Nathalie Davis-Lameloise

Depression: an important comorbidity with metabolic syndrome in a general population.

OBJECTIVE—There is a recognized association among depression, diabetes, and cardiovascular disease. The aim of this study was to examine in a sample representative of the general population whether depression, anxiety, and psychological distress are associated with metabolic syndrome and its components. RESEARCH DESIGN AND METHODS—Three cross-sectional surveys including clinical health measures were completed in rural regions of Australia during 2004–2006. A stratified random sample (n = 1,690, response rate 48%) of men and women aged 25–84 years was selected from the electoral roll. Metabolic syndrome was defined by the Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, Adult Treatment Panel III (NCEP ATP III), and International Diabetes Federation (IDF) criteria. Anxiety and depression were assessed by the Hospital Anxiety and Depression Scale and psychological distress by the Kessler 10 measure. RESULTS—Metabolic syndrome was associated with depression but not psychological distress or anxiety. Participants with the metabolic syndrome had higher scores for depression (n = 409, mean score 3.41, 95% CI 3.12–3.70) than individuals without the metabolic syndrome (n = 936, mean 2.95, 95% CI 2.76–3.13). This association was also present in 338 participants with the metabolic syndrome and without diabetes (mean score 3.37, 95% CI 3.06–3.68). Large waist circumference and low HDL cholesterol showed significant and independent associations with depression. CONCLUSIONS—Our results show an association between metabolic syndrome and depression in a heterogeneous sample. The presence of depression in individuals with the metabolic syndrome has implications for clinical management.

Scaling-up from an implementation trial to state-wide coverage: results from the preliminary Melbourne Diabetes Prevention Study.

BackgroundThe successful Greater Green Triangle Diabetes Prevention Program (GGT DPP), a small implementation trial, has been scaled-up to the Victorian state-wide ‘Life!’ programme with over 10,000 individuals enrolled. The Melbourne Diabetes Prevention Study (MDPS) is an evaluation of the translation from the GGT DPP to the Life! programme. We report results from the preliminary phase (pMDPS) of this evaluation.MethodsThe pMDPS is a randomised controlled trial with 92 individuals aged 50 to 75 at high risk of developing type 2 diabetes randomised to Life! or usual care. Intervention consisted of six structured 90-minute group sessions: five fortnightly sessions and the final session at 8 months. Participants underwent anthropometric and laboratory tests at baseline and 12 months, and provided self-reported psychosocial, dietary, and physical activity measures. Intervention group participants additionally underwent these tests at 3 months. Paired t tests were used to analyse within-group changes over time. Chi-square tests were used to analyse differences between groups in goals met at 12 months. Differences between groups for changes over time were tested with generalised estimating equations and analysis of covariance.ResultsIntervention participants significantly improved at 12 months in mean body mass index (−0.98 kg/m2, standard error (SE)%20=%200.26), weight (−2.65 kg, SE%20=%200.72), waist circumference (−7.45 cm, SE%20=%201.15), and systolic blood pressure (−3.18 mmHg, SE%20=%201.26), increased high-density lipoprotein-cholesterol (0.07 mmol/l, SE%20=%200.03), reduced energy from total (−2.00%, SE%20=%200.78) and saturated fat (−1.54%, SE%20=%200.41), and increased fibre intake (1.98 g/1,000 kcal energy, SE%20=%200.47). In controls, oral glucose at 2 hours deteriorated (0.59 mmol/l, SE%20=%200.27). Only waist circumference reduced significantly (−4.02 cm, SE%20=%200.95).Intervention participants significantly outperformed controls over 12 months for body mass index and fibre intake. After baseline adjustment, they also showed greater weight loss and reduced saturated fat versus total energy intake.At least 5% weight loss was achieved by 32% of intervention participants versus 0% controls.ConclusionspMDPS results indicate that scaling-up from implementation trial to state-wide programme is possible. The system design for Life! was fit for purpose of scaling-up from efficacy to effectiveness.Trial registrationAustralian and New Zealand Clinical Trials Registry ACTRN12609000507280

The association of levels of physical activity with metabolic syndrome in rural Australian adults.

BackgroundPhysical activity (PA) reduces risk factors related to metabolic syndrome. Rurality influences the way people incorporate physical activity into daily life. The aim of this study is to determine the association of PA level with metabolic syndrome in a rural Australian population. The influence of adiposity on these associations is also investigated.MethodsThree cross-sectional population health surveys were conducted in south-east Australia during 2004–2006 using a random population sample (n = 1563, participation rate 49%) aged 25–74 years. PA was assessed via a self-administered questionnaire, and components of the metabolic syndrome via anthropometric measurements taken by specially trained nurses and laboratory tests.ResultsApproximately one-fifth of participants were inactive in leisure-time and over one-third had metabolic syndrome (men 39%, women 33%; p = 0.022). There was an inverse association between level of PA and metabolic syndrome (p < 0.001). Men who were inactive in leisure-time were more than twice as likely and women more than three times as likely to have metabolic syndrome compared with those having high PA. Body mass index (BMI) is a mediating factor in the association between level of PA and metabolic syndrome.ConclusionSome PA is better than none if adults, particularly women, are to reduce their risk of metabolic syndrome and associated vascular diseases. Specialised interventions that take rurality into consideration are recommended for adults who are inactive.

Predicting changes in lifestyle and clinical outcomes in preventing diabetes: the Greater Green Triangle Diabetes Prevention Project.

