Applying Sydney Triage to Admission Risk Tool (START) to improve patient flow in emergency departments: a multicentre randomised, implementation study.

BACKGROUND: To determine the effectiveness of applying the Sydney Triage to Admission Risk Tool (START) in conjunction with senior early assessment in different Emergency Departments (EDs). METHODS: This multicentre implementation study, conducted in two metropolitan EDs, used a convenience sample of ED patients. Patients who were admitted, after presenting to both EDs, and were assessed using the existing senior ED clinician assessment, were included in the study. Patients in the intervention group were assessed with the assistance of START, while patients in the control group were assessed without the assistance of START. Outcomes measured were ED length of stay and proportion of patients correctly identified as an in-patient admission by START. RESULTS: A total of 773 patients were evaluated using the START tool at triage across both sites (Intervention group n = 355 and control group n = 418 patients). The proportion of patients meeting the 4-hour length of stay thresholds was similar between the intervention and control groups (30.1% vs. 28.2%; p = 0.62). The intervention group was associated with a reduced ED length of stay when compared to the control group (351 min, interquartile range (IQR) 221.0-565.0 min versus 383 min, IQR 229.25-580.0 min; p = 0.85). When stratified into admitted and discharged patients, similar results were seen. CONCLUSION: In this extension of the START model of care implementation study in two metropolitan EDs, START, when used in conjunction with senior early assessment was associated with some reduced ED length of stay.

Clinical and longitudinal patterns of frequent presenters to emergency departments: A multi-centre data linkage analysis.

OBJECTIVE: To describe clinical characteristics and longitudinal patterns of representation in a cohort of patients who frequently present to EDs for care. METHODS: A retrospective data analysis linking routinely collected ED data across three hospitals. The study population consisted of patients who presented to any ED on 10 or more occasions in any continuous 365-day period from 1 July 2015 to 30 June 2021. Presenting complaints were divided into those with any mental health, drug and alcohol, or social presentations (MHDAS group) and those without (non-MHDAS group). Outcomes of interest were number of presentations as well as temporal and facility clustering of presentations. A per patient regression analysis was performed to identify independent risk factors for increased presentations. RESULTS: Presentations by 1640 frequent ED presenters in the study constituted 4.6% of total ED presentations. MHDAS study group were younger, predominantly English speaking, twice as likely to be married, had lower hospital admission rates and almost three times as many of them did not wait for treatment. Statistically significant differences were also found between these groups regarding presentation clustering, facility entropy, each of the four categories of the number of ED presentations, and Index of Relative Socio-Economic Advantage and Disadvantage. CONCLUSION: Representations associated with MHDAS have a different trajectory of representation episodes compared to non-MHDAS group. Escalating number of presentations and clustering are important predictors of future representation numbers. Those 'did not waits' who appear to be representing would be the highest risk of ongoing and persistent representations in the future and should be the target of early interventions to ensure they are accessing appropriate care before this happens.

The Emergency nurse Protocols Initiating Care-Sydney Triage to Admission Risk Tool (EPIC-START) trial: protocol for a stepped wedge implementation trial.

INTRODUCTION: Emergency department (ED) overcrowding is a global problem and a threat to the quality and safety of emergency care. Providing timely and safe emergency care therein is challenging. To address this in New South Wales (NSW), Australia, the Emergency nurse Protocol Initiating Care-Sydney Triage to Admission Risk Tool (EPIC-START) was developed. EPIC-START is a model of care incorporating EPIC protocols, the START patient admission prediction tool, and a clinical deterioration tool to support ED flow, timely care, and patient safety. The aim of this study is to evaluate the impact of EPIC-START implementation across 30 EDs on patient, implementation, and health service outcomes. METHODS AND ANALYSIS: This study protocol adopts an effectiveness-implementation hybrid design (Med Care 50: 217-226, 2012) and uses a stepped-wedge cluster randomised control trial of EPIC-START, including uptake and sustainability, within 30 EDs across four NSW local health districts spanning rural, regional, and metropolitan settings. Each cluster will be randomised independently of the research team to 1 of 4 dates until all EDs have been exposed to the intervention. Quantitative and qualitative evaluations will be conducted on data from medical records and routinely collected data, and patient, nursing, and medical staff pre- and post-surveys. ETHICS AND DISSEMINATION: Ethical approval for the research was received from the Sydney Local Health District Research Ethics Committee (Reference Number 2022/ETH01940) on 14 December 2022. TRIAL REGISTRATION: Australian and New Zealand Clinical trial, ACTRN12622001480774p. Registered on 27 October 2022.

