complex regulatory package is likely to be necessary to effectively reduce obesity prevalence in developed countries. This study investigated the barriers and facilitators to implementing regulatory interventions to prevent obesity within the executive arm of the Australian Commonwealth Government. Policy reviews were conducted on nine government departments to understand their roles and interests in obesity. From this process we identified regulatory review carried out by the Office of Best Practice Regulation as possibly posing a barrier to law reform for obesity prevention, along with the complexity of the food policymaking structures. The policy reviews informed subsequent in-depth semi-structured interviews with senior Commonwealth government officers (n = 13) focused on refining our understanding of the barriers to enacting obesity prevention policy. In addition to the two barriers already identified, interviewees identified a lack of evidence for interventions, which would reduce obesity prevalence, and the influence of politicians on executive decisions as posing obstacles. Most interviewees believed that the barriers to regulating to prevent obesity were strong and that intervention by elected politicians would be the most likely method of implementing obesity prevention policy.

Multilevel analysis of the Be Active Eat Well intervention: environmental and behavioural influences on reductions in child obesity risk.

BACKGROUND: The Be Active Eat Well (BAEW) community-based child obesity prevention intervention was successful in modestly reducing unhealthy weight gain in primary school children using a multi-strategy and multi-setting approach. OBJECTIVE: To (1) examine the relationship between changes in obesity-related individual, household and school factors and changes in standardised child body mass index (zBMI), and (2) determine if the BAEW intervention moderated these effects. METHODS: The longitudinal relationships between changes in individual, household and school variables and changes in zBMI were explored using multilevel modelling, with measurement time (baseline and follow-up) at level 1, individual (behaviours, n = 1812) at level 2 and households (n = 1318) and schools (n = 18) as higher levels (environments). The effect of the intervention was tested while controlling for child age, gender and maternal education level. RESULTS: This study confirmed that the BAEW intervention lowered child zBMI compared with the comparison group (-0.085 units, P = 0.03). The variation between household environments was found to be a large contributor to the percentage of unexplained change in child zBMI (59%), compared with contributions from the individual (23%) and school levels (1%). Across both groups, screen time (P = 0.03), sweet drink consumption (P = 0.03) and lack of household rules for television (TV) viewing (P = 0.05) were associated with increased zBMI, whereas there was a non-significant association with the frequency the TV was on during evening meals (P = 0.07). The moderating effect of the intervention was only evident for the relationship between the frequency of TV on during meals and zBMI, however, this effect was modest (P = 0.04). CONCLUSIONS: The development of childhood obesity involves multi-factorial and multi-level influences, some of which are amenable to change. Obesity prevention strategies should not only target individual behaviours but also the household environment and family practices. Although zBMI changes were modest, these findings are encouraging as small reductions can have population level impacts on childhood obesity levels.

Experiences and challenges in implementing complex community-based research project: the Pacific Obesity Prevention in Communities project.

Policy makers throughout the world are struggling to find effective ways to prevent the rising trend of obesity globally, particularly among children. The Pacific Obesity Prevention in Communities project was the first large-scale, intervention research project conducted in the Pacific aiming to prevent obesity in adolescents. The project spanned four countries: Australia, New Zealand, Fiji and Tonga. This paper reports on the strengths and challenges experienced from this complex study implemented from 2004 to 2009 across eight cultural groups in different community settings. The key strengths of the project were its holistic collaborative approach, participatory processes and capacity building. The challenges inherent in such a large complex project were underestimated during the project's development. These related to the scale, complexity, duration, low research capacity in some sites and overall coordination across four different countries. Our experiences included the need for a longer lead-in time prior to intervention for training and up-skilling of staff in Fiji and Tonga, investment in overall coordination, data quality management across all sites and the need for realistic capacity building requirements for research staff. The enhanced research capacity and skills across all sites include the development and strengthening of research centres, knowledge translation and new obesity prevention projects.

The Pacific Obesity Prevention in Communities project: project overview and methods.

