RESUMEN

AIM: To examine the hypothesis that there would be ethnic differences in the relationship between ectopic fat and tissue-specific insulin resistance (IR) across a spectrum of glucose tolerance in Black African (BA) and White European (WE) men. MATERIALS AND METHODS: Fifty-three WE men (23/10/20 normal glucose tolerance [NGT]/impaired glucose tolerance [IGT]/type 2 diabetes [T2D]) and 48 BA men (20/10/18, respectively) underwent a two-step hyperinsulinaemic-euglycaemic clamp with infusion of D-[6,6-2H2]-glucose and [2H5]-glycerol to assess hepatic, peripheral and adipose tissue IR. Magnetic resonance imaging was used to measure subcutaneous adipose tissue, visceral adipose tissue (VAT) and intrahepatic lipid (IHL). Associations between ectopic fat and IR were assessed using linear regression models. RESULTS: There were no differences in tissue-specific IR between ethnic groups at any stage of glucose tolerance. VAT level was consistently lower in the BA population; NGT (p = 0.013), IGT (p = 0.006) and T2D (p = 0.015). IHL was also lower in the BA compared with the WE men (p = 0.013). VAT and IHL levels were significantly associated with hepatic IR in the BA population (p = 0.001) and with peripheral IR in the WE population (p = 0.027). CONCLUSIONS: The present study suggests that BA and WE men exhibit the same degree of IR across a glucose tolerance continuum, but with lower VAT and IHL levels in the BA population, suggesting that IR may be driven by a mechanism other than increased ectopic fat accumulation in BA men.

RESUMEN

AIMS: Health education is integral to cardiometabolic disease (CMD) management. This study aimed to assess whether and how education preferences have changed over time, and whether trends differ by sociodemographic characteristics (education status, age, ethnicity, and sex). METHODS: A cross-sectional questionnaire was deployed across five counties in the East Midlands, UK between 2017 and 2022 to adults with CMD (type 2 diabetes, cardiovascular disease or cerebrovascular disease). Respondent demographic data were collected alongside health education preferences. Statistical analyses ascertained whether demographic characteristics influenced preferences. The distribution of preferences over time was charted to identify trends. RESULTS: A total of 4301 eligible responses were collected. Face-to-face one-to-one education was preferred (first choice for 75.1% of participants) but popularity waned over the five-year period. Trends were similar amongst demographic groups. Online education showed a U-shaped trend: In 2017, 44% of respondents ranked it as acceptable, peaking at 53% in 2019, but declining again, to below base line, 43%, by 2022. This modality was more popular with participants aged younger than 65 years, but popularity in people older than 65 years increased over the study period. The popularity of printed information also declined over time across all demographic groups except those of South Asian ethnicity, for whom it remained static. CONCLUSIONS: The overwhelming preference for face-to-face one-to-one health education from a doctor or nurse highlights the importance of preserving access to this modality, even in the face of current NHS pressures and trends towards digitalisation. Trends are changing, and should continue to be monitored, including between different sociodemographic groups.

RESUMEN

Background: An effective prescribing pathway for liraglutide 3 mg, an approved obesity pharmacotherapy, may improve treatment access. This trial compared a targeted prescribing pathway for liraglutide 3 mg with multiple stopping rules in specialist weight management services (SWMS) to standard SWMS care. Methods: This phase four, two-year, multicentre, open-label, parallel-group, real-world randomized clinical trial (ClinicalTrials.gov: NCT03036800) enrolled adults with BMI ≥35 kg/m2 plus prediabetes, type 2 diabetes, hypertension or sleep apnoea from five SWMS in Ireland and UK. Participants were randomly allocated (2:1, stratified by centre and BMI) to SWMS care plus a targeted prescribing pathway for once daily subcutaneous liraglutide 3 mg (intervention) with stopping rules at 16 (≥5% weight loss, WL), 32 (≥10% WL) and 52 weeks (≥15% WL) or to SWMS care alone (control) through an online randomization service. The primary outcome was WL ≥15% at 52 weeks, assessed by complete cases analysis. All randomized participants were included in safety analysis. Findings: From November 28, 2017 to February 28, 2020, 434 participants were screened, and 392 randomized (260 intervention; 132 control), while 294 (201 intervention; 93 control) included in the 52 weeks complete case analysis. More intervention than control participants achieved WL ≥15% at 52 weeks [51/201 (25.4%) vs 6/93 (6.5%); odds ratio 5.18; 95% CI 2.09, 12.88; p < 0.0001]. More adverse events occurred in the intervention (238/260, 91.5%; two deaths) than control (89/132, 67.4%; no deaths) group. Interpretation: A targeted prescribing pathway for liraglutide 3 mg helps more people achieve ≥15% WL at 52 weeks than standard care alone. Funding: Novo Nordisk A/S.