24 hours - Life in the E.R.: A state-wide data linkage analysis of in-patients with prolonged emergency department length of stay in New South Wales, Australia.

OBJECTIVE: Describe the characteristics and predictors of mortality for patients who spend more than 24 h in the ED waiting for an in-patient bed and compare baseline clinical and demographic characteristics between tertiary and non-tertiary hospitals. METHODS: This was a state-wide analysis data linkage analysis of adult (age >16 years) ED presentations across New South Wales from 2019 to 2020. Cases were included if their mode of separation from ED indicated admission to an in-patient unit including critical care ward and their ED length of stay was greater than or equal to 24 h. Cases were categorised by service-related groups based on principle diagnosis. RESULTS: A total of 26 854 eligible cases were identified. The most common diagnosis groups were psychiatry, cardiology and respiratory. The odds ratio (OR) for 30-day all-cause mortality in admitted patients with an ED length of stay greater than 24 h were highest in those aged >75 years (OR 15.18, 95% confidence interval [CI] 9.99-23.07, P < 0.001), oncology (OR 10.45, 95% CI 7.93-13.77, P < 0.001) and haematology patients (OR 2.95, 95% CI 2.01-4.33, P < 0.001). CONCLUSION: Interventions and models of care to address ED access block need to focus on mental health patients, older patients particularly those with cardiorespiratory illness and oncology and haematology patients for whom risk of mortality is disproportionately higher.

Effects of total diet replacement programs on mental well-being: A systematic review with meta-analyses.

This systematic review with meta-analyses assessed the effects of total diet replacement (TDR) programs on mental well-being in clinical trial participants with a body mass index greater than or equal to 25 kg/m2 . TDR programs involve replacing all dietary requirements with nutritionally replete formula foods and are generally administered to induce rapid weight loss. To date, it is largely unclear what effects TDR programs may have on mental well-being, particularly in the long-term. To address this, we screened 25,976 references across six databases and extracted 35 publications. These 35 publications provided sufficient data to evaluate the effects of TDR programs on depression, anxiety, stress, positive affect, negative affect, vitality, role-emotional, social functioning, mental health, mental composite summary score, self-esteem, and general psychological health in 24 meta-analyses. Due to the lack of research comparing TDR programs to comparator groups, 22 of our 24 meta-analyses explored change in these mental well-being sub-domains over time in TDR programs without comparators. Specifically, we assessed the change from pre-diet (before the TDR program) to either post-diet (up to and including two months after the TDR program); and/or follow-up (more than two months after the TDR program). For depression and anxiety, we were also able to assess the change from pre-diet to mid-diet (which fell within two weeks of the diet half-way point). The remaining two meta-analyses assessed the difference in depression scores between a TDR group and a food-based comparator group from pre-diet to post-diet and from pre-diet to follow-up. Across all meta-analyses, our results found no marked adverse effects of TDR programs on any mental well-being sub-domain. In fact, clear improvements were observed for depression, anxiety, stress, vitality, role-emotional, and social functioning at post-diet. Interestingly, the improvements for depression, vitality and role-emotional were maintained at follow-up. All improvements were observed in meta-analyses without comparators. While the two comparator-based meta-analyses showed no difference between TDR programs and food-based diets in depression symptoms, there was low statistical power. For all meta-analyses containing three or more independent samples, we constructed prediction intervals to determine the range within which the mean of the true effects may fall for future populations. While these prediction intervals varied between sub-domains, we found that mean depression scores are only likely to increase (i.e., depression will worsen) in less than 3% of future TDR interventions which meet our inclusion/exclusion criteria. Taken together, we concluded that for adults with a body mass index greater than or equal to 25 kg/m2 , TDR programs are unlikely to lead to marked adverse effects on mental well-being. These findings do not support the exclusion of participants from trials or interventions involving TDR programs based on concerns that these programs may adversely affect mental well-being. In fact, by excluding these participants, they may be prevented from improving their metabolic health and mental well-being.

Maternal and neonatal outcomes of women with gestational diabetes and without specific medical conditions: an Australian population-based study comparing induction of labor with expectant management.

