Mobile health technologies to improve walking distance in people with intermittent claudication.

BACKGROUND: Peripheral arterial disease (PAD) is the obstruction or narrowing of the large arteries of the lower limbs, which can result in impaired oxygen supply to the muscle and other tissues during exercise, or even at rest in more severe cases. PAD is classified into five categories (Fontaine classification). It may be asymptomatic or various levels of claudication pain may be present; at a later stage, there may be ulceration or gangrene of the limb, with amputation occasionally being required. About 20% of people with PAD suffer from intermittent claudication (IC), which is muscular discomfort in the lower extremities induced by exertion and relieved by rest within 10 minutes; IC causes restriction of movement in daily life. Treatment for people with IC involves addressing lifestyle risk factors. Exercise is an important part of treatment, but supervised exercise programmes for individuals with IC have low engagement levels and high attrition rates. The use of mobile technologies has been suggested as a new way to engage people with IC in walking exercise interventions. The novelty of the intervention, low cost for the user, automation, and ease of access are some of the advantages mobile health (mhealth) technologies provide that give them the potential to be effective in boosting physical activity in adults. OBJECTIVES: To assess the benefits and harms of mobile health (mhealth) technologies to improve walking distance in people with intermittent claudication. SEARCH METHODS: The Cochrane Vascular Information Specialist conducted systematic searches of the Cochrane Vascular Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and CINAHL, and also searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov. The most recent searches were carried out on 19 December 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) in people aged 18 years or over with symptomatic PAD and a clinical diagnosis of IC. We included RCTs comparing mhealth interventions to improve walking distance versus usual care (no intervention or non-exercise advice), exercise advice, or supervised exercise programmes. We excluded people with chronic limb-threatening ischaemia (Fontaine III and IV). DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were change in absolute walking distance from baseline, change in claudication distance from baseline, amputation-free survival, revascularisation-free survival. Our secondary outcomes were major adverse cardiovascular events, major adverse limb events, above-ankle amputation, quality of life, and adverse events. We used GRADE to assess the certainty of the evidence. MAIN RESULTS: We included four RCTs involving a total of 614 participants with a clinical diagnosis of IC. The duration of intervention of the four included RCTs ranged from 3 to 12 months. Participants were randomised to either mhealth or control (usual care or supervised exercise programme). All four studies had an unclear or high risk of bias in one or several domains. The most prevalent risk of bias was in the area of performance bias, which was rated high risk as it is not possible to blind participants and personnel in this type of trial. Based on GRADE criteria, we downgraded the certainty of the evidence to low, due to concerns about risk of bias, imprecision, and clinical inconsistency. Comparing mhealth with usual care, there was no clear evidence of an effect on absolute walking distance (mean difference 9.99 metres, 95% confidence interval (CI) -27.96 to 47.93; 2 studies, 503 participants; low-certainty evidence). None of the included studies reported on change in claudication walking distance, amputation-free survival, or revascularisation-free survival. Only one study reported on major adverse cardiovascular events (MACE) and found no clear difference between groups (risk ratio 1.37, 95% CI 0.07 to 28.17; 1 study, 305 participants; low-certainty evidence). None of the included studies reported on major adverse limb events (MALE) or above-ankle amputations. AUTHORS' CONCLUSIONS: Mobile health technologies can be used to provide lifestyle interventions for people with chronic conditions, such as IC. We identified a limited number of studies that met our inclusion criteria. We found no clear difference between mhealth and usual care in improving absolute walking distance in people with IC; however, we judged the evidence to be low certainty. Larger, well-designed RCTs are needed to provide adequate statistical power to reliably evaluate the effects of mhealth technologies on walking distance in people with IC.

Factors associated with weight loss and health gains in a structured lifestyle modification programme for adults with severe obesity: a prospective cohort study.

