Patient and healthcare practitioner evaluation of patient-reported outcomes in bariatric surgery - a modified Delphi study.

BACKGROUND: Patient-reported outcomes are an important emerging metric increasingly utilised in clinical, research and registry settings. These outcomes, while vital, are underutilised and require refinement for the specific patient population of those undergoing bariatric surgery. This study aimed to investigate and compare how pre-surgical patients, post-surgical patients, and healthcare practitioners evaluate patient-reported outcomes of bariatric surgery to identify outcomes that are considered most important. METHODS: A modified Delphi survey was distributed to patients pre- and post-surgery, and to a variety of healthcare practitioners involved in bariatric care. Across two rounds, participants were asked to rate a variety of physical and psychosocial outcomes of bariatric surgery from 0 (Not Important) to 10 (Extremely Important). Outcomes rated 8-10 by at least 70% of participants were considered highly important (prioritised). The highest-rated outcomes were compared between the three groups as well as between medical and allied health practitioner subgroups. RESULTS: 20 pre-surgical patients, 95 post-surgical patients, and 28 healthcare practitioners completed both rounds of the questionnaire. There were 58 outcomes prioritised, with 21 outcomes (out of 90, 23.3%) prioritised by all three groups, 13 (14.4%) by two groups, and 24 (26.7%) prioritised by a single group or subgroup. Unanimously prioritised outcomes included 'Co-morbidities', 'General Physical Health', 'Overall Quality of Life' and 'Overall Mental Health'. Discordant outcomes included 'Fear of Weight Regain', 'Suicidal Thoughts', 'Addictive Behaviours', and 'Experience of Stigma or Discrimination'. CONCLUSION: While there was considerable agreement between stakeholder groups on many outcomes, there remain several outcomes with discordant importance valuations that must be considered. In particular, healthcare practitioners prioritised 20 outcomes that were not prioritised by patients, emphasising the range of priorities across stakeholder groups. Future work will consider these priorities to ensure resulting measures encompass all important outcomes and are beneficial and valid for end users.

Young children's choices and thoughts about pro-social behaviour towards others with overweight.

OBJECTIVES: This study aimed to investigate weight bias within young children's pro-social choices between characters who differed in body size. METHODS: Seventy-six children aged 4-6 years read stories asking them to choose who they would first help, share with, comfort, and steal from, between a healthy weight and child with overweight. They also selected the one character they would most like to play with. Children's reasoning for these choices was recorded and analysed. RESULTS: The character with overweight was helped first in only a third of the choices made. Children chose the characters with overweight more often as the target for anti-social action. In friendship selections, children overwhelmingly rejected the characters with overweight. However, weight bias was not prominent in the reasons children gave for the choices. Most children were not negative about body shape, weight or appearance. Similarly, in friendship choices, these were mostly expressed positively to the character chosen. Only a small minority of children were explicitly negative about the character with overweight. CONCLUSIONS: A better understanding of weight bias acquisition and variation between children will benefit those working in health care and educational settings. Future research should link with developmental theory, such as on social categorization and theory of mind.

Cost-effectiveness analysis of recruitment strategies in a large diabetes prevention trial conducted across two sites in Sydney, Australia.

BACKGROUND: Diabetes prevention trials require large samples and community-based recruitment, which can be protracted and expensive. We analysed the cost-effectiveness of recruitment strategies used in a randomised placebo-controlled supplement trial in adults with prediabetes and overweight or obesity conducted in Sydney, Australia. METHODS: Recruitment strategies included advertising through local radio stations and newspapers, television news coverage, online advertising and editorials, advertising in and referral from primary care settings, university- and hospital-based advertising, and attending or hosting local events. For each strategy, the number of expressions of interest, screenings booked, and randomised participants were collated. The percentage contribution from each strategy, overall cost, and cost per participant were calculated. RESULTS: Of 4498 expressions of interest, 551 (12%) were eligible for onsite screening and 401 (9%) were randomised. Recruitment costs totalled AU$218,501, averaging AU$545 per participant. The recruitment strategy was recorded for 49% who expressed interest in the trial, and for 75% randomised into the trial. From these data, advertising on local radio stations was the most cost-effective strategy, contributing 46% of participants at AU$286 per participant, then advertising in and referral from primary care settings (57 participants [19%], AU$1438 per participant). The least cost-effective strategy was television news coverage, which was not targeted to the Sydney-based audience, contributing only six participants (AU$10,000 per participant). CONCLUSION: Radio advertising and recruitment through healthcare were the most effective recruitment strategies in this trial. Recruitment strategies should be location-specific and appropriate for the target population, prioritising low-effort high-yield strategies. Trial investigators should seek opportunities for free advertising.