RESUMEN

INTRODUCTION: Efgartigimod and ravulizumab, both approved for treating acetylcholine receptor auto-antibody-positive (AChR-Ab+) generalized myasthenia gravis (gMG), have not been directly compared. This paper assessed comparative effects of efgartigimod vs. ravulizumab for treating adults with AChR-Ab+ gMG using indirect treatment comparison methods. METHODS: The matching-adjusted indirect comparison used data from two randomized trials of adult men and women. The ADAPT (efgartigimod vs. placebo; individual patient data available) population was reweighted to match the CHAMPION (ravulizumab vs. placebo; index study; aggregate data available) population. The relative effect of efgartigimod versus placebo was estimated in this reweighted population and compared with the observed ravulizumab versus placebo effect to estimate the efgartigimod versus ravulizumab effect. The outcomes were Myasthenia Gravis Activities of Daily Living (MG-ADL), Quantitative Myasthenia Gravis (QMG), and Myasthenia Gravis Quality of Life 15-item-revised scale (MG-QoL15r) assessed as cumulative effect (area under the curve; AUC) over 26 weeks (primary) and change from baseline at 4 weeks and time of best response (week 4 for efgartigimod; week 26 for ravulizumab). RESULTS: For MG-QoL15r, efgartigimod had a statistically significant improvement compared with ravulizumab over 26 weeks [mean difference (95% confidence interval): - 52.6 (- 103.0, - 2.3)], at week 4 [- 4.0 (- 6.6, - 1.4)], and at time of best response [- 3.9 (- 6.5, - 1.3)]. Efgartigimod had a statistically significant improvement over ravulizumab in MG-ADL at week 4 [- 1.9 (- 3.3, - 0.5)] and at time of best response [- 1.4 (- 2.8, 0.0)] and in QMG at week 4 [- 3.2 (- 5.2, - 1.2)] and at time of best response [- 3.0 (- 5.0, - 1.0)]. For AUC over 26 weeks, improvements were not significantly different between efgartigimod and ravulizumab for MG-ADL [- 8.7 (- 36.1, 18.8)] and QMG [- 13.7 (- 50.3, 22.9)]. CONCLUSION: Efgartigimod may provide a faster and greater improvement over 26 weeks in quality of life than ravulizumab in adults with AChR-Ab+ gMG. Efgartigimod showed faster improvements in MG-ADL and QMG than ravulizumab.

Asunto(s)

RESUMEN

BACKGROUND: Self-management education programmes are cost-effective in helping people with type 2 diabetes manage their diabetes, but referral and attendance rates are low. This study reports on the effectiveness of the Embedding Package, a programme designed to increase type 2 diabetes self-management programme attendance in primary care. METHODS: Using a cluster randomised design, 66 practices were randomised to: (1) a wait-list group that provided usual care for nine months before receiving the Embedding Package for nine months, or (2) an immediate group that received the Embedding Package for 18 months. 'Embedders' supported practices and self-management programme providers to embed programme referral into routine practice, and an online 'toolkit' contained embedding support resources. Patient-level HbA1c (primary outcome), programme referral and attendance data, and clinical data from 92,977 patients with type 2 diabetes were collected at baseline (months - 3-0), step one (months 1-9), step 2 (months 10-18), and 12 months post-intervention. An integrated ethnographic study including observations, interviews, and document analysis was conducted using interpretive thematic analysis and Normalisation Process Theory. RESULTS: No significant difference was found in HbA1c between intervention and control conditions (adjusted mean difference [95% confidence interval]: -0.10 [-0.38, 0.18] mmol/mol; -0.01 [-0.03, 0.02] %). Statistically but not clinically significantly lower levels of HbA1c were found in people of ethnic minority groups compared with non-ethnic minority groups during the intervention condition (-0.64 [-1.08, -0.20] mmol/mol; -0.06% [-0.10, -0.02], p = 0.004), but not greater self-management programme attendance. Twelve months post-intervention data showed statistically but not clinically significantly lower HbA1c (-0.56 [95% confidence interval: -0.71, -0.42] mmol/mol; -0.05 [-0.06, -0.04] %; p < 0.001), and higher self-management programme attendance (adjusted odds ratio: 1.13; 95% confidence interval: 1.02, 1.25; p = 0.017) during intervention conditions. Themes identified through the ethnographic study included challenges for Embedders in making and sustaining contact with practices and providers, and around practices' interactions with the toolkit. CONCLUSIONS: Barriers to implementing the Embedding Package may have compromised its effectiveness. Statistically but not clinically significantly improved HbA1c among ethnic minority groups and in longer-term follow-up suggest that future research exploring methods of embedding diabetes self-management programmes into routine care is warranted. TRIAL REGISTRATION: ISRCTN23474120, registered 05/04/2018.

