The burden of cardiovascular disease attributable to high dietary sodium intake in Australia between 1990 and 2019.

BACKGROUND: Diets high in sodium are associated with adverse cardiovascular outcomes. We aimed to quantify the burden of cardiovascular disease (CVD) attributable to high dietary sodium consumption in the Australian population. METHODS: Using data from the Global Burden of Disease (GBD) 2019, we estimated the age-standardised rates (per 100 000 population) and the total numbers of years lived with a disability (YLDs), years of life lost (YLLs), disability-adjusted life years (DALYs), and deaths for CVD attributable to high sodium (≥1000 mg/day) consumption in the Australian population, by sex and age groups (≥25 years) between 1990 and 2019. The study compared Australian estimates with similar high-income countries (Group of 20 [G20] members). RESULTS: From 1990 to 2019, the age-standardized rates of CVD deaths, DALYs, YLDs, and YLLs per 100 000 population in Australia attributable to high sodium decreased. However, between 2013 and 2019, the total number of CVD deaths increased, and the number of CVD YLDs increased exponentially for both sexes for the whole period between 1990 and 2019. Men had a two-fold higher rate for high sodium CVD burden, compared to females between 1990 to 2019. Individuals aged between 80 and 84 years had the highest rates of CVD burden during the same period; however, older age groups reported the greatest decline in CVD burden compared to young and middle-aged adults in Australia. The age-standardised rates for high sodium attributable CVD consistently contributed more towards DALYs than YLDs in 2019 for both sexes. When compared to G20 countries, Australians displayed the lowest age-standardized rates for CVD deaths, DALYs, YLDs, and YLLs alongside Turkey, France, and the United Kingdom in 2019. CONCLUSION: While age-standardized CVD burden attributable to high sodium consumption decreased for both sexes over the past 30 years, the total number of CVD deaths showed an increase between 2013 and 2019. This study underscores the need for sustained efforts to address the rising absolute number of CVD deaths, especially among men and older people, and emphasizes the importance of continued vigilance in monitoring and implementing strategies to reduce the impact of high sodium consumption on cardiovascular health in Australia.

Determining the feasibility of a codesigned and personalised intervention (Veg4Me) to improve vegetable intake in young adults living in rural Australian communities: protocol for a randomised controlled trial.

INTRODUCTION: Diets low in vegetables are a main contributor to the health burden experienced by young adults in rural communities. Digital health interventions provide an accessible delivery model that can be personalised to meet the diverse preferences of young adults. A personalisable digital vegetable intake intervention (Veg4Me) was codesigned to meet the needs of young adults living in rural communities. This study will determine the feasibility of delivering a personalised Veg4Me programme and compare preliminary effects with a non-personalised Veg4Me (control). METHODS AND ANALYSIS: A 12-week assessor-blinded, two-arm, parallel randomised controlled trial will be undertaken from August 2023 until April 2024. A total of 150 eligible and consenting young adults (18-35 years; eat<5 serves of vegetables/day; have an internet connected mobile device/computer) living in Loddon Campaspe or Colac Otway Shire in Victoria, Australia, will be randomised to receive 12 weeks of personalised (intervention) or non-personalised (control) support to increase vegetable intake via a free web application (app; Veg4Me). The primary outcome is feasibility (recruitment, participation and retention rates). Secondary outcomes are user engagement, usability and experience, as well as vegetable intake, eating habits and digital health equity. Process evaluation will be conducted in a subsample of participants using semistructured interviews. Descriptive statistics will be presented for the personalised and non-personalised groups at baseline and 12 weeks. Generalised linear models will be used to evaluate group differences in outcomes. Interviews will be transcribed and analysed thematically. ETHICS AND DISSEMINATION: All procedures involving human subjects were approved by Deakin University's Human Ethics Advisory Group-Health (HEAG-H 06_2023) on 6 March 2023. Dissemination events will be held in the City of Greater Bendigo and the Colac Otway Shire. Summaries of the results will be disseminated to participants via email. Results will be disseminated to the scientific community through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: Australia New Zealand Clinical Trials Registry, ACTRN12623000179639p, prospectively registered on 21 February 2023, according to the World Health Organizational Trial Registration Data Set. Universal Trial Number U1111-1284-9027.

The burden of cardiovascular disease attributable to dietary risk factors in Australia between 1990 and 2019.