Barriers to progression through Australian obesity management pathways: Survey data from the ACTION-IO study.

BACKGROUND AND OBJECTIVES: Our previous work uncovered a nine-year delay, from when Australian people with obesity (PwO) first began struggling with excess weight and first discussed weight with a healthcare professional (HCP). In this study we explore barriers to having an obesity consultation, making and discussing the diagnosis of obesity and arranging a management plan, including a follow-up appointment. METHOD: Australian PwO (n = 1000) and HCPs (n = 200; 50% general practitioners [GPs]), completed the Awareness, Care & Treatment In Obesity Management - An International Observation (ACTION-IO) online survey. RESULTS: Of Australian PwO, 53% had discussed weight with an HCP in the past five years, 25% were informed of their obesity diagnosis and 15% had weight-related follow-up appointments scheduled. Fewer GPs than other specialists reported recording obesity diagnoses, but GPs scheduled more follow-up appointments. Receiving formal obesity training was reported by 22% of GPs and 44% of other specialists. DISCUSSION: Barriers to obesity care in Australia include unrealistic expectations from both PwO and HCPs, lack of evidence-based strategies and insufficient training. Further exploration of barriers is required.

Incidence of adverse mental health outcomes after sleeve gastrectomy compared with gastric bypass and restrictive bariatric procedures: a retrospective cohort study.

OBJECTIVE: This study examined rates of suicide and hospitalization with psychiatric diagnoses after sleeve gastrectomy compared with gastric bypass and restrictive procedures (gastric banding/gastroplasty). METHODS: This was a longitudinal retrospective cohort study comprising all patients who underwent primary bariatric surgery in New South Wales or Queensland, Australia, between July 2001 and December 2020. Hospital admission records, death registration, and cause of death records (if applicable) within these dates were extracted and linked. Primary outcome was death by suicide. Secondary outcomes were admissions with self-harm; substance-use disorder, schizophrenia, mood, anxiety, behavioral, and personality disorders; any of these; and psychiatric inpatient admission. RESULTS: A total of 121,203 patients were included, with median follow-up of 4.5 years per patient. There were 77 suicides, with no evidence of difference in rates by surgery type (rates [95% CI] per 100,000 person years: 9.6 [5.0-18.4] restrictive, 10.8 [8.4-13.9] sleeve gastrectomy, 20.4 [9.7-42.8] gastric bypass; p = 0.18). Rates of admission with self-harm declined after restrictive and sleeve procedures. Admission with anxiety disorders, any psychiatric diagnosis, and as a psychiatric inpatient increased after sleeve gastrectomy and gastric bypass, but not restrictive procedures. Admissions with substance-use disorder increased after all surgery types. CONCLUSIONS: Variable associations between bariatric surgeries and hospitalization with psychiatric diagnoses might indicate distinct vulnerabilities among patient cohorts or that differing anatomical and/or functional changes may contribute to effects on mental health.

Changes in Prediabetes Status Among Adults During a 6-Month Randomized Placebo-controlled Supplement Trial With Nutrition and Lifestyle Counselling and 6-Month Follow-up.