Obesity is increasing worldwide with the Pacific region having the highest prevalence among adults. The most common precursor of adult obesity is adolescent obesity making this a critical period for prevention. The Pacific Obesity Prevention in Communities project was a four-country project (Fiji, Tonga, New Zealand and Australia) designed to prevent adolescent obesity. This paper overviews the project and the methods common to the four countries. Each country implemented a community-based intervention programme promoting healthy eating, physical activity and healthy weight in adolescents. A community capacity-building approach was used, with common processes employed but with contextualized interventions within each country. Changes in anthropometric, behavioural and perception outcomes were evaluated at the individual level and school environments and community capacity at the settings level. The evaluation tools common to each are described. Additional analytical studies included economic, socio-cultural and policy studies. The project pioneered many areas of obesity prevention research: using multi-country collaboration to build research capacity; testing a capacity-building approach in ethnic groups with very high obesity prevalence; costing complex, long-term community intervention programmes; systematically studying the powerful socio-cultural influences on weight gain; and undertaking a participatory, national, priority-setting process for policy interventions using simulation modelling of cost-effectiveness of interventions.

Reducing unhealthy weight gain in Fijian adolescents: results of the Healthy Youth Healthy Communities study.

Obesity is a significant problem among adolescents in Pacific populations. This paper reports on the outcomes of a 3-year obesity prevention study, Healthy Youth Healthy Communities, which was part of the Pacific Obesity Prevention in Communities project, undertaken with Fijian adolescents. The intervention was developed with schools and comprised social marketing, nutrition and physical activity initiatives and capacity building designed to reduce unhealthy weight, and the individual exposure period was just over 2-year duration. The evaluation incorporated a quasi-experimental, longitudinal design in seven intervention secondary schools near Suva (n=874) and a matched sample of 11 comparison secondary schools from western Viti Levu (n=2,062). There were significant differences between groups at baseline; the intervention group was shorter, weighed less, had a higher proportion of underweight and lower proportion of overweight, and better quality of life (Pediatric Quality of Life Inventory only). At follow-up, the intervention group had lower percentage body fat (-1.17) but also a lower increase in quality of life (Assessment of Quality of Life instrument: -0.02; Pediatric Quality of Life Inventory: -1.94) than the comparison group. There were no other differences in anthropometry, and behaviours' changes showed a mixed pattern. In conclusion, this school-based health promotion programme lowered percentage body fat but did not reduce unhealthy weight gain or influence most obesity-promoting behaviours among Fijian adolescents. Despite growing evidence supporting the efficacy of community-based approaches to reduce obesity among children of European descent, findings from this study failed to demonstrate the efficacy of a community capacity-building approach among an adolescent sample drawn from a different sociocultural, economic and geographical context. Additional 'top-down' or other innovative approaches may be needed to reduce adolescent obesity in the Pacific.

Reduction in overweight and obesity from a 3-year community-based intervention in Australia: the 'It's Your Move!' project.

'It's Your Move!' was a 3-year intervention study implemented in secondary schools in Australia as part of the Pacific Obesity Prevention In Communities Project. This paper reports the outcome results of anthropometric indices and relevant obesity-related behaviours. The interventions focused on building the capacity of families, schools and communities to promote healthy eating and physical activity. Baseline response rates and follow-up rates were 53% and 69% respectively for the intervention group (n=5 schools) and 47% and 66% respectively for the comparison group (n=7 schools). Statistically significant relative reductions in the intervention versus comparison group were observed: weight (-0.74 kg, P < 0.04), and standardized body mass index (-0.07, P<0.03), and non-significant reductions in prevalence of overweight and obesity (0.75 odds ratio, P=0.12) and body mass index (-0.22, P=0.06). Obesity-related behavioural variables showed mixed results with no pattern of positive intervention outcomes. In conclusion, this is the first study to show that long-term, community-based interventions using a capacity-building approach can prevent unhealthy weight gain in adolescents. Obesity prevention efforts in this important transitional stage of life can be successful and these findings need to be translated to scale for a national effort to reverse the epidemic in children and adolescents.

Outcome results for the Ma'alahi Youth Project, a Tongan community-based obesity prevention programme for adolescents.

