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Background Research investigating the nutritional status of older people in residential care homes is scant. Objective To determine the anthropometric measures and dietary intakes of older people in this setting as a basis for future intervention studies. Methods Dietary intake was assessed using 3-day-weighed food records, nutritional status was evaluated using anthropometric measurements (knee height to predict standing height, and body weight). Catering provision was assessed using a computer-based menu assessment tool (CORA). Results Mean body mass index (BMI) for the 34 participants was 22.2 kg m(2) (range 14.5-34.4). Six participants (17.6%) had a BMI 18.5 but <20 kg m(2). Only two subjects with BMI <18.5 kg m(2) were prescribed oral supplements. In both men and women, recorded mean energy intakes were below current estimated average requirements by 24% and 22% respectively. Conclusion Despite adequate food provision, under-nutrition was prevalent and, in the majority of cases, unidentified and untreated. A larger study is warranted to investigate whether improved nutritional intake is achievable through dietary modification. These data indicate that a sample size of around 60, with 90% power and at the 5% significance level, is required to detect a difference of 1674 kJ between groups of residents in an intervention study following a cluster randomized design. [ABSTRACT FROM AUTHOR]

OBJECTIVES: Survivors of acute myocardial infarction (MI) often experience weight changes and weight management is often appropriate. Estimates of the sample size required in intervention weight loss studies are essential to the success of future evaluations. The aims of this study were therefore two-fold: (1) to describe pilot data on the effectiveness of advice for weight loss; (2) to provide information on the sample size required for future research to assess weight management in similar patients. METHODS: Further analysis of data from a randomized controlled study carried out in 84 post-MI patients attending cardiac rehabilitation. Forty-three intervention patients received dietary advice in line with current UK guidelines. Additionally, overweight intervention subjects were given individualized weight management advice. Forty-two control patients were recruited and received usual care. Anthropometric measurements were made at baseline and followed up at 52 weeks post-rehabilitation. Power calculations were performed using these data to determine the required sample size to adequately power a study examining the effectiveness of weight management. RESULTS: Seventy patients completed the study. At 52 weeks anthropometric measurements were unchanged in the 25 overweight patients provided with weight management advice, and also for all those (n = 20) with body mass index <25 kg m-2. In contrast, anthropometric measurements increased significantly (body weight +2.4 kg, P = 0.02; waist circumference +2.6 cm, P = 0.008) in overweight control patients. A minimum sample size of 71 patients is required for a future study of weight change in overweight subjects, and 58 for a study of healthy weight subjects. CONCLUSIONS: Pilot data suggested that significant weight changes occur in patients not given nutritional or weight management advice after MI. Power calculations carried out on these data indicate that a sample size at least three times as large as the present study is required to accurately evaluate weight management in this group. [ABSTRACT FROM AUTHOR]

Objective: To determine the reasons for delay in calling for help during acute myocardial infarction and the reasons for choice of first medical contact.Design: Review of routine medical records and one to one semi-structured interviews.Setting: Community survey in city of Glasgow, north of the river Clyde.Patients: 228 men and 85 women aged between 25 and 65 years, respectively, who survived acute myocardial infarction between October 1994 and December 1996.Results: Only 25% of the subjects made a call for help within one hour of the onset of coronary symptoms; in 40% the delay was greater than four hours. Symptoms were not recognised as coronary in origin in the majority of cases. In all cases where delay was more than one hour the main reasons for the delay were thinking that symptoms would go away or that they were not serious. Requesting the attendance of a general practitioner was the first course of action in the majority of cases (55%); the main reason given was that the patient believed this should always be the first course of action. Reluctance to call the emergency services reflected the belief that the symptoms were not serious enough to warrant an ambulance.Conclusions: Strategies to reduce patient delay times in this deprived urban population must focus on educating the public on the recognition and diversity of coronary symptoms and the benefits of presenting promptly to hospital by way of the emergency ambulance service. [ABSTRACT FROM AUTHOR]