OBJECTIVES: In this work, we present an exploratory within-trial analysis of the changing prevalence of prediabetes in response to nutrition and lifestyle counselling provided as part of a randomized placebo-controlled supplement trial with follow-up. We aimed to identify factors associated with changing glycemia status. METHODS: Participants (n=401) in this clinical trial were adults with a body mass index (BMI) of ≥25 kg/m2 and prediabetes (defined by the American Diabetes Association as a fasting plasma glucose [FPG] of 5.6 to 6.9 mmol/L or a glycated hemoglobin [A1C] of 5.7% to 6.4%) within 6 months before trial entry. The trial consisted of a 6-month randomized intervention with 2 dietary supplements and/or placebo. At the same time, all participants received nutrition and lifestyle counselling. This was followed by a 6-month follow-up. Glycemia status was assessed at baseline and at 6 and 12 months. RESULTS: At baseline, 226 participants (56%) met a threshold for prediabetes, including 167 (42%) with elevated FPG and 155 (39%) with elevated A1C. After the 6-month intervention, the prevalence of prediabetes decreased to 46%, driven by a reduction in prevalence of elevated FPG to 29%. The prevalence of prediabetes then increased to 51% after follow-up. Risk of prediabetes was associated with older age (odds ratio [OR], 1.05; p<0.01), BMI (OR, 1.06; p<0.05), and male sex (OR, 1.81; p=0.01). Participants who reverted to normoglycemia had greater weight loss and lower baseline glycemia. CONCLUSIONS: Glycemia status can fluctuate over time and improvements can be gained from lifestyle interventions, with certain factors associated with a higher likelihood of reverting to normoglycemia.

Patients with treated indolent lymphomas immunized with BNT162b2 have reduced anti-spike neutralizing IgG to SARS-CoV-2 variants, but preserved antigen-specific T cell responses.

Patients with indolent lymphoma undertaking recurrent or continuous B cell suppression are at risk of severe COVID-19. Patients and healthy controls (HC; N = 13) received two doses of BNT162b2: follicular lymphoma (FL; N = 35) who were treatment naïve (TN; N = 11) or received immunochemotherapy (ICT; N = 23) and Waldenström's macroglobulinemia (WM; N = 37) including TN (N = 9), ICT (N = 14), or treated with Bruton's tyrosine kinase inhibitors (BTKi; N = 12). Anti-spike immunoglobulin G (IgG) was determined by a high-sensitivity flow-cytometric assay, in addition to live-virus neutralization. Antigen-specific T cells were identified by coexpression of CD69/CD137 and CD25/CD134 on T cells. A subgroup (N = 29) were assessed for third mRNA vaccine response, including omicron neutralization. One month after second BNT162b2, median anti-spike IgG mean fluorescence intensity (MFI) in FL ICT patients (9977) was 25-fold lower than TN (245 898) and HC (228 255, p = .0002 for both). Anti-spike IgG correlated with lymphocyte count (r = .63; p = .002), and time from treatment (r = .56; p = .007), on univariate analysis, but only with lymphocyte count on multivariate analysis (p = .03). In the WM cohort, median anti-spike IgG MFI in BTKi patients (39 039) was reduced compared to TN (220 645, p = .0008) and HC (p < .0001). Anti-spike IgG correlated with neutralization of the delta variant (r = .62, p < .0001). Median neutralization titer for WM BTKi (0) was lower than HC (40, p < .0001) for early-clade and delta. All cohorts had functional T cell responses. Median anti-spike IgG decreased 4-fold from second to third dose (p = .004). Only 5 of 29 poor initial responders assessed after third vaccination demonstrated seroconversion and improvement in neutralization activity, including to the omicron variant.

Single-gene long-read sequencing illuminates Escherichia coli strain dynamics in the human intestinal microbiome.

Gut microbiome is of major interest due to its close relationship to health and disease. Bacteria usually vary in gene content, leading to functional variations within species, so resolution higher than species-level methods is needed for ecological and clinical relevance. We design a protocol to identify strains in selected species with high discrimination and in high numbers by amplicon sequencing of the flagellin gene. We apply the protocol to fecal samples from a human diet trial, targeting Escherichia coli. Across the 119 samples from 16 individuals, there are 1,532 amplicon sequence variants (ASVs), but only 32 ASVs are dominant in one or more fecal samples, despite frequent dominant strain turnover. Major strains in an intestine are found to be commonly accompanied by a large number of satellite cells, and many are identified as potential extraintestinal pathogens. The protocol could be used to track epidemics or investigate the intra- or inter-host diversity of pathogens.