BACKGROUND/AIMS: To evaluate maternal birth and neonatal outcomes among women with gestational diabetes mellitus (GDM), but without specific medical conditions and eligible for vaginal birth who underwent induction of labour (IOL) at term compared with those who were expectantly managed. MATERIALS AND METHODS: Population-based cohort study of women with GDM, but without medical conditions, who had a singleton, cephalic birth at 38-41 completed weeks gestation, in New South Wales, Australia between January 2010 and December 2016. Women who underwent IOL at 38, 39, 40 weeks gestation (38-, 39-, 40-induction groups) were compared with those who were managed expectantly and gave birth at and/or beyond the respective gestational age group (38-, 39-, 40-expectant groups). Multivariable logistic regression analysis was used to assess the association between IOL and adverse maternal birth and neonatal outcomes taking into account potential confounding by maternal age, country of birth, smoking, residential location, residential area of socioeconomic disadvantage and birth year. RESULTS: Of 676 762 women who gave birth during the study period, 66 606 (10%) had GDM; of these, 34799 met the inclusion criteria. Compared with expectant management, those in 38- (adjusted odds ratio (aOR) 1.11; 95% CI, 1.04-1.18), 39- (aOR 1.21; 95% CI, 1.14-1.28) and 40- (aOR 1.50; 95% CI, 1.40-1.60) induction groups had increased risk of caesarean section. Women in the 38-induction group also had an increased risk of composite neonatal morbidity (aOR 1.10; 95% CI, 1.01-1.21), which was not observed at 39- and 40-induction groups. We found no difference between groups in perinatal death or neonatal intensive care unit admission for births at any gestational age. CONCLUSION: In women with GDM but without specific medical conditions and eligible for vaginal birth, IOL at 38, 39, 40 weeks gestation is associated with an increased risk of caesarean section.

"Dietitians May Only Have One Chance"-The Realities of Treating Obesity in Private Practice in Australia.

INTRODUCTION: Overweight and obesity are the leading contributors to non-fatal burden of disease in Australia. Very low energy diets (VLEDs) comprising of meal replacement products (MRP) effectively induce substantial weight loss in people with obesity, yet they are rarely used as a first line treatment. Dietitians in private practice are perfectly placed to administer treatments for obesity; however, little is known about the preferred interventions used or their attitudes to incorporating VLEDs and MRPs into their treatments for overweight and obesity. METHODS: This study used descriptive qualitative methods to explore accredited practicing dietitians' (APDs') perspectives and practices regarding obesity and obesity interventions, including the use of VLEDs and MRPs. Qualitative in-depth semi-structured interviews were conducted with 20 dietitians who had experience in private practice and in treating obesity. Transcribed interviews were analysed thematically using the technique of template analysis. RESULTS: In the context within which dietitians' practice was found to be a barrier to using evidence-based practice (EBP) for obesity treatment, four overarching themes were found. These were: (1) patient-centred care is the dietitians' preferred intervention model; (2) VLEDs promote weight loss in specific situations; (3) systemic barriers constrain effective dietetic practice and equitable access to all, and (4) successful outcomes are predicated on working outside of systemic barriers. CONCLUSION: Dietitians in private practice are well placed and able to provide life-enhancing and evidence-based treatments for overweight and obesity and associated chronic disease in the community. However, systemic barriers need to be addressed to provide equitable access to effective care irrespective of socio-economic status.

Effect of severe compared with moderate energy restriction on physical activity among postmenopausal female adults with obesity: a prespecified secondary analysis of the Type of Energy Manipulation for Promoting optimum metabolic health and body composition in Obesity (TEMPO) Diet randomized controlled Trial.

BACKGROUND: An under-explored strategy for increasing physical activity is the dietary treatment of obesity, but empirical evidence is lacking. OBJECTIVES: We aimed to compare the effects of weight loss via severe as opposed to moderate energy restriction on physical activity over 36 mo. METHODS: A total of 101 postmenopausal female adults (45-65 y, BMI 30-40 kg/m2, <180 min/wk of structured exercise) were randomly assigned to either 12 mo of moderate energy restriction (25%-35% of energy requirement) with a food-based diet, or a severe intervention involving 4 mo of severe energy restriction (65%-75% of energy requirement) with a total meal replacement diet, followed by 8 mo of moderate energy restriction. Physical activity was encouraged, but no tailored or supervised exercise prescription was provided. Physical activity was assessed with an accelerometer worn for 7 d before baseline (0 mo) and 0.25, 1, 4, 6, 12, 24, and 36 mo after intervention commencement. RESULTS: Compared with the moderate group, the severe group exhibited greater mean: total volume of physical activity; duration of moderate-to-vigorous-intensity physical activity (MVPA); duration of light-intensity physical activity; step counts, as well as lower mean duration of sedentary time. All these differences (except step counts) were apparent at 6 mo [e.g., 1006 metabolic equivalent of task (MET)-min/wk; 95% CI: 564, 1449 MET-min/wk for total volume of physical activity], and some were also apparent at 4 and/or 12 mo. There were no differences between groups in the 2 other outcomes investigated (self-efficacy to regulate exercise; and proportion of participants meeting the WHO's 2020 Physical Activity Guidelines for MVPA). When the analyses were adjusted for weight at each time point, the differences between groups were either attenuated or abolished. CONCLUSIONS: Among female adults with obesity, including a dietary component to reduce excess body weight-notably one involving severe energy restriction-could potentially enhance the effectiveness of physical activity interventions.This trial was registered at www.anzctr.org.au as ACTRN12612000651886.