Background: Individual responses to behavioural weight loss interventions can vary significantly, and a better understanding of the factors associated with successful treatment might help to target interventions for those who will benefit the most. We sought to identify demographic and clinical characteristics that predicted intervention "success" (defined as ≥5% weight loss) and other health gains in patients with severe obesity attending a ten-week structured lifestyle modification programme. Methods: We conducted a prospective cohort study of all 1122 patients (751 (66.9%) female, mean age 47.3 ± 11.9 years, mean body mass index (BMI) 46.7 ± 7.8 kgm-2) referred from our hospital-based obesity clinic, who started the structured lifestyle programme between 2012-2019. We compared routine clinical measures such as weight, fitness, blood pressure, lipids and HbA1c at baseline and follow-up. We also used validated questionnaires to quantify anxiety, depression and health-related quality of life. Results: Of 1122 patients who started, 877 (78.2%) completed the programme and attended for follow up. Of these, 12.8% lost ≥5% body weight. The amount of weight lost was a strong and consistent predictor of improvements in metabolic, cardiovascular, and mental health, even after adjusting for age, sex, programme attendance and baseline fitness. Older age, male sex, being physically active and having lower anxiety and depression scores at baseline predicted greater weight loss. Younger age, depression and longer wait time to start the intervention were associated with drop-out. Conclusions: In adults with severe obesity completing a structured lifestyle modification programme, older age and good mental health were associated with programme completion and attaining ≥5% weight loss. The magnitude of weight lost was a strong predictor of improvements in cardiovascular, metabolic and mental health associated with programme completion.

Harnessing digital health to optimise the delivery of guideline-based cardiac rehabilitation during COVID-19: an observational study.

BACKGROUND: The COVID-19 pandemic accelerated the uptake of digital health interventions for the delivery of cardiac rehabilitation (CR). However, there is a need to evaluate these interventions. METHODS: We examined the impact of an evidence-based, digital CR programme on medical, lifestyle and psychosocial outcomes. Delivered by an interdisciplinary team of healthcare professionals, the core components of this 12-week programme included lifestyle modification, medical risk factor management, psychosocial and behavioural change support. To support self-management, patients were provided with a Fitbit, a home blood pressure (BP) monitor and an interactive workbook. Patients received access to a bespoke web-based platform and were invited to attend weekly, online group-based supervised exercise sessions and educational workshops. Outcomes were assessed at baseline, end of programme and at 6-month follow-up. RESULTS: Over a 3-month period, 105 patients (88% with coronary heart disease) were referred with 74% (n=77) attending initial assessment. Of these, 97% (n=75) enrolled in the programme, with 85% (n=64) completing the programme, 86% (n=55) of completers attended 6-month follow-up. Comparing baseline to end of programme, we observed significant improvements in the proportion of patients meeting guideline-recommended targets for physical activity (+68%, p<0.001), BP (+44%, p<0.001) and low-density lipoprotein cholesterol (+27%, p<0.001). There were significant reductions in mean weight (-2.6 kg, p<0.001). Adherence to the Mediterranean diet score improved from 5.2 to 7.3 (p<0.001). Anxiety and depression levels (Hospital Anxiety and Depression score) both reduced by more than 50% (p<0.001). The majority of these improvements were sustained at 6-month follow-up. CONCLUSION: Outcomes from this study suggest that interdisciplinary digital CR programmes can be successfully implemented and help patients achieve guideline recommended lifestyle, medical and therapeutic targets.

Using a digital health intervention "INTERCEPT" to improve secondary prevention in coronary heart disease (CHD) patients: protocol for a mixed methods non-randomised feasibility study.

