A web-based low carbohydrate diet intervention significantly improves glycaemic control in adults with type 2 diabetes: results of the T2Diet Study randomised controlled trial.

BACKGROUND/OBJECTIVES: In people with type 2 diabetes mellitus (T2DM), low carbohydrate diets (LCD), defined as 10-<26% total energy intake from carbohydrate, have indicated improved glycaemic control and clinical outcomes. Web-based interventions can help overcome significant challenges of accessibility and availability of dietary education and support for T2DM. No previous study had evaluated a web-based LCD intervention using a randomised controlled trial (RCT) design. The objective of this study was to assess whether a web-based LCD programme provided in conjunction with standard care improves glycaemic control in adults with T2DM. SUBJECTS/METHODS: A 16-week parallel RCT was conducted remotely during Covid-19 among the general community, recruiting adults with T2DM not on insulin aged 40-89 years. Participants were randomly assigned (1:1) to standard care plus the web-based T2Diet healthy LCD education programme (intervention) or standard care only (control). The primary outcome was haemoglobin A1c (HbA1c). Secondary outcomes were weight, body mass index (BMI), anti-glycaemic medication, dietary intake, and self-efficacy. Blinded data analysis was conducted by intention-to-treat. RESULTS: Ninety-eight participants were enrolled, assigning 49 to each group, with 87 participants (n = 40 intervention; n = 47 control) included in outcome analysis. At 16 weeks, there was a statistically significant between-group difference favouring the intervention group, with reductions in HbA1c -0.65% (95% CI: -0.99 to -0.30; p < 0.0001), weight -3.26 kg (p < 0.0001), BMI -1.11 kg/m2 (p < 0.0001), and anti-glycaemic medication requirements -0.40 (p < 0.0001), with large effect sizes Cohen's d > 0.8. CONCLUSION: This study demonstrated that as an adjunct to standard care, the web-based T2Diet programme significantly improved glycaemic control and clinical outcomes in adults with T2DM. In addition, the results highlight the potential to improve access and availability for people with T2DM to achieve glycaemic control and improved health through web-based dietary education and support.

Exploring engagement with a web-based dietary intervention for adults with type 2 diabetes: A mixed methods evaluation of the T2Diet study.

BACKGROUND: Improved understanding of participant engagement in web-based dietary interventions is needed. Engagement is a complex construct that may be best explored through mixed methods to gain comprehensive insight. To our knowledge, no web-based dietary intervention in people with type 2 diabetes (T2D) has previously used a mixed methods approach. The aim of this study was to explore factors that may contribute to effective engagement in a web-based dietary program for people with T2D. METHODS: This study employed a mixed methods intervention design, with a convergent design embedded for post-intervention evaluation. The convergent design collected and analyzed quantitative and qualitative data independent of each other, with the two datasets merged/compared during results/interpretation. Quantitative data collected from intervention group participants (n = 40) were self-administered questionnaires and usage data with average values summarized. Qualitative data were participant semi-structured interviews (n = 15) incorporating a deductive-inductive thematic analysis approach. RESULTS: The results from the quantitative and qualitative data indicated positive overall engagement with the web-based dietary program. Factors that contributed to effective engagement were sustained frequency and intensity of engagement; structured weekly program delivery; participants affective engagement prior to and during the intervention, with positive affective states enhancing cognitive and behavioral engagement; and participants experience of value and reward. In addition, the user-centered development process employed prior to intervention delivery played an important role in facilitating positive engagement outcomes. CONCLUSION: This study yielded novel findings by integrating qualitative and quantitative data to explore engagement with a web-based dietary program involving people with T2D. Effective engagement occurred in this intervention through a combination of factors related to usage and participants' affective, cognitive and behavioral states. The engagement outcomes that emerged will be useful to current and future researchers using digital technologies to deliver lifestyle interventions for T2D or other chronic health conditions.

Healthcare providers' perspectives on using smart home systems to improve self-management and care in people with heart failure: A qualitative study.

BACKGROUND: Smart home systems can potentially improve heart failure (HF) self-management and care. However, evidence is lacking on clinicians' expectations and opinions about these systems. This study aimed to investigate key healthcare providers' perspectives on using smart home systems for self-management and care in people with HF. METHODS: Semi-structured interviews were conducted with purposively selected healthcare providers experienced in caring for people with HF in Australia. Participants were presented with a schematic for a prototype smart home system comprising a central hub connected with medical devices and sensors. An inductive thematic analysis approach was used to establish the perceived benefits and barriers to using smart home systems and enhance the self-management of people with HF. RESULTS: Overall, participants reported that smart home systems could improve the self-management of people with HF with some reservations and suggestions. Four substantive themes emerged from the qualitative findings: role of smart home systems in self-management, suggested features of a smart home system, benefits of smart home system, and factors that may influence smart home system uptake. Participants shared several reservations, such as the potential for increased workload and difficulty of technology use for some patients due to age and HF-related disabilities. Participants highlighted that the abilities and needs of people with HF must be considered when developing any smart home systems. Furthermore, these systems might benefit health institutions and people with HF by allowing remote monitoring and services and allowing patients to live at home independently. CONCLUSION: Healthcare providers considered smart home systems might be potentially helpful to monitor HF patients and deliver interventions to improve their lives, despite several reservations. Future research is needed to address these reservations, identify the needs and abilities of people with HF to use technologies, effects of smart home systems on HF self-management and their impact on clinical practice and health outcomes.

User-centered development of a digitally-delivered dietary intervention for adults with type 2 diabetes: The T2Diet study.