Diet Quality following Total Meal Replacement Compared with Food-Based Weight-Loss Diets in Postmenopausal Women with Obesity: A Secondary Analysis of the TEMPO Diet Trial.

BACKGROUND: Severely energy-restricted diets that utilize meal-replacement products are the most effective dietary treatment for obesity. However, there are concerns they may fail to educate individuals on how to adopt a healthy food-based diet after weight loss. OBJECTIVES: The aim of this research was to compare changes in diet quality following total meal replacement compared with food-based weight-loss diets. METHODS: In this secondary analysis of a randomized controlled trial, 79 postmenopausal women aged 45-65 y, with a BMI (in kg/m2) of 30-40, were randomly assigned to either a total meal-replacement diet (energy intake restricted by 65-75% relative to requirements) for 16 wks, followed by a food-based diet (energy intake restricted by 25-35% relative to requirements) until 52 wks, or the food-based diet for the entire 52-wk period. Diet quality was scored at baseline and 52 wks using the Healthy Eating Index for Australian Adults, with score changes compared between groups using an independent t test. RESULTS: Diet quality improved from baseline in both groups, but less so in the total meal-replacement group, with a mean (SD) increase of 3.6 (10.8) points compared with 11.8 (13.9) points in the food-based group, resulting in a mean between-group difference of -8.2 (P = 0.004; 95% CI: -13.8, -2.7) points. This improvement in diet quality within both groups was mostly driven by a reduction in the intake of discretionary foods. Intake remained below the recommendations at 52 wks for 4 of the 5 food groups in both dietary interventions. CONCLUSIONS: In postmenopausal women with obesity, weight-loss interventions that involve either a total meal-replacement diet or a food-based diet both improve diet quality, however, not sufficiently to meet recommendations. This highlights the importance of addressing diet quality as a part of all dietary weight-loss interventions. This trial is registered with the Australia and New Zealand Clinical Trials Registry as 12612000651886.

Corrigendum: A High-Protein, Low Glycemic Index Diet Suppresses Hunger but Not Weight Regain After Weight Loss: Results From a Large, 3-Years Randomized Trial (PREVIEW).

[This corrects the article DOI: 10.3389/fnut.2021.685648.].

A High-Protein, Low Glycemic Index Diet Suppresses Hunger but Not Weight Regain After Weight Loss: Results From a Large, 3-Years Randomized Trial (PREVIEW).

Background: Previous studies have shown an increase in hunger during weight-loss maintenance (WLM) after diet-induced weight loss. Whether a combination of a higher protein, lower glycemic index (GI) diet and physical activity (PA) can counteract this change remains unclear. Aim: To compare the long-term effects of two diets [high protein (HP)-low GI vs. moderate protein (MP)-moderate GI] and two PA programs [high intensity (HI) vs. moderate intensity (MI)] on subjective appetite sensations during WLM after ≥8% weight loss (WL). Methods: Data derived from the 3-years PREVIEW randomized intervention study. An 8-weeks WL phase using a low-energy diet was followed by a 148-weeks randomized WLM phase. For the WLM phase, participants were assigned to one of the four groups: HP-MI, HP-HI, MP-MI, and MP-HI. Available data from 2,223 participants with overweight or obesity (68% women; BMI ≥ 25 kg/m2). Appetite sensations including satiety, hunger, desire to eat, and desire to eat something sweet during the two phases (at 0, 8 weeks and 26, 52, 104, and 156 weeks) were assessed based on the recall of feelings during the previous week using visual analogue scales. Differences in changes in appetite sensations from baseline between the groups were determined using linear mixed models with repeated measures. Results: There was no significant diet × PA interaction. From 52 weeks onwards, decreases in hunger were significantly greater in HP-low GI than MP-moderate GI (P time × diet = 0.018, P dietgroup = 0.021). Although there was no difference in weight regain between the diet groups (P time × diet = 0.630), hunger and satiety ratings correlated with changes in body weight at most timepoints. There were no significant differences in appetite sensations between the two PA groups. Decreases in hunger ratings were greater at 52 and 104 weeks in HP-HI vs. MP-HI, and greater at 104 and 156 weeks in HP-HI vs. MP-MI. Conclusions: This is the first long-term, large-scale randomized intervention to report that a HP-low GI diet was superior in preventing an increase in hunger, but not weight regain, during 3-years WLM compared with a MP-moderate GI diet. Similarly, HP-HI outperformed MP-HI in suppressing hunger. The role of exercise intensity requires further investigation. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT01777893.