Pfizer/BioNtech BNT162b2: adverse events and insights from an Australian mass vaccination clinic for COVID-19.

The Pfizer/BioNtech BNT162b2 is a major vaccine used in the Australian COVID-19 immunisation programme. We report on BNT162b2 safety in the observation period in a dedicated vaccination clinic linked to a quaternary teaching hospital. We performed a retrospective review of medical records for 57 842 vaccinations, and describe the model of care and adverse event rate at the clinic during its first 2 months of operation. A total of 243 adverse events following immunisation (0.42% of total vaccine doses) were recorded in the immediate observation period post-vaccination, which were predominantly immunisation stress-related responses. Of the 110 patients who experienced an adverse event with their first dose of the vaccine, 90% returned for their second dose of the vaccine, with 87% not reporting any further adverse reaction with the subsequent dose. Nineteen (0.03% of total doses) people were reviewed for an allergic reaction, of which 10 (53%) reported a history of prior allergies. A female predominance was present in both total adverse reactions (70%) and allergic vaccine reactions (79%). Only two patients experienced anaphylaxis (0.003% of total doses), in keeping with low rates of adverse reactions to the BNT162b2 vaccine in the current literature. Overall, the present study reinforces the safety of BNT162b2 in the Australian population, describes vaccination completion rates after adverse events and identifies predisposing factors for rare allergic reactions to the vaccine.

Cardiac and vascular health in late preterm infants.

Adults who were born preterm are at increased risk of hypertension and cardiovascular disease in later life. Infants born late preterm are the majority of preterm births; however, the effect of late preterm on risk of cardiovascular disease is unclear. The objective of this study was to assess whether vascular health and cardiac autonomic control differ in a group of late preterm newborn infants compared to a group of term-born infants.A total of 35 healthy late preterm newborn infants, with normal growth (34-36 completed weeks' gestation) and 139 term-born infants (37-42 weeks' gestation) were compared in this study. Aortic wall thickening, assessed as aortic intima-media thickness (IMT) by high-resolution ultrasound, and cardiac autonomic control, assessed by heart rate variability, were measured during the first week of life. Postnatal age of full-term and late preterm infants at the time of the study was 5 days (standard deviation [SD] 5) and 4 days (SD 3), respectively.Infants born late preterm show reduced aortic IMT (574 µm [SD 51] vs. 612 µm [SD 73]) and reduced heart rate variability [log total power 622.3 (606.5) ms2 vs. 1180. 6 (1114.3) ms2], compared to term infants. These associations remained even after adjustment for sex and birth weight.Infants born late preterm show selective differences in markers of cardiovascular risk, with potentially beneficial differences in aortic wall thickness in contrast to potentially detrimental differences in autonomic control, when compared with term-born control infants. These findings provide pathophysiologic evidence to support an increased risk of hypertension and sudden cardiac death in individuals born late preterm.

Association between Single Nucleotide Polymorphisms and Weight Reduction in Behavioural Interventions-A Pooled Analysis.

Knowledge of the association between single nucleotide polymorphisms (SNPs) and weight loss is limited. The aim was to analyse whether selected obesity-associated SNPs within the fat mass and obesity-associated (FTO), transmembrane protein 18 (TMEM18), melanocortin-4 receptor (MC4R), SEC16 homolog B (SEC16B), and brain-derived neurotrophic factor (BDNF) gene are associated with anthropometric changes during behavioural intervention for weight loss. genetic and anthropometric data from 576 individuals with overweight and obesity from four lifestyle interventions were obtained. A genetic predisposition score (GPS) was calculated. Our results show that study participants had a mean age of 48.2 ± 12.6 years and a mean baseline body mass index of 33.9 ± 6.4 kg/m2. Mean weight reduction after 12 months was -7.7 ± 10.9 kg. After 12 months of intervention, the MC4R SNPs rs571312 and rs17782313 were significantly associated with a greater decrease in body weight and BMI (p = 0.012, p = 0.011, respectively). The investigated SNPs within the other four genetic loci showed no statistically significant association with changes in anthropometric parameters. The GPS showed no statistically significant association with weight reduction. In conclusion there was no consistent evidence for statistically significant associations of SNPs with anthropometric changes during a behavioural intervention. It seems that other factors play a more significant in weight management than the investigated SNPs.

