On the estimation of the effect of weight change on a health outcome using observational data, by utlilising the target trial emulation framework

Background/Objectives: When studying the effect of weight change between two time points on a health outcome using observational data, two main problems arise initially (i) ‘when is time zero?’ and (ii) ‘which confounders should we account for?’ From the baseline date or the 1st follow-up (when the weight change can be measured)? Different methods have been previously used in the literature that carry different sources of bias and hence produce different results. Methods: We utilised the target trial emulation framework and considered weight change as a hypothetical intervention. First, we used a simplified example from a hypothetical randomised trial where no modelling is required. Then we simulated data from an observational study where modelling is needed. We demonstrate the problems of each of these methods and suggest a strategy. Interventions: weight loss/gain vs maintenance. Results: The recommended method defines time-zero at enrolment, but adjustment for confounders (or exclusion of individuals based on levels of confounders) should be performed both at enrolment and the 1st follow-up. Conclusions: The implementation of our suggested method [adjusting for (or excluding based on) confounders measured both at baseline and the 1st follow-up] can help researchers attenuate bias by avoiding some common pitfalls. Other methods that have been widely used in the past to estimate the effect of weight change on a health outcome are more biased. However, two issues remain (i) the exposure is not well-defined as there are different ways of changing weight (however we tried to reduce this problem by excluding individuals who develop a chronic disease); and (ii) immortal time bias, which may be small if the time to first follow up is short

Comparison of predictive equations for resting metabolic rate in obese psychiatric patients taking olanzapine

Objective: The prediction of resting metabolic rate (RMR) is important to determine the energy expenditure of obese patients with severe mental illnesses (SMIs). However, there is lack of research concerning the most accurate RMR predictive equations. The purpose of this study was to compare the validity of four RMR equations on patients with SMIs taking olanzapine. Methods: One hundred twenty-eight obese (body mass index >30 kg/m(2)) patients with SMIs (41 men and 87 women) treated with olanzapine were tested from 2005 to 2008. Measurements of anthropometric parameters (height, weight, body mass index, waist circumference) and body composition (using the BodPod) were performed at the beginning of the study. RMR was measured using indirect calorimetry. Comparisons between measured and estimated RMRs from four equations (Harris-Benedict adjusted and current body weights, Schofield, and Mifflin-St. Jeor) were performed using Pearson's correlation coefficient and Bland-Altman analysis. Results: Significant correlations were found between the measured and predicted RMRs with all four equations (P 0.05). However, in men and women, the Harris-Benedict current body weight and the Schofield equations showed significant overestimation error in the RMR prediction (P < 0.001). Conclusion: When estimating RMR in men and women with SMIs taking olanzapine, the Mifflin-St. Jeor and Harris-Benedict adjusted body weight equations appear to be the most appropriate for clinical use

Vitamin D insufficiency in obese patients with severe mental illness taking olanzapine

The purpose of the study was to assess the vitamin D status of obese patients with severe mental illness (SMI) treated with olanzapine. Fifteen obese SMI patients treated with olanzapine were pair-matched with healthy obese subjects. Another 52 overweight and obese SMI patients volunteered to participate in the study (total n = 67) and were divided into three subgroups (group A = overweight, group B = obese, group C = severely obese). Anthropometric, body composition, blood glucose, lipids, 25(OH)D, intact parathyroid hormone, and calcium measurements were performed. No differences were found between healthy and SMI subjects in any of the dependent variables (p &gt; 0.05). The obese and severely obese patients demonstrated significantly lower levels of serum 25(OH)D concentration (p &lt; 0.01) compared with overweight. A significant inverse correlation was found between serum 25(OH)D concentration and all anthropometric parameters (p &lt; 0.05). The results indicate that obese SMI patients appear to be vitamin D deficient, similar to healthy obese subjects. The level of obesity seems to play a significant role in their vitamin D status: the greater the body fat of the patients the lower the serum 25(OH)D concentration. Thus, as in healthy individuals, an inverse association exists between the degree of adiposity and the serum 25(OH)D concentration in SMI patients © 2012 Springer-Verlag

Serum antioxidant capacity, biochemical profile and body composition of breast cancer survivors in a randomized Mediterranean dietary intervention study