Background: In DiRECT, a randomised controlled effectiveness trial, weight management intervention after 2 years resulted in mean weight loss of 7·6 kg, with 36% of participants in remission of type 2 diabetes. Of 36 in the intervention group who maintained over 10 kg weight loss at 2 years, 29 (81%) were in remission. Continued low-intensity dietary support was then offered up to 5 years from baseline to intervention participants, aiming to maintain weight loss and gain clinical benefits. This extension study was designed to provide observed outcomes at 5 years., Methods: The DiRECT trial took place in primary care practices in the UK. Participants were individuals aged 20-65 years who had less than 6 years' duration of type 2 diabetes, a BMI greater than 27 kg/m 2 , and were not on insulin. The intervention consisted of withdrawal of antidiabetic and antihypertensive drugs, total diet replacement (825-853 kcal per day formula diet for 12-20 weeks), stepped food reintroduction (2-8 weeks), and then structured support for weight-loss maintenance. After sharing the 2-year results with all participants, UK National Health Service data were collected annually until year 5 from remaining intervention participants who received low-intensity dietary support, intervention withdrawals, and the original randomly allocated groups. The primary outcome was remission of type 2 diabetes; having established in the DiRECT trial that sustained weight loss was the dominant driver of remission, this was assumed for the Extension study. The trial is registered with the ISRCTN registry, number 03267836., Findings: Between July 25, 2014, and Aug 5, 2016, 149 participants were randomly assigned to the intervention group and 149 were assigned to the control group in the original DiRECT study. After 2 years, all intervention participants still in the trial (101 [68%] of 149) were approached to receive low-intensity support for a further 3 years. 95 (94%) of 101 were able to continue and consented and were allocated to the DiRECT extension group. 54 participants were allocated to the non-extension group, where intervention was withdrawn. At 5 years, DiRECT extension participants (n=85) lost an average of 6·1 kg, with 11 (13%) of 85 in remission. Compared with the non-extension group, DiRECT extension participants had more visits with HbA 1c <48 mmol/mol (<6·5%; 36% vs 17%, p=0·0004), without glucose-lowering medication (62% vs 30%, p<0·0001), and in remission (34% vs 12%, p<0·0001). Original control participants (n=149) had mean weight loss 4·6 kg (n=82), and 5 (5%) of 93 were in remission. Compared with control participants, original intervention participants had more visits with weight more than 5% below baseline (61% vs 29%, p<0·0001), HbA 1c below 48 mmol/mol (29% vs 15%, p=0·0002), without antidiabetic medication (51% vs 16%, p<0·0001), and in remission (27% vs 4%, p<0·0001). Of those in remission at year 2, 26% remained in remission at 5 years. Serious adverse events in the original intervention group (4·8 events per 100 patient-years) were under half those in the control group (10·2 per 100 patient-years, p=0·0080)., Interpretation: The extended DiRECT intervention was associated with greater aggregated and absolute weight loss, and suggested improved health status over 5 years., Funding: Diabetes UK., Competing Interests: Declaration of interests MEJL reports grants and personal fees unconnected with the present work from Counterweight, Novo Nordisk, Novartis, and Eli Lilly. RT has received lecture fees from Novartis and Eli Lilly, and has served on an advisory panel for Wilmington Healthcare. NB reports employment and shareholding in Counterweight, and PhD fees funded by Cambridge Weight Plan (outside the submitted work). GT received funding for PhD fees and conference attendance from Cambridge Weight Plan outside the submitted work. WSL reports support for conference attendance from Cambridge Weight Plan outside the submitted work. NS reports grants and personal fees from AstraZeneca, Boehringer Ingelheim, Novartis, and Roche Diagnostics; and personal fees from Abbott Laboratories, Amgen, Eli Lilly, Hanmi Pharmaceuticals, Janssen, Merck Sharp & Dohme, Novo Nordisk, Pfizer, and Sanofi, outside the submitted work. LM reports employment by Counterweight during the conduct of study, was previously a shareholder in Counterweight, and previous employment from Cambridge Weight Plan outside the submitted work. All other authors declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Aims: As sustained weight loss is vital for achieving remission of type 2 diabetes, we explored whether randomisation to weight loss plus maintenance in the DiRECT trial was associated with physical activity, inactivity or sleep., Methods: Participants were randomised to either a dietary weight management programme or best-practice care. The weight management group were encouraged to increase daily physical activity to their sustainable maximum. Objective measurement was achieved using a wrist-worn GENEActiv accelerometer for 7 days at baseline, 12 and 24 months in both groups., Results: Despite average weight loss of 10 kg at 12 months in the intervention (n = 66) group, there were no differences in total physical activity or inactivity compared with the control (n = 104) at any time point. However, in our exploratory analysis, those who lost more than 10% of their baseline body weight performed on average 11 mins/day more light activity than the <10% group at 24 months (p = 0.033) and had significantly lower bouts of Inactivity 30min (interaction, p = 0.005) across 12 and 24 months. At 24 months, the ≥10% group had higher daily acceleration (38.5 ± 12.1 vs. 33.2 ± 11.1 mg, p = 0.020), and higher accelerations in the most active 5-hour period (59.4 ± 21.8 vs. 50.6 ± 18.3 mg, p = 0.023). Wakefulness after sleep onset decreased in the intervention group compared with the control group and also in the ≥10% weight loss group at 12 and 24 months., Conclusions: Randomisation to a successful intensive weight loss intervention, including regular physical activity encouragement, was not associated with increased physical activity although sleep parameters improved. Physical activity was greater, and night-time waking reduced in those who maintained >10% weight loss at 12 and 24 months. TRIAL REGISTRATION ISRCTN03267836., (© 2022 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.)

Background: We aimed to assess whether a structured weight management programme incorporating a total diet replacement (TDR) (3-5 months ∼850 kcal/day formula diet) weight loss phase is acceptable to people of South Asian ethnicity and can achieve type 2 diabetes (T2D) remissions similarly to other populations., Methods: Adults of South Asian ethnicity, aged 18-65 years, with T2D for ≤4 years, and BMI 25-45 kg/m 2 were recruited from primary care and social media, and randomised to commence TDR either immediately (iTDR), or delayed (dTDR) for 3-5 months as a usual care control arm during this period. Intervention effects were tested in randomised comparisons powered to detect significant weight loss, and in an expanded observational analysis to determine remission effect size, including both iTDR and dTDR groups. Acceptability in those recruited was explored by questionnaire and weight change., Trial Registration: Current Controlled Trials, ISRCTN10720065. Date of Registration 27/09/2017., Findings: Twenty-five eligible individuals were recruited. Mean baseline (SD) age was 45.8 (11.1) years, weight 88.2 (13.7) kg, BMI 32.1 (3.8) kg/m 2 , HbA1c 60.4 (11.3) mmol/mol, liver fat by MRI 15.6 (9.4)%. In the RCT, mean(SD) weight change after TDR was -7.7 (7.2)% in the intervention group (n = 13), and -1.2 (1.4)% in the usual-care control group (n = 12) (p = 0.005), with T2D remission achieved by 5/13, compared to 0/12 respectively (p = 0.039). In the observational study, 23/25 started TDR and 19/23 participants completed the TDR phase. Median time spent in TDR was 105 days (IQR 77-134 days). T2D remission was achieved in 10/23 (43%), and weight changes were concordant with the RCT. Overall, 8/23 (35%) lost over 10% bodyweight. Absolute liver fat proportion near halved from 15.3% at the start of TDR to 8.6% (p < 0.001)., Interpretation: In UK-based South Asians, TDR-led weight loss and T2D remission rates are comparable to those observed in white cohorts, and the intervention was acceptable in most of those recruited. There is potential to further improve outcomes, but one-third lost >10% body weight, and the mechanism underpinning T2D remission appears similar, driven by weight change with loss of excess ectopic body-fat., Funding: We gratefully acknowledge funding for the MRI scans from the, Miss MJM Smith Trust (registered charity: SC040586). No other external funds were provided for this trial. NS is supported by the British Heart Foundation Research Excellence Award (RE/18/6/34217)., Competing Interests: PW reports grant income from Roche Diagnostics, Astrazeneca, Boehringer Ingelheim, and Novartis, and speaker fees from Novo Nordisk, outside the submitted work. NS has received grant and personal fees from AstraZeneca, Boehringer Ingelheim, and Novartis; grant from Roche Diagnostics; and personal fees from Abbott Laboratories, Afimmune, Amgen, Eli Lilly, Hanmi Pharmaceuticals, Janssen, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, and Sanofi outside the submitted work. ML declares department/university grant funding from NIHR, All Saints Educational Trust and Diabetes UK, and personal fees for lecturing and advisory boards from Novo Nordisk, Roche, Merck, Sanofi, Nestle and Oviva. All other authors declare no conflicts of interest., (© 2022 The Author(s).)