Asunto(s)

RESUMEN

BACKGROUND/OBJECTIVES: Inadequate movement, excess adiposity, and insulin resistance augment cardiometabolic risk. This study examined the associations of objectively measured moderate-to-vigorous intensity physical activity (MVPA), sedentary time and cardiorespiratory fitness (CRF), with adipose tissue insulin resistance and ectopic fat. METHODS: Data were combined from two previous experimental studies with community volunteers (n = 141, male = 60%, median (interquartile range) age = 37 (19) years, body mass index (BMI) = 26.1 (6.3) kg·m-2). Adipose tissue insulin resistance was assessed using the adipose tissue insulin resistance index (Adipo-IR); whilst magnetic resonance imaging (MRI) was used to measure liver, visceral (VAT) and subcutaneous abdominal adipose tissue (ScAT). Sedentary time and MVPA were measured via an ActiGraph GT3X+ accelerometer. Generalized linear models examined the association of CRF, MVPA, and sedentary time with Adipo-IR and fat depots. Interaction terms explored the moderating influence of age, sex, BMI and CRF. RESULTS: After controlling for BMI and cardiometabolic variables, sedentary time was positively associated with Adipo-IR (ß = 0.68 AU [95%CI = 0.27 to 1.10], P < 0.001). The association between sedentary time and Adipo-IR was moderated by age, CRF and BMI; such that it was stronger in individuals who were older, had lower CRF and had a higher BMI. Sedentary time was also positively associated with VAT (ß = 0.05 L [95%CI = 0.01 to 0.08], P = 0.005) with the relationship being stronger in females than males. CRF was inversely associated with VAT (ß = -0.02 L [95%CI = -0.04 to -0.01], P = 0.003) and ScAT (ß = -0.10 L [95%CI = -0.13 to -0.06], P < 0.001); with sex and BMI moderating the strength of associations with VAT and ScAT, respectively. CONCLUSIONS: Sedentary time is positively associated with adipose tissue insulin resistance which regulates lipogenesis and lipolysis. CRF is independently related to central fat storage which is a key risk factor for cardiometabolic disease.

Asunto(s)

RESUMEN

OBJECTIVES: To evaluate how sociodemographic factors influence educational modality preferences in people with cardiometabolic disease. METHODS: This was a cross-sectional study performed in people with diabetes and cardiovascular disease, who completed a questionnaire to denote their previous experience and ranked preferences for different educational modalities. RESULTS: The questionnaire was completed by 3751 people, of whom 59% were men, median (interquartile range) age was 68 (59-76) years, and 78% were White European. In total, 73% had diabetes, 35% had heart disease, and 10% had history of stroke; the majority (83.4%) had one of these conditions. Overall preference was for one-to-one education (77% ranked first choice), and telephone education ranked the lowest. People tended to prefer modalities they had previously experienced. CONCLUSIONS: We highlight the importance of considering factors that could influence selection of educational modalities including age, ethnicity, gender and educational level. We anticipate this approach will aid in the design, delivery and tailoring of educational programmes that are accessible to the diverse cohort of people living with chronic diseases, including diabetes and cardiovascular disease. PRACTICE IMPLICATIONS: Given the influence of multiple demographic factors and previous experiences on expressed preferences, providers should support individuals to make informed decisions about educational interventions to maximise engagement.

Asunto(s)