Background: Digital health interventions (DHIs) are increasingly used for the secondary prevention of cardiovascular disease (CVD). The aim of this study is to determine the feasibility of "INTERCEPT", a co-designed DHI developed to improve secondary prevention in hospitalised coronary heart disease patients (CHD). Methods: This non-randomised feasibility study will be conducted using a mixed methods process evaluation with a sample of 40 patients in an acute hospital setting. Informed by behaviour change theory, the Intercept application (I-App) integrates a smartphone interface, health care professional portal, a fitness wearable and a blood pressure monitor. I-App is designed to support and motivate patients to set goals, self-monitor lifestyle and medical risk factors, and manage their medications, with the health care professional portal enabling monitoring and communication with patients. Using convenience sampling, eligible patients will be recruited in two phases, a pre-implementation phase and an implementation phase. During the pre-implementation phase participants will not immediately receive the I-App but will be invited to receive the I-App at 3 months follow-up. This will enable early learning about the processes of recruitment and conducting the assessment prior to full scale deployment of the I-App. During the implementation phase, participants will be invited to download the I-App to their smartphone prior to hospital discharge. Qualitative interviews will be conducted among a subset of patients and health care professionals to gain a greater insight into their experience of using the I-App. Primary outcomes will be assessed at baseline and 3-month follow-up. Using pre-defined feasibility criteria, including recruitment, retention and engagement rates, together with data on intervention acceptability, will determine the appropriateness of progressing to a definitive trial. Discussion: This study will provide important insights to help inform the feasibility of conducting a definitive trial of "INTERCEPT" among coronary heart disease patients in a critical health care setting.

Obesity in Adults: A 2022 Adapted Clinical Practice Guideline for Ireland.

BACKGROUND: This Clinical Practice Guideline (CPG) for the management of obesity in adults in Ireland, adapted from the Canadian CPG, defines obesity as a complex chronic disease characterised by excess or dysfunctional adiposity that impairs health. The guideline reflects substantial advances in the understanding of the determinants, pathophysiology, assessment, and treatment of obesity. SUMMARY: It shifts the focus of obesity management toward improving patient-centred health outcomes, functional outcomes, and social and economic participation, rather than weight loss alone. It gives recommendations for care that are underpinned by evidence-based principles of chronic disease management; validate patients' lived experiences; move beyond simplistic approaches of "eat less, move more" and address the root drivers of obesity. KEY MESSAGES: People living with obesity face substantial bias and stigma, which contribute to increased morbidity and mortality independent of body weight. Education is needed for all healthcare professionals in Ireland to address the gap in skills, increase knowledge of evidence-based practice, and eliminate bias and stigma in healthcare settings. We call for people living with obesity in Ireland to have access to evidence-informed care, including medical, medical nutrition therapy, physical activity and physical rehabilitation interventions, psychological interventions, pharmacotherapy, and bariatric surgery. This can be best achieved by resourcing and fully implementing the Model of Care for the Management of Adult Overweight and Obesity. To address health inequalities, we also call for the inclusion of obesity in the Structured Chronic Disease Management Programme and for pharmacotherapy reimbursement, to ensure equal access to treatment based on health-need rather than ability to pay.

Yeast ß-Glucan Improves Insulin Sensitivity and Hepatic Lipid Metabolism in Mice Humanized with Obese Type 2 Diabetic Gut Microbiota.

SCOPE: Gut microbiota alterations are associated with obesity and type 2 diabetes. Yeast ß-glucans are potential modulators of the innate immune-metabolic response, by impacting glucose, lipid, and cholesterol homeostasis. The study examines whether yeast ß-glucan interacts differentially with either an obese healthy or obese diabetic gut microbiome, to impact metabolic health through hepatic effects under high-fat dietary challenge. METHODS AND RESULTS: Male C57BL/6J mice are pre-inoculated with gut microbiota from obese healthy (OBH) or obese type 2 diabetic (OBD) subjects, in conjunction with a high-fat diet (HFD) with/without yeast ß-glucan. OBD microbiome colonization adversely impacts metabolic health compared to OBH microbiome engraftment. OBD mice are more insulin resistant and display hepatic lipotoxicity compared to weight matched OBH mice. Yeast ß-glucan supplementation resolves this adverse metabolic phenotype, coincident with increasing the abundance of health-related bacterial taxa. Hepatic proteomics demonstrates that OBD microbiome transplantation increases HFD-induced hepatic mitochondrial dysfunction, disrupts oxidative phosphorylation, and reduces protein synthesis, which are partly reverted by yeast ß-glucan supplementation. CONCLUSIONS: Hepatic metabolism is adversely affected by OBD microbiome colonization with high-fat feeding, but partially resolved by yeast ß-glucan. More targeted dietary interventions that encompass the interactions between diet, gut microbiota, and host metabolism may have greater treatment efficacy.

