Engagement With mHealth COVID-19 Digital Biomarker Measurements in a Longitudinal Cohort Study: Mixed Methods Evaluation.

BACKGROUND: The COVID-19 pandemic accelerated the interest in implementing mobile health (mHealth) in population-based health studies, but evidence is lacking on engagement and adherence in studies. We conducted a fully remote study for ≥6 months tracking COVID-19 digital biomarkers and symptoms using a smartphone app nested within an existing cohort of adults. OBJECTIVE: We aimed to investigate participant characteristics associated with initial and sustained engagement in digital biomarker collection from a bespoke smartphone app and if engagement changed over time or because of COVID-19 factors and explore participants' reasons for consenting to the smartphone substudy and experiences related to initial and continued engagement. METHODS: Participants in the Fenland COVID-19 study were invited to the app substudy from August 2020 to October 2020 until study closure (April 30, 2021). Participants were asked to complete digital biomarker modules (oxygen saturation, body temperature, and resting heart rate [RHR]) and possible COVID-19 symptoms in the app 3 times per week. Participants manually entered the measurements, except RHR that was measured using the smartphone camera. Engagement was categorized by median weekly frequency of completing the 3 digital biomarker modules (categories: 0, 1-2, and ≥3 times per week). Sociodemographic and health characteristics of those who did or did not consent to the substudy and by engagement category were explored. Semistructured interviews were conducted with 35 participants who were purposively sampled by sex, age, educational attainment, and engagement category, and data were analyzed thematically; 63% (22/35) of the participants consented to the app substudy, and 37% (13/35) of the participants did not consent. RESULTS: A total of 62.61% (2524/4031) of Fenland COVID-19 study participants consented to the app substudy. Of those, 90.21% (2277/2524) completed the app onboarding process. Median time in the app substudy was 34.5 weeks (IQR 34-37) with no change in engagement from 0 to 3 months or 3 to 6 months. Completion rates (≥1 per week) across the study between digital biomarkers were similar (RHR: 56,517/77,664, 72.77%; temperature: 56,742/77,664, 73.06%; oxygen saturation: 57,088/77,664, 73.51%). Older age groups and lower managerial and intermediate occupations were associated with higher engagement, whereas working, being a current smoker, being overweight or obese, and high perceived stress were associated with lower engagement. Continued engagement was facilitated through routine and personal motivation, and poor engagement was caused by user error and app or equipment malfunctions preventing data input. From these results, we developed key recommendations to improve engagement in population-based mHealth studies. CONCLUSIONS: This mixed methods study demonstrated both high initial and sustained engagement in a large mHealth COVID-19 study over a ≥6-month period. Being nested in a known cohort study enabled the identification of participant characteristics and factors associated with engagement to inform future applications in population-based health research.

Body mass index cut-points to identify cardiometabolic risk in black South Africans.

PURPOSE: To determine optimal body mass index (BMI) cut-points for the identification of cardiometabolic risk in black South African adults. METHODS: We performed a cross-sectional study of a weighted sample of healthy black South Africans aged 25-65 years (721 men, 1386 women) from the North West and Free State Provinces. Demographic, lifestyle and anthropometric measures were taken, and blood pressure, fasting serum triglycerides, high-density lipoprotein (HDL) cholesterol and blood glucose were measured. We defined elevated cardiometabolic risk as having three or more risk factors according to international metabolic syndrome criteria. Receiver operating characteristic curves were applied to identify an optimal BMI cut-point for men and women. RESULTS: BMI had good diagnostic performance to identify clustering of three or more risk factors, as well as individual risk factors: low HDL-cholesterol, elevated fasting glucose and triglycerides, with areas under the curve >.6, but not for high blood pressure. Optimal BMI cut-points averaged 22 kg/m2 for men and 28 kg/m2 for women, respectively, with better sensitivity in men (44.0-71.9 %), and in women (60.6-69.8 %), compared to a BMI of 30 kg/m2 (17-19.1, 53-61.4 %, respectively). Men and women with a BMI >22 and >28 kg/m2, respectively, had significantly increased probability of elevated cardiometabolic risk after adjustment for age, alcohol use and smoking. CONCLUSION: In black South African men, a BMI cut-point of 22 kg/m2 identifies those at cardiometabolic risk, whereas a BMI of 30 kg/m2 underestimates risk. In women, a cut-point of 28 kg/m2, approaching the WHO obesity cut-point, identifies those at risk.