RESUMEN

BACKGROUND: Long distance heavy goods vehicle (HGV) drivers exhibit higher than nationally representative rates of obesity, and obesity-related co-morbidities, and are underserved in terms of health promotion initiatives. The purpose of this study was to evaluate the effectiveness of the multicomponent 'Structured Health Intervention For Truckers' (SHIFT), compared to usual care, at 6- and 16-18-month follow-up. METHODS: We conducted a two-arm cluster RCT in transport sites throughout the Midlands, UK. Outcome measures were assessed at baseline, at 6- and 16-18-month follow-up. Clusters were randomised (1:1) following baseline measurements to either the SHIFT arm or usual practice control arm. The 6-month SHIFT programme included a group-based interactive 6-h education and behaviour change session, health coach support and equipment provision (Fitbit® and resistance bands/balls to facilitate a 'cab workout'). The primary outcome was device-assessed physical activity (mean steps/day) at 6 months. Secondary outcomes included the following: device-assessed sitting, physical activity intensity and sleep; cardiometabolic health, diet, mental wellbeing and work-related psychosocial variables. Data were analysed using mixed-effect linear regression models using a complete-case population. RESULTS: Three hundred eighty-two HGV drivers (mean ± SD age: 48.4 ± 9.4 years, BMI: 30.4 ± 5.1 kg/m2, 99% male) were recruited across 25 clusters (sites) and randomised into either the SHIFT (12 clusters, n = 183) or control (13 clusters, n = 199) arms. At 6 months, 209 (55%) participants provided primary outcome data. Significant differences in mean daily steps were found between groups, in favour of the SHIFT arm (adjusted mean difference: 1008 steps/day, 95% CI: 145-1871, p = 0.022). Favourable differences were also seen in the SHIFT group, relative to the control group, in time spent sitting (- 24 mins/day, 95% CI: - 43 to - 6), and moderate-to-vigorous physical activity (6 mins/day, 95% CI: 0.3-11). Differences were not maintained at 16-18 months. No differences were observed between groups in the other secondary outcomes at either follow-up. CONCLUSIONS: The SHIFT programme led to a potentially clinically meaningful difference in daily steps, between trial arms, at 6 months. Whilst the longer-term impact is unclear, the programme offers potential to be incorporated into driver training courses to promote activity in this at-risk, underserved and hard-to-reach essential occupational group. TRIAL REGISTRATION: ISRCTN10483894 (date registered: 01/03/2017).

Asunto(s)

RESUMEN

AIM: To assess the impact of the sodium-glucose co-transporter-2 (SGLT2) inhibitor empagliflozin (25 mg once-daily), dietary energy restriction, or both combined, on circulating appetite-regulatory peptides in people with type 2 diabetes (T2D) and overweight or obesity. MATERIALS AND METHODS: In a double-blind, placebo-controlled trial, 68 adults (aged 30-75 years) with T2D (drug naïve or on metformin monotherapy; HbA1c 6.0%-10.0% [42-86 mmol/mol]) and body mass index of 25 kg/m2 or higher were randomized to (a) placebo only, (b) placebo plus diet, (c) empagliflozin only or (d) empagliflozin plus diet for 24 weeks. Dietary energy restriction matched the estimated energy deficit elicited by SGLT2 inhibitor therapy through urinary glucose excretion (~360 kcal/day). The primary outcome was change in postprandial circulating total peptide-YY (PYY) during a 3-hour mixed-meal tolerance test from baseline to 24 weeks. Postprandial total glucagon-like peptide-1 (GLP-1), acylated ghrelin and subjective appetite perceptions formed secondary outcomes, along with other key components of energy balance. RESULTS: The mean weight loss in each group at 24 weeks was 0.44, 1.91, 2.22 and 5.74 kg, respectively. The change from baseline to 24 weeks in postprandial total PYY was similar between experimental groups and placebo only (mean difference [95% CI]: -8.6 [-28.6 to 11.4], 13.4 [-6.1 to 33.0] and 1.0 [-18.0 to 19.9] pg/ml in placebo-plus diet, empagliflozin-only and empagliflozin-plus-diet groups, respectively [all P ≥ .18]). Similarly, there was no consistent pattern of difference between groups for postprandial total GLP-1, acylated ghrelin and subjective appetite perceptions. CONCLUSIONS: In people with T2D and overweight or obesity, changes in postprandial appetite-regulatory gut peptides may not underpin the less than predicted weight loss observed with empagliflozin therapy. CLINICAL TRIALS REGISTRATION: NCT02798744, www. CLINICALTRIALS: gov; 2015-001594-40, www.EudraCT.ema.europa.eu; ISRCTN82062639, www.ISRCTN.org.

