A digital Acceptance and Commitment Therapy and education intervention targeting stress of parents and caregivers with preterm babies in the neonatal intensive care unit: A randomised controlled cluster trial protocol.

BACKGROUND: Parents with babies in the neonatal intensive care unit (NICU) experience high levels of stress, anxiety, and depression. The NICU experience may also lead to impaired parenting and early childhood socio-emotional problems. Psychosocial interventions can reduce NICU parent distress. Yet many are time-intensive and costly to deliver. Acceptance and Commitment Therapy (ACT), an evidence-based psychological therapy, may address these needs. ACT has been shown to be effective in reducing distress of parents of children with chronic illnesses, particularly when combined with parent education. Therefore, the primary aim of this study is to determine if a digital intervention that uses a brief form of ACT plus parent education will reduce the stress of primary caregivers with preterm babies in the NICU more than a digital education-only intervention or standard care control group. METHODS: In a randomised controlled cluster trial design, participants will be randomly assigned to one of three groups: ACT plus education; education-only; or standard care control. The primary outcome will be parental/caregiver stress levels, measured on the Parental Stress Scale: Neonatal Intensive Care Unit. Secondary outcomes include overall stress, anxiety, and depression. Outcome measures will be evaluated at baseline, two weeks after enrolment, discharge to home, and 3-months post-discharge. CONCLUSION: This study will explore the efficacy of a digital ACT plus education intervention on parental stress levels. While position papers have advocated for the use of ACT with NICU parents, this study will be the first to test ACT as a stand-alone intervention with this population. TRIAL REGISTRATION: This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry on 14 June 2023 (ACTRN12623000641695p).

Finding kindness: A randomized controlled trial of an online self-compassion intervention for weight management (SC4WM).

INTRODUCTION: Weight loss is hard to achieve and even harder to maintain. Engaging in effortful behavioural change to manage body weight can sometimes result in feelings of guilt and shame. Self-compassion, the tendency to find kindness for oneself in times of struggle, may facilitate coping with the unique challenges of weight management. This study assessed whether a remotely delivered self-compassion intervention improved weight management outcomes when delivered as a supplement to an existing digital behavioural weight management programme, Weight Watchers (WW). METHOD: Using a mixed-method study design, 249 adults seeking to manage weight were randomized to either the WW programme or WW supplemented with the self-compassion for weight management intervention (SC4WM). Participants completed measures of self-compassion, eating behaviour, physical activity, body weight and emotional well-being along with potential moderators, including weight self-stigma, eating restraint, psychological coping and perceived stress at baseline, post-intervention (4 weeks) and follow-up (12 weeks). RESULTS: There was no evidence that the SC4WM intervention had a significantly different effect than WW alone. Other than body weight, all outcomes improved over time in both groups. Self-compassion was slightly higher overall in the SC4WM group (p = .05), with this group reporting higher self-kindness at 4 weeks (p = .014) and lower self-judgement at 12 weeks (p = .023) compared to the control group. CONCLUSIONS: Although the SC4WM intervention group did show a small increase in self-kindness and reduction in self-judgement, weight management outcomes were not improved over and above the existing WW programme. Recommendations for adapting the SC4WM intervention to improve efficacy to augment weight management outcomes are provided.

Bringing an end to diabetes stigma and discrimination: an international consensus statement on evidence and recommendations.

People with diabetes often encounter stigma (ie, negative social judgments, stereotypes, prejudice), which can adversely affect emotional, mental, and physical health; self-care, access to optimal health care; and social and professional opportunities. To accelerate an end to diabetes stigma and discrimination, an international multidisciplinary expert panel (n=51 members, from 18 countries) conducted rapid reviews and participated in a three-round Delphi survey process. We achieved consensus on 25 statements of evidence and 24 statements of recommendations. The consensus is that diabetes stigma is driven primarily by blame, perceptions of burden or sickness, invisibility, and fear or disgust. On average, four in five adults with diabetes experience diabetes stigma and one in five experience discrimination (ie, unfair and prejudicial treatment) due to diabetes, such as in health care, education, and employment. Diabetes stigma and discrimination are harmful, unacceptable, unethical, and counterproductive. Collective leadership is needed to proactively challenge, and bring an end to, diabetes stigma and discrimination. Consequently, we achieved unanimous consensus on a pledge to end diabetes stigma and discrimination.

Exploring the Usability and Acceptability of a Well-Being App for Adolescents Living With Type 1 Diabetes: Qualitative Study.