Objective: The Diabetes Remission Clinical Trial (DiRECT) used a formula total diet replacement programme followed by structured weight loss maintenance to induce and sustain weight loss and remission of type 2 diabetes (T2D) in 36% of participants after 2 years. Nurses and dietitians delivering DiRECT in 22 primary care practices in Tyneside and Scotland provided behavioural support to participants. Participant experiences with DiRECT highlighted the key role of support by healthcare professionals (HCPs). We evaluated HCPs' experiences with DiRECT., Research Design and Methods: Healthcare professionals delivering DiRECT were interviewed at 12 months, while general practices (GPs) were sent an implementation questionnaire. The interviews were analysed thematically. The questionnaires were analysed using frequencies and a narrative synthesis., Results: Healthcare professionals representing 11 of 22 intervention practices were interviewed and 10 of 22 GPs completed questionnaires. HCPs' initial concerns over perceived potential negative intervention effects, particularly withdrawing anti-diabetes and anti-hypertensive medications, were barriers to engagement. Trust of HCPs towards the research team and perceived credibility of the study facilitated engagement and adoption. Ongoing support by research dietitians was key to the management of participants. Involvement in DiRECT inspired more focus on behaviour modification in the treatment of other people living with T2D in routine practice., Conclusions: Diabetes Remission Clinical Trial was considered highly appropriate for the management of T2D in primary care when supported by trained dietitians. Addressing limitations, including varying training needs of HCPs may improve intervention scale-up and tailoring to clinical contexts., (© 2021 Diabetes UK.)

Introduction: The Diabetes REmission Clinical Trial (DiRECT) has shown that sustained remission of type 2 diabetes in primary care is achievable through weight loss using total diet replacement (TDR) with continued behavioural support. Understanding participants' experiences can help optimise the intervention, support implementation into healthcare, and understand the process of behaviour change., Methods: Thirty-four DiRECT participants were recruited into this embedded qualitative evaluation study. In-person and telephone interviews were conducted before the TDR; at week 6-8 of the TDR; 2 weeks into food reintroduction (FR); and at 1 year, to learn about participant experiences with the programme. Transcribed narratives were analysed thematically, and we used interpretation to develop overarching themes., Results: Initiation of the TDR and transition to FR were challenging and required increased behavioural support. In general, adhering to TDR proved easier than the participants had anticipated. Some participants chose the optional extension of TDR. Rapid weight loss and changes in diabetes markers provided ongoing motivation. Further weight loss, behavioural support and occasional use of TDR facilitated weight loss maintenance (WLM). A process of behaviour adaptation to change following regime disruption was identified in three stages: (1) expectations of the new, (2) overcoming difficulties with adherence, and (3) acceptance of continuous effort and establishment of routines., Conclusions: The DiRECT intervention was acceptable and regularity, continuity, and tailoring of behavioural support was instrumental in its implementation in primary care. The adaptation process accounts for some of the individual variability of experiences with the intervention and highlights the need for programme flexibility., (© 2021 Diabetes UK.)

Aims/hypothesis: Our aim was to evaluate the safety and efficacy of a planned therapeutic withdrawal of all antihypertensive and diuretic medications, on commencing a formula low-energy diet replacement, targeting remission of type 2 diabetes., Methods: Post hoc analysis of changes in BP, antihypertensive medication prescriptions and symptoms during the initial total diet replacement phase was performed in the intervention arm of the Diabetes Remission Clinical Trial (n = 143) and in the subset (n = 69) who discontinued antihypertensive medications at the start of total diet replacement. The Counterweight-Plus total diet replacement provided about 3470 kJ/day (830 kcal) with automatic reductions in all nutrients, including sodium, to achieve marked negative energy balance and rapid weight loss over 12-20 weeks, with regular BP monitoring and an antihypertensive reintroduction protocol based on current clinical guidelines., Results: Of 143 intervention group participants who commenced total diet replacement, 78 (55%) were on treatment for hypertension at baseline. The overall mean BP fell significantly from the start of total diet replacement (week 1) and was significantly lower at week 20, after total diet replacement finished, and also at 12 and 24 months. Of the 78 participants previously on treatment for hypertension, 65 (83%) stopped all antihypertensive and diuretic medications as per protocol, and four (5%) stopped some drugs. These 69 participants experienced no immediate (within the first week) change in BP, but their mean BP fell significantly from 9 weeks. No excessive rises in BP were recorded in individuals, but antihypertensive medications were reintroduced during total diet replacement to manage raised BP for 19/69 (27.5%) participants, mostly within the first 3-7 weeks, despite some weight loss. Reintroduction of antihypertensive medications was necessary for 5/19 participants previously on one drug, and for 14/19 previously on two or more drugs. Of the 69 who stopped antihypertensives, 19 (28%) remained off medications at 24 months. Among the 53 participants who achieved sustained remissions of diabetes at 24 months (with a mean weight loss of 11.4 kg), 31 had been previously treated for hypertension. Twenty-seven stopped medication at baseline, and 15/27 required reintroduction of antihypertensive medications. Mild to moderate dizziness, suggesting some postural hypotension, was reported during total diet replacement by 51 participants, 15 of whom had recorded dizziness at baseline prior to starting total diet replacement, with nine of these on antihypertensive or diuretic medications., Conclusions/interpretation: Replacing antihypertensive medications with a 3470 kJ/day (830 kcal) diet to induce weight loss reduces BP substantially and may increase mild dizziness. It is safe to stop antihypertensives, but BP should be monitored regularly, particularly for those taking two or more antihypertensives, as over two-thirds will require reintroduction of some medications. Long-term support to maintain weight loss is vital., Trial Registration: ISRCTN registry, number 03267836., (© 2021. The Author(s).)