Unhealthy diet is associated with increased risk of cardiovascular diseases (CVD). However, there are no studies reporting the impact and trends of dietary risk factors on CVD in Australia. This study aimed to determine the burden of CVDs attributable to dietary risk factors in Australia between 1990 and 2019. We used data from the Global Burden of Diseases (GBD) study and quantified the rate (per 100,000) of deaths, disability-adjusted life years (DALYs), years lived with a disability (YLDs), and years of life lost (YLLs) for 21 CVDs attributable to 13 dietary risk factors (eight food groups and five nutrients) in Australia by sex and age groups (≥25 years and over). In 2019, the age-standardised rates of deaths, YLDs, YLLs, and DALYs attributable to dietary risk factors attributable to CVDs in the Australian population were 26.5, 60.8, 349.9, and 410.8 per 100,000 in women and 46.1, 62.6, 807.0, and 869.6 in men. Between 1990 and 2019, YLLs consistently contributed more towards the rates of DALYs than YLDs. Over the 30-year period, CVD deaths, YLLs, and DALYs attributable to dietary risk factors declined in both women and men. The leading dietary risk factors for CVD deaths and DALYs were a diet high in red meat (6.1 deaths per 100,000 [3.6, 8.7] and 115.6 DALYs per 100,000 [79.7, 151.6]) in women and a diet low in wholegrains (11.3 deaths [4.4, 15.1] and 220.3 DALYs [86.4, 291.8]) in men. Sex differences were observed in the contribution of dietary risk factors to CVD over time such that the lowest rate of decrease in deaths and DALYs occurred with diets high in sodium in women and diets high in processed meat in men. Although the burden of diet-related CVD has decreased significantly in the Australian population over the past 30 years, diets low in wholegrains and high in red meat continue to contribute significantly to the overall CVD burden. Future nutrition programs and policies should target these dietary risk factors.

Burden of Hypertensive Heart Disease and High Systolic Blood Pressure in Australia from 1990 to 2019: Results From the Global Burden of Diseases Study.

BACKGROUND: There is a dearth of comprehensive studies examining the burden and trends of hypertensive heart disease (HHD) and high systolic blood pressure (SBP) among the Australian population. We aimed to explore the burden of HHD and high SBP, and how they changed over time from 1990 to 2019 in Australia. METHODS: We analysed data from the Global Burden of Disease study in Australia. We assessed the prevalence, mortality, disability-adjusted life-years (DALY), years lived with disability (YLD) and years of life lost (YLL) attributable to HHD and high SBP. Data were presented as point estimates with 95% uncertainty intervals (UI). We compared the burden of HHD and high SBP in Australia with World Bank defined high-income countries and six other comparator countries with similar sociodemographic characteristics and economies. RESULTS: From 1990 to 2019, the burden of HHD and high SBP in Australia reduced. Age standardised prevalence rate of HHD was 119.3 cases per 100,000 people (95% UI 86.6-161.0) in 1990, compared to 80.1 cases (95% UI 57.4-108.1) in 2019. Deaths due to HDD were 3.4 cases per 100,000 population (95% UI 2.6-3.8) in 1990, compared to 2.5 (95% UI 1.9-3.0) in 2019. HHD contributed to 57.2 (95% UI 46.6-64.7) DALYs per 100,000 population in 1990 compared to 38.4 (95% UI 32.0-45.2) in 2019. Death rates per 100,000 population attributable to high SBP declined significantly over time for both sexes from 1990 (155.6 cases; 95% UI 131.2-177.0) to approximately one third in 2019 (53.8 cases; 95% UI 43.4-64.4). Compared to six other countries in 2019, the prevalence of HHD was highest in the USA (274.3%) and lowest in the UK (52.6%), with Australia displaying the third highest prevalence. Australia ranked second in term of lowest rates of deaths and third for lowest DALYs respectively due to high SBP. From 1990-2019, Australia ranked third best for reductions in deaths and DALYs due to HHD and first for reductions in deaths and DALYs due to high SBP. CONCLUSION: Over the past three decades, the burden of HHD in Australia has reduced, but its prevalence remains relatively high. The contribution of high SBP to deaths, DALYs and YLLs also reduced over the three decades.

The burden of type 2 diabetes in Australia during the period 1990-2019: Findings from the global burden of disease study.