EAPC Core Curriculum for Preventive Cardiology.

Preventive cardiology encompasses the whole spectrum of cardiovascular disease (CVD) prevention, at individual and population level, through all stages of life. This includes promotion of cardiovascular (CV) health, management of individuals at risk of developing CVD, and management of patients with established CVD, through interdisciplinary care in different settings. Preventive cardiology addresses all aspects of CV health in the context of the social determinants of health, including physical activity, exercise, sports, nutrition, weight management, smoking cessation, psychosocial factors and behavioural change, environmental, genetic and biological risk factors, and CV protective medications. This is the first European Core Curriculum for Preventive Cardiology, which will help to standardize, structure, deliver, and evaluate training in preventive cardiology across Europe. It will be the basis for dedicated fellowship programmes and a European Society of Preventive Cardiology (EAPC) subspecialty certification for cardiologists, with the intention to improve quality and outcome in CVD prevention.

Improved Quality of Life, Fitness, Mental Health and Cardiovascular Risk Factors with a Publicly Funded Bariatric Lifestyle Intervention for Adults with Severe Obesity: A Prospective Cohort Study.

BACKGROUND: Lifestyle modification is the cornerstone of management for patients with severe and complicated obesity, but the effects of structured lifestyle programmes on quality of life, anxiety and depression scores and cardiovascular risk factors are not well-described. We sought to describe changes in self-reported quality of life and mental health-related outcomes as well as cardiovascular risk factors in patients completing a 10-week multidisciplinary lifestyle-modification programme. METHODS: We conducted a prospective cohort study of all patients referred from our bariatric service who completed the programme between 2013 and 2019. In addition to weight, body mass index (BMI), blood pressure, HbA1c, lipid profile and functional capacity, we quantified health-related quality of life using the Dartmouth COOP Questionnaire and the European Quality of Life Questionnaire Visual Analogue Scale (EQVAS) and mental health using the Hospital Anxiety and Depression Scale (HADS). RESULTS: Of 1122 patients who started the programme, 877 (78.2%) completed it and were included in per protocol analyses. Mean age was 47.3 ± 11.9 years, 66.9% were female, 34.8% were in full- or part-time employment and 69.4% were entitled to state-provided medical care. BMI decreased from 47.0 ± 7.8 to 46.2 ± 7.8 kg m-2 and weight decreased from 131.6 ± 25.5 to 129.5 ± 25.4 kg (both p < 0.001). There were significant reductions in anxiety and depression scores and improvements in all Dartmouth COOP domains. The EQVAS score increased from 52 ± 22 to 63 ± 19 (p < 0.001). Small but statistically significant reductions in LDL cholesterol, systolic blood pressure and HBA1c were also observed. CONCLUSIONS: Adults with severe and complicated obesity completing a specialised bariatric lifestyle-modification programme showed significant improvements in self-reported mental health and quality of life, in addition to reductions in cardiovascular risk factors.

Interhospital and interindividual variability in secondary prevention: a comparison of outpatients with a history of chronic coronary syndrome versus outpatients with a history of acute coronary syndrome (the iASPIRE Study).