Asunto(s)

RESUMEN

AIMS: 'Chronotype' describes an individual's sleep-wake schedule, and can be classified into morning, intermediate or evening types. Evening chronotype has been widely associated with increased cardiometabolic risk and mortality in people with type 2 diabetes. We explored associations between chronotype and markers of well-being in people with type 2 diabetes. METHODS: Participants of the 'Chronotype of Patients with Type 2 Diabetes and Effect on Glycaemic Control' (CODEC) observational study completed questionnaires to determine chronotype (Morningness-Eveningness Questionnaire, MEQ) and concurrent measures of well-being (Diabetes-related Distress scale, Patient Health Questionnaire-9 to measure depression, and Self-Compassion Scale), as a secondary endpoint of the study. Adjusted generalised linear models were used to compare well-being between chronotype subgroups in this cohort. RESULTS: Of the 808 individuals included in the CODEC study, from convenience sampling, 476 individuals completed the psychosocial questionnaire substudy. Of these, 67% (n = 321) were male, and 86% (n = 408) were white European. From the MEQ, 24% (n = 114) were morning chronotype, 24% (n = 113) were evening and 52% (n = 249) were intermediate chronotype. Diabetes-related distress was significantly higher in evening chronotypes (exponentiated adjusted coefficient = 1.18 (CI: 1.05-1.32)), compared to morning (padjusted  = 0.005) and intermediate chronotypes (padjusted  = 0.039). Similarly, depression was significantly higher in evening chronotypes (exponentiated adjusted coefficient = 1.84 (CI: 1.28-2.65)) compared to morning (padjusted  = 0.001) and intermediate chronotypes (padjusted  = 0.016). DISCUSSION: Evening chronotype in people with type 2 diabetes may be associated with higher levels of diabetes-related distress and depression. These findings warrant further investigation to establish causality and evidence-based interventions that negate the effects of evening chronotype in people with type 2 diabetes.

Asunto(s)

RESUMEN

BACKGROUND: Without inclusion of diverse research participants, it is challenging to understand how study findings will translate into the real world. Despite this, a lack of inclusion of those from under-served groups in research is a prevailing problem due to multi-faceted barriers acting at multiple levels. Therefore, we rapidly reviewed international published literature, in relation to clinical trials, on barriers relating to inclusion, and evidence of approaches that are effective in overcoming these. METHODS: A rapid literature review was conducted searching PubMed for peer-reviewed articles that discussed barriers to inclusion or strategies to improve inclusion in clinical trial research published between 2010 and 2021. Grey literature articles were excluded. RESULTS: Seventy-two eligible articles were included. The main barriers identified were language and communication, lack of trust, access to trials, eligibility criteria, attitudes and beliefs, lack of knowledge around clinical trials, and logistical and practical issues. In relation to evidence-based strategies and enablers, two key themes arose: [1] a multi-faceted approach is essential [2]; no single strategy was universally effective either within or between trials. The key evidence-based strategies identified were cultural competency training, community partnerships, personalised approach, multilingual materials and staff, communication-specific strategies, increasing understanding and trust, and tackling logistical barriers. CONCLUSIONS: Many of the barriers relating to inclusion are the same as those that impact trial design and healthcare delivery generally. However, the presentation of these barriers among different under-served groups may be unique to each population's particular circumstances, background, and needs. Based on the literature, we make 15 recommendations that, if implemented, may help improve inclusion within clinical trials and clinical research more generally. The three main recommendations include improving cultural competency and sensitivity of all clinical trial staff through training and ongoing personal development, the need to establish a diverse community advisory panel for ongoing input into the research process, and increasing recruitment of staff from under-served groups. Implementation of these recommendations may help improve representation of under-served groups in clinical trials which would improve the external validity of associated findings.

Asunto(s)

RESUMEN

AIMS: The primary aim was to evaluate the effectiveness of a model integrating diabetes services across primary, secondary and community care (Transformation model). The secondary aim was to understand whether changes resulted from the model. METHODS: The model was implemented In Leicester, Leicestershire and Rutland (UK) across three clinical commissioning groups, the acute trust and accompanying stakeholders. One clinical commissioning group (Leicester City) implemented the entire model and was the primary evaluation population. A quasi-experimental interrupted time series design was employed. The primary outcome was number of Type 2 diabetes-related bed-days per 1000 patients. RESULTS: In the primary population, the mean number of Type 2 diabetes-related bed-days per 1000 patients was increasing before model implementation by 0.33/month (95% confidence interval: -0.07, 0.72), whereas it was decreasing after implementation by a mean value of -0.14/month (-0.33, 0.06); a statistically significant difference (p = 0.04). Secondary analyses showed: nationally, there was no significant change between the pre- and post-periods so it is unlikely that large secular change drove the improvement; the other two Leicestershire clinical commissioning groups saw improvement or stability; underlying processes worked as hypothesised overall; diabetes biomedical markers deteriorated in the primary care population suggesting a change in case-mix due to moving some patients out of secondary care. CONCLUSIONS: Given that the initial aim was to shift services from secondary to primary care without causing harm, an improvement is better than expected. This observational evaluation cannot show conclusively that improvements were due to the Transformation model, but secondary analyses support this.