OBJECTIVES To analyse how psychosocial determinants of lifestyle changes targeted in the Greater Green Triangle Diabetes Prevention Project conducted in Southeast Australia in 2004-2006 predict changes in dietary behaviour and clinical risk factors. METHODS A longitudinal pre-test and post-test study design was used. The group program was completed by 237 people at high risk of type 2 diabetes. Associations between changes in the variables were examined by structural equation modelling using a path model in which changes in psychological determinants for lifestyle predicted changes in dietary behaviours (fat and fibre intake), which subsequently predicted changes in waist circumference and other clinical outcomes. Standardised regression weights are presented, with β=±0.1 and β=±0.3 representing small and medium associations, respectively. RESULTS Improvements in coping self-efficacy and planning predicted improvements in fat (β=-0.15, p<0.05 and β=-0.32, p<0.001, respectively) and fibre intake (β=0.15, p<0.05 and β=0.23, p<0.001, respectively) which in turn predicted improvements in waist circumference (β=0.18, p<0.01 and β=-0.16, p<0.05, respectively). Improvements in waist circumference predicted improvements in diastolic blood pressure (β=0.13, p<0.05), HDL (β=-0.16, p<0.05), triglycerides (β=0.17, p<0.01), and fasting glucose (β=0.15, p<0.05). CONCLUSIONS Psychological changes predicted behaviour changes, resulting in 12-month biophysical changes. The findings support the theoretical basis of the interventions.

Mothers after gestational diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: study protocol for a randomized controlled trial

BackgroundGestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70% of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58% for high-risk individuals.Methods/DesignThe Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women. This trial has an intervention group participating in a diabetes prevention program (DPP), and a control group receiving usual care from their general practitioners during the same time period. The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals, and two follow-up telephone calls. A total of 574 women will be recruited, with 287 in each arm. The women will undergo blood tests, anthropometric measurements, and self-reported health status, diet, physical activity, quality of life, depression, risk perception and healthcare service usage, at baseline and 12 months. At completion, primary outcome (changes in diabetes risk) and secondary outcome (changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors) will be assessed in both groups.DiscussionThis study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women. The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population.Trial registrationAustralian New Zealand Clinical Trials Registry ANZCTRN 12610000338066

The Melbourne Diabetes Prevention Study (MDPS): study protocol for a randomized controlled trial

BackgroundWorldwide, type 2 diabetes (T2DM) prevalence has more than doubled over two decades. In Australia, diabetes is the second highest contributor to the burden of disease. Lifestyle modification programs comprising diet changes, weight loss and moderate physical activity, have been proven to reduce the incidence of T2DM in high risk individuals.As part of the Council of Australia Governments, the State of Victoria committed to develop and support the diabetes prevention program ‘Life! Taking action on diabetes’ (Life!) which has direct lineage from effective clinical and implementation trials from Finland and Australia. The Melbourne Diabetes Prevention Study (MDPS) has been set up to evaluate the effectiveness and cost-effectiveness of a specific version of the Life! program.Methods/designWe intend to recruit 796 participants for this open randomized clinical trial; 398 will be allocated to the intervention arm and 398 to the usual care arm. Several methods of recruitment will be used in order to maximize the number of participants. Individuals aged 50 to 75 years will be screened with a risk tool (AUSDRISK) to detect those at high risk of developing T2DM. Those with existing diabetes will be excluded. Intervention participants will undergo anthropometric and laboratory tests, and comprehensive surveys at baseline, following the fourth group session (approximately three months after the commencement of the intervention) and 12 months after commencement of the intervention, while control participants will undergo testing at baseline and 12 months only.The intervention consists of an initial individual session followed by a series of five structured-group sessions. The first four group sessions will be carried out at two week intervals and the fifth session will occur eight months after the first group session. The intervention is based on the Health Action Process Approach (HAPA) model and sessions will empower and enable the participants to follow the five goals of the Life! program.DiscussionThis study will determine whether the effect of this intervention is larger than the effect of usual care in reducing central obesity and cardiovascular risk factors and thus the risk of developing diabetes and cardiovascular disease. Also it will evaluate how these two options compare economically.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12609000507280

Implementation salvage experiences from the Melbourne diabetes prevention study

BackgroundMany public health interventions based on apparently sound evidence from randomised controlled trials encounter difficulties when being scaled up within health systems. Even under the best of circumstances, implementation is exceedingly difficult. In this paper we will describe the implementation salvage experiences from the Melbourne Diabetes Prevention Study, which is a randomised controlled trial of the effectiveness and cost-effectiveness nested in the state-wide Life! Taking Action on Diabetes program in Victoria, Australia.DiscussionThe Melbourne Diabetes Prevention Study sits within an evolving larger scale implementation project, the Life! program. Changes that occurred during the roll-out of that program had a direct impact on the process of conducting this trial. The issues and methods of recovery the study team encountered were conceptualised using an implementation salvage strategies framework. The specific issues the study team came across included continuity of the state funding for Life! program and structural changes to the Life! program which consisted of adjustments to eligibility criteria, referral processes, structure and content, as well as alternative program delivery for different population groups. Staff turnover, recruitment problems, setting and venue concerns, availability of potential participants and participant characteristics were also identified as evaluation roadblocks. Each issue and corresponding salvage strategy is presented.SummaryThe experiences of conducting such a novel trial as the preliminary Melbourne Diabetes Prevention Study have been invaluable. The lessons learnt and knowledge gained will inform the future execution of this trial in the coming years. We anticipate that these results will also be beneficial to other researchers conducting similar trials in the public health field. We recommend that researchers openly share their experiences, barriers and challenges when conducting randomised controlled trials and implementation research. We encourage them to describe the factors that may have inhibited or enhanced the desired outcomes so that the academic community can learn and expand the research foundation of implementation salvage.