Effect of weight loss on cardiometabolic risk: observational analysis of two randomised controlled trials of community weight-loss programmes.

BACKGROUND: Guidelines recommend that clinicians identify individuals at high cardiometabolic risk and support weight loss in those with overweight or obesity. However, we lack individual level data quantifying the benefits of weight change for individuals to guide consultations in primary care. AIM: To examine how weight change affects cardiometabolic risk factors, and to facilitate shared decision making between patients and clinicians regarding weight loss. DESIGN AND SETTING: Observational analysis using data from two trials of referral of individuals with overweight or obesity in primary care to community weight-loss groups. METHOD: Linear mixed effects regression modelling examining the association between weight change and change in systolic blood pressure (SBP), diastolic blood pressure (DBP), fasting glucose, glycated haemoglobin (HbA1c), and lipid profile across multiple timepoints (baseline to 24 months). Subgroup analyses examined changes in individuals with hypertension, diabetes, and hyperlipidaemia. RESULTS: In total, 2041 participants had a mean (standard deviation) age of 50 (SD 13.5) years, mean baseline weight of 90.6 (14.8) kg and mean body mass index (BMI) of 32.7 (SD 4.1) kg/m2. Mean (SD) weight change was -4.3 (SD 6.0) kg. All outcome measures showed statistically significant improvements. Each 1 kg weight loss was associated with 0.4 mmHg reduction in SBP and 0.3 mmHg reduction in DBP, or 0.5 mmHg and 0.4 mmHg/kg respectively in people with hypertension. Each 1 kg weight loss was associated with 0.2 mmol/mol reduction in HbA1c, or 0.6 mmol/mol in people with diabetes. Effects on plasma lipids were negligible. CONCLUSION: Weight loss achieved through referral to community weight-loss programmes, which are commonly accessible in primary care, can lead to clinically relevant reductions in BP and glucose regulation, especially in those at highest risk.

Degree of adiposity and obesity severity is associated with cutaneous microvascular dysfunction in type 2 diabetes.

BACKGROUNDS AND AIMS: Obesity and diabetes independently contribute to cutaneous microvascular dysfunction via pathological processes that are not fully understood. We sought to determine if obesity severity is associated with cutaneous microvascular dysfunction and measures of peripheral arterial disease in adults with type 2 diabetes in cross-sectional observational study design. METHODS AND RESULTS: Primary outcomes were post-occlusive reactive hyperaemia as determined by laser-Doppler fluxmetry (peak flux post-occlusion, time to peak flux post-occlusion, peak as a percentage of baseline, and area under the curve [AuC] index post-occlusion to pre-occlusion). Secondary outcomes were ankle- and toe-brachial indices (ABI and TBI) and systolic toe pressure. Thirty-six participants (20 men, 16 women) with mean age 55 ± 8 years, BMI of 36 ± 5 kg/m2 and duration of diabetes 8 ± 6 years underwent measurements. After adjusting for age and duration of diabetes, SAT and total percentage body fat were able to explain 29% (p = 0.001) and 20% (p = 0.01) of variance of AuC index models, as well as 29% (p = 0.02) and 18% (p = 0.02) of peak as a percentage of baseline models, respectively. Though TBI demonstrated moderate, significant correlations with SAT (r:0.37, p = 0.04) and total percentage body fat (r:0.39, p = 0.03), these were not upheld by regression analyses. Neither ABI nor systolic toe pressure significantly correlated with any measure of adiposity or obesity. CONCLUSION: These findings demonstrate impairment in cutaneous microvascular function related to adiposity and obesity severity in adults with type 2 diabetes, suggesting that obesity may pathologically effect cutaneous microvascular function in the absence of overt macrovascular disease, warranting further investigation.