Background: Adolescents living with either type 1 diabetes (T1D) or type 2 diabetes (T2D) have an increased risk of psychological disorders due to the demands of managing a chronic illness and the challenges of adolescence. Psychological disorders during adolescence increase the risk of suboptimal glycemic outcomes and may lead to serious diabetes-related complications. Research shows that digital health interventions may increase access to psychological support for adolescents and improve physical and mental health outcomes for youth with diabetes. To our knowledge, there are no evidence-based, publicly available mental health apps with a focus on improving the psychological well-being of adolescents with diabetes. Objective: This study aimed to explore the acceptability and usability of our evidence-based well-being app for New Zealand adolescents, Whitu: 7 Ways in 7 Days (Whitu), to allow us to further tailor it for youth with diabetes. We interviewed adolescents with T1D and T2D, their parents, and health care professionals to explore their views on the Whitu app and suggestions for tailoring the app for adolescent with diabetes. We also explored the cultural acceptability of the Whitu app for Maori and Pacific adolescents. Methods: A total of 34 participants, comprising 13 adolescents aged 12-16 years (11 with T1D and 2 with T2D), 10 parents, and 11 health care professionals, were recruited from a specialist diabetes outpatient clinic and Facebook diabetes groups. Each participant attended one 1-hour focus group on Zoom, in person, or via phone. Researchers gathered general feedback on what makes an effective and engaging app for adolescents with diabetes, as well as specific feedback about Whitu. Transcribed audio recordings of the focus groups were analyzed using directed content analysis. Results: Adolescents with T1D, their parents, and health care professionals found Whitu to be acceptable and usable. Adolescents with T1D and their parents signaled a preference for more diabetes-specific content. Health care professionals expressed less awareness and trust of digital health interventions and, as such, recommended that they be used with external support. Due to challenges in recruitment and retention, we were unable to include the views of adolescents with T2D in this qualitative study. Conclusions: There appears to be sufficient openness to the use of an app such as Whitu for supporting the well-being of adolescents with T1D, albeit with modifications to make its content more diabetes specific. Based on this qualitative study, we have recently developed a diabetes-specific version of Whitu (called LIFT: Thriving with Diabetes). We are also planning a qualitative study to explore the views of youth with T2D and their perspectives on the new LIFT app, where we are using alternative research approaches to recruit and engage adolescents with T2D and their families.

Effects of 12-Week Freestyle Libre 2.0 in Children with Type 1 Diabetes and Elevated HbA1c: A Multicenter Randomized Controlled Trial.

Objective: To investigate whether intermittently scanned continuous glucose monitoring (isCGM) reduced glycated hemoglobin (HbA1c) compared with capillary self-monitored capillary blood glucose (SMBG) in children with type 1 diabetes (T1D) and elevated glycemic control. Research Design and Methods: This multicenter 12-week 1:1 randomized, controlled, parallel-arm trial included 100 participants with established T1D aged 4-13 years (mean 10.9 ± 2.3 years) naive to isCGM and with elevated HbA1c 7.5%-12.2% [58-110 mmol/mol] [mean HbA1c was 9.05 (1.3)%] [75.4 (13.9) mmol/mol]. Participants were allocated to 12-week intervention (isCGM; FreeStyle Libre 2.0; Abbott Diabetes Care, Witney, United Kingdom) (n = 49) or control (SMBG; n = 51). The primary outcome was the difference in change of HbA1c from baseline to 12 weeks. Results: There was no evidence of a difference between groups for change in HbA1c at 12 weeks (0.23 [95% confidence interval; CI: -0.21 to 0.67], P = 0.3). However, glucose-monitoring frequency increased with isCGM +4.89/day (95% CI 2.97-6.81; P < 0.001). Percent time below range (TBR) <3.9 mmol/L (70-180 mg/dL) was reduced with isCGM -6.4% (10.6 to -4.2); P < 0.001. There were no differences in within group changes for Parent or Child scores of psychosocial outcomes at 12 weeks. Conclusions: For children aged 4-13 years with elevated Hba1c isCGM led to improvements in glucose testing frequency and reduced time below range. However, isCGM did not translate into reducing Hba1c or psychosocial outcomes compared to usual care over 12-weeks. The trial is registered within the Australian New Zealand Trial Registry on February 19, 2020 (ACTRN12620000190909p; ANZCTR.org.au) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1237-0090).

Developing digital mental health tools for youth with diabetes: an agenda for future research.