BACKGROUND: Studying variability in the care provided to secondary prevention coronary heart disease (CHD) outpatients can identify interventions to improve their outcomes. METHODS: We studied outpatients who had an index CHD event in the preceding 6-24 months. Eligible CHD events included acute coronary syndrome (ACS) and coronary revascularisation for stable chronic coronary syndrome (CCS). Site training was provided by a core team and data were collected using standardised methods. RESULTS: Between 2017 and 2019, we enrolled 721 outpatients at nine Irish study sites; 81% were men and mean age was 63.9 (SD ±8.9) years. The study examination occurred a median of 1.16 years after the index CHD event, which was ACS in 399 participants (55%) and stable-CCS in 322. On examination, 42.5% had blood pressure (BP) >140/90 mm Hg, 63.7% had low-density lipoprotein cholesterol (LDL-C) >1.8 mmol/L and 44.1% of known diabetics had an HbA1c >7%. There was marked variability in risk factor control, both by study site and, in particular, by index presentation type. For example, 82% of outpatients with prior-ACS had attended cardiac rehabilitation versus 59% outpatients with prior-CCS (p<0.001) and there were also large differences in control of traditional risk factors like LDL-C (p=0.002) and systolic BP (p<0.001) among outpatients with prior-ACS versus prior-CCS as the index presentation. CONCLUSIONS: Despite international secondary prevention guidelines broadly recommending the same risk factor targets for all adults with CHD, we found marked differences in outpatient risk factor control and management on the basis of hospital location and index CHD presentation type (acute vs chronic). These findings highlight the need to reduce hospital-level and patient-level variability in preventive care to improve outcomes; a lesson that should inform CHD prevention programmes in Ireland and around the world.

Evaluation of a Community-Based Cardiovascular Prevention Program in Patients With Type 2 Diabetes.

PURPOSE: An outcomes' evaluation of a community-based cardiovascular disease (CVD) prevention program in persons with newly diagnosed type 2 diabetes. DESIGN: A prospective, observational study. SETTING: A community-setting in Ireland. PARTICIPANTS: Persons with newly diagnosed type 2 diabetes, aged 40 years or older, and 2 or more cardiovascular risk factors. INTERVENTION: A 16-week community-based, cardiovascular prevention program, with health promotion seminars, group exercise, and individual consultations, delivered by a multidisciplinary team. MEASURES: Medical, lifestyle, and well-being measures. ANALYSIS: Changes in categorical and continuous variables were analyzed using the paired exact test and the t test/Wilcoxin matched-pairs test, respectively. RESULTS: In total, 218 persons (134 men) participated, mean age was 59.8 (10.2) years. Completion rate was 75.2% (n = 164). The proportion achieving target glycosylated hemoglobin (HbA1c) increased from 53% at baseline to 75% (P < .001) at end of program. Systolic and diastolic blood pressures reduced by 8.8 mm Hg (95% CI: -11.2 to -6.4, P < .001) and 5.2 mm Hg (95% CI: -6.9 to -3.5, P < .001), respectively. Mean low-density lipoprotein cholesterol reduced from 2.45 to 2.05 mmol/L (P < .001). Significantly higher proportions met recommended targets in diet (6.9% vs 43.4%, P < .001) and physical activity (9.2% vs 56.6%, P < .001). Psychosocial measures significantly improved at end of program. The majority of improvements were sustained at 1 year. CONCLUSION: Participation in this CVD prevention program was associated with significant improvements in glycemia and CVD risk factors in newly diagnosed patients with type 2 diabetes.

A telephone reminder to enhance adherence to interventions in cardiovascular randomized trials: A protocol for a study within a trial (SWAT).

The impact of reduced adherence in randomized clinical trials is well documented in the literature. Nonadherence can negatively affect the trial sample size and estimation of the treatment effect. This protocol aims to evaluate the effects of a telephone call reminder on the adherence rates of participants to interventions in a cardiovascular randomized trial. This is a study within a trial (SWAT). The host trial is evaluating the effectiveness of a multidisciplinary 16-wk cardiovascular disease prevention program on risk factor profile among patients with carotid artery stenosis. Simultaneously, this SWAT will evaluate the effectiveness of telephone call reminders on the participants' adherence to the host trial intervention. The primary outcome is adherence to the protocol of the host trial. Secondary outcomes are level of adherence, number of dropouts, and time to drop out from the host trial.