AIMS: To describe morbidity and mortality trends of type 2 diabetes in Australia, from 1990 to 2019, compared with similar sociodemographic index (SDI) countries. METHODS: Australia-specific Global Burden of Diseases data were used to estimate age-standardised, age-specific, and sex-specific rates for prevalence, years lived with disability (YLDs), years of life lost (YLLs), disability-adjusted life years (DALYs), and deaths due to type 2 diabetes between 1990 and 2019. Australian data were compared with 14 similar SDI countries. RESULTS: Type 2 diabetes increased in Australia between 1990 and 2019. The age-standardised prevalence increased from 1,985 [95% Confidence Interval (CI): 1,786.7-2195.3] per 100,000 population, to 3,429 [95% CI 3,053.3-3,853.7]. Cases tripled, from 379,532 [342,465-419,475] to 1,307,261 [1,165,522-1,461,180]. The age-standardised death rates doubled, from 2,098 [1,953-2,203] per 100,000, to 4,122 [3,617-4,512]. DALYs doubled, from 70,348 [59,187-83,500] to 169,763 [129,792-216,150], with increases seen in YLDs and YLLs. Men displayed higher rates. Compared to similar SDI countries, Australia ranked 4th in terms of burden for type 2 diabetes. CONCLUSIONS: The burden of type 2 diabetes in Australia has increased considerably over three decades. There is an urgent need to prioritise resource allocation for prevention programs, screening initiatives to facilitate early detection, and effective and accessible management strategies for the large proportion of the population impacted by type 2 diabetes.

Results from Aotearoa New Zealand's 2022 Report Card on Physical Activity for Children and Youth: A call to address inequities in health-promoting activities.

Background: This article reports the methods and findings for Aotearoa New Zealand's 2022 Report Card on Physical Activity for Children and Youth indicators, and on inequities within these indicators. Methods: Grades were assigned to indicators using the Active Healthy Kids Global Alliance criteria depending on data availability, and inequities reported based on gender, ethnicity, disability status, area-level socioeconomic deprivation, urbanicity, and school year. Two additional indicators were included in this report card: Sleep, and Physical literacy. Results: Grades were assigned to indicators as follows: Overall physical activity: C+, Organised sport and physical activity: B-, Physical literacy: B, Active transportation: D, Sedentary behaviours: C-, Sleep: B+, Whanau (family) and peers: D, School: C+, Government: A. Inequities across all socio-demographic variables were observed. An 'inconclusive' grade was assigned to the Active play, Physical fitness, and Community and Environment indicators due to insufficient data. Conclusion: It is imperative that targeted, comprehensive, and population-specific approaches are implemented to support health-promoting physical activity behaviours and reduce inequities among children and youth in Aotearoa. There is a need to promote all dimensions of physical activity (overall activity, active play, recreation, organised sport, active transportation) and the reduction of screen time through policy, research, evidence-based social marketing campaigns, and urban design. Regular, nationally representative surveys that enable the consistent and regular measurement of key Report Card indicators are needed.

Development of a behavioural support intervention for e-bike use in Australia.

BACKGROUND: Insufficient physical activity (PA) is a risk factor for the development of many non-communicable diseases. Electric bicycles (e-bikes) offer considerable potential to support people to be physically active, however, no previous e-bike intervention studies have supported e-bike use with behavioural support. The aim of this study was to co-develop theory-based intervention components which can be used to increase physical activity through e-cycling among people who are overweight or obese and physically inactive. METHODS: We conducted a mixed-methods study using an online survey and virtual co-design workshops. We utilised the Behaviour Change Wheel (BCW) to inform the development of the behavioural support intervention to facilitate day-to-day e-cycling. RESULTS: One hundred participants completed an online survey and seven participated in the online co-design workshops. The development of the intervention identified five intervention functions (enablement, training, environmental restructuring, education, and persuasion) and 16 behaviour change techniques (BCTs) from 11 BCT groups (goals and planning, feedback and monitoring, social support, shaping knowledge, natural consequences, comparison of behaviour, associations, repetition and substitution, comparison of outcomes, antecedents, and self-belief). CONCLUSION: To our knowledge, this is the first study to combine co-design and the BCW to develop a comprehensive behavioural support intervention for e-bike use. Theory based intervention options should be considered when providing e-bikes to individuals to help them increase their habitual PA levels.

Qualitative study of the views of people living with cardiovascular disease, and healthcare professionals, towards the use of a digital platform to support cardiovascular disease self-management.