Can a Higher Protein/Low Glycemic Index vs. a Conventional Diet Attenuate Changes in Appetite and Gut Hormones Following Weight Loss? A 3-Year PREVIEW Sub-study.

Background: Previous research showed that weight-reducing diets increase appetite sensations and/or circulating ghrelin concentrations for up to 36 months, with transient or enduring perturbations in circulating concentrations of the satiety hormone peptide YY. Objective: This study assessed whether a diet that is higher in protein and low in glycemic index (GI) may attenuate these changes. Methods: 136 adults with pre-diabetes and a body mass index of ≥25 kg/m2 underwent a 2-month weight-reducing total meal replacement diet. Participants who lost ≥8% body weight were randomized to one of two 34-month weight-maintenance diets: a higher-protein and moderate-carbohydrate (CHO) diet with low GI, or a moderate-protein and higher-CHO diet with moderate GI. Both arms involved recommendations to increase physical activity. Fasting plasma concentrations of total ghrelin and total peptide YY, and appetite sensations, were measured at 0 months (pre-weight loss), at 2 months (immediately post-weight loss), and at 6, 12, 24, and 36 months. Results: There was a decrease in plasma peptide YY concentrations and an increase in ghrelin after the 2-month weight-reducing diet, and these values approached pre-weight-loss values by 6 and 24 months, respectively (P = 0.32 and P = 0.08, respectively, vs. 0 months). However, there were no differences between the two weight-maintenance diets. Subjective appetite sensations were not affected by the weight-reducing diet nor the weight-maintenance diets. While participants regained an average of ~50% of the weight they had lost by 36 months, the changes in ghrelin and peptide YY during the weight-reducing phase did not correlate with weight regain. Conclusion: A higher-protein, low-GI diet for weight maintenance does not attenuate changes in ghrelin or peptide YY compared with a moderate-protein, moderate-GI diet. Clinical Trial Registry: ClinicalTrials.gov registry ID NCT01777893 (PREVIEW) and ID NCT02030249 (Sub-study).

Does volume or occupancy influence emergency access block? A multivariate time series analysis from a single emergency department in Sydney, Australia during the COVID-19 pandemic.

OBJECTIVE: The study aims to determine whether ED presentation volume or hospital occupancy had a greater impact on ED performance before and during the COVID-19 health response at a tertiary referral hospital in Sydney, Australia. METHODS: Single centre time series analysis using routinely collected hospital and ED data from January 2019 to September 2020. The primary outcome was ED access block measured by emergency treatment performance (ETP; i.e. percentage of patients who were discharged or transferred to a ward from ED within 4 h of ED arrival time). Secondary outcomes were hospital occupancy, elective theatre cases and ambulance ramping. Multivariate time series analysis was performed using vector autoregression, to model effects of changes in various endogenous and correlated variables on ETP. RESULTS: There was an increase in ETP, drop in ED presentations and decrease in hospital occupancy between April and June 2020. Elective surgery and hospital occupancy had significant effects up to 2 days prior on ETP, while there were no significant effects of either ED or ambulance presentations on ETP. Hospital occupancy itself increased with ED presentations after 2-4 days and decreased with elective surgery after 1 day. Shocks (a one standard deviation increase) in hospital occupancy had a peak impact nearly two times greater compared to ED presentations (-1.43, 95% confidence interval -1.92, -0.93 vs -0.73, 95% confidence interval -1.21, -0.25). CONCLUSION: The main determinants of the reduction of ED overcrowding and access block during the pandemic were associated with reductions in hospital occupancy and elective surgery levels, and more research is required to assess more complex associations beyond the scope of this manuscript.

Urine dipsticks are not accurate for detecting mild ketosis during a severely energy restricted diet.