The role of public health nurses in risk factor modification within a high-risk cardiovascular disease population in Ireland - a qualitative analysis.

BACKGROUND/AIMS: Health promotion for cardiovascular disease risk factors management is essential to secondary prevention of cardiovascular disease events. In Ireland, post-cardiac rehabilitation patients are discharged into the care of community public health nurses, who have a health promotion role. Little is known of the public health nurses' perceptions or knowledge surrounding their role in cardiovascular disease risk factor management. Underpinned by a constructivist viewpoint, this study aims to generate empirical evidence on the phenomenon directly from public health nurses' encounters within the context of the current health service. METHODS: This qualitative cross-sectional analysis involved face-to-face, semi-structured interviews with a purposeful sample of 17 public health nurses. Interviews were audio-recorded, transcribed, subjected to thematic content analysis and subsequently reported incorporating verbatim quotes. RESULTS: A significant gap exists between evidence-based guidelines for cardiovascular disease prevention and current practices. Variations in public health nurses' training, experience and knowledge result in inconsistent practices, and public health nurses feel this is specialised area for which they are not equipped. The changing public health nurse role and increasing workloads result in prioritisation of other nursing duties over health promotion. Ineffective systems for care delivery and a lack of community-based rehabilitation programmes also negatively impact on secondary prevention practices. CONCLUSIONS: Findings support the need to develop a community cardiovascular disease specialist role to effectively support ongoing cardiovascular disease risk factor management. Evaluation of the mechanisms of current service delivery is required to ensure a quality-assured equitable service, in line with community needs and current evidence-based guidelines for practice. A quantitative triangulation study is recommended.

Sleep to Lower Elevated Blood Pressure: A Randomized Controlled Trial (SLEPT).

BACKGROUND: Impaired sleep quality is common and associated with an increased risk of cardiovascular disease (CVD), thought to be mediated through adverse effects on established vascular risk factors, particularly hypertension. We determined if a web-delivered sleep intervention (sleep-hygiene education, stimulus control, and cognitive behavioral therapy) reduces blood pressure compared to vascular risk factor education (standard care) alone. METHODS: Phase II randomized, blinded, controlled trial of 134 participants without CVD with mild sleep impairment and blood pressure 130-160/<110 mm Hg. The primary outcome was the difference in the mean change in 24-hour ambulatory systolic blood pressure (SBP) over 8 weeks between intervention and control groups. Secondary outcomes included measures of sleep quality and psychosocial health, namely Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory (BDI), and Beck Anxiety Inventory (BAI). RESULTS: Participants in the sleep intervention group showed significantly greater improvements in sleep quality, including ISI [difference in mean improvement 2.8; 95% confidence interval (CI), 1.3-4.4], PSQI (1.1; 95% CI, 0.1-2.2), sleep condition indicator (0.8; 95% CI, 0.2-1.4), and psychosocial health, including BDI (2.0; 95% CI, 0.3-3.7) and BAI (1.4; 95% CI, 0.02-2.8). The mean improvement in 24-hour ambulatory SBP did not differ between the sleep intervention (0.9 mm Hg) and control (0.8 mm Hg) arms, (difference in mean improvement 0.1; 95% CI, -3.4 to 3.2). CONCLUSION: A simple, low-cost, web-delivered sleep intervention is feasible and significantly improves sleep quality and measures of psychosocial health in individuals with mild sleep impairment but does not result in short-term improvements in blood pressure.

Effects of an icon-based menu labelling initiative on consumer food choice.