Digital Intervention Promoting Physical Activity in People Newly Diagnosed with Parkinson's Disease: Feasibility and Acceptability of the Knowledge, Exercise-Efficacy and Participation (KEEP) Intervention.

Background: Exercise promotion interventions for people with Parkinson's disease (PD) are often offered on a face-to-face basis, follow a generic "one-size-fit-all" approach, and are not typically delivered at diagnosis. Considering PD's heterogenous nature, the existing evidence on the merits of exercise on symptom management and the expressed wishes of people living with PD for access to timely and tailored evidence-based information, there is a demand for interventions that are easily accessible, scalable and co-designed with people living with PD. Objective: Evaluate the feasibility and acceptability of a co-designed digital intervention promoting exercise and physical activity, in people newly diagnosed with PD. Methods: Thirty people living with PD for less than one year participated in an assessor-blinded randomized feasibility trial from June 2022 to April 2023. The intervention group received the 8-week Knowledge, Exercise Efficacy and Participation (KEEP) intervention comprising 6 interactive digital modules and 4 online live group discussions facilitated by a specialist physiotherapist. Assessments were performed at baseline, post intervention and at 6-month follow up. Results: Thirty participants were recruited to target with a 64% recruitment rate (30/47). All but one participant completed the 6-month follow-up assessment. There was high retention (97%), module completion (91%), and online discussion attendance (88%). Outcome measure collection was feasible, including accelerometer data with a daily average wear time of 23.9 hours (SD:0.295). Conclusions: The KEEP intervention was feasible and acceptable in people newly diagnosed with PD. A larger trial is needed to assess intervention efficacy and correlation between knowledge, self-efficacy, and activity levels.

Exercise and physical activity have been found beneficial in managing both motor and non-motor symptoms in people living with Parkinson's. But there aren't many programs available right after diagnosis that focus on exercise and explain why it's important for managing PD symptoms and how to exercise with PD. Most existing programs use a one-size-fits-all approach and don't give personalized information. In this study, researchers wanted to see if people who were recently diagnosed with PD would join a study promoting exercise through an online program. This program included educational information and live online group discussions with both people living with Parkinson's and a specialist physiotherapist. The program was developed together with people living with Parkinson's and healthcare professionals to ensure that it better suited the needs of people newly diagnosed with PD. Thirty people took part in the study. They were randomly put into two groups: one received the online program, while the other group continued with their usual care. Participants filled out questionnaires and wore a wrist accelerometer for seven days to track their physical activity levels. The researchers found that most participants stayed in the study (97%), completed the program modules (91%), and attended the live discussions (88%) and wore the accelerometers for 23.9 hours a day on average. Overall, the study showed that the program was doable and well-received. Participants said they had a better understanding on the benefits of exercise in PD. However, a larger study is needed to see if the program helps increase activity levels.

Diet and physical activity interventions to improve cardiovascular disease risk factors in liver transplant recipients: Systematic review and meta-analysis.