OBJECTIVES: This paper focuses on formative research as part of a broader study to develop and evaluate an innovative digital health platform for the self-management of cardiovascular disease (CVD). The primary objective is to better understand the perceptions of key stakeholders towards the proposed platform (Salvio) and to identify the development considerations they may prioritise based on their own experiences of CVD management. DESIGN: A qualitative research study using thematic analysis to explore patterns and themes within the various participant contributions. SETTING: Triangulation of data collection methods were used to generate data, including focus group discussions, semistructured interviews and guided conversations. PARTICIPANTS: Participants (n=26) were people with a diagnosis of CVD (n=18) and relevant healthcare professionals (n=8). RESULTS: Findings indicate that the proposed platform would be a beneficial solution for certain groups whose health behaviour change is not currently supported by discrete solutions. Both participant groups perceive the digital health platform more trustworthy than accessing multiple interventions through unsupported digital repositories. Healthcare professionals agreed that they would endorse an evidence-based platform that had been rigorously developed and evaluated. CVD participants prioritised a decision support tool to guide them through the platform, as they perceive an unstructured approach as overly complex. Both participant groups perceived data sharing with certain self-selected individuals (eg, spouse) to be a useful method for gaining support with their health behaviour change. CONCLUSIONS: A digital health platform offering a variety of existing, evidence-based interventions would provide users with suitable self-management solution(s) based on their own individual needs and preferences. Salvio could be enhanced by providing adequate support to platform users, guiding the diverse CVD population through a host of digital solutions, ensuring that Salvio is endorsed by trusted healthcare professionals and maintaining connections with usual care. Such a platform would augment existing self-management and secondary prevention services.

EatSmart, a Web-Based and Mobile Healthy Eating Intervention for Disadvantaged People With Type 2 Diabetes: Protocol for a Pilot Mixed Methods Intervention Study.

BACKGROUND: People of low socioeconomic position (SEP) are disproportionately affected by type 2 diabetes (T2D), partly due to unhealthy eating patterns that contribute to inadequate disease self-management and prognosis. Digital technologies have the potential to provide a suitable medium to facilitate diabetes education, support self-management, and address some of the barriers to healthy eating, such as lack of nutritional knowledge or shopping or cooking skills, in this target group. OBJECTIVE: This study aims to test the feasibility, appeal, and potential effectiveness of EatSmart, a 12-week, evidence-based, theoretically grounded, fully automated web-based and mobile-delivered healthy eating behavior change program to help disadvantaged people living with T2D to eat healthily on a budget and improve diabetes self-management. METHODS: EatSmart is a mixed methods (quantitative and qualitative) pre-post design pilot study. Sixty socioeconomically disadvantaged people with T2D aged 18 to 75 years will be recruited. Participants will complete self-reported baseline assessments of their basic demographic and clinical data, dietary intake, dietary self-efficacy, and barriers to healthy eating. They will be provided with login access to the EatSmart web program, which includes six progressive skill-based modules covering healthy eating planning; smart food budgeting and shopping; time-saving meal strategies, healthy cooking methods, modifying recipes; and a final reinforcement and summary module. Over the 3-month intervention, participants will also receive 3 text messages weekly, encouraging them to review goals, continue to engage with different components of the EatSmart web program, and eat healthily. Participants will undertake follow-up assessments directly following the intervention 3 months post baseline and again after a 6-month postintervention follow-up period (9 months post baseline). Feasibility will be evaluated using the number of participants recruited and retained and objective indicators of engagement with the website. Program appeal and potential effects on primary and secondary outcomes will be assessed via the same surveys used at baseline, with additional questions asking about experience with and perceptions of the program. In-depth qualitative interviews will also be conducted 6 months post intervention to provide deeper insight into experiences with EatSmart and a more comprehensive description of the program's appeal. RESULTS: The EatSmart website has been developed, and all participants have viewed the modules as of May 2020. Results are expected to be submitted for publication in December 2020. CONCLUSIONS: This study will provide data to address the currently limited evidence regarding whether disadvantaged populations with T2D may benefit from digitally delivered behavior change programs that facilitate eating healthily on a budget. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12619001111167; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12619001111167. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19488.

Economic evaluation protocol for a multicentre randomised controlled trial to compare Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) versus usual care cardiac rehabilitation among people with coronary heart disease.

INTRODUCTION: It is important to ascertain the cost-effectiveness of alternative services to traditional cardiac rehabilitation while the economic credentials of the Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) programme among people with coronary heart disease (CHD) are unknown. This economic protocol outlines the methods for undertaking a trial-based economic evaluation of SCRAM in the real-world setting in Australia. METHODS AND ANALYSIS: The within-trial economic evaluation will be undertaken alongside a randomised controlled trial (RCT) designed to determine the effectiveness of SCRAM in comparison with the usual care cardiac rehabilitation (UC) alone in people with CHD. Pathway analysis will be performed to identify all the costs related to the delivery of SCRAM and UC. Both a healthcare system and a limited societal perspective will be adopted to gauge all costs associated with health resource utilisation and productivity loss. Healthcare resource use over the 6-month participation period will be extracted from administrative databases (ie, Pharmaceutical Benefits Scheme and Medical Benefits Schedule). Productivity loss will be measured by absenteeism from work (valued by human capital approach). The primary outcomes for the economic evaluation are maximal oxygen uptake (VO2max, mL/kg/min, primary RCT outcome) and quality-adjusted life years estimated from health-related quality of life as assessed by the Assessment of Quality of Life-8D instrument. The incremental cost-effectiveness ratio will be calculated using the differences in costs and benefits (ie, primary and secondary outcomes) between the two randomised groups from both perspectives with no discounting. All costs will be valued in Australian dollars for year 2020. ETHICS AND DISSEMINATION: The study protocol has been approved under Australia's National Mutual Acceptance agreement by the Melbourne Health Human Research Ethics Committee (HREC/18/MH/119). It is anticipated that SCRAM is a cost-effective cardiac telerehabilitation programme for people with CHD from both a healthcare and a limited societal perspective in Australia. The evaluation will provide evidence to underpin national scale-up of the programme to a wider population. The results of the economic analysis will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12618001458224).