Aim: To identify predictors of type 2 diabetes remission in the intervention arm of DiRECT (Diabetes Remission Clinical Trial)., Methods: Participants were aged 20-65 years, with type 2 diabetes duration of <6 years and BMI 27-45 kg/m 2 , and were not receiving insulin. Weight loss was initiated by total diet replacement (825-853 kcal/day, 3-5 months, shakes/soups), and weight loss maintenance support was provided for 2 years. Remissions (HbA 1c <48 mmol/mol [<6.5%], without antidiabetes medications) in the intervention group (n = 149, mean age 53 years, BMI 35 kg/m 2 ) were achieved by 68/149 participants (46%) at 12 months and by 53/149 participants (36%) at 24 months. Potential predictors were examined by logistic regression analyses, with adjustments for weight loss and effects independent of weight loss., Results: Baseline predictors of remission at 12 and 24 months included being prescribed fewer antidiabetes medications, having lower triglyceride and gamma-glutamyl transferase levels, and reporting better quality of life with less anxiety/depression. Lower baseline HbA 1c was a predictor at 12 months, and older age and male sex were predictors at 24 months. Being prescribed antidepressants predicted non-remission. Some, but not all effects were explained by weight loss. Weight loss was the strongest predictor of remission at 12 months (adjusted odds ratio per kg weight loss 1.24, 95% CI 1.14, 1.34; P < 0.0001) and 24 months (adjusted odds ratio 1.23, 95% CI 1.13, 1.35; P <0.0001). Weight loss in kilograms and percentage weight loss were equally good predictors. Early weight loss and higher programme attendance predicted more remissions. Baseline BMI, fasting insulin, fasting C-peptide and diabetes duration did not predict remission., Conclusions: Other than weight loss, most predictors were modest, and not sufficient to identify subgroups for which remission was not a worthwhile target., (© 2020 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.)

Aim: To investigate whether appetite-related hormones were predictors of weight regain in the Diabetes Remission Clinical Trial (DiRECT)., Materials and Methods: DiRECT is a cluster-randomized clinical trial, designed to assess the effect of weight loss on type 2 diabetes remission. For this post hoc analysis, data were available for 253 (147 interventions, 106 controls) individuals with type 2 diabetes (age 53.6 ± 7.5 years, body mass index 34.7 ± 4.4 kg/m 2 , 59% men). Intervention participants received a 24-month weight management programme, and controls remained on usual diabetes care. Fasting plasma concentrations of leptin, ghrelin, glucagon-like peptide-1 and peptide YY were measured at baseline, 12 months and 24 months in all participants, and at 5 months in a subset of participants in the intervention (n = 56) and control groups (n = 22). Potential predictors were examined using multivariable linear regression models., Results: The intervention group lost 14.3 ± 6.0% body weight at 5 months but regained weight over time, with weight losses of 10.0 ± 7.5% at 12 months and 7.6 ± 6.3% at 24 months. Weight loss in controls was 1.1 ± 3.7% and 2.1 ± 5.0% at 12 and 24 months, respectively. Body weight increased by 2.3% (95% confidence interval [CI] 0.4, 4.1; P = 0.019) between 12 and 24 months for every 1-ng/mL increase in ghrelin between baseline and 12 months, and weight regain between 12 and 24 months was increased by 1.1% (95% CI 0.2, 2.0; P = 0.023) body weight for every 1-ng/mL increase in ghrelin at 12 months., Conclusion: The rise in ghrelin (but not any other measured hormone) during diet-induced weight loss was a predictor of weight regain during follow-up, and concentrations remained elevated over time, suggesting a small but significant compensatory drive to regain weight. Attenuating the effects of ghrelin may improve weight-loss maintenance., (© 2020 John Wiley & Sons Ltd.)

Aims/hypothesis: Approximately 10% of total healthcare budgets worldwide are spent on treating diabetes and its complications, and budgets are increasing globally because of ageing populations and more expensive second-line medications. The aims of the study were to estimate the within-trial and lifetime cost-effectiveness of the weight management programme, which achieved 46% remissions of type 2 diabetes at year 1 and 36% at year 2 in the Diabetes Remission Clinical Trial (DiRECT)., Methods: Within-trial analysis assessed costs of the Counterweight-Plus intervention in DiRECT (including training, programme materials, practitioner appointments and low-energy diet), along with glucose-lowering and antihypertensive medications, and all routine healthcare contacts. Lifetime cost per quality-adjusted life-year (QALY) was estimated according to projected durations of remissions, assuming continued relapse rates as seen in year 2 of DiRECT and consequent life expectancy, quality of life and healthcare costs., Results: Mean total 2 year healthcare costs for the intervention and control groups were £3036 and £2420, respectively: an incremental cost of £616 (95% CI -£45, £1269). Intervention costs (£1411; 95% CI £1308, £1511) were partially offset by lower other healthcare costs (£796; 95% CI £150, £1465), including reduced oral glucose-lowering medications by £231 (95% CI £148, £314). Net remission at 2 years was 32.3% (95% CI 23.5%, 40.3%), and cost per remission achieved was £1907 (lower 95% CI: intervention dominates; upper 95% CI: £4212). Over a lifetime horizon, the intervention was modelled to achieve a mean 0.06 (95% CI 0.04, 0.09) QALY gain for the DiRECT population and mean total lifetime cost savings per participant of £1337 (95% CI £674, £2081), with the intervention becoming cost-saving within 6 years., Conclusions/interpretation: Incorporating the lifetime healthcare cost savings due to periods of remission from diabetes and its complications, the DiRECT intervention is predicted to be both more effective (QALY gain) and cost-saving in adults with type 2 diabetes compared with standard care. This conclusion appears robust to various less favourable model scenarios, providing strong evidence that resources could be shifted cost-effectively to support achieving remissions with the DiRECT intervention., Trial Registration: ISRCTN03267836 Graphical abstract.

Aim: The Counterweight-Plus weight management programme achieved 46% remission of Type 2 diabetes at 1 year in the DiRECT trial. We estimated the implementation costs of the Counterweight-Plus programme and its 1-year cost-effectiveness in terms of diabetes remission, compared with usual care, from the UK National Health Service (NHS) perspective., Methods: Within-trial total costs included programme set-up and running costs (practitioner appointment visits, low-energy formula diet sachets and training), oral anti-diabetes and anti-hypertensive medications, and healthcare contacts. Total costs were calculated for aggregated resource use for each participant and 95% confidence intervals (CI) were based on 1000 non-parametric bootstrap iterations., Results: One-year programme costs under trial conditions were estimated at £1137 per participant (95% CI £1071, £1205). The intervention led to a significant cost-saving of £120 (95% CI £78, £163) for the oral anti-diabetes drugs and £14 (95% CI £7.9, £22) for anti-hypertensive medications compared with the control. Deducting the cost-savings of all healthcare contacts from the intervention cost resulted an incremental cost of £982 (95% CI £732, £1258). Cost per 1 year of diabetes remission was £2359 (95% CI £1668, £3250)., Conclusions: Remission of Type 2 diabetes within 1-year can be achieved at a cost below the annual cost of diabetes (including complications). Providing a reasonable proportion of remissions can be maintained over time, with multiple medical gains expected, as well as immediate social benefits, there is a case for shifting resources within diabetes care budgets to offer support for people with Type 2 diabetes to attempt remission. (Clinical Trial Registry No.: ISRCTN03267836)., (© 2019 Diabetes UK.)