Tonga has a very high prevalence of obesity with steep increases during youth, making adolescence a critical time for obesity prevention. The Ma'alahi Youth Project, the Tongan arm of the Pacific Obesity Prevention in Communities project, was a 3-year, quasi-experimental study of community-based interventions among adolescents in three districts on Tonga's main island (Tongatapu) compared to the island of Vava'u. Interventions focused mainly on capacity building, social marketing, education and activities promoting physical activity and local fruit and vegetables. The evaluation used a longitudinal design (mean follow-up duration 2.4 years). Both intervention and comparison groups showed similar large increases in overweight and obesity prevalence (10.1% points, n = 815; 12.6% points, n = 897 respectively). Apart from a small relative decrease in percentage body fat in the intervention group (-1.5%, P < 0.0001), there were no differences in outcomes for any anthropometric variables between groups and behavioural changes did not follow a clear positive pattern. In conclusion, the Ma'alahi Youth Project had no impact on the large increase in prevalence of overweight and obesity among Tongan adolescents. Community-based interventions in such populations with high obesity prevalence may require more intensive or longer interventions, as well as specific strategies targeting the substantial socio-cultural barriers to achieving a healthy weight.

Evaluation of the Living 4 Life project: a youth-led, school-based obesity prevention study.

The Living 4 Life study was a youth-led, school-based intervention to reduce obesity in New Zealand. The study design was quasi-experimental, with comparisons made by two cross-sectional samples within schools. Student data were collected at baseline (n=1634) and at the end of the 3-year intervention (n=1612). A random-effects mixed model was used to test for changes in primary outcomes (e.g. anthropometry and obesity-related behaviours) between intervention and comparison schools. There were no significant differences in changes in anthropometry or behaviours between intervention and comparison schools. The prevalence of obesity in intervention schools was 32% at baseline and 35% at follow-up and in comparison schools was 29% and 30%, respectively. Within-school improvements in obesity-related behaviours were observed in three intervention schools and one comparison school. One intervention school observed several negative changes in student behaviours. In conclusion, there were no significant improvements to anthropometry; this may reflect the intervention's lack of intensity, insufficient duration, or that by adolescence changes in anthropometry and related behaviours are difficult to achieve. School-based obesity prevention interventions that actively involve young people in the design of interventions may result in improvements in student behaviours, but require active support from leaders within their schools.

The role of policy in improving diets: experiences from the Pacific Obesity Prevention in Communities food policy project.

There is global interest in using multisectoral policy approaches to improve diets, and reduce obesity and non-communicable disease. However, there has been ad hoc implementation, which in some sectors such as the economic sector has been very limited, because of the lack of quality evidence on potential costs and impacts, and the inherent challenges associated with cross-sectoral policy development and implementation. The Pacific Obesity Prevention in Communities food policy project aimed to inform relevant policy development and implementation in Pacific Island countries. The project developed an innovative participatory approach to identifying and assessing potential policy options in terms of their effectiveness and feasibility. It also used policy analysis methodology to assess three policy initiatives to reduce fatty meat availability and four soft drink taxes in the region, in order to identify strategies for supporting effective policy implementation.

The influence of caffeine on energy content of sugar-sweetened beverages: 'the caffeine-calorie effect'.