Asunto(s)

RESUMEN

BACKGROUND: Structured self-management education (SSME) for people with type 2 diabetes mellitus (T2DM) improves biomedical and psychological outcomes, whilst being cost-effective. Yet uptake in the UK remains low. An 'Embedding Package' addressing barriers and enablers to uptake at patient, health care professional and organisational levels has been developed. The aim of this study was to test the feasibility of conducting a subsequent randomised controlled trial (RCT) to evaluate the Embedding Package in primary care, using a mixed methods approach. METHODS: A concurrent mixed methods approach was adopted. Six general practices in the UK were recruited and received the intervention (the Embedding Package). Pseudonymised demographic, biomedical and SSME data were extracted from primary care medical records for patients recorded as having a diagnosis of T2DM. Descriptive statistics assessed quantitative data completeness and accuracy. Quantitative data were supplemented and validated by a patient questionnaire, for which two recruitment methods were trialled. Where consent was given, the questionnaire and primary care data were linked and compared. The cost of the intervention was estimated. An integrated qualitative study comprising ethnography and stakeholder and patient interviews explored the process of implementation, sustainability of change and 'fit' of the intervention. Qualitative data were analysed using a thematic framework guided by the Normalisation Process Theory (NPT). RESULTS: Primary care data were extracted for 2877 patients. The primary outcome for the RCT, HbA1c, was over 90% complete. Questionnaires were received from 423 (14.7%) participants, with postal invitations yielding more participants than general practitioner (GP) prompts. Ninety-one percent of questionnaire participants consented to data linkage. The mean cost per patient for the Embedding Package was £8.94, over a median follow-up of 162.5 days. Removing the development cost, this reduces to £5.47 per patient. Adoption of ethnographic and interview methods in the collection of data was appropriate, and the use of NPT, whilst challenging, enhanced the understanding of the implementation process. The need to delay the collection of patient interview data to enable the intervention to inform patient care was highlighted. CONCLUSIONS: It is feasible to collect data with reasonable completeness and accuracy for the subsequent RCT, although refinement to improve the quality of the data collected will be undertaken. Based on resource use data collected, it was feasible to produce cost estimates for each individual component of the Embedding Package. The methods chosen to generate, collect and analyse qualitative data were satisfactory, keeping participant burden low and providing insight into potential refinements of the Embedding Package and customisation of the methods for the RCT. TRIAL REGISTRATION: ISRCTN, ISRCTN21321635, Registered 07/07/2017-retrospectively registered.

RESUMEN

As a consequence of responding to colleagues who asked about the publication of the original article [1], the authors have determined that the data published in Table 4 of the paper are incorrect.

RESUMEN

BACKGROUND: Prolonged sitting is common in older adults and is associated with insulin resistance and poor cardiometabolic health. We investigate whether breaking prolonged sitting with regular short bouts of standing or light walking improves postprandial metabolism in older white European and South Asian adults and whether effects are modified by ethnic group. METHODS: Thirty South Asian (15 women) and 30 white European (14 women) older adults (aged 65-79 years) undertook three experimental conditions in random order. (a) Prolonged sitting: continuous sitting during an observation period if 7.5 hours consuming two standardized mixed meals. (b) Standing breaks: sitting interrupted with 5 minutes of standing every 30 minutes (accumulating 60 minutes of standing over the observation period). (c) Walking breaks: sitting interrupted with 5 minutes of self-paced light walking every 30 minutes (accumulating 60 minutes of walking). Blood samples (glucose, insulin, triglycerides) and blood pressure were sampled regularly throughout each condition. RESULTS: Compared with prolonged sitting, walking breaks lowered postprandial insulin by 16.3 mU/L, (95% CI: 19.7, 22.0) with greater reductions (p = .029) seen in South Asians (22.4 mU/L; 12.4, 32.4) than white Europeans (10.3 mU/L; 5.9, 14.7). Glucose (0.3 mmol/L; 0.1, 0.5) and blood pressure (4 mm Hg; 2, 6), but not triglycerides, were lower with walking breaks, with no ethnic differences. Standing breaks did not improve any outcome. CONCLUSIONS: Breaking prolonged sitting with short bouts of light walking, but not standing, resulted in clinically meaningful improvements in markers of metabolic health in older adults, with South Asians gaining a greater reduction in postprandial insulin. TRIAL REGISTRATION: NCT02453204.