Background: The DiRECT trial assessed remission of type 2 diabetes during a primary care-led weight-management programme. At 1 year, 68 (46%) of 149 intervention participants were in remission and 36 (24%) had achieved at least 15 kg weight loss. The aim of this 2-year analysis is to assess the durability of the intervention effect., Methods: DiRECT is an open-label, cluster-randomised, controlled trial done at primary care practices in the UK. Practices were randomly assigned (1:1) via a computer-generated list to provide an integrated structured weight-management programme (intervention) or best-practice care in accordance with guidelines (control), with stratification for study site (Tyneside or Scotland) and practice list size (>5700 or ≤5700 people). Allocation was concealed from the study statisticians; participants, carers, and study research assistants were aware of allocation. We recruited individuals aged 20-65 years, with less than 6 years' duration of type 2 diabetes, BMI 27-45 kg/m 2 , and not receiving insulin between July 25, 2014, and Aug 5, 2016. The intervention consisted of withdrawal of antidiabetes and antihypertensive drugs, total diet replacement (825-853 kcal per day formula diet for 12-20 weeks), stepped food reintroduction (2-8 weeks), and then structured support for weight-loss maintenance. The coprimary outcomes, analysed hierarchically in the intention-to-treat population at 24 months, were weight loss of at least 15 kg, and remission of diabetes, defined as HbA 1c less than 6·5% (48 mmol/mol) after withdrawal of antidiabetes drugs at baseline (remission was determined independently at 12 and 24 months). The trial is registered with the ISRCTN registry, number 03267836, and follow-up is ongoing., Findings: The intention-to-treat population consisted of 149 participants per group. At 24 months, 17 (11%) intervention participants and three (2%) control participants had weight loss of at least 15 kg (adjusted odds ratio [aOR] 7·49, 95% CI 2·05 to 27·32; p=0·0023) and 53 (36%) intervention participants and five (3%) control participants had remission of diabetes (aOR 25·82, 8·25 to 80·84; p<0·0001). The adjusted mean difference between the control and intervention groups in change in bodyweight was -5·4 kg (95% CI -6·9 to -4·0; p<0·0001) and in HbA 1c was -4·8 mmol/mol (-8·3 to -1·4 [-0·44% (-0·76 to -0·13)]; p=0·0063), despite only 51 (40%) of 129 patients in the intervention group using anti-diabetes medication compared with 120 (84%) of 143 in the control group. In a post-hoc analysis of the whole study population, of those participants who maintained at least 10 kg weight loss (45 of 272 with data), 29 (64%) achieved remission; 36 (24%) of 149 participants in the intervention group maintained at least 10 kg weight loss. Serious adverse events were similar to those reported at 12 months, but were fewer in the intervention group than in the control group in the second year of the study (nine vs 22)., Interpretation: The DiRECT programme sustained remissions at 24 months for more than a third of people with type 2 diabetes. Sustained remission was linked to the extent of sustained weight loss., Funding: Diabetes UK., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Aims/hypothesis: Substantial weight loss in type 2 diabetes can achieve a return to non-diabetic biochemical status, without the need for medication. The Diabetes Remission Clinical Trial (DiRECT), a cluster-randomised controlled trial, is testing a structured intervention designed to achieve and sustain this over 2 years in a primary care setting to determine practicability for routine clinical practice. This paper reports the characteristics of the baseline cohort., Methods: People with type 2 diabetes for <6 years with a BMI of 27-45 kg/m 2 were recruited in 49 UK primary care practices, randomised to either best-practice diabetes care alone or with an additional evidence-based weight management programme (Counterweight-Plus). The co-primary outcomes, at 12 months, are weight loss ≥15 kg and diabetes remission (HbA 1c <48 mmol/mol [6.5%]) without glucose-lowering therapy for at least 2 months. Outcome assessors are blinded to group assignment., Results: Of 1510 people invited, 423 (28%) accepted; of whom, 306 (72%) were eligible at screening and gave informed consent. Seven participants were later found to have been randomised in error and one withdrew consent, leaving 298 (176 men, 122 women) who will form the intention to treat (ITT) population for analysis. Mean (SD) age was 54.4 (7.6) years, duration of diabetes 3.0 (1.7) years, BMI 34.6 (4.4) kg/m 2 for all participants (34.2 (4.2) kg/m 2 in men and 35.3 (4.6) kg/m 2 in women) and baseline HbA 1c (on treatment) 59.3 (12.7) mmol/mol (7.6% [1.2%]). The recruitment rate in the intervention and control groups, and comparisons between the subgroups recruited in Scotland and England, showed few differences., Conclusions/interpretation: DiRECT has recruited a cohort of people with type 2 diabetes with characteristics similar to those seen in routine practice, indicating potential widespread applicability. Over 25% of the eligible population wished to participate in the study, including a high proportion of men, in line with the prevalence distribution of type 2 diabetes., Trial Registration: www.controlled-trials.com/ISRCTN03267836 ; date of registration 20 December 2013.