BACKGROUND AND AIMS: Cardiovascular disease, associated risk factors and obesity are prevalent after liver transplant and modifiable through lifestyle changes. Understanding what lifestyle interventions and their respective components are effective is essential for translation to clinical practice. We aimed to investigate the effects of diet and physical activity interventions on weight, body mass index and other cardiovascular disease risk factors in liver transplant recipients, and systematically describe the interventions. METHODS: We systematically searched Embase, MEDLINE, Psycho Info, CINAHL, Cochrane central register of controlled trials, PeDro, AMED, BNI, Web of Science, OpenGrey, ClinicalTrials.gov and the international clinical trials registry from inception to 31 May 2023. Search results were screened by two independent reviewers: randomised control trials with interventions that targeted diet and physical activity behaviours in liver transplant recipients were considered eligible. Two independent reviewers extracted and synthesised data for study, participant and intervention details and results. We used the Revised Cochrane Risk of Bias Tool for Randomised Trials to assess risk of bias for outcomes and the GRADE approach to rate the quality of the body of evidence. When two or more studies reported findings for an outcome, we pooled data using random-effects meta-analysis. RESULTS: Six studies were included, reporting three physical activity and three combined diet and physical activity interventions. Participants were 2 months-4 years post-transplant. Interventions lasted 12 weeks-10 months and were delivered remotely and/or in-person, most commonly delivered to individual participants by health care or sports professionals. Five studies described individual tailoring, e.g. exercise intensity. Adherence to interventions ranged from 51% to 94%. No studies reported fidelity. Intervention components were not consistently reported. In meta-analysis, diet and physical activity interventions did not significantly reduce weight or body mass index compared to control groups, however no studies targeted participants with obesity. Diet and physical activity interventions reduced percentage body fat and triglycerides compared to control groups but did not reduce total cholesterol or increase activity. The GRADE quality of evidence was low or very low. CONCLUSION: Diet and physical activity interventions reduced percentage body fat and triglycerides in liver transplant recipients. Further good quality research is needed to evaluate their effect on other cardiovascular disease risk factors, including weight and BMI. Interventions need to be better described and evaluated to improve evidence base and inform patient care.

The relationship of within-individual and between-individual variation in mental health with bodyweight: An exploratory longitudinal study.

BACKGROUND: Poor mental health is associated with obesity, but existing studies are either cross-sectional or have long time periods between measurements of mental health and weight. It is, therefore, unclear how small fluctuations in mental wellbeing within individuals predict bodyweight over short time periods, e.g. within the next month. Studying this could identify modifiable determinants of weight changes and highlight opportunities for early intervention. METHODS: 2,133 UK adults from a population-based cohort completed monthly mental health and weight measurements using a mobile app over a period of 6-9 months. We used random intercept regression models to examine longitudinal associations of depressive symptoms, anxiety symptoms and stress with subsequent weight. In sub-group analyses, we included interaction terms of mental health variables with baseline characteristics. Mental health variables were split into "between-individual" measurements (= the participant's median score across all timepoints) and "within-individual" measurements (at each timepoint, the difference between the participant's current score and their median). RESULTS: Within-individual variation in depressive symptoms predicted subsequent weight (0.045kg per unit of depressive symptom severity, 95% CI 0.021-0.069). We found evidence of a moderation effect of baseline BMI on the association between within-individual fluctuation in depressive symptoms and subsequent weight: The association was only apparent in those with overweight/obesity, and it was stronger in those with obesity than those with overweight (BMI<25kg/m2: 0.011kg per unit of depressive symptom severity [95% CI -0.017 to 0.039]; BMI 25-29.9kg/m2: 0.052kg per unit of depressive symptom severity [95%CI 0.010-0.094kg]; BMI≥30kg/m2: 0.071kg per unit of depressive symptom severity [95%CI 0.013-0.129kg]). We found no evidence for other interactions, associations of stress and anxiety with weight, or for a reverse direction of association. CONCLUSION: In this exploratory study, individuals with overweight or obesity were more vulnerable to weight gain following higher-than-usual (for that individual) depressive symptoms than individuals with a BMI<25kg/m2.

Marketing foods to children: a comparison of nutrient content between children's and non-children's products.

OBJECTIVE: The predominance of marketing of products high in fat, sugar and/or salt to children has been well documented and implicated in the incidence of obesity. The present study aimed to determine whether foods marketed to children in UK supermarkets are nutritionally similar to the non-children's equivalent, focusing on food categories that may be viewed as healthier options. DESIGN: Nutritional data were collected on yoghurts (n 147), cereal bars (n 145) and ready meals (n 144) from seven major UK supermarkets and categorised as children's or non-children's products based on the characteristics, promotional nature or information on the product packaging. Fat, sugar and salt content was compared per 100 g and per recommended portion size. SETTING: UK. RESULTS: Per 100 g, children's yoghurts and cereal bars were higher in total sugars, fat and saturated fat than the non-children's; this was significant for all except sugar and total fat in cereal bars. Per portion these differences remained, except for sugars in yoghurts. Conversely children's ready meals were significantly lower in these nutrients per portion than non-children's, but not when expressed per 100 g. Children's yoghurts and ready meals had significantly lower sodium content than non-children's both per portion and per 100 g. CONCLUSIONS: Significant differences between the nutritional composition of children's and non-children's products were observed but varied depending on the unit reference. A significant number of products marketed towards children were higher in fat, sugar and salt than those marketed to the general population.