Smartphone Cardiac Rehabilitation, Assisted Self-Management Versus Usual Care: Protocol for a Multicenter Randomized Controlled Trial to Compare Effects and Costs Among People With Coronary Heart Disease.

BACKGROUND: Alternative evidence-based cardiac rehabilitation (CR) delivery models that overcome significant barriers to access and delivery are needed to address persistent low utilization. Models utilizing contemporary digital technologies could significantly improve reach and fidelity as complementary alternatives to traditional center-based programs. OBJECTIVE: The aim of this study is to compare the effects and costs of the innovative Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) intervention with usual care CR. METHODS: In this investigator-, assessor-, and statistician-blinded parallel 2-arm randomized controlled trial, 220 adults (18+ years) with coronary heart disease are being recruited from 3 hospitals in metropolitan and regional Victoria, Australia. Participants are randomized (1:1) to receive advice to engage with usual care CR or the SCRAM intervention. SCRAM is a 24-week dual-phase intervention that includes 12 weeks of real-time remote exercise supervision and coaching from exercise physiologists, which is followed by 12 weeks of data-driven nonreal-time remote coaching via telephone. Both intervention phases include evidence- and theory-based multifactorial behavior change support delivered via smartphone push notifications. Outcomes assessed at baseline, 12 weeks, and 24 weeks include maximal aerobic exercise capacity (primary outcome at 24 weeks), modifiable cardiovascular risk factors, exercise adherence, secondary prevention self-management behaviors, health-related quality of life, and adverse events. Economic and process evaluations will determine cost-effectiveness and participant perceptions of the treatment arms, respectively. RESULTS: The trial was funded in November 2017 and received ethical approval in June 2018. Recruitment began in November 2018. As of September 2019, 54 participants have been randomized into the trial. CONCLUSIONS: The innovative multiphase SCRAM intervention delivers real-time remote exercise supervision and evidence-based self-management behavioral support to participants, regardless of their geographic proximity to traditional center-based CR facilities. Our trial will provide unique and valuable information about effects of SCRAM on outcomes associated with cardiac and all-cause mortality, as well as acceptability and cost-effectiveness. These findings will be important to inform health care providers about the potential for innovative program delivery models, such as SCRAM, to be implemented at scale, as a complement to existing CR programs. The inclusion of a cohort comprising metropolitan-, regional-, and rural-dwelling participants will help to understand the role of this delivery model across health care contexts with diverse needs. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN): 12618001458224; anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374508. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15022.

Rugby Fans in Training New Zealand (RUFIT-NZ): protocol for a randomized controlled trial to assess the effectiveness and cost-effectiveness of a healthy lifestyle program for overweight men delivered through professional rugby clubs in New Zealand.