Background: Type 2 diabetes is a chronic disorder that requires lifelong treatment. We aimed to assess whether intensive weight management within routine primary care would achieve remission of type 2 diabetes., Methods: We did this open-label, cluster-randomised trial (DiRECT) at 49 primary care practices in Scotland and the Tyneside region of England. Practices were randomly assigned (1:1), via a computer-generated list, to provide either a weight management programme (intervention) or best-practice care by guidelines (control), with stratification for study site (Tyneside or Scotland) and practice list size (>5700 or ≤5700). Participants, carers, and research assistants who collected outcome data were aware of group allocation; however, allocation was concealed from the study statistician. We recruited individuals aged 20-65 years who had been diagnosed with type 2 diabetes within the past 6 years, had a body-mass index of 27-45 kg/m 2 , and were not receiving insulin. The intervention comprised withdrawal of antidiabetic and antihypertensive drugs, total diet replacement (825-853 kcal/day formula diet for 3-5 months), stepped food reintroduction (2-8 weeks), and structured support for long-term weight loss maintenance. Co-primary outcomes were weight loss of 15 kg or more, and remission of diabetes, defined as glycated haemoglobin (HbA 1c ) of less than 6·5% (<48 mmol/mol) after at least 2 months off all antidiabetic medications, from baseline to 12 months. These outcomes were analysed hierarchically. This trial is registered with the ISRCTN registry, number 03267836., Findings: Between July 25, 2014, and Aug 5, 2017, we recruited 306 individuals from 49 intervention (n=23) and control (n=26) general practices; 149 participants per group comprised the intention-to-treat population. At 12 months, we recorded weight loss of 15 kg or more in 36 (24%) participants in the intervention group and no participants in the control group (p<0·0001). Diabetes remission was achieved in 68 (46%) participants in the intervention group and six (4%) participants in the control group (odds ratio 19·7, 95% CI 7·8-49·8; p<0·0001). Remission varied with weight loss in the whole study population, with achievement in none of 76 participants who gained weight, six (7%) of 89 participants who maintained 0-5 kg weight loss, 19 (34%) of 56 participants with 5-10 kg loss, 16 (57%) of 28 participants with 10-15 kg loss, and 31 (86%) of 36 participants who lost 15 kg or more. Mean bodyweight fell by 10·0 kg (SD 8·0) in the intervention group and 1·0 kg (3·7) in the control group (adjusted difference -8·8 kg, 95% CI -10·3 to -7·3; p<0·0001). Quality of life, as measured by the EuroQol 5 Dimensions visual analogue scale, improved by 7·2 points (SD 21·3) in the intervention group, and decreased by 2·9 points (15·5) in the control group (adjusted difference 6·4 points, 95% CI 2·5-10·3; p=0·0012). Nine serious adverse events were reported by seven (4%) of 157 participants in the intervention group and two were reported by two (1%) participants in the control group. Two serious adverse events (biliary colic and abdominal pain), occurring in the same participant, were deemed potentially related to the intervention. No serious adverse events led to withdrawal from the study., Interpretation: Our findings show that, at 12 months, almost half of participants achieved remission to a non-diabetic state and off antidiabetic drugs. Remission of type 2 diabetes is a practical target for primary care., Funding: Diabetes UK., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Background: Despite improving evidence-based practice following clinical guidelines to optimise drug therapy, Type 2 diabetes (T2DM) still exerts a devastating toll from vascular complications and premature death. Biochemical remission of T2DM has been demonstrated with weight loss around 15kg following bariatric surgery and in several small studies of non-surgical energy-restriction treatments. The non-surgical Counterweight-Plus programme, running in Primary Care where obesity and T2DM are routinely managed, produces >15 kg weight loss in 33% of all enrolled patients. The Diabetes UK-funded Counterpoint study suggested that this should be sufficient to reverse T2DM by removing ectopic fat in liver and pancreas, restoring first-phase insulin secretion. The Diabetes Remission Clinical Trial (DiRECT) was designed to determine whether a structured, intensive, weight management programme, delivered in a routine Primary Care setting, is a viable treatment for achieving durable normoglycaemia. Other aims are to understand the mechanistic basis of remission and to identify psychological predictors of response., Methods/design: Cluster-randomised design with GP practice as the unit of randomisation: 280 participants from around 30 practices in Scotland and England will be allocated either to continue usual guideline-based care or to add the Counterweight-Plus weight management programme, which includes primary care nurse or dietitian delivery of 12-20weeks low calorie diet replacement, food reintroduction, and long-term weight loss maintenance. Main inclusion criteria: men and women aged 20-65 years, all ethnicities, T2DM 0-6years duration, BMI 27-45 kg/m(2). Tyneside participants will undergo Magnetic Resonance (MR) studies of pancreatic and hepatic fat, and metabolic studies to determine mechanisms underlying T2DM remission. Co-primary endpoints: weight reduction ≥ 15 kg and HbA1c <48 mmol/mol at one year. Further follow-up at 2 years., Discussion: This study will establish whether a structured weight management programme, delivered in Primary Care by practice nurses or dietitians, is a viable treatment to achieve T2DM remission. Results, available from 2018 onwards, will inform future service strategy., Trial Registration: Current Controlled Trials ISRCTN03267836 . Date of Registration 20/12/2013.

Objective: To test the appeal of the eatwell week, a nutritionally balanced 7 d menu which satisfies nutritional guidelines of the Food Standards Agency in Scotland; determine the clarity and understanding of the main messages; and gather views on the usability and acceptability of the eatwell week resource format., Design: Focus group discussions with consumers and health professionals., Setting: Four locations across the UK., Results: The eatwell week was considered realistic by consumers as it contained foods they recognised and already ate. A preconceived idea had been that there would be more fruit and vegetables and fewer 'treats'. Consumers found the recipes simple and lack of cooking skills was not an apparent barrier. However, the message of 'balance' was poorly understood. Consumers often lacked the knowledge to make informed substitutions in the week. Both the general public and some health professionals felt the menu contained too much carbohydrate. Health professionals felt it was unclear who the eatwell week was intended for and what purpose it served., Conclusions: Use of familiar foods and the provision of simple, easy-to-follow recipes have the potential to overcome some barriers to healthy eating encountered by the general public and encourage improvements in dietary intakes. The eatwell week shows promise as a resource to facilitate implementation of the principles of the eatwell plate and supports government priorities and policies for health.