BACKGROUND/OBJECTIVES: Caffeine is a mildly addictive psychoactive chemical and controversial additive to sugar-sweetened beverages (SSBs). The objective of this study is to assess if removal of caffeine from SSBs allows co-removal of sucrose (energy) without affecting flavour of SSBs, and if removal of caffeine could potentially affect population weight gain. SUBJECTS/METHODS: The research comprised of three studies; study 1 used three-alternate forced choice and paired comparison tests to establish detection thresholds for caffeine in water and sucrose solution (subjects, n=63), and to determine if caffeine suppressed sweetness. Study 2 (subjects, n=30) examined the proportion of sucrose that could be co-removed with caffeine from SSBs without affecting the flavour of the SSBs. Study 3 applied validated coefficients to estimate the impact on the weight of the United States population if there was no caffeine in SSBs. RESULTS: Detection threshold for caffeine in water was higher (1.09 ± 0.08 mM) than the detection threshold for caffeine in sucrose solution (0.49 ± 0.04 mM), and a paired comparison test revealed caffeine significantly reduced the sweetness of sucrose (P<0.001). Removing caffeine from SSBs allowed co-removal of 10.3% sucrose without affecting flavour of the SSBs, equating to 116 kJ per 500 ml serving. The effect of this on body weight in adults and children would be 0.600 and 0.142 kg, which are equivalent to 2.08 and 1.10 years of observed existing trends in weight gain, respectively. CONCLUSION: These data suggest the extra energy in SSBs as a result of caffeine's effect on sweetness may be associated with adult and child weight gain.

Decreasing trends in overweight and obesity among an Australian population of preschool children.

BACKGROUND: After several decades of increasing prevalence, recent evidence suggests a levelling of obesity rates in some groups, although little is known about trends in children under 5 years of age. AIM: To investigate the prevalence, trends and sociodemographic correlates of overweight and obesity in Australian preschool children between 1999 and 2007. METHODS: Child anthropometric and demographic data were extracted from records of routine maternal and child health consultations for children aged 2 and 3.5 years in the Australian state of Victoria. Data were analysed for prevalence of overweight and obesity (according to International Obesity Task Force definitions), trends in prevalence from 1999 to 2007 and sociodemographic correlates of prevalence and trends. RESULTS: Complete data were available for 129,266 2-year-old children and 96,164 3.5-year-old children from 41 local government areas across Victoria. Combined prevalence of overweight and obesity decreased significantly between 1999 and 2007 in 3.5-year-old children (by 3.1% points from 18.5 to 15.4%) and in 2-year-old children (1.1% point decrease from 13.5 to 12.4%). There was no accompanying increase in rates of underweight. Decreases were more pronounced in areas of lower socioeconomic status (SES). Prevalence of both overweight and obesity was consistently higher across time in the older group of children, in the lowest quartile of SES and among girls. CONCLUSIONS: Prevalence of overweight and obesity in preschool children in Victoria has decreased significantly between 1999 and 2007, whereas socioeconomic disparities have narrowed. Further research is needed to understand the reasons for the decreasing prevalence, and to better evaluate existing and emerging health promotion initiatives. Such evidence will be important to build on the findings of this study and to transfer lessons learnt to other population groups.

Selection of priority groups for obesity prevention: current approaches and development of an evidence-informed framework.

Resources for obesity prevention interventions are inevitably limited, necessitating the selection of priority groups to ensure effective and equitable use of funds. This paper aims to review published approaches to selection of priority groups ('target populations') for obesity prevention, and to present the development of a new systematic framework for organizing and assessing evidence for selecting priority groups. A review was conducted of the process and justification described for selecting priority groups in a sample of obesity prevention publications. Using the results of this review and adaptation of theory and frameworks in both the obesity prevention and health promotion priority-setting literature, a framework was developed for assessment of potential priority groups for obesity prevention. The published literature lacks discussion of and explicit processes for selection of priority groups for obesity prevention intervention. The new framework describes specific types of evidence that should be considered in the assessment of a potential priority group for obesity prevention and has applications for funding and implementing community-based or settings-level obesity prevention interventions and research. Application of this framework has the potential to enhance the effective use of limited obesity prevention resources and to identify areas in need of additional research evidence.

Creating community action plans for obesity prevention using the ANGELO (Analysis Grid for Elements Linked to Obesity) Framework.