BACKGROUND: A healthy lifestyle program that appeals to, and supports, obese New Zealand (NZ) European, Maori (indigenous) and Pasifika men to achieve weight loss is urgently needed. In Scotland, Football Fans in Training (FFIT), a weight management and healthy lifestyle program for overweight and obese men aged 35-65 years , delivered by community coaching staff at professional football clubs, has been shown to be beneficial and cost-effective. A pilot program inspired by FFIT but delivered by professional rugby clubs in NZ (n = 96) was shown to be effective in weight loss, improved physiological outcomes, and adherence to healthy lifestyle behaviors in overweight and obese men. The objective of this trial is to determine the effectiveness and cost-effectiveness of the Rugby Fans in Training New Zealand (RUFIT-NZ) program. METHODS: A pragmatic, two-arm, multi-center, randomized controlled trial involving 308 overweight and obese men aged 30-65 years, randomized to either an intervention group (n = 154) or a wait-list control group (n = 154). The intervention-group participated in the 12-week RUFIT-NZ program, a gender-sensitized, healthy lifestyle intervention adapted to the environment and cultural diversity of NZ and delivered through professional rugby clubs. Participants in the intervention group undergo physical training sessions, in addition to workshop-based sessions to learn about nutrition, physical activity, sleep, sedentary behavior, and a range of behavior-change strategies for sustaining a healthier lifestyle. The control group receives the program after 52 weeks. The primary outcome is change in body weight from baseline to 52 weeks. Secondary outcomes include change in body weight at 12 weeks; waist circumference, blood pressure, fitness, and lifestyle behaviors at 12 and 52 weeks; and cost-effectiveness. A process evaluation informed by the RE-AIM framework will evaluate potential implementation of RUFIT-NZ as an ongoing program in NZ after the trial. DISCUSSION: This trial will investigate the effectiveness and cost-effectiveness of the RUFIT-NZ program in overweight and obese NZ men. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry, ACTRN12619000069156. Registered on 18 January 2019, according to the World Health Organization Trial Registration Data Set. Universal Trial Number, U1111-1245-0645.

Validation and Acceptability of a Cuffless Wrist-Worn Wearable Blood Pressure Monitoring Device Among Users and Health Care Professionals: Mixed Methods Study.

BACKGROUND: Blood pressure (BP) is an important modifiable cardiovascular risk factor, yet its long-term monitoring remains problematic. Wearable cuffless devices enable the capture of multiple BP measures during everyday activities and could improve BP monitoring, but little is known about their validity or acceptability. OBJECTIVE: This study aimed to validate a wrist-worn cuffless wearable BP device (Model T2; TMART Technologies Limited) and assess its acceptability among users and health care professionals. METHODS: A mixed methods study was conducted to examine the validity and comparability of a wearable cuffless BP device against ambulatory and home devices. BP was measured simultaneously over 24 hours using wearable and ambulatory devices and over 7 days using wearable and home devices. Pearson correlation coefficients compared the degree of association between the measures, and limits of agreement (LOA; Bland-Altman plots) were generated to assess measurement bias. Semistructured interviews were conducted with users and 10 health care professionals to assess acceptability, facilitators, and barriers to using the wearable device. Interviews were audio recorded, transcribed, and analyzed. RESULTS: A total of 9090 BP measurements were collected from 20 healthy volunteers (mean 20.3 years, SD 5.4; N=10 females). Mean (SD) systolic BP (SBP)/diastolic BP (DBP) measured using the ambulatory (24 hours), home (7 days), and wearable (7 days) devices were 126 (SD 10)/75 (SD 6) mm Hg, 112 (SD 10)/71 (SD 9) mm Hg and 125 (SD 4)/77 (SD 3) mm Hg, respectively. Mean (LOA) biases and precision between the wearable and ambulatory devices over 24 hours were 0.5 (-10.1 to 11.1) mm Hg for SBP and 2.24 (-17.6 to 13.1) mm Hg for DBP. The mean biases (LOA) and precision between the wearable and home device over 7 days were -12.7 (-28.7 to 3.4) mm Hg for SBP and -5.6 (-20.5 to 9.2) mm Hg for DBP. The wearable BP device was well accepted by participants who found the device easy to wear and use. Both participants and health care providers agreed that the wearable cuffless devices were easy to use and that they could be used to improve BP monitoring. CONCLUSIONS: Wearable BP measures compared well against a gold-standard ambulatory device, indicating potential for this user-friendly method to augment BP management, particularly by enabling long-term monitoring that could improve treatment titration and increase understanding of users' BP response during daily activity and stressors.

Examining Development Processes for Text Messaging Interventions to Prevent Cardiovascular Disease: Systematic Literature Review.

BACKGROUND: Interventions delivered by mobile phones have the potential to prevent cardiovascular disease (CVD) by supporting behavior change toward healthier lifestyles and treatment adherence. To allow replication and adaptation of these interventions across settings, it is important to fully understand how they have been developed. However, the development processes of these interventions have not previously been systematically examined. OBJECTIVE: This study aimed to systematically describe and compare the development process of text messaging interventions identified in the Text2PreventCVD systematic review. METHODS: We extracted data about the development process of the 9 interventions identified in the Text2PreventCVD systematic review. Data extraction, which was guided by frameworks for the development of complex interventions, considered the following development stages: intervention planning, design, development, and pretesting. Following data extraction, we invited the developers of the interventions to contribute to our study by reviewing the accuracy of the extracted data and providing additional data not reported in the available publications. RESULTS: A comprehensive description of the development process was available for 5 interventions. Multiple methodologies were used for the development of each intervention. Intervention planning involved gathering information from stakeholder consultations, literature reviews, examination of relevant theory, and preliminary qualitative research. Intervention design involved the use of behavior change theories and behavior change techniques. Intervention development involved (1) generating message content based on clinical guidelines and expert opinions; (2) conducting literature reviews and primary qualitative research to inform decisions about message frequency, timing, and level of tailoring; and (3) gathering end-user feedback concerning message readability, intervention acceptability, and perceived utility. Intervention pretesting involved pilot studies with samples of 10 to 30 participants receiving messages for a period ranging from 1 to 4 weeks. CONCLUSIONS: The development process of the text messaging interventions examined was complex and comprehensive, involving multiple studies to guide decisions about the scope, content, and structure of the interventions. Additional research is needed to establish whether effective messaging systems can be adapted from work already done or whether this level of development is needed for application in other conditions and settings.