Purpose: Increasing evidence suggests that Mediterranean Diet (MD) is correlated with reduced risk of breast cancer (BC) and cancer mortality, since it modifies patients’ serum antioxidant capacity, body composition and biochemical parameters. The aim of the study was to investigate whether a dietary intervention based on MD has a beneficial effect on these factors. Methods: In this intervention study, seventy female BC survivors were randomly assigned to (1) the intervention group (personalized dietary intervention based on MD) and (2) the control group (received the updated American Cancer Society Guidelines on Nutrition and Physical Activity for Cancer Prevention and ad libitum diet). Both groups were assessed twice [beginning, end of study (after 6 months)] regarding their anthropometric and biochemical parameters, serum vitamin C, vitamin A, a-tocopherol and CoQ10 levels, dietary intake and adherence to MD. An additional intermediate analysis was conducted on participants’ body composition and biochemical profile. Results: Concerning the intervention group, body weight, body fat mass, waist circumference, body mass index as well as HDL-cholesterol were significantly decreased (P &lt; 0.2%). An increase was observed in the vitamin C levels in blood (P &lt; 0.2%). In the control group, body weight, body fat mass and serum total cholesterol rose (P &lt; 0.2%). At the end of the study the two groups were significantly different considering blood glucose, vitamin C, polyunsaturated fatty acids, vitamin A and a-tocopherol levels. Conclusions: This randomized dietary intervention based on MD managed to ameliorate serum antioxidant capacity, body composition, adherence to MD and glycemic profile of postmenopausal BC survivors. © 2017, Springer-Verlag GmbH Germany

Effects of nutritional intervention on body weight and body composition of obese psychiatric patients taking olanzapine

Objective: Weight gain is an established side effect of atypical antipsychotics in patients with severe mental illness (SMI). Previous studies have shown positive effects of nutritional interventions in weight loss. The purpose of this study was to investigate the effects of a nutritional intervention on the body weight and body composition of patients with SMI taking olanzapine in Greece. Methods: Eighty-two patients with SMI treated with olanzapine (22 men, 60 women) and, 58 healthy controls (12 men, 46 women) were followed for 3 mo. All patients with SMI were obese, with an average body mass index of 33.12 +/- 0.74 kg/m(2) and body weight of 94.61 +/- 2.50 kg. A nutritional program was designed for each participant based on anthropometric characteristics, health profile, and dietary needs. Pre- and postintervention anthropometric and body composition measurements were performed. Results: Significant weight loss and fat loss were found in the healthy controls and patients with SMI from baseline to 3 mo (P < 0.05). However, the patients with SMI had a less significant decrease in waist circumference (P < 0.05) compared with healthy controls. The healthy male controls and male patients with SMI demonstrated greater decreases in body weight and waist circumference compared with female participants (P < 0.05). Conclusion: Patients with SMI appear to respond effectively to a nutritional program demonstrating significant decreases in body weight and body composition despite the use of olanzapine. Because gender differences may exist in weight loss, it is possible that gender should be taken into account for a more appropriate treatment of obesity in this population. (C) 2009 Published by Elsevier Inc

Analysis of seawater microbiological quality data in Greece from 1997 to 2006: association of risk factors with bacterial indicators

This study deals with the examination of quality of seawater bathing areas in Greece over a 10-year period and identifies risk factors for high bacteria indicator organism concentrations. Qualitative descriptive analysis was applied and the microbiological test results of 231,205 water samples were associated with pollution markers and other parameters. Measurements of Escherichia coli (99.6%) and enterococci (100%) were found to be in accordance with the mandatory value guidelines set by the new European Directive. An increasing trend for the yearly mean value of faecal streptococci was noted. Using logistic regression analysis, phenolic smell (OR 2.10, CI 2.04-2.16), rainfall the day before sampling (OR 1.67, CI = 1.64-1.74), high seas (OR = 1.42, CI 1.39-1.46) and rainfall on the day of sampling (OR = 1.27, CI = 1.20-1.33) were positively independently associated with high levels of bacterial indicators (total coliforms, faecal coliforms, faecal streptococci and E. coli). The highest risk, absolute risk value 42.8% (RR = 3.17, CI 2.97-3.38), was measured when previous day rainfall, phenolic smell and high seas were simultaneously recorded. Such parameters should be further investigated as predetermining factors for the assessment of beach bathing water quality, providing a timely indication of water risk assessment

Legionella colonization of hotel water systems in touristic places of Greece: association with system characteristics and physicochemical parameters