Community-based interventions are an important component of obesity prevention efforts. The literature provides little guidance on priority-setting for obesity prevention in communities, especially for socially and culturally diverse populations. This paper reports on the process of developing prioritized, community-participatory action plans for obesity prevention projects in children and adolescents using the ANGELO (Analysis Grid for Elements Linked to Obesity) Framework. We combined stakeholder engagement processes, the ANGELO Framework (scans for environmental barriers, targeted behaviours, gaps in skills and knowledge) and workshops with key stakeholders to create action plans for six diverse obesity prevention projects in Australia (n = 3), New Zealand, Fiji and Tonga from 2002 to 2005. Some sites included sociocultural contextual analyses in the environmental scans. Target groups were under-5-year-olds (Australia), 4-12-year-olds (Australia) and 13-18-year-olds (all four countries). Over 120 potential behavioural, knowledge, skill and environmental elements were identified for prioritization leading into each 2-day workshop. Many elements were common across the diverse cultural communities; however, several unique sociocultural elements emerged in some cultural groups which informed their action plans. Youth were actively engaged in adolescent projects, allowing their needs to be incorporated into the action plans initiating the process of ownership. A common structure for the action plan promoted efficiencies in the process while allowing for community creativity and innovation. The ANGELO is a flexible and efficient way of achieving an agreed plan for obesity prevention with diverse communities. It is responsive to community needs, combines local and international knowledge and creates stakeholder ownership of the action plan.

Reducing unhealthy weight gain in children through community capacity-building: results of a quasi-experimental intervention program, Be Active Eat Well.

BACKGROUND: Be Active Eat Well (BAEW) was a multifaceted community capacity-building program promoting healthy eating and physical activity for children (aged 4-12 years) in the Australian town of Colac. OBJECTIVE: To evaluate the effects of BAEW on reducing children's unhealthy weight gain. METHODS: BAEW had a quasi-experimental, longitudinal design with anthropometric and demographic data collected on Colac children in four preschools and six primary schools at baseline (2003, n=1001, response rate: 58%) and follow-up (2006, n=839, follow-up rate: 84%). The comparison sample was a stratified random selection of preschools (n=4) and primary schools (n=12) from the rest of the Barwon South Western region of Victoria, with baseline assessment in 2003-2004 (n=1183, response rate: 44%) and follow-up in 2006 (n=979, follow-up rate: 83%). RESULTS: Colac children had significantly lower increases in body weight (mean: -0.92 kg, 95% CI: -1.74 to -0.11), waist (-3.14 cm, -5.07 to -1.22), waist/height (-0.02, -0.03 to -0.004), and body mass index z-score (-0.11, -0.21 to -0.01) than comparison children, adjusted for baseline variable, age, height, gender, duration between measurements and clustering by school. In Colac, the anthropometric changes were not related to four indicators of socioeconomic status (SES), whereas in the comparison group 19/20 such analyses showed significantly greater gains in anthropometry in children from lower SES families. Changes in underweight and attempted weight loss were no different between the groups. CONCLUSIONS: Building community capacity to promote healthy eating and physical activity appears to be a safe and effective way to reduce unhealthy weight gain in children without increasing health inequalities.

Active transport to work in Australia: is it all downhill from here?

Physical inactivity is increasing in Australia and active forms of transportation may be one way to increase the working population's daily physical activity. We used travel-to-work data from employed persons aged 15 years and over participating in the 1996 (n = 7,636,319) and 2001 (n = 8,298,606) Australian censuses to determine prevalence and trends in walking and cycling to work by state and gender, and differences in prevalence by age. In 2001, 3.8% of Australians walked to work and < 1% cycled. Over 64% travelled to work by car. There have been small declines in walking (men and women) and cycling (men) over the 5-years from 1996 to 2001. People were more likely to walk or cycle to work if they lived in the Northern Territory, if they were male or if they were aged 15 to 24 years. They were more likely to travel by car if they lived in the Australian Capital Territory, if they were male, or if they were aged 45-54 years. Few people walk or cycle to work in Australia. Efforts to encourage active transportation are urgently needed.

Overweight and obesity prevalence in children based on 6- or 12-month IOTF cut-points: does interval size matter?