Effects and costs of real-time cardiac telerehabilitation: randomised controlled non-inferiority trial.

OBJECTIVE: Compare the effects and costs of remotely monitored exercise-based cardiac telerehabilitation (REMOTE-CR) with centre-based programmes (CBexCR) in adults with coronary heart disease (CHD). METHODS: Participants were randomised to receive 12 weeks of telerehabilitation or centre-based rehabilitation. REMOTE-CR provided individualised exercise prescription, real-time exercise monitoring/coaching and theory-based behavioural strategies via a bespoke telerehabilitation platform; CBexCR provided individualised exercise prescription and coaching via established rehabilitation clinics. Outcomes assessed at baseline, 12 and/or 24 weeks included maximal oxygen uptake (V̇O2max, primary) modifiable cardiovascular risk factors, exercise adherence, motivation, health-related quality of life and programme delivery, hospital service utilisation and medication costs. The primary hypothesis was a non-inferior between-group difference in V̇O2max at 12 weeks (inferiority margin=-1.25 mL/kg/min); inferiority margins were not set for secondary outcomes. RESULTS: 162 participants (mean 61±12.7 years, 86% men) were randomised. V̇O2 max was comparable in both groups at 12 weeks and REMOTE-CR was non-inferior to CBexCR (REMOTE-CR-CBexCR adjusted mean difference (AMD)=0.51 (95% CI -0.97 to 1.98) mL/kg/min, p=0.48). REMOTE-CR participants were less sedentary at 24 weeks (AMD=-61.5 (95% CI -117.8 to -5.3) min/day, p=0.03), while CBexCR participants had smaller waist (AMD=1.71 (95% CI 0.09 to 3.34) cm, p=0.04) and hip circumferences (AMD=1.16 (95% CI 0.06 to 2.27) cm, p=0.04) at 12 weeks. No other between-group differences were detected. Per capita programme delivery (NZD1130/GBP573 vs NZD3466/GBP1758) and medication costs (NZD331/GBP168 vs NZD605/GBP307, p=0.02) were lower for REMOTE-CR. Hospital service utilisation costs were not statistically significantly different (NZD3459/GBP1754 vs NZD5464/GBP2771, p=0.20). CONCLUSION: REMOTE-CR is an effective, cost-efficient alternative delivery model that could-as a complement to existing services-improve overall utilisation rates by increasing reach and satisfying unique participant preferences.

The Smart City Active Mobile Phone Intervention (SCAMPI) study to promote physical activity through active transportation in healthy adults: a study protocol for a randomised controlled trial.

BACKGROUND: The global pandemic of physical inactivity represents a considerable public health challenge. Active transportation (i.e., walking or cycling for transport) can contribute to greater total physical activity levels. Mobile phone-based programs can promote behaviour change, but no study has evaluated whether such a program can promote active transportation in adults. This study protocol presents the design and methodology of The Smart City Active Mobile Phone Intervention (SCAMPI), a randomised controlled trial to promote active transportation via a smartphone application (app) with the aim to increase physical activity. METHODS/DESIGN: A two-arm parallel randomised controlled trial will be conducted in Stockholm County, Sweden. Two hundred fifty adults aged 20-65 years will be randomised to either monitoring of active transport via the TRavelVU app (control), or to a 3-month evidence-based behaviour change program to promote active transport and monitoring of active travel via the TRavelVU Plus app (intervention). The primary outcome is moderate-to-vigorous intensity physical activity (MVPA in minutes/day) (ActiGraph wGT3x-BT) measured post intervention. Secondary outcomes include: time spent in active transportation measured via the TRavelVU app, perceptions about active transportation (the Transport and Physical Activity Questionnaire (TPAQ)) and health related quality of life (RAND-36). Assessments are conducted at baseline, after the completed intervention (after 3 months) and 6 months post randomisation. DISCUSSION: SCAMPI will determine the effectiveness of a smartphone app to promote active transportation and physical activity in an adult population. If effective, the app has potential to be a low-cost intervention that can be delivered at scale. TRIAL REGISTRATION: ClinicalTrials.gov NCT03086837 ; 22 March, 2017.