Background: To examine whether the nutritional status of aged undernourished residents in care could be improved through dietary modification to increase energy intake but not portion size., Methods: A 12-week cluster randomised controlled trial was carried out in 21 residential care homes. Participants comprised undernourished residents with a body mass index (BMI) <18.5 kg m(-2) . All menus were analysed to evaluate nutrient provision. Energy and macronutrient intakes of undernourished residents were estimated using 3-day weighed food intake diaries. Those resident in homes randomised to intervention had their usual meals enriched with energy-dense foods to a maximum of +1673 kJ day(-1) ., Results: Of 445 residents screened, 41 (9%) had a BMI <18.5 kg m(-2) and entered the study. Despite adequate food provision, energy and macronutrient intakes were below UK dietary reference values. Mean (SEM) energy intake increased [+556 (372) kJ, P = 0.154] in residents allocated to intervention but fell in those residents in 'control homes' receiving usual care [-151 (351) kJ, P = 0.676]. Weight change [+1.3 (0.53) kg, P = 0.03] was seen in intervention residents but not in controls [-0.2 (1.5) kg, P = 0.536]. Between-group differences for changes in weight and energy intake were not significant (P = 0.08 and 0.20, respectively). Six residents allocated to the intervention increased their BMI >18.5 kg m(-2) (P = 0.018)., Conclusions: Achieving weight gain in frail older people is difficult. These results suggest that enriching food could help address undernutrition and slow chronic weight loss. Interventions of a longer duration are needed to confirm or exclude the value of food enrichment., (© 2012 The Authors Journal of Human Nutrition and Dietetics © 2012 The British Dietetic Association Ltd.)

Objective: To develop a menu and resource to illustrate to consumers and health professionals what a healthy balanced diet looks like over the course of a week., Design: Development and analysis of an illustrative 7 d 'eatwell week' menu to meet current UK recommendations for nutrients with a Dietary Reference Value, with a daily energy base of 8368 kJ (2000 kcal). Foods were selected using market research data on meals and snacks commonly consumed by UK adults. Analysis used the food composition data set from year 1 (2008) of the UK National Diet and Nutrition Survey rolling programme. The eatwell week menu was developed using an iterative process of nutritional analysis with adjustments made to portion sizes and the inclusion/exclusion of foods in order to achieve the target macronutrient composition., Results: Three main meals and two snacks were presented as interchangeable within the weekdays and two weekend days to achieve adult food and nutrient recommendations. Main meals were based on potatoes, rice or pasta with fish (two meals; one oily), red meat (two meals), poultry or vegetarian accompaniments. The 5-a-day target for fruit and vegetables (range 5-6·7 portions) was achieved daily. Mean salt content was below recommended maximum levels (<6 g/d). All key macro- and micronutrient values were achieved., Conclusions: Affordable foods, and those widely consumed by British adults, can be incorporated within a 7 d healthy balanced menu. Future research should investigate the effect of using the eatwell week on adults' dietary habits and health-related outcomes.

Background: Excessive gestational weight gain is associated with adverse infant, childhood and maternal outcomes and research to develop interventions to address this issue is ongoing. The views of women on gestational weight gain and the resources they would consider helpful in addressing this are however largely unknown. This survey aimed to determine the views of newly pregnant women, living in areas of social disadvantage, on 1) their current body weight and potential gestational weight gain and 2) the resources or interventions they would consider helpful in preventing excessive gestational weight gain., Methods: A convenience sample of overweight and obese pregnant women living in Fife, UK, were invited to complete a short anonymised questionnaire at their 12 week booking visit., Results: 428 women, BMI>25 kg/m(2), completed the questionnaire. Fifty-four per cent of respondents were obese (231) and 62% were living in areas of mild to moderate deprivation. Over three-quarters of participants felt dissatisfied with their current weight (81%). The majority of women (60%) expressed some concern about potential weight gain. Thirty-nine percent were unconcerned about weight gain during their pregnancy, including 34 women (19%) who reported having retained weight gained in earlier pregnancies. Amongst those concerned about weight gain advice on physical activity (41%) and access to sports/leisure facilities were favoured resources (36%). Fewer women (12%) felt that group sessions on healthy eating or attending a clinic for individualised advice (14%) would be helpful. "Getting time off work" was the most frequently cited barrier (48%) to uptake of resources other than leaflets., Conclusions: These data suggest a lack of awareness amongst overweight and obese women regarding excessive gestational weight gain. Monitoring of gestational weight gain, and approaches for its management, should be formally integrated into routine antenatal care. Barriers to the uptake of resources to address weight gain are numerous and must be considered in the design of future interventions and services.

Background: Fear of weight gain is a barrier to smoking cessation and significant cause of relapse for many people. The provision of nutritional advice as part of a smoking cessation programme may assist some in smoking cessation and perhaps limit weight gain. The aim of this study was to determine the effect of a structured programme of dietary advice on weight change and food choice, in adults attempting smoking cessation., Methods: Cluster randomised controlled design. Classes randomised to intervention commenced a 24-week intervention, focussed on improving food choice and minimising weight gain. Classes randomised to control received "usual care"., Results: Twenty-seven classes in Greater Glasgow were randomised between January and August 2008. Analysis, including those who continued to smoke, showed that actual weight gain and percentage weight gain was similar in both groups. Examination of data for those successful at giving up smoking showed greater mean weight gain in intervention subjects (3.9 (SD 3.1) vs. 2.7 (SD 3.7) kg). Between group differences were not significant (p = 0.23, 95% CI -0.9 to 3.5). In comparison to baseline improved consumption of fruit and vegetables and breakfast cereal were reported in the intervention group. A higher percentage of control participants continued smoking (74% vs. 66%)., Conclusions: The intervention was not successful at minimising weight gain in comparison to control but was successful in facilitating some sustained improvements in the dietary habits of intervention participants. Improved quit rates in the intervention group suggest that continued contact with advisors may have reduced anxieties regarding weight gain and encouraged cessation despite weight gain. Research should continue in this area as evidence suggests that the negative effects of obesity could outweigh the health benefits achieved through reductions in smoking prevalence.

As a population subgroup, older people are more vulnerable to malnutrition especially those who are institutionalised. Recognition of deteriorating or poor nutritional status is key in reversing the effects of undernutrition and reinforces the value of regular weight checks and/or the use of screening tools. Commercially produced supplements are often the first option used to address undernutrition in both acute and community settings. They can be expensive and, although regularly prescribed, have undergone only limited evaluation of their effectiveness in community settings. An alternative but less researched approach to improve the nutritional status of undernourished people is food fortification. This approach may be particularly useful for older people, given their often small appetites. The ability to eat independently has been significantly related to decreased risk of undernutrition. Assisting people who have difficulty feeding themselves independently should become a designated duty and may be crucial in optimising nutritional status. Lack of nutrition knowledge has been identified as the greatest barrier to the provision of good nutritional care. Education and training of care staff are pivotal for the success of any intervention to address undernutrition. The development of undernutrition is a multi-factorial process and a package of approaches may be required to prevent or treat undernutrition. Nutrition must be at the forefront of care if national care standards are to be met.