Patient motivation to lose weight: Importance of healthcare professional support, goals and self-efficacy.

BACKGROUND: People with obesity (PwO) often struggle to achieve and maintain weight loss. This can perpetuate and/or be influenced by feelings of low motivation. This analysis from ACTION-IO data identified factors associated with PwO motivation to lose weight. METHODS: PwO completed an online survey in 11 countries. Exploratory multinomial logistic regression analyses identified independent variables associated with self-report of feeling motivated versus not motivated to lose weight. RESULTS: Data from 10,854 PwO were included (5,369 motivated; 3,312 neutral; 2,173 not motivated). Variables associated with feeling motivated versus not motivated included (odds ratio [95% confidence interval]): acknowledgement of healthcare professional (HCP) responsibility to contribute to weight loss (2.32 [1.86-2.88]), comfort in talking to their HCP about weight (1.46 [1.24-1.72), agreement that it is easy to lose weight (1.73 [1.30-2.31]), and a goal of reducing risks from excess weight (1.45 [1.22-1.73]). Conversely, if PwO considered obesity less important than other diseases they were less likely to report feeling motivated (0.49 [0.41-0.58]). PwO who reported being motivated to lose weight were more likely to exercise ≥5 times a week versus <1 time a week (2.77 [2.09-3.68]) than those who reported they were not motivated. CONCLUSIONS: Positive interactions with HCPs, self-efficacy, setting goals and knowledge of the importance of weight management, in addition to regular exercising, may increase PwO motivation for weight loss. Appropriate HCP support may help PwO who are ready to engage in weight management. CLINICAL TRIAL REGISTRATION: NCT03584191.

The 3Ds - Discussion, diagnosis and direction: Elements for effective obesity care by healthcare professionals.

BACKGROUND: The care of people with obesity is often suboptimal due to both physician and patient perceptions about obesity itself and clinical barriers. Using data from the ACTION-IO study, we aimed to identify factors that might improve the quality of obesity care through adoption of the 3D approach (Discussion, Diagnosis and Direction [follow-up]) by healthcare professionals (HCPs). METHODS: An online survey was completed by HCPs in 11 countries. Exploratory beta regression analyses identified independent variables associated with each component of the 3D approach. RESULTS: Data from 2,331 HCPs were included in the statistical models. HCPs were significantly more likely to initiate weight discussions and inform patients of obesity diagnoses, respectively, if (odds ratio [95% confidence interval]): they recorded an obesity diagnosis in their patient's medical notes (1.59, [1.43-1.76] and 2.16 [1.94-2.40], respectively); and they were comfortable discussing weight with their patients (1.53 [1.39-1.69] and 1.15 [1.04-1.27]). HCPs who reported feeling motivated to help their patients lose weight were also more likely to initiate discussions (1.36 [1.21-1.53]) and schedule follow-up appointments (1.21 [1.06-1.38]). By contrast, HCPs who lacked advanced formal training in obesity management were less likely to inform patients of obesity diagnoses (0.83 [0.74-0.92]) or schedule follow-up appointments (0.69 [0.62-0.78]). CONCLUSION: Specific actions that could improve obesity care through the 3D approach include: encouraging HCPs to record an obesity diagnosis; providing tools to help HCPs feel more comfortable initiating weight discussions; and provision of training in obesity management. CLINICAL TRIAL REGISTRATION: NCT03584191.

Effects of α-Cyclodextrin on Cholesterol Control and Hydrolyzed Ginseng Extract on Glycemic Control in People With Prediabetes: A Randomized Clinical Trial.