Influence of nutrition labelling on food portion size consumption.

Nutrition labelling is an important strategic approach for encouraging consumers to make healthier food choices. The availability of highly palatable foods labelled as 'low fat or reduced calorie' may encourage the over-consumption of these products. This study aimed to determine whether the manipulation of nutrition labelling information can influence food portion size consumption. Normal and overweight men (n=24) and women (n=23) were served an identical lunch meal on three separate days, but the information they received prior to consuming the lunch meal was manipulated as follows: "baseline", "high fat/energy" and "low fat/energy". Food and energy intake was significantly increased in the low fat/energy condition compared with both baseline and the high fat/energy condition. An additional 3% (162 kJ) energy was consumed by subjects under the low fat/energy condition compared to baseline. No differences were observed between the baseline and high fat/energy condition. Subjects who consumed most in the low fat/energy condition were found to be mostly men, to have a higher BMI and to be overweight. Low fat/energy information can positively influence food and energy intake, suggesting that foods labelled as 'low fat' or 'low calorie' may be one factor promoting the consumption of large food portions.

Feasibility of using intermittent active monitoring of vital signs by smartphone users to predict SARS-CoV-2 PCR positivity.

Early detection of highly infectious respiratory diseases, such as COVID-19, can help curb their transmission. Consequently, there is demand for easy-to-use population-based screening tools, such as mobile health applications. Here, we describe a proof-of-concept development of a machine learning classifier for the prediction of a symptomatic respiratory disease, such as COVID-19, using smartphone-collected vital sign measurements. The Fenland App study followed 2199 UK participants that provided measurements of blood oxygen saturation, body temperature, and resting heart rate. Total of 77 positive and 6339 negative SARS-CoV-2 PCR tests were recorded. An optimal classifier to identify these positive cases was selected using an automated hyperparameter optimisation. The optimised model achieved an ROC AUC of 0.695 ± 0.045. The data collection window for determining each participant's vital sign baseline was increased from 4 to 8 or 12 weeks with no significant difference in model performance (F(2) = 0.80, p = 0.472). We demonstrate that 4 weeks of intermittently collected vital sign measurements could be used to predict SARS-CoV-2 PCR positivity, with applicability to other diseases causing similar vital sign changes. This is the first example of an accessible, smartphone-based remote monitoring tool deployable in a public health setting to screen for potential infections.

Nutritional Intake after Liver Transplant: Systematic Review and Meta-Analysis.

Cardiovascular disease and its concurrent risk factors are prevalent after liver transplant (LT). Most of these risk factors are modifiable by diet. We aimed to synthesise the literature reporting the nutritional intake of liver transplant recipients (LTR) and the potential determinants of intake. We performed a systematic review and meta-analyses of studies published up until July 2021 reporting the nutritional intake of LTR. The pooled daily mean intakes were recorded as 1998 (95% CI 1889, 2108) kcal, 17 (17, 18)% energy from protein, 49 (48, 51)% energy from carbohydrates, 34 (33, 35)% energy from total fat, 10 (7, 13)% energy from saturated fat, and 20 (18, 21) g of fibre. The average fruit and vegetable intake ranged from 105 to 418 g/day. The length of time post-LT and the age and sex of the cohorts, as well as the continent and year of publication of each study, were sources of heterogeneity. Nine studies investigated the potential determinants of intake, time post-LT, gender and immunosuppression medication, with inconclusive results. Energy and protein requirements were not met in the first month post-transplant. After this point, energy intake was significantly higher and remained stable over time, with a high fat intake and low intake of fibre, fruits and vegetables. This suggests that LTR consume a high-energy, low-quality diet in the long term and do not adhere to the dietary guidelines for cardiovascular disease prevention.