BACKGROUND: Detection of the mild ketosis induced by severely energy-restricted diets may be a clinically useful way to monitor and promote dietary adherence. Mild ketosis is often assessed using urine dipsticks, but accuracy for this purpose has not been tested. OBJECTIVE: To determine the accuracy of urine dipsticks to detect mild ketosis during adherence to a severely energy-restricted diet. METHODS: Two hundred and sixty three (263) fasting urine and 263 fasting blood samples were taken from 50 women (mean [standard deviation, SD] age 58.0 [4.3] years and body mass index 34.3 [2.4] kg/m2) before and at six time points during or for up to 10 weeks after 16 weeks of severe energy restriction, achieved with a total meal replacement diet. The amount of ketones (acetoacetate) in the urine was classified as '0 (Negative)', '+/- (Trace)', '+ (Weak)' or '++ (Medium)' by urine dipsticks (Ketostix, Bayer). The concentration of ketones (ß-hydroxybutyrate) in the blood was measured with our reference method, a portable ketone monitor (FreeStyle Optium, Abbott). The diagnostic accuracy of the urine dipsticks was assessed from the percent of instances when a person was actually 'in ketosis' (as defined by a blood ß-hydroxybutyrate concentration at or above three different thresholds) that were also identified by the urine dipsticks as being from a person in ketosis (the percent 'true positives' or sensitivity), as well as the percent of instances when a person was not in ketosis (as defined by the blood monitor result) was correctly identified as such with the urine dipstick (the percent 'true negatives' or specificity). Thresholds of ≥0.3mM, ≥0.5mM or ≥1.0mM were selected, because mean blood concentrations of ß-hydroxybutyrate during ketogenic diets are approximately 0.5mM. Sensitivity and specificity were then used to generate receiver operating characteristic curves, with the area under these curves indicating the ability of the dipsticks to correctly identify people in ketosis (1 = perfect results, 0.5 = random results). RESULTS: At threshold blood ß-hydroxybutyrate concentrations of ≥0.3mM, ≥0.5mM and ≥1.0mM, the sensitivity of the urine dipsticks was 35%, 52% and 76%; the specificity was 100%, 97% and 78%; and the area under the receiver operating characteristic curves was 0.67, 0.74 and 0.77, respectively. These low levels of sensitivity mean that 65%, 48% or 24% of the instances when a person was in ketosis were not detected by the urine dipsticks. CONCLUSION: Urine dipsticks are not an accurate or clinically useful means of detecting mild ketosis in people undergoing a severely energy-restricted diet and should thus not be recommended in clinical treatment protocols. If monitoring of mild ketosis is indicated (eg, to monitor or help promote adherence to a severely energy-restricted diet), then blood monitors should be used instead.

3-Year effect of weight loss via severe versus moderate energy restriction on body composition among postmenopausal women with obesity - the TEMPO Diet Trial.

We have previously shown that a severely energy-restricted diet leads to greater loss of weight, fat, lean mass and bone mineral density (BMD) at 12 months in postmenopausal women with obesity than a moderately energy-restricted diet. We now aim to evaluate whether these effects are sustained longer term (ie, at 36 months). 101 postmenopausal women were randomized to either 12 months of moderate (25 to 35%) energy restriction with a food-based diet (moderate intervention), or 4 months of severe (65 to 75%) energy restriction with a total meal replacement diet followed by moderate energy restriction for 8 months (severe intervention). Body weight and composition were measured at 0, 24 and 36 months. Participants in the severe intervention lost ~1.5 to 1.7 times as much weight, waist circumference, whole-body fat mass and visceral adipose tissue compared to those in the moderate intervention, and were 2.6 times more likely (42% versus 16%) to have lost 10% or more of their initial body weight at 36 months (P < 0.01 for all). However, those in the severe versus moderate intervention lost ~1.4 times as much whole-body lean mass (P < 0.01), albeit this was proportional to total weight lost and there was no greater loss of handgrip strength, and they also lost ~2 times as much total hip BMD between 0 and 36 months (P < 0.05), with this bone loss occurring in the first 12 months. Thus, severe energy restriction is more effective than moderate energy restriction for reducing weight and adiposity in postmenopausal women in the long term (3 years), but attention to BMD loss in the first year is required. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry Reference Number: 12612000651886, anzctr.org.au.

Effect of Weight Loss via Severe vs Moderate Energy Restriction on Lean Mass and Body Composition Among Postmenopausal Women With Obesity: The TEMPO Diet Randomized Clinical Trial.