Importance: Effective strategies for preventing type 2 diabetes are needed. Many people turn to complementary medicines, but there is little well-conducted scientific evidence to support their use. Objective: To assess the efficacy of α-cyclodextrin for cholesterol control and that of hydrolyzed ginseng for glycemic control in people with prediabetes and overweight or obesity. Design, Setting, and Participants: This 6-month double-blind, placebo-controlled, randomized clinical trial, with a 2 × 2 factorial design, was conducted between July 2015 and October 2018 at 2 locations in Sydney, Australia. Eligible participants were aged 18 years or older, had a body mass index (weight in kilograms divided by height in meters squared) of 25 or higher, and had prediabetes within 6 months of study entry according to the American Diabetes Association guidelines. Data analysis was performed from May to August 2019. Interventions: Participants were randomized to 1 of 4 groups to take active or placebo versions of each supplement (α-cyclodextrin plus hydrolyzed ginseng, α-cyclodextrin plus placebo, placebo plus hydrolyzed ginseng, or placebo plus placebo) for 6 months. All participants received dietetic advice for weight loss. Main Outcomes and Measures: The primary outcomes were the differences in total cholesterol and fasting plasma glucose between groups after 6 months. The primary analysis used the intention-to-treat principle. Multiple predetermined subsample analyses were conducted. Results: A total of 401 participants were eligible for the study (248 women [62%]; mean [SD] age, 53.5 [10.2] years; mean [SD] body mass index, 34.6 [6.2]). One hundred one patients were randomized to receive α-cyclodextrin plus hydrolyzed ginseng, 99 were randomized to receive α-cyclodextrin plus placebo, 101 were randomized to receive placebo plus hydrolyzed ginseng, and 100 were randomized to receive placebo plus placebo. For 200 participants taking α-cyclodextrin compared with 201 participants taking placebo, there was no difference in total cholesterol after 6 months (-1.5 mg/dL; 95% CI, -6.6 to 3.5 mg/dL; P = .51). For 202 participants taking hydrolyzed ginseng compared with 199 participants taking placebo, there was no difference in fasting plasma glucose after 6 months (0.0 mg/dL; 95% CI, -1.6 to 1.8 mg/dL; P = .95). Use of α-cyclodextrin was associated with constipation (16 participants vs 4 participants; P = .006) and cough (8 participants vs 1 participant; P = .02). Use of hydrolyzed ginseng was associated with rash and pruritus (13 participants vs 2 participants; P = .006). Only 37 of 401 participants (9.2%) experienced these adverse events. Conclusions and Relevance: Although they are safe for use, there was no benefit found for either α-cyclodextrin for cholesterol control or hydrolyzed ginseng for glycemic control in people with prediabetes and overweight or obesity. Trial Registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12614001302640.

Delays in healthcare consultations about obesity - Barriers and implications.

BACKGROUND: The prevalence of obesity continues to rise, affecting nearly a third of Australian adults in 2017-18. The stigma and bias people with obesity (PwO) experience is one of the barriers hindering the dialogue between PwO and their Health Care Professionals (HCPs). The results from the ACTION IO Australian cohort are reported here. Identification of local barriers can inform strategies to improve access to quality obesity care within Australia. METHODS: The ACTION-IO study was an online cross-sectional survey conducted in 11 countries during June-October 2018. In Australia 1,000 community based adult PwO (body mass index ≥30 kg/m based on self-reported height and weight) and 200 HCPs involved with direct patient care (seeing ≥10 patients with obesity/month) completed the survey. RESULTS: There was a mean delay of 8.9 years from when a PwO first started to struggle with their weight, and the initial discussion with an HCP about this. HCPs acknowledged weight loss efforts in only 38.5% of their patients, although 74.6% of PwO had attempted weight loss. Most PwO (82.0%) assumed full responsibility for their weight loss. HCPs identified short appointment times (60.5%) and the cost of obesity medication, programmes and services (58.5%) as barriers to weight management conversations and weight loss, respectively. Most PwO want their HCP to raise the issue of weight with 64 % reporting finding such conversations positive and helpful. CONCLUSION: Compared to global results, Australian PwO took 3 years longer to seek medical care about their weight. Better recognition of obesity's impact and targeting barriers to care are needed.