Resistance to thyroid hormone induced tachycardia in RTHα syndrome.

Mutations in thyroid hormone receptor α1 (TRα1) cause Resistance to Thyroid Hormone α (RTHα), a disorder characterized by hypothyroidism in TRα1-expressing tissues including the heart. Surprisingly, we report that treatment of RTHα patients with thyroxine to overcome tissue hormone resistance does not elevate their heart rate. Cardiac telemetry in male, TRα1 mutant, mice indicates that such persistent bradycardia is caused by an intrinsic cardiac defect and not due to altered autonomic control. Transcriptomic analyses show preserved, thyroid hormone (T3)-dependent upregulation of pacemaker channels (Hcn2, Hcn4), but irreversibly reduced expression of several ion channel genes controlling heart rate. Exposure of TRα1 mutant male mice to higher maternal T3 concentrations in utero, restores altered expression and DNA methylation of ion channels, including Ryr2. Our findings indicate that target genes other than Hcn2 and Hcn4 mediate T3-induced tachycardia and suggest that treatment of RTHα patients with thyroxine in high dosage without concomitant tachycardia, is possible.

The development, validation and application of remote blood sample collection in telehealth programmes.

INTRODUCTION: The ability to collect blood samples remotely without the involvement of healthcare professionals is a key element of future telehealth applications. We developed and validated the application of the Drawbridge OneDraw device for use at home for blood sample collection. The device was then applied in a large population-based remote monitoring study to assess changes in SARS-CoV-2 IgG antibody levels. METHODS: We tested: (1) feasibility of participants using the device at home without a healthcare professional on the upper arm and thigh sites (2) stability of the dried blood sample collected remotely (3) participant acceptability of the device compared with finger-prick and venous blood samples and the validity of SARS-CoV-2 virus antibody measurement versus venous blood sample (4) application to the Fenland COVID-19 study in which 4023 participants at 3 timepoints across 6 months. RESULTS: Participant acceptability was high, with a significantly lower median perceived pain score and 76% of participants preferring the OneDraw device over the other blood collection methods. There was high level of agreement in SARS-CoV-2 virus antibody results with venous blood samples in 120 participants (Cohen's kappa 0.68 (95% CI 0.56, 0.83). In the Fenland COVID-19 study, 92% of participants returned a sample at baseline (3702/4023), 89% at 3 months (3492/3918) and 93% at 6 months (3453/3731), with almost all samples received successfully processed (99.9%). DISCUSSION: The OneDraw device enables a standardised blood sample collection at home by participants themselves. Due to its ease-of-use and acceptability the OneDraw device is particularly useful in telehealth approaches where multiple samples need to be collected.

Association of Accelerometer-Measured Sedentary Accumulation Patterns With Incident Cardiovascular Disease, Cancer, and All-Cause Mortality.

Background Emerging evidence suggests accruing sedentary behavior (SB) in relatively more prolonged periods may convey additional cardiometabolic risks, but few studies have examined prospective outcomes. We examined the association of SB accumulation patterns with incident cardiovascular disease (CVD), cancer, and all-cause mortality (ACM). Methods and Results Data were from 7671 EPIC-Norfolk (European Prospective Investigation Into Cancer and Nutrition-Norfolk) cohort middle- to older-aged adults who wore accelerometers on the right hip for 4 to 7 days. Cox proportional hazards regression modeled associations between 2 measures of SB accumulation and incident CVD, cancer, and ACM. These were usual SB bout duration (the midpoint of each individual's SB accumulation curve, fitted using nonlinear regression) and alpha (hybrid measure of bout frequency and duration, with higher values indicating relatively shorter bouts and fewer long bouts). Models were adjusted for potential confounders, then further for 24-hour time-use compositions. During mean follow-up time of 6.4 years, 339 ACM, 1106 CVD, and 516 cancer events occurred. Elevated rates of incident cancer and ACM were seen with more prolonged SB accumulation (lower alpha, higher usual SB bout duration) but not CVD. For usual SB bout duration and alpha, respectively, the confounder-adjusted hazard ratios per SD of the exposure were 1.12 (95% CI, 1.02-1.23) and 0.88 (95% CI, 0.79-0.98) with incident cancer and 1.16 (95% CI, 1.07-1.26) and 0.80 (95% CI, 0.72-0.89) with ACM (all P<0.05). Further adjustment for 24-hour time use weakened associations with ACM for usual bout duration (hazard ratio, 1.06; 95% CI, 0.97-1.16; P=0.209) and partially for alpha (hazard ratio, 0.87; 95% CI, 0.77-0.99; P=0.029). Conclusions Accruing SB in longer bout durations was associated with higher rates of incident cancer and ACM but not with incident CVD, with some evidence of direct SB accumulation effects independent of 24-hour time use. Findings provide some support for considering SB accumulation as an adjunct target of messaging to "sit less and move more."