BACKGROUND: Web-based interventions can help address challenges of accessibility and availability of dietary support for people with type 2 diabetes (T2D). However, concerns regarding adherence and engagement in web-based interventions have been noted. Implementing a user-centered approach to intervention development has been shown to encourage better participant engagement. The overarching aim of this paper was to describe the user-centered approach used in the T2Diet Study to develop a new web-based dietary intervention for adults with T2D, exploring strategies for enhancing adherence and engagement. METHODS: Intervention development was based on a flexible iterative user-centered approach to enable new product development. Twenty-one adults with T2D were engaged in six guided discussion groups across four iterative development phases, alongside reference to evidence and theory throughout the process. The phases of user inquiry progressed from broad discussion on areas to support dietary needs; to design feedback on aspects of site layout; through to further feedback on aesthetics and functionality; then into a two-week field test followed by final user inquiry and participation in user experience polls. A hybrid approach of thematic data analysis was used, incorporating both a data-driven inductive approach and a deductive approach based on a priori identification of themes. RESULTS: Group discussion across the four phases highlighted factors the participants considered may motivate them to adhere and engage, which predominantly included relevance of resources, clear and simple positive communication, and flexibility for personal tailoring. Participant feedback provided an actionable list of intervention developments and input to inform intervention structure and theoretical framework. The two-week field test highlighted factors participants valued in terms of the user experience, most notably usability and accessibility. Additionally, the field test indicated a positive user experience, with no significant usability issues identified. CONCLUSION: This paper provided the first detailed report of a user-centered approach to iterative development in the context of a web-based T2D dietary intervention. The insights will be useful to inform future digitally-delivered dietary interventions for adults with T2D or to inform a similar user-centered approach for other chronic health conditions.

Randomised controlled trial of a web-based low carbohydrate diet intervention for adults with type 2 diabetes: the T2Diet study protocol.

INTRODUCTION: Type 2 diabetes (T2D) management frequently involves a multidisciplinary care team. However, standard care for patients with T2D is the central role of the general practice physician, and consists of routine appointments to monitor glycaemic status and overall health. Dietary modification is an essential component of T2D management. Evidence suggests that a low carbohydrate diet (LCD) provides better clinical outcomes for people with T2D compared with other diets. However, providing dietary support in face-to-face settings is challenged by issues of availability and accessibility. Provided in conjunction with standard care, digital interventions can help bridge this gap. The objective of this paper is to describe the protocol of a randomised controlled trial (RCT) of a web-based intervention that will evaluate the effectiveness of standard care plus web-based LCD intervention when compared with standard care only. METHODS AND ANALYSIS: In a two-arm parallel RCT, 100 adults with non-insulin-dependent T2D aged between 40 and 89 years will be randomised to either a theoretically informed 16-week automated web-based LCD intervention plus standard care or standard care only. LCD recommendations emphasise consuming nutrient-dense whole foods and encourage a daily carbohydrate goal of 50-100 g, with an objective of achieving 10% to <26% carbohydrates from total energy intake. Assessments will take place at baseline and 16 weeks. The primary outcome will be haemoglobin A1c. Additional data collected will include dietary intake, self-efficacy, weight and height, anti-diabetes medication and dosages, and diabetes-related comorbidities. Process evaluation will consist of a mixed-methods assessment of website engagement metrics, user experience and participants' perspectives. ETHICS AND DISSEMINATION: All study procedures have been approved by the Deakin University Human Research Ethics Committee (2020-349). Study findings will be disseminated widely through public, professional and academic presentation and publication. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12621000096853).

Web-Based Interventions for Dietary Behavior in Adults With Type 2 Diabetes: Systematic Review of Randomized Controlled Trials.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is among the most prevalent noncommunicable health conditions worldwide, affecting over 500 million people globally. Diet is a key aspect of T2DM management with dietary modification shown to elicit clinically meaningful outcomes such as improved glycemic control, and reductions in weight and cardiovascular disease risk factors. Web-based interventions provide a potentially convenient and accessible method for delivering dietary education, but its effects on dietary behavior in people with T2DM are unknown. OBJECTIVE: The objective of this review was to determine the effectiveness of web-based interventions on dietary behavior change and glycemic control in people with T2DM. METHODS: Per PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, systematic literature searches were performed using Medline, Embase, The Cochrane Library, and CINAHL to retrieve papers from January 2013 to May 2019. Randomized controlled trials of web-based interventions in adults with T2DM with reported dietary assessment were included. Population and intervention characteristics, dietary guidelines and assessments, and significant clinical outcomes were extracted. Differences between groups and within groups were assessed for dietary behavior and clinical outcomes. RESULTS: There were 714 records screened, and five studies comprising 1056 adults were included. Studies measured dietary changes by assessing overall diet quality, changes in specific dietary components, or dietary knowledge scores. Significant improvements in dietary behavior were reported in four out of the five studies, representing healthier food choices, improvements in eating habits, reductions in carbohydrates, added sugar, sodium, saturated fat and overall fat intake, and/or increases in dietary knowledge. Three studies found significant mean reductions for hemoglobin A1c ranging from -0.3% to -0.8%, and/or weight ranging from -2.3 kg to -12.7 kg, fasting blood glucose (-1 mmol/L), waist circumference (-1 cm), and triglycerides (-60.1 mg/dL). These studies provided varied dietary recommendations from standard dietary guidelines, national health program guidelines, and a very low carbohydrate ketogenic diet. CONCLUSIONS: This review provided evidence that web-based interventions may be an effective way to support dietary behavior change in people with T2DM, potentially leading to changes in glycemic control and other clinical outcomes. However, the evidence should be viewed as preliminary as there were only five studies included with considerable heterogeneity in terms of the diets recommended, the dietary assessment measures used, the complexity of the interventions, and the modes and methods of delivery.