AIMS: The purpose of this study was to examine the impact of an icon-based menu labelling initiative on consumer buying behaviour. METHODS: This quasi-experimental study recruited a convenience sample of eight food service establishments, all with at least one menu item meeting the heart healthy criteria. Data from sales of all menu items sold over an 8-week period were collated 4 weeks prior to and 4 weeks during the display of information icons related to healthy food choices on menus. RESULTS: The absolute change in menu item sales showed a non-significant trend towards an increase in healthier menu item selections. Furthermore, there was no association between the type of food service establishment and the percentage change in labelled menu item sales. CONCLUSION: The study did not find a statistically significant influence of the icon-based menu labels on consumer food choice. Given the limited amount of research that examines alternative menu labelling formats in real-world settings, more studies are necessary to confirm these results. Further research is needed to identify the optimal format, content and impact of menu labels on consumer behaviour.

Can the Onset of Type 2 Diabetes Be Delayed by a Group-Based Lifestyle Intervention in Women with Prediabetes following Gestational Diabetes Mellitus (GDM)? Findings from a Randomized Control Mixed Methods Trial.

OBJECTIVE: To evaluate a 12-week group-based lifestyle intervention programme for women with prediabetes following gestational diabetes (GDM). DESIGN: A two-group, mixed methods randomized controlled trial in which 50 women with a history of GDM and abnormal glucose tolerance postpartum were randomly assigned to intervention (n = 24) or wait control (n = 26) and postintervention qualitative interviews with participants. MAIN OUTCOME MEASURES: Modifiable biochemical, anthropometric, behavioural, and psychosocial risk factors associated with the development of type 2 diabetes. The primary outcome variable was the change in fasting plasma glucose (FPG) from study entry to one-year follow-up. RESULTS: At one-year follow-up, the intervention group showed significant improvements over the wait control group on stress, diet self-efficacy, and quality of life. There was no evidence of an effect of the intervention on measures of biochemistry or anthropometry; the effect on one health behaviour, diet adherence, was close to significance. CONCLUSIONS: Prevention programmes must tackle the barriers to participation faced by this population; home-based interventions should be investigated. Strategies for promoting long-term health self-management need to be developed and tested.

Effects of an eight-week supervised, structured lifestyle modification programme on anthropometric, metabolic and cardiovascular risk factors in severely obese adults.

BACKGROUND: Lifestyle modification is fundamental to obesity treatment, but few studies have described the effects of structured lifestyle programmes specifically in bariatric patients. We sought to describe changes in anthropometric and metabolic characteristics in a cohort of bariatric patients after participation in a nurse-led, structured lifestyle programme. METHODS: We conducted a retrospective, observational cohort study of adults with a body mass index (BMI) ≥ 40 kgm(-2) (or ≥ 35 kgm(-2) with significant co-morbidity) who were attending a regional bariatric service and who completed a single centre, 8-week, nurse-led multidisciplinary lifestyle modification programme. Weight, height, waist circumference, blood pressure, HbA1c, fasting glucose and lipid profiles as well as functional capacity (Incremental Shuttle Walk Test) and questionnaire-based anxiety and depression scores before and after the programme were compared in per-protocol analyses. RESULTS: Of 183 bariatric patients enrolled, 150 (81.9%) completed the programme. Mean age of completers was 47.9 ± 1.2 years. 34.7% were male. There were statistically significant reductions in weight (129.6 ± 25.9 v 126.9 ± 26.1 kg, p < 0.001), BMI (46.3 ± 8.3 v 44.9 ± 9.0 kgm(-2), p < 0.001), waist circumference (133.0 ± 17.1 v 129.3 ± 17.5 cm in women and 143.8 ± 19.0 v 135.1 ± 17.9 cm in men, both p < 0.001) as well as anxiety and depression scores, total- and LDL-cholesterol and triglyceride levels, with an increase in functional capacity (5.9 ± 1.7 v 6.8 ± 2.1 metabolic equivalents of thermogenesis (METS), p < 0.001) in completers at the end of the programme compared to the start. Blood pressure improved, with reductions in systolic and diastolic blood pressure from 135 ± 16.2 to 131.6 ± 17.1 (p = 0.009) and 84.7 ± 10.2 to 81.4 ± 10.9 mmHg (p < 0.001), respectively. The proportion of patients achieving target blood pressure increased from 50.3 to 59.3% (p = 0.04). The proportion of patients with diabetes achieving HbA1c <53 mmol/mol increased from 28.6 to 42.9%, p = 0.02. CONCLUSIONS: Bariatric patients completing an 8 week, nurse-led structured lifestyle programme had improved adiposity, fitness, lipid profiles, psychosocial health, blood pressure and glycaemia. Further assessment of this programme in a pragmatic randomised controlled trial seems warranted.