Antenatal Determinants of Childhood Obesity in High-Risk Offspring: Protocol for the DiGest Follow-Up Study.

Childhood obesity is an area of intense concern internationally and is influenced by events during antenatal and postnatal life. Although pregnancy complications, such as gestational diabetes and large-for-gestational-age birthweight have been associated with increased obesity risk in offspring, very few successful interventions in pregnancy have been identified. We describe a study protocol to identify if a reduced calorie diet in pregnancy can reduce adiposity in children to 3 years of age. The dietary intervention in gestational diabetes (DiGest) study is a randomised, controlled trial of a reduced calorie diet provided by a whole-diet replacement in pregnant women with gestational diabetes. Women receive a weekly dietbox intervention from enrolment until delivery and are blinded to calorie allocation. This follow-up study will assess associations between a reduced calorie diet in pregnancy with offspring adiposity and maternal weight and glycaemia. Anthropometry will be performed in infants and mothers at 3 months, 1, 2 and 3 years post-birth. Glycaemia will be assessed using bloodspot C-peptide in infants and continuous glucose monitoring with HbA1c in mothers. Data regarding maternal glycaemia in pregnancy, maternal nutrition, infant birthweight, offspring feeding behaviour and milk composition will also be collected. The DiGest follow-up study is expected to take 5 years, with recruitment finishing in 2026.

Associations of physical activity with inflammatory factors, adipocytokines, and metabolic syndrome in middle-aged and older chinese people.

BACKGROUND: Inflammatory factors, adipocytokines, and the metabolic syndrome are important determinants of cardiometabolic disease. It remains unclear how physical activity is related to these risk factors. Our objective was to investigate single and joint associations of physical activity with inflammatory factors, adipocytokines, and the metabolic syndrome among middle-aged and older Chinese people. METHODS AND RESULTS: A total of 3289 individuals (1458 men, 1831 women) 50 to 70 years of age participated in a population-based cross-sectional survey in Beijing and Shanghai, China. Levels of total physical activity were assessed with the International Physical Activity Questionnaire. High-sensitivity C-reactive protein, interleukin-6, tumor necrosis factor-alpha receptor 2, adiponectin, and retinol-binding protein 4 were measured. The metabolic syndrome was defined using the updated National Cholesterol Education Program/Adult Treatment Panel III criteria for Asian Americans. Plasma concentrations of high-sensitivity C-reactive protein were 1.58, 1.74, and 1.27 mg/L (P=0.0138) and of adiponectin were 16.12, 16.20, and 17.21 mg/L (P=0.0078) among individuals with low, medium, and high levels of total physical activity, respectively, with adjustment for potential confounders. In the multivariable-adjusted logistic regression analyses, participants with higher levels of total physical activity had a lower risk of having the metabolic syndrome (odds ratio, 0.68; 95% confidence interval, 0.54 to 0.85; P for trend=0.001) compared with those with lower levels. CONCLUSIONS: Being physically active is associated with a better profile of inflammatory factors and adipocytokines and a reduced risk of having the metabolic syndrome among Chinese people.

Erratum: Dietary Intervention in Pregnant Women with Gestational Diabetes; Protocol for the DiGest Randomised Controlled Trial; Nutrients 2020, 12, 1165.