Text4Heart II - improving medication adherence in people with heart disease: a study protocol for a randomized controlled trial.

BACKGROUND: Cardiac rehabilitation (CR) is an essential component of contemporary management for patients with coronary heart disease, including following an acute coronary syndrome (ACS). CR typically involves education and support to assist people following an ACS to make lifestyle changes and prevent subsequent events. Despite its benefits, uptake and participation in tradition CR programs is low. The use of mobile technologies (mHealth) offers the potential to improve reach, access, and delivery of CR support. We aim to determine the effectiveness and cost-effectiveness of a text-messaging intervention (Text4Heart II) to improve adherence to medication and lifestyle change in addition to usual care in people following an ACS. A second aim is to use the RE-AIM framework to inform the potential implementation of Text4Heart II within health services in New Zealand. METHODS: Text4Heart II is a two-arm, parallel, superiority randomized controlled trial conducted in two large metropolitan hospitals in Auckland, New Zealand. Three hundred and thirty participants will be randomized to either a 24-week theory- and evidence-based personalized text message program to support self-management in addition to usual CR, or usual CR alone (control). Outcomes are assessed at 6 and 12 months. The primary outcome is the proportion of participants adhering to medication at 6 months as measured by dispensed records. Secondary outcomes include medication adherence at 12 months, the proportion of participants adhering to self-reported healthy behaviors (physical activity, fruit and vegetable consumption, moderating alcohol intake and smoking status) measured using a composite health behavior score, self-reported medication adherence, cardiovascular risk factors (lipids, blood pressure), readmissions and related hospital events at 6 and 12 months. A cost-effectiveness analysis will also be conducted. Using the RE-AIM framework, we will determine uptake and sustainability of the intervention. DISCUSSION: The Text4Heart II trial will determine the effectiveness of a text-messaging intervention to improve adherence to medication and lifestyle behaviors at both 6 and 12 months. Using the RE-AIM framework this trial will provide much needed data and insight into the potential implementation of Text4Heart II. This trial addresses many limitations/criticisms of previous mHealth trials; it builds on our Text4Heart pilot trial, it is adequately powered, has sufficient duration to elicit behavior change, and the follow-up assessments (6 and 12 months) are long enough to determine the sustained effect of the intervention. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ID: ACTRN12616000422426 . Registered retrospectively on 1 April 2016.

Economic evaluation of an exercise-counselling intervention to enhance smoking cessation outcomes: The Fit2Quit trial.

BACKGROUND: In the Fit2Quit randomised controlled trial, insufficiently-active adult cigarette smokers who contacted Quitline for support to quit smoking were randomised to usual Quitline support or to also receive ≤10 face-to-face and telephone exercise-support sessions delivered by trained exercise facilitators over the 24-week trial. This paper aims to determine the cost-effectiveness of an exercise-counselling intervention added to Quitline compared to Quitline alone in the Fit2Quit trial. METHODS: Within-trial and lifetime cost-effectiveness were assessed. A published Markov model was adapted, with smokers facing increased risks of lung cancer and cardiovascular disease. RESULTS: Over 24 weeks, the incremental programme cost per participant in the intervention was NZ$428 (US$289 or €226; purchasing power parity-adjusted [PPP]). The incremental cost-effectiveness ratio (ICER) for seven-day point prevalence measured at 24-week follow-up was NZ$31,733 (US$21,432 or €16,737 PPP-adjusted) per smoker abstaining. However, for the 52% who adhered to the intervention (≥7 contacts), the ICER for point prevalence was NZ$3,991 (US$2,695 or €2,105 PPP-adjusted). In this adherent subgroup, the Markov model estimated 0.057 and 0.068 discounted quality-adjusted life-year gains over the lifetime of 40-year-old males (ICER: NZ$4,431; US$2,993 or €2,337 PPP-adjusted) and females (ICER: NZ$2,909; US$1,965 or €1,534 PPP-adjusted). CONCLUSIONS: The exercise-counselling intervention will only be cost-effective if adherence is a minimum of ≥7 intervention calls, which in turn leads to a sufficient number of quitters for health gains. TRIAL REGISTRATION: Australasian Clinical Trials Registry Number ACTRN12609000637246.