Asunto(s)

RESUMEN

BACKGROUND: Girls Active is a physical activity programme, delivered in UK secondary schools, with the aim of increasing moderate-to-vigorous physical activity (MVPA) in girls aged 11-14 years. This study presents the process evaluation as part of a 14-month cluster randomised controlled trial designed to evaluate the effectiveness of the Girls Active programme and which showed no difference in the primary outcome (MVPA at 14 months) between intervention and control arms. METHODS: Quantitative and qualitative data were collected from intervention schools over the course of the 14 month trial. Feedback forms and attendance records were completed at the end of all teacher and peer leader training and review days. At 7- and 14-months, semi-structured interviews were conducted with the lead Girls Active teacher in all intervention schools (n = 10) and staff from the intervention provider (n = 4) and hub school (n = 1). At 14 months, separate focus groups with peer leaders (n = 8 schools), girls who participated in the evaluation component of the trial (n = 8 schools), and a sample of boys (n = 6 schools) were conducted. All participants in the intervention schools were asked to complete an exit survey at 14 months. Teachers (intervention and control) completed a school environment questionnaire at baseline, 7- and 14-months. RESULTS: The Girls Active programme, i.e., the training and resources, appeared to be well received by teachers and pupils. Factors that may have contributed to the lack of effectiveness include: some initial uncertainty by teachers as to what to do following the initial training, a predominant focus on support activities (e.g., gathering opinions) rather than actual physical activity provision, and school-level constraints that impeded implementation. CONCLUSIONS: Girls Active and what it was trying to achieve was valued by schools. The programme could be improved by providing greater guidance to teachers throughout, the setting of timelines, and providing formal training to peer leaders. TRIAL REGISTRATION: ISRCTN, ISRCTN10688342 . Registered 12 January 2015.

Asunto(s)

RESUMEN

Physical inactivity has been identified as a leading risk factor for premature mortality globally, and adolescents, in particular, have low physical activity levels. Schools have been identified as a setting to tackle physical inactivity. Economic evidence of school-based physical activity programmes is limited, and the costs of these programmes are not always collected in full. This paper describes a micro-costing and cost-consequence analysis of the 'Girls Active' secondary school-based programme as part of a cluster randomised controlled trial (RCT). Micro-costing and cost-consequence analyses were conducted using bespoke cost diaries and questionnaires to collect programme delivery information. Outcomes for the cost-consequence analysis included health-related quality of life measured by the Child Health Utility-9D (CHU-9D), primary care General Practitioner (GP) and school-based (school nurse and school counsellor) service use as part of a cluster RCT of the 'Girls Active' programme. Overall, 1,752 secondary pupils were recruited and a complete case sample of 997 participants (Intervention n = 570, Control n = 427) was used for the cost-consequence analysis. The micro-costing analysis demonstrated that, depending upon how the programme was delivered, 'Girls Active' costs ranged from £1,054 (£2 per pupil, per school year) to £3,489 (£7 per pupil, per school year). The least costly option was to absorb 'Girls Active' strictly within curriculum hours. The analysis demonstrated no effect for the programme for the three main outcomes of interest (health-related quality of life, physical activity and service use).Micro-costing analyses demonstrated the costs of delivering the 'Girls Active' programme, addressing a gap in the United Kingdom (UK) literature regarding economic evidence from school-based physical activity programmes. This paper provides recommendations for those gathering cost and service use data in school settings to supplement validated and objective measures, furthering economic research in this field. Trial registration: -ISRCTN, ISRCTN10688342.

Asunto(s)

RESUMEN

INTRODUCTION: Despite their young age and relatively short duration of disease, younger adults with type 2 diabetes (T2D) already have diastolic dysfunction and may be at risk of incipient heart failure. Whether weight loss or exercise training improve cardiac dysfunction in people with T2D remains to be established. METHODS AND ANALYSIS: Prospective, randomised, open-label, blind endpoint trial. The primary aim of the study is to determine if diastolic function can be improved by either a meal replacement plan or a supervised exercise programme, compared with guideline-directed care. A total of 90 obese participants with T2D (aged 18-65 years), diabetes duration <12 years and not on insulin treatment will be randomised to either guideline-directed clinical care with lifestyle coaching, a low-energy meal replacement diet (average ≈810 kcal/day) or a supervised exercise programme for 12 weeks. Participants undergo glycometabolic profiling, cardiopulmonary exercise testing, echocardiography and MRI scanning to assesses cardiac structure and function and dual-energy X-ray absorptiometry scanning for body composition. Key secondary aims are to assess the effects of the interventions on glycaemic control and insulin resistance, exercise capacity, blood pressure, changes in body composition and association of favourable cardiac remodelling with improvements in weight loss, exercise capacity and glycometabolic control. ETHICS AND DISSEMINATION: The study has full ethical approval, and data collection was completed in August 2018. The study results will be submitted for publication within 6 months of completion. TRIAL REGISTRATION NUMBER: NCT02590822; Pre-results.