The authors would like to correct an error in a recent published paper [...].

Dietary Intervention in Pregnant Women with Gestational Diabetes; Protocol for the DiGest Randomised Controlled Trial.

Gestational diabetes mellitus (GDM) annually affects 35,000 pregnancies in the United Kingdom, causing suboptimal health outcomes to the mother and child. Obesity and excessive gestational weight gain are risk factors for GDM. The Institute of Medicine recommends weight targets for women that are overweight and obese, however, there are no clear guidelines for women with GDM. Observational data suggest that modest weight loss (0.6-2 kg) after 28 weeks may reduce risk of caesarean section, large-for-gestational-age (LGA), and maternal postnatal glycaemia. This protocol for a multicentre randomised double-blind controlled trial aims to identify if a fully controlled reduced energy diet in GDM pregnancy improves infant birthweight and reduces maternal weight gain (primary outcomes). A total of 500 women with GDM (National Institute of Health and Care Excellence (NICE) 2015 criteria) and body mass index (BMI) ≥25 kg/m2 will be randomised to receive a standard (2000 kcal/day) or reduced energy (1200 kcal/day) diet box containing all meals and snacks from 28 weeks to delivery. Women and caregivers will be blinded to the allocations. Food diaries, continuous glucose monitoring, and anthropometry will measure dietary compliance, glucose levels, and weight changes. Women will receive standard antenatal GDM management (insulin/metformin) according to NICE guidelines. The secondary endpoints include caesarean section rates, LGA, and maternal postnatal glucose concentrations.

Two-year outcomes among stable high-risk patients following acute MI. Insights from a global registry in 25 countries.

BACKGROUND: Evidence is lacking on long-term outcomes in unselected patients surviving the first year following myocardial infarction (MI). METHODS AND RESULTS: The TIGRIS (long-Term rIsk, clinical manaGement and healthcare Resource utilization of stable coronary artery dISease in post-myocardial infarction patients) prospective registry enrolled 9176 eligible patients aged ≥50 years, 1-3 years post-MI, from 25 countries. All had ≥1 risk factor: age ≥ 65 years, diabetes mellitus, second prior MI, multivessel coronary artery disease, chronic kidney disease (CKD). Primary outcome was a composite of MI, unstable angina with urgent revascularization, stroke, or all-cause death at 2-year follow-up. Bleeding requiring hospitalization was also recorded. 9027 patients (98.4%) provided follow-up data: the primary outcome occurred in 621 (7.0%), all-cause mortality in 295 (3.3%), and bleeding in 109 (1.2%) patients. Events accrued linearly over time. In multivariable analyses, qualifying risk factors were associated with increased risk of primary outcome (incidence rate ratio [RR] per 100 patient-years [95% confidence interval]): CKD 2.06 (1.66, 2.55), second prior MI 1.71 (1.38, 2.10), diabetes mellitus 1.63 (1.39, 1.92), age ≥ 65 years 1.53 (1.28, 1.83), and multivessel disease 1.24 (1.05, 1.48). Risk of bleeding events was greater in older patients (vs <65 years) 65-74 years 2.68 (1.53, 4.70), ≥75 years 4.62 (2.57, 8.28), and those with CKD 1.99 (1.18, 3.35). CONCLUSION: In stable patients recruited 1-3 years post-MI, recurrent cardiovascular and bleeding events accrued linearly over 2 years. Factors independently predictive of ischemic and bleeding events were identified, providing a context for deciding on treatment options.

Predicting risk of cardiovascular events 1 to 3 years post-myocardial infarction using a global registry.