Importance: Severely energy-restricted diets are the most effective dietary obesity treatment. However, there are concerns regarding potential adverse effects on body composition. Objective: To compare the long-term effects of weight loss via severe vs moderate energy restriction on lean mass and other aspects of body composition. Design, Setting, and Participants: The Type of Energy Manipulation for Promoting Optimum Metabolic Health and Body Composition in Obesity (TEMPO) Diet Trial was a 12-month, single-center, randomized clinical trial. A total of 101 postmenopausal women, aged 45 to 65 years with body mass index (calculated as weight in kilograms divided by height in meters squared) from 30 to 40, who were at least 5 years after menopause, had fewer than 3 hours of structured physical activity per week, and lived in the Sydney metropolitan area of New South Wales, Australia, were recruited between March 2013 and July 2016. Data analysis was conducted between October 2018 and August 2019. Intervention: Participants were randomized to either 12 months of moderate (25%-35%) energy restriction with a food-based diet (moderate intervention) or 4 months of severe (65%-75%) energy restriction with a total meal replacement diet followed by moderate energy restriction for an additional 8 months (severe intervention). Both interventions had a prescribed protein intake of 1.0 g/kg of actual body weight per day, and physical activity was encouraged but not supervised. Main Outcomes and Measures: The primary outcome was whole-body lean mass at 12 months after commencement of intervention. Secondary outcomes were body weight, thigh muscle area and muscle function (strength), bone mineral density, and fat mass and distribution, measured at 0, 4, 6, and 12 months. Results: A total of 101 postmenopausal women were recruited (mean [SD] age, 58.0 [4.2] years; mean [SD] weight, 90.8 [9.1] kg; mean [SD] body mass index, 34.4 [2.5]). Compared with the moderate group at 12 months, the severe group lost more weight (effect size, -6.6 kg; 95% CI, -8.2 to -5.1 kg), lost more whole-body lean mass (effect size, -1.2 kg; 95% CI, -2.0 to -0.4 kg), and lost more thigh muscle area (effect size, -4.2 cm2; 95% CI, -6.5 to -1.9 cm2). However, decreases in whole-body lean mass and thigh muscle area were proportional to total weight loss, and there was no difference in muscle (handgrip) strength between groups. Total hip bone mineral density (effect size, -0.017 g/cm2; 95% CI, -0.029 to -0.005 g/cm2), whole-body fat mass (effect size, -5.5 kg; 95% CI, -7.1 to -3.9 kg), abdominal subcutaneous adipose tissue (effect size, -1890 cm3; 95% CI, -2560 to -1219 cm3), and visceral adipose tissue (effect size, -1389 cm3; 95% CI, -1748 to -1030 cm3) loss were also greater for the severe group than for the moderate group at 12 months. Conclusions and Relevance: Severe energy restriction had no greater adverse effect on relative whole-body lean mass or handgrip strength compared with moderate energy restriction and was associated with 2-fold greater weight and fat loss over 12 months. However, there was significantly greater loss of total hip bone mineral density with severe vs moderate energy restriction. Therefore, caution is necessary when implementing severe energy restriction in postmenopausal women, particularly those with osteopenia or osteoporosis. Trial Registration: anzctr.org.au Identifier: 12612000651886.

Less Binge Eating and Loss of Control over Eating Are Associated with Greater Levels of Mindfulness: Identifying Patterns in Postmenopausal Women with Obesity.

Obesity is a public health concern resulting in widespread personal, social, and economic burden. Many individuals with obesity report feeling unable to stop eating or to control their food intake (i.e., a loss of control over eating) despite their best efforts. Experiencing loss of control over eating predicts further eating pathology and is a key feature of binge eating. Mindfulness (i.e., awareness and acceptance of current thoughts, feelings, sensations, and surrounding events) has emerged as a potential strategy to treat such eating disorder behaviors, but it is not known whether there is merit in investigating this strategy to address binge eating in postmenopausal women with obesity. Thus, this study aimed to examine the relationships between binge eating and mindfulness in postmenopausal women with obesity seeking weight loss treatment. Participants (n = 101) were assessed with the Eating Disorder Examination Questionnaire, the Loss of Control over Eating Scale, the Five-Facet Mindfulness Questionnaire, and the Langer Mindfulness Scale. Participants´ overall scores on both mindfulness scales were significantly and negatively correlated with binge eating frequency or the severity of loss of control over eating. Moreover, participants who reported fewer binge eating episodes were significantly more mindful than those who reported greater frequencies of binge eating episodes within the past 28 days. These findings suggest a merit in investigating the use of mindfulness-based therapies to treat binge eating in postmenopausal women with obesity.