Background: The prevention and treatment of overweight and obesity is a priority for all health professionals and requires resources that are regularly evaluated to ensure that they meet the needs of their target population. Dietitians in Obesity Management UK (DOM UK), a specialist group of the British Dietetic Association, commissioned an evaluation of their resources. These have been developed for use by Dietitians to determine the uptake and implementation of DOM UK resources in dietetic practice, as well as the opinions and suggestions of Dietitians concerning the resource pack., Methods: A random sample of 20% (n = 33) of the 165 Dietitians who had ordered resources were selected from the DOM UK database along with 20% of DOM UK members who had not (n = 38). Data were then collected using telephone-administered questionnaires., Results: Most of the Dietitians who used the resources favoured them because they improved their consultations and were liked by patients. Resources 'j' (controlling your portions) and 'k' (planning your meals) were most frequently used. However, the cost of the pack was a deterrent to both new and repeat orders. The evaluation also revealed that 17% of DOM UK members were unaware of these resources and 23% who ordered them were unaware that online samples were available., Conclusion: The evaluation showed that most Dietitians who used the resources found them very useful especially resources concerning meal planning and portion sizes. However, concerns about cost and the need for greater awareness about the resources among Dietitians were highlighted.

Several drugs, or categories of drugs, listed by the WHO and other writers and used in the treatment of chronic disease, are consistently associated with weight gain as a side effect and considered 'obesogenic'. The extent to which they may contribute to the multifactorial process behind obesity is not well documented. We systematically reviewed papers from Medline 1966-2004, Embase 1980-2004, PsycINFO 1967-2004, and Cochrane Register of Controlled Trials, to determine the effect on body weight of some drugs that are believed to favour weight gain. We included randomized controlled studies of adult participants (>18 years) prescribed a drug considered obesogenic, that compared the 'obesogenic' drug with placebo, an alternative drug or other treatment, and that had a duration of at least 3 months: 43 studies totalling 25,663 subjects met these criteria. The main objective of the majority of studies was to compare the efficacy and safety of drug therapy, with weight change recorded under safety outcomes; weight change was a primary outcome measure in only six studies. There was evidence of weight gain for all drugs included, up to 10 kg at 52 weeks. Differences in dosage, patient population, duration of treatment and dietary advice make generalization of the results difficult. Data on body weight are often not recorded in published clinical trials or is reported in insufficient detail. This side-effect has potentially serious consequences, and should be mentioned to patients. Weight management measures should be routinely considered when prescribing drugs known to promote weight gain. Future clinical trials should always document weight changes.

Objective: To determine the current practices in relation to weight management currently provided for overweight/obese patients attending different secondary care outpatient clinics., Methods: Postal questionnaire sent to 100 consultant clinicians working in a range of specialist areas in three NHS Trust areas in Scotland, between January and March 2004., Results: Overall response rate was 55%. Only 9% (five) of clinicians reported having a protocol in place for the management of patients who were overweight or obese. Lack of expertise and inaccessibility to expertise were cited frequently as reasons for having no protocol in place. Fifty-one per cent felt that weight management (including obesity treatment) should be undertaken by a specialist service either run by general practitioners (GPs), or by clinicians in a secondary care setting. Around a third of all those surveyed reported willingness to incorporate obesity management within their own routine specialty practice., Conclusion: Clinicians acknowledged the adverse health effects of obesity within their specialist area, but felt unskilled and under-resourced to provide effective management. Effective prevention and management are required to challenge the obesity epidemic and will require the involvement of both primary and secondary care NHS settings. It is encouraging that a third of respondents felt prepared to incorporate obesity and weight management within their routine specialist practice.

Objective: To evaluate the response to simple innovative dietary counselling in post myocardial infarction patients., Design: Randomised controlled trial., Setting: Cardiac rehabilitation programmes of two acute hospitals in Lanarkshire, Scotland., Patients: A total of 69 men and 29 women aged 35-75 y who survived acute myocardial infarction and participated in the cardiac rehabilitation programmes of the study hospitals between 1st September 1997 and 1st August 1998., Results: At 12 weeks follow-up, diet composition had improved significantly in intervention subjects, but no such change was evident in the control group. The target of five portions of fruit and vegetables per day was achieved by 65% of intervention subjects but only 31% of control subjects (P=0.004). Between-group differences in food intakes were no longer evident at 1 y. Diet composition did however remain in line with current dietary targets in intervention subjects., Conclusion: Compared to conventional cardiac rehabilitation, this intervention, focused on targets known to improve mortality, improved diet in post myocardial infarction patients. However, a more sustained programme is required to maintain improvements. Delivery of the intervention was expensive and further research is required to determine the feasibility of a group approach using the same package., Sponsorship: The study was supported by Chief Scientist Office of the Scottish Executive Department of Health.

Objective: To assess the actual impact on coronary mortality of equipping ambulances with defibrillators., Design: Retrospective analysis of routine medical and legal records of all those who had a cardiac arrest attributed to coronary heart disease occurring outside hospital in a defined population before and after the introduction of Heartstart., Setting: City of Glasgow, North of the River Clyde, 1984 and 1990., Patients: 296 and 267 men and women aged 25-64 inclusive in 1984 and 1990 respectively who had a cardiac arrest outside hospital which was attributed to coronary heart disease (International Classification of Diseases codes 410-414, ninth revision)., Results: The impact on coronary mortality in 1990 of equipping ambulances with defibrillators concurred with the earlier prediction of less than 1% of all coronary deaths. The circumstances of cardiac arrest were largely unchanged; most occurred outside hospital in the victim's home and the principal witnesses were members of the victim's family. A call for help before cardiac arrest was made in very few cases and cardiopulmonary resuscitation was attempted by laypersons in less than a third of the deaths they witnessed. There was a significant increase in the number of cardiopulmonary resuscitation attempts made by ambulance crews (16% v 32%, P < 0.01). Ambulance crews, however, still attended less than half of all cases (44% and 47%)., Conclusion: The impact of equipping ambulances with defibrillators will remain small unless strategies are introduced that focus on improving the public's response to coronary emergencies by calling for help promptly and initiating cardiopulmonary resuscitation before the arrival of the emergency services.