This study aimed to assess the colonization of hotel water systems in central Greece and Corfu by Legionella, and to investigate the association between physicochemical parameters and Legionella colonization. Standardized hygiene inspection was conducted in 51 hotels, and 556 water samples were analyzed for Legionella spp. Free chlorine concentration, pH, hardness, conductivity, and trace metals were defined in cold water samples. The results of inspections and chemical analyses were associated with the microbiological results using univariate and logistic regression analysis. According to the score of the checklist used for the inspections, 17.6% of the hotels were classified as satisfactory, 15.7% as adequate, and 66.7% as unsatisfactory. Moreover, 74.5% of the hotels were colonized by Legionella spp. and 31.4% required remedial measures according to the European guidelines. Legionella spp. were isolated in 28% of the samples. Unsatisfactory results of inspections were associated with Legionella presence (relative risk (RR) = 7.67, p-value = 0.043). In hot-water systems, &lt;50 °C temperatures increased the risk of Legionella colonization (RR = 5.36, p-value &lt; 0.001). In cold-water systems, free chlorine concentration &lt;0.375 mg/L (odds ratio (OR) = 9.76, p-value = 0.001), pH ≥ 7.45 (OR = 4.05, p-value = 0.007), and hardness ≥321 mgCaCO 3 /L (OR = 5.63, p-value = 0.003) increased the risk, whereas copper pipes demonstrated a protective role (OR = 0.29, p-value = 0.0024). The majority of the hotels inspected were colonized with Legionella. Supplementary monitoring of the risk factors that were identified should be considered. © 2018 by the authors. Licensee MDPI, Basel, Switzerland

The effect of transcranial direct current stimulation (tDCS) combined with cognitive training on EEG spectral power in adolescent boys with ADHD

Transcranial direct current stimulation (tDCS) is a possible alternative to psychostimulants in Attention-Deficit/Hyperactivity Disorder (ADHD), but its mechanisms of action in children and adolescents with ADHD are poorly understood. We conducted the first 15-session, sham-controlled study of anodal tDCS over right inferior frontal cortex (rIFC) combined with cognitive training (CT) in 50 children/adolescents with ADHD. We investigated the mechanisms of action on resting and Go/No-Go Task-based QEEG measures in a subgroup of 23 participants with ADHD (n, sham = 10; anodal tDCS = 13). We failed to find a significant sham versus anodal tDCS group differences in QEEG spectral power during rest and Go/No-Go Task performance, a correlation between QEEG and Go/No-Go Task performance, and changes in clinical and cognitive measures. These findings extend the non-significant clinical and cognitive effects in our sample of 50 children/adolescents with ADHD. Given that the subgroup of 23 participants would have been underpowered, the interpretation of our findings is limited and should be used as a foundation for future investigations. Larger, adequately powered randomized controlled trials should explore different protocols titrated to the individual and using comprehensive measures to assess cognitive, clinical, and neural effects of tDCS and its underlying mechanisms of action in ADHD

Diet and exercise effects on aerobic fitness and body composition in seriously mentally ill adults

Low exercise capacity and high obesity levels are the main characteristics of people with serious mental illness (SMI). We conducted a pilot study on the effects of a 3-month exercise and dietary intervention on the aerobic capacity and body composition of obese adults with SMI taking Olanzapine, a second generation antipsychotic medication known to induce weight increments. Fifty adults with SMI (15 males and 35 females) followed a 3-month weight loss intervention programme based on exercise and diet. Pre- and post-intervention, a submaximal O2 exercise test was performed in order to assess O2max anthropometric and body composition measurements were also performed. All participants were obese (body mass index (BMI): 33.61 ± 0.91 kg/m2). Pre- and post-intervention, a submaximal O2 exercise test on the treadmill was performed in order to assess O2max anthropometric and body composition measurements were also performed. Significant reductions in body weight, BMI, body fat and waist circumference were found from pre to post (p &lt; 0.01). O2max was significantly improved in both genders (males: pre: 30.63 ± 2.06 vs. post: 33.19 ± 1.77 ml.kg-1 min-1, females: pre: 25.93 ± 1.01 vs. post: 29.51 ± 1.06 ml.kg-1 min-1, p &lt; 0.01). A significant correlation was found between the change in O2max and the change in body weight and BMI (p &lt; 0.05). Multiple regression analysis revealed that the relative change in O2max explained approximately 26% of the variance in the changes for both BMI (p = 0.07) and body weight (p = 0.06). A treatment of exercise and diet improves the aerobic capacity and body composition of obese adults with SMI, despite the use of Olanzapine