The International Obesity Taskforce (IOTF) recommends using age- and gender-specific body mass index (BMI) cut-points for defining the prevalence of overweight and obesity in children. These are given in both 6- and 12-month age intervals. Since the BMI-for-age curves are nonlinear, a degree of bias will be introduced when age intervals are wide. We aimed to quantify this bias in prevalence estimates in 2178 Australian children aged 4-12 years using 12- versus 6-month age intervals. Using the 12-month interval, the prevalence of overweight and obesity was underestimated by 1.4% compared to the 6-month interval estimates; however, this was age-dependent. It overestimated prevalence for 4-year olds, but underestimated it for older ages by up to 2.6%. Overweight prevalence was generally affected more than obesity prevalence. The use of different age intervals for IOTF cut-points introduces a small but systematic bias in prevalence estimates of overweight and obesity.

Lunchbox contents of Australian school children: room for improvement.

OBJECTIVE: In light of the increasing prevalence of obesity in children and the potential of schools as a setting for intervention, we aimed to identify the main foods and beverages consumed at primary school and to determine differences in consumption patterns between children who used the school canteen and those who did not. DESIGN: Cross-sectional survey of school foods in 1681 5-12 y old children, 2003-2004. SETTING: Barwon South-Western region of Victoria, Australia. RESULTS: The school food provided an average (+/-s.e.m.) of 3087+/-26 kJ. Bread was the most frequently consumed food and contributed 20% of total energy at school, biscuits 13%, fruit 10%, muesli/fruit bars 8%, packaged snacks 7%, and fruit juice/cordial 6%. About 10% of children used the school canteen and these children obtained more total energy and more energy from cakes, fast foods and soft drink than noncanteen users (P<0.001). In all, 68% of children had fruit in their lunchboxes, however, over 90% of children had energy-dense, micronutrient-poor snacks ('junk food'). CONCLUSIONS: Fruit intake in primary schools seems reasonably high but could be targeted for further increase as part of promoting a healthy diet. Of concern, however, are the excessive amounts of energy-dense foods in school lunchboxes. These should be considered a priority for health promotion efforts along with reducing the consumption of sweetened drinks. These measures are urgently needed to improve the school-based diets of Australian children and attempt to curb the increasing prevalence of childhood obesity.

Effect of orlistat on cardiovascular disease risk in obese adults.

AIM: The aim of this study is to compare the effect of orlistat vs. placebo on the predicted 10-year cardiovascular disease (CVD) risk in obese people with one or more cardiovascular risk factors treated for 12 months, in conjunction with a fat-reduced, but otherwise ad libitum, diet. METHODS: A double-blind, randomized, placebo-controlled, parallel study was performed in conjunction with a fat-reduced diet and physical activity advice for 1 year. Participants (n = 339) from eight centres in Australia and New Zealand were randomized to either orlistat (120 mg) three times daily (n = 104 women, 66 men; mean +/- s.d. age = 52.0 +/- 7.5 years, body mass index (BMI) = 37.6 +/- 5.1 kg/m(2)) or placebo three times daily (n = 89 women, 80 men; age = 52.5 +/- 7.4 years, BMI = 38.0 +/- 4.9 kg/m(2)). The primary efficacy criterion was the 10-year risk of developing CVD calculated from the Framingham equation. Secondary efficacy criteria were body weight, waist circumference, blood pressure and serum concentrations of triglycerides, cholesterol (total, LDL and HDL), glucose, insulin and glycated haemoglobin and quality of life. RESULTS: There was no difference in the change in 10-year CVD risk between orlistat and placebo groups over 1 year. The orlistat group, however, had significant favourable changes in many of the individual CVD risk factors (total cholesterol, LDL-cholesterol, glucose, glycated haemoglobin, insulin, body weight and waist circumference) and one of the domains of quality of life measured by means of the SF-36 questionnaire (vitality), compared to the placebo group. Significant reductions in medication use for hypertension and diabetes were observed in the orlistat group, compared to those in placebo, but there were no significant differences in medication use for blood lipids. CONCLUSIONS: Orlistat may have reduced CVD risk, as judged by the favourable changes in individual risk factors and reductions in medication use, but the method used in order to measure absolute CVD risk in this study (Framingham CVD equation) was not sensitive enough to detect the changes in this relatively low-risk group (approximately 10% of risk of a CVD event over 10 years).