Effect of Ramadan Fasting on Weight and Body Composition in Healthy Non-Athlete Adults: A Systematic Review and Meta-Analysis.

BACKGROUND: Ramadan involves one month of fasting from sunrise to sunset. In this meta-analysis, we aimed to determine the effect of Ramadan fasting on weight and body composition. METHODS: In May 2018, we searched six databases for publications that measured weight and body composition before and after Ramadan, and that did not attempt to influence physical activity or diet. RESULTS: Data were collected from 70 publications (90 comparison groups, 2947 participants). There was a significant positive correlation between starting body mass index and weight lost during the fasting period. Consistently, there was a significant reduction in fat percentage between pre-Ramadan and post-Ramadan in people with overweight or obesity (-1.46 (95% confidence interval: -2.57 to -0.35) %, p = 0.010), but not in those of normal weight (-0.41 (-1.45 to 0.63) %, p = 0.436). Loss of fat-free mass was also significant between pre-Ramadan and post-Ramadan, but was about 30% less than loss of absolute fat mass. At 2⁻5 weeks after the end of Ramadan, there was a return towards, or to, pre-Ramadan measurements in weight and body composition. CONCLUSIONS: Even with no advice on lifestyle changes, there are consistent-albeit transient-reductions in weight and fat mass with the Ramadan fast, especially in people with overweight or obesity.

Rationale and Protocol for a Randomized Controlled Trial Comparing Fast versus Slow Weight Loss in Postmenopausal Women with Obesity-The TEMPO Diet Trial.

Very low energy diets (VLEDs), commonly achieved by replacing all food with meal replacement products and which result in fast weight loss, are the most effective dietary obesity treatment available. VLEDs are also cheaper to administer than conventional, food-based diets, which result in slow weight loss. Despite being effective and affordable, these diets are underutilized by healthcare professionals, possibly due to concerns about potential adverse effects on body composition and eating disorder behaviors. This paper describes the rationale and detailed protocol for the TEMPO Diet Trial (Type of Energy Manipulation for Promoting optimal metabolic health and body composition in Obesity), in a randomized controlled trial comparing the long-term (3-year) effects of fast versus slow weight loss. One hundred and one post-menopausal women aged 45⁻65 years with a body mass index of 30⁻40 kg/m² were randomized to either: (1) 16 weeks of fast weight loss, achieved by a total meal replacement diet, followed by slow weight loss (as for the SLOW intervention) for the remaining time up until 52 weeks ("FAST" intervention), or (2) 52 weeks of slow weight loss, achieved by a conventional, food-based diet ("SLOW" intervention). Parameters of body composition, cardiometabolic health, eating disorder behaviors and psychology, and adaptive responses to energy restriction were measured throughout the 3-year trial.

Recruitment Strategies for a Randomised Controlled Trial Comparing Fast Versus Slow Weight Loss in Postmenopausal Women with Obesity-The TEMPO Diet Trial.

Current research around effective recruitment strategies for clinical trials of dietary obesity treatments have largely focused on younger adults, and thus may not be applicable to older populations. The TEMPO Diet Trial (Type of Energy Manipulation for Promoting optimal metabolic health and body composition in Obesity) is a randomised controlled trial comparing the long-term effects of fast versus slow weight loss on body composition and cardio-metabolic health in postmenopausal women with obesity. This paper addresses the recruitment strategies used to enrol participants into this trial and evaluates their relative effectiveness. 101 post-menopausal women aged 45⁻65 years, with a body mass index of 30⁻40 kg/m² were recruited and randomised to either fast or slow weight loss. Multiple strategies were used to recruit participants. The total time cost (labour) and monetary cost per randomised participant from each recruitment strategy was estimated, with lower values indicating greater cost-effectiveness and higher values indicating poorer cost-effectiveness. The most cost-effective recruitment strategy was word of mouth, followed (at equal second place) by free publicity on TV and radio, and printed advertorials, albeit these avenues only yielded 26/101 participants. Intermediate cost-effective recruitment strategies were flyer distribution at community events, hospitals and a local tertiary education campus, internet-based strategies, and clinical trial databases and intranets, which recruited a further 40/101 participants. The least cost-effective recruitment strategy was flyer distribution to local health service centres and residential mailboxes, and referrals from healthcare professionals were not effective. Recruiting for clinical trials involving postmenopausal women could benefit from a combination of recruitment strategies, with an emphasis on word of mouth and free publicity via radio, TV, and print media, as well as strategic placement of flyers, supplemented with internet-based strategies, databases and intranets if a greater yield of participants is needed.