Youth living with diabetes face a concurrent challenge: managing a chronic health condition and managing the psychosocial and developmental changes that are characteristic of adolescence and young adulthood. Despite these unique challenges, psychological support is often difficult for youth with diabetes to access due to a lack of trained mental health professionals and other resource constraints. Digital wellbeing tools offer the potential to improve access to psychological support for this population. However, very few digital wellbeing tools exist for youth with diabetes. Of those that do exist, very few are evidence-based therapies, undermining their contribution to the field. Given the increasing global prevalence of diabetes in young people, the support necessitated by the challenges experienced by this population is not always accessible in a face-to-face setting and cannot be effectively scaled to meet demand. To support the health and wellbeing of youth with diabetes, there is a clear need to develop digital interventions that are widely accessible to users, but, more saliently, grounded in empirical evidence that supports their efficacy. Thus, the purpose of this paper is to offer an agenda for future research, including insights into which psychological techniques and behavioral change theories may be a good conceptual fit for digital mental health interventions, and how these tools may be best developed and utilized by the individuals that need them. Scalable, evidence-based wellbeing tools for this population are urgently required to improve psychological outcomes, and potentially, improve the equity of service access.

Psychosocial Support Provided to Parents of Infants in Neonatal Intensive Care Units: An International Survey.

OBJECTIVE: To describe current psychosocial support practices and programs for parents with infants in level II nurseries and level III neonatal intensive care units (NICUs) across Australia and New Zealand. STUDY DESIGN: A staff member from each level II and level III hospital completed an online survey about the psychosocial support services available for parents in Australia and New Zealand. Mixed methods (descriptive and statistical analysis; descriptive content analysis) were used to describe current services and practices. RESULTS: Of 66 eligible units, 44 participated in the survey (67%). Hospital-based pediatricians (32%) and clinical directors (32%) were the most common respondents. Level III NICUs reported providing significantly more services for parents than level II nurseries (median [IQR]: level III, 7 [5.25-8.75]; level II, 4.5 [3.25-5]; P < .001), with variability in the type and number of services available (range, 4-13). Less than half of units (43%) reported using standardized screening tools to assess parents for mental health distress, and just 4 units (9%) provided staff-led parent mental health support programs. In qualitative feedback, respondents frequently reported a lack of resources (staffing, funding, and training) to support parents. CONCLUSIONS: Despite the well-documented distress that parents with infants in neonatal units experience and the evidence-based practices known to reduce this distress, this study identifies significant gaps in parent support services in level II and level III NICUs across Australia and New Zealand.

Improving the Well-being of Adolescents With Type 1 Diabetes During the COVID-19 Pandemic: Qualitative Study Exploring Acceptability and Clinical Usability of a Self-compassion Chatbot.

BACKGROUND: Before the COVID-19 pandemic, adolescents with type 1 diabetes (T1D) had already experienced far greater rates of psychological distress than their peers. With the pandemic further challenging mental health and increasing the barriers to maintaining optimal diabetes self-management, it is vital that this population has access to remotely deliverable, evidence-based interventions to improve psychological and diabetes outcomes. Chatbots, defined as digital conversational agents, offer these unique advantages, as well as the ability to engage in empathetic and personalized conversations 24-7. Building on previous work developing a self-compassion program for adolescents with T1D, a self-compassion chatbot (COMPASS) was developed for adolescents with T1D to address these concerns. However, the acceptability and potential clinical usability of a chatbot to deliver self-compassion coping tools to adolescents with T1D remained unknown. OBJECTIVE: This qualitative study was designed to evaluate the acceptability and potential clinical utility of COMPASS among adolescents aged 12 to 16 years with T1D and diabetes health care professionals. METHODS: Potential adolescent participants were recruited from previous participant lists, and on the web and in-clinic study flyers, whereas health care professionals were recruited via clinic emails and from diabetes research special interest groups. Qualitative Zoom (Zoom Video Communications, Inc) interviews exploring views on COMPASS were conducted with 19 adolescents (in 4 focus groups) and 11 diabetes health care professionals (in 2 focus groups and 6 individual interviews) from March 2022 to April 2022. Transcripts were analyzed using directed content analysis to examine the features and content of greatest importance to both groups. RESULTS: Adolescents were broadly representative of the youth population living with T1D in Aotearoa (11/19, 58% female; 13/19, 68% Aotearoa New Zealand European; and 2/19, 11% Maori). Health care professionals represented a range of disciplines, including diabetes nurse specialists (3/11, 27%), health psychologists (3/11, 27%), dieticians (3/11, 27%), and endocrinologists (2/11, 18