Reasons for participation and non-participation in a diabetes prevention trial among women with prior gestational diabetes mellitus (GDM).

BACKGROUND: Gestational diabetes mellitus (GDM) is a risk factor for the development of type 2 diabetes. Lifestyle intervention can prevent progression to type 2 diabetes in high risk populations. We designed a randomised controlled trial (RCT) to evaluate the effectiveness of an established lifestyle intervention compared to standard care for delaying diabetes onset in European women with recent GDM. Recruitment into the RCT was more challenging than anticipated with only 89 of 410 (22%) women agreeing to participate. This paper identifies factors that could enhance participation of the target population in future interventions. METHODS: We hypothesised that women who agreed to participate would have higher diabetes risk profiles than those who declined, and secondly that it would be possible to predict participation on the bases of those risk factors. To test our hypothesis, we identified the subset of women for whom we had comprehensive data on diabetes risks factors 3-5 years following GDM, reducing the sample to 43 participants and 73 decliners. We considered established diabetes risk factors: smoking, daily fruit and vegetable intake, participation in exercise, family history of diabetes, glucose values and BMI scores on post-partum re-screens, use of insulin during pregnancy, and age at delivery. We also analysed narrative data from 156 decliners to further understand barriers to and facilitators of participation. RESULTS: Two factors differentiated participants and decliners: age at delivery (with women older than 34 years being more likely to participate) and insulin use during pregnancy (with women requiring the use of insulin in pregnancy less likely to participate). Binary logistic regression confirmed that insulin use negatively affected the odds of participation. The most significant barriers to participation included the accessibility, affordability and practicality of the intervention. CONCLUSIONS: Women with recent GDM face multiple barriers to lifestyle change. Intervention designers should consider: (i) the practicalities of participation for this population, (ii) research designs that capitalise on motivational differences between participants, (iii) alleviating concerns about long-term diabetes management. We hope this work will support future researchers in developing interventions that are more relevant, effective and successful in recruiting the desired population. TRIAL REGISTRATION: Current Controlled Trials ISRCTN41202110.

Translating guidelines to practice: findings from a multidisciplinary preventive cardiology programme in the west of Ireland.

AIMS: The aim of this observational, descriptive study is to evaluate the impact of an intensive, evidence-based preventive cardiology programme on medical and lifestyle risk factors in patients at high risk of developing cardiovascular disease (CVD). METHODS: Increased CVD risk patients and their family members/partners were invited to attend a 16-week programme consisting of a professional multidisciplinary lifestyle intervention, with appropriate risk factor and therapeutic management in a community setting. Smoking, dietary habits, physical activity levels, waist circumference and body mass index, and medical risk factors were measured at initial assessment, at end of programme, and at 1-year follow up. RESULTS: Adherence to the programme was high, with 375 (87.2%) participants and 181 (84.6%) partners having completed the programme, with 1-year data being obtained from 235 (93.6%) patients and 107 (90.7%) partners. There were statistically significant improvements in both lifestyle (body mass index, waist circumference, physical activity, Mediterranean diet score, fish, fruit, and vegetable consumption, smoking cessation rates), psychosocial (anxiety and depression scales and quality of life indices), and medical risk factors (blood pressure, lipid and glycaemic targets) between baseline and end of programme, with these improvements being sustained at 1-year follow up. CONCLUSIONS: These findings demonstrate how a holistic model of CVD prevention can improve cardiovascular risk factors by achieving healthier lifestyles and optimal medical management.