The Effect of a Novel Low-Volume Aerobic Exercise Intervention on Liver Fat in Type 2 Diabetes: A Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to examine the effect of a novel low-volume high-intensity interval training (HIIT), moderate-intensity continuous training (MICT), or placebo (PLA) intervention on liver fat, glycemia, and cardiorespiratory fitness using a randomized placebo-controlled design. RESEARCH DESIGN AND METHODS: Thirty-five inactive adults (age 54.6 ± 1.4 years, 54% male; BMI 35.9 ± 0.9 kg/m2) with obesity and type 2 diabetes were randomized to 12 weeks of supervised MICT (n = 12) at 60% VO2peak for 45 min, 3 days/week; HIIT (n = 12) at 90% VO2peak for 4 min, 3 days/week; or PLA (n = 11). Liver fat percentage was quantified through proton MRS. RESULTS: Liver fat reduced in MICT (-0.9 ± 0.7%) and HIIT (-1.7 ± 1.1%) but increased in PLA (1.2 ± 0.5%) (P = 0.046). HbA1c improved in MICT (-0.3 ± 0.3%) and HIIT (-0.3 ± 0.3%) but not in PLA (0.5 ± 0.2%) (P = 0.014). Cardiorespiratory fitness improved in MICT (2.3 ± 1.2 mL/kg/min) and HIIT (1.1 ± 0.5 mL/kg/min) but not in PLA (-1.5 ± 0.9 mL/kg/min) (P = 0.006). CONCLUSIONS: MICT or a low-volume HIIT approach involving 12 min of weekly high-intensity aerobic exercise may improve liver fat, glycemia, and cardiorespiratory fitness in people with type 2 diabetes in the absence of weight loss. Further studies are required to elucidate the relationship between exercise-induced reductions in liver fat and improvements in glycemia.

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.

Targeting the Intestinal Microbiota to Prevent Type 2 Diabetes and Enhance the Effect of Metformin on Glycaemia: A Randomised Controlled Pilot Study.

Early treatment may prevent or delay the onset of type 2 diabetes mellitus (T2DM) in individuals who are at high risk. Lifestyle interventions and the hypoglycemic drug metformin have been shown to reduce T2DM incidence. The effectiveness of such interventions may be enhanced by targeting environmental factors such as the intestinal microbiota, which has been proven to predict the response to lifestyle interventions and play a part in mediating the glucose-lowering effects of metformin. Shifts in the intestinal microbiota "towards a more balanced state" may promote glucose homeostasis by regulating short-chain fatty acids' production. This study aimed to investigate the safety and effect of a multi-strain probiotic on glycemic, inflammatory, and permeability markers in adults with prediabetes and early T2DM and to assess whether the probiotic can enhance metformin's effect on glycaemia. A randomised controlled pilot study was conducted in 60 adults with a BMI ≥ 25 kg/m2 and with prediabetes or T2DM (within the previous 12 months). The participants were randomised to a multi-strain probiotic (L. plantarum, L. bulgaricus, L. gasseri, B. breve, B. animalis sbsp. lactis, B. bifidum, S. thermophilus, and S. boulardii) or placebo for 12 weeks. Analyses of the primary outcome (fasting plasma glucose) and secondary outcomes, including, but not limited to, circulating lipopolysaccharide, zonulin, and short chain fatty acids and a metagenomic analysis of the fecal microbiome were performed at baseline and 12 weeks post-intervention. The results showed no significant differences in the primary and secondary outcome measures between the probiotic and placebo group. An analysis of a subgroup of participants taking metformin showed a decrease in fasting plasma glucose, HbA1c, insulin resistance, and zonulin; an increase in plasma butyrate concentrations; and an enrichment of microbial butyrate-producing pathways in the probiotic group but not in the placebo group. Probiotics may act as an adjunctive to metformin by increasing the production of butyrate, which may consequently enhance glucose management.