BACKGROUND: Risk prediction tools are lacking for patients with stable disease some years after myocardial infarction (MI). HYPOTHESIS: A practical long-term cardiovascular risk index can be developed. METHODS: The long-Term rIsk, Clinical manaGement and healthcare Resource utilization of stable coronary artery dISease in post-myocardial infarction patients prospective global registry enrolled patients 1 to 3 years post-MI (369 centers; 25 countries), all with ≥1 risk factor (age ≥65 years, diabetes mellitus requiring medication, second prior MI, multivessel coronary artery disease, or chronic non-end-stage kidney disease [CKD]). Self-reported health was assessed with EuroQoL-5 dimensions. Multivariable Poisson regression models were used to determine key predictors of the primary composite outcome (MI, unstable angina with urgent revascularization [UA], stroke, or all-cause death) over 2 years. RESULTS: The primary outcome occurred in 621 (6.9%) of 9027 eligible patients: death 295 (3.3%), MI 195 (2.2%), UA 103 (1.1%), and stroke 58 (0.6%). All events accrued linearly. In a multivariable model, 11 significant predictors of primary outcome (age ≥65 years, diabetes, second prior MI, CKD, history of major bleed, peripheral arterial disease, heart failure, cardiovascular hospitalization (prior 6 months), medical management (index MI), on diuretic, and poor self-reported health) were identified and combined into a user-friendly risk index. Compared with lowest-risk patients, those in the top 16% had a rate ratio of 6.9 for the primary composite, and 18.7 for all-cause death (overall c-statistic; 0.686, and 0.768, respectively). External validation was performed using the Australian Cooperative National Registry of Acute Coronary Care, Guideline Adherence and Clinical Events registry (c-statistic; 0.748, and 0.849, respectively). CONCLUSIONS: In patients >1-year post-MI, recurrent cardiovascular events and deaths accrue linearly. A simple risk index can stratify patients, potentially helping to guide management.

Obesity related metabolic abnormalities: distribution and geographic differences among middle-aged and older Chinese populations.

OBJECTIVE: To investigate geographic differences in obesity related metabolic abnormalities in middle-aged and older Chinese people with different levels of adiposity. METHOD: Data from 3289 individuals aged 50-70 years who participated in a cross-sectional survey in 2005 (1641 from northern [Beijing] and 1648 from southern [Shanghai] China) were analyzed. Overweight or obesity and abdominal obesity were classified as body mass index > or =24 kg/m2 and waist circumference > or =90 cm for men and > or =80 cm for women. Metabolic abnormalities (metabolic syndrome, dyslipidemia, hypertension and diabetes) were defined using the NCEP/ATPIII criteria. RESULTS: The overall prevalence of overweight and obesity was 53.4%, and the prevalence of abdominal obesity was 48.0%, respectively. The prevalence of the metabolic abnormalities was significantly higher among obese individuals than their normal weight counterparts. The association between obesity and the higher prevalence of the metabolic abnormalities was more pronounced among people who were overweight or obese in the north, especially for those living in rural areas. CONCLUSION: The prevalence of obesity and associated metabolic abnormalities varies substantially among Chinese people in different geographic region. Individuals who were overweight or obese living in rural areas in the north contribute importantly to the north-south differences in obesity-related metabolic abnormalities among Chinese populations.

Increased portion size leads to a sustained increase in energy intake over 4 d in normal-weight and overweight men and women.

Large food portions may be facilitating excess energy intake (EI) and adiposity among adults. The present study aimed to assess the extent to which EI and amounts of foods consumed are influenced by the availability of different-sized food portions. A randomised within-subject cross-over, fully residential design was used, where forty-three (twenty-one men and twenty-two women) normal-weight and overweight adults were randomly allocated to two separate 4 d periods where they were presented with either 'standard' or 'large' food portions of the same foods and beverages. The main outcome measures were the amount of food (g) and EI (MJ) consumed throughout each study period. Mean EI over 4 d was significantly higher on the large portion condition compared with the standard condition in the total group (59.1 (sd 6.6) v. 52.2 (sd 14.3) MJ; P = 0.020); men and women increased their EI by 17 % (10 (sd 6.5) MJ; P < 0.001) and 10 % (4 (sd 6.5) MJ; P = 0.005) respectively when served the large food portions relative to the standard food portions. The increased intakes were sustained over the 4 d in the large portion condition with little evidence of down-regulation of EI and food intake being made by subjects. Increased food portion size resulted in significant and sustained increases in EI in men and women over 4 d under fully residential conditions. The availability and consumption of larger portions of food may be a significant factor contributing to excess EI and adiposity.