Asunto(s)

RESUMEN

BACKGROUND: Self-reported data have consistently shown South Asians (SAs) to be less physically active than White Europeans (WEs) in developed countries, however objective data is lacking. Differences in sedentary time have not been elucidated in this population. This study aimed to quantify differences in objectively measured physical activity and sedentary behaviour between WEs and SAs recruited from primary care and to investigate differences in demographic and lifestyle correlates of these behaviours. METHODOLOGY: Baseline data were utilised from a randomised control trial recruiting individuals identified at high risk of type 2 diabetes from primary care. Light intensity physical activity, moderate-to-vigorous intensity physical activity (MVPA) and steps were measured using the Actigraph GT3X+, while sitting, standing and stepping time were measured using the activPAL3™. Devices were worn concurrently for seven days. Demographic (employment, sex, age, education, postcode) and behavioural (fruit and vegetable consumption, alcohol consumption, smoking status) characteristics were measured via self and interview administered questionnaires. RESULTS: A total of 963 WE (age = 62 ± 8, female 51%) and 289 SA (age = 55 ± 11, female 43%) were included. Compared to WEs, SAs did less MVPA (24 vs 33 min/day, p = 0.001) and fewer steps (6404 vs 7405 per day, p ≤ 0.001), but sat less (516 vs 552 min/day, p ≤ 0.001) and stood more (328 vs 283 min/day, p ≤ 0.001). Ethnicity also modified the extent to which demographic and behavioural factors act as correlates of physical activity and sedentary behaviour. Differences between sex in levels of MVPA and sitting time were greater in SAs compared to WEs, with SA women undertaking the least amount of MVPA (19 min/day), the least sitting time (475 min/day) and most standing time (377 min/day) than any other group. Smoking and alcohol status also acted as stronger correlates of sitting time in SAs compared to WEs. In contrast, education level acted as a stronger correlate of physical activity in WEs compared to SAs. CONCLUSION: SAs were less active yet less sedentary than WEs, which demonstrates the need to tailor the behavioural targets of interventions in multi-ethnic communities. Common correlates of physical activity and sedentary behaviour also differed between ethnicities. TRIAL REGISTRATION: ISRCTN83465245 Trial registration date: 14/06/2012.

Asunto(s)

RESUMEN

BACKGROUND: Coronary heart disease (CHD) represents approximately 13% of deaths worldwide and is the leading cause of death in the UK with considerable associated health care costs. After a CHD event, timely cardiac rehabilitation optimises patient outcomes. However, a high percentage of these services do not meet necessary performance indicators such as course length and follow-up attendance. Uptake of such services is only 50% in UK patients and support provided 12 months after an event is often limited. To delay and prevent further CHD events leading to hospitalisation, supplementary self-management strategies such as group education, are necessary. METHODS: This is a single-centre, randomised controlled trial (RCT) recruiting participants (n = 290) aged ≥18 years who are 12 to 48 months post diagnosis of a CHD-related cardiac event (myocardial infarction, angina and any other acute coronary syndrome). The study aims to implement a structured education programme, with text-message support over 12 months, and identify whether delivery of the programme, to individuals who have a history of a cardiac event, would be an effective and cost-effective strategy for increasing walking. The primary outcome, objectively measured average daily physical activity, specifically step count through walking activity, is assessed using the wrist-worn GENEActiv accelerometer at baseline, 6 and 12 months. Secondary outcomes at 12 months include cardiovascular risk factors such as smoking status, blood pressure, lipid profile, glycated haemoglobin (HbA1c), obesity, self-efficacy, quality of life, physical activity and physical function. Participants are randomised to either the control group receiving standard care and a physical activity information leaflet, or the intervention group whose partcipants receive the leaflet and are invited to attend two group-based structured education sessions. These encourage participants to adopt and maintain healthy behaviours and self-manage their lifestyle. They are delivered approximately 2 weeks apart by trained facilitators and reinforced via subsequent text-message support. DISCUSSION: To our knowledge, this is the first trial designed to assess the effectiveness of a group education programme 12 to 48 months after a CHD event diagnosis. If successful, the PACES programme could be translated into effective post-operative cardiac care and complement the current post-operative services available. TRIAL REGISTRATION: ISRCTN, ID: ISRCTN91163727 . The trial was registered on 27 February 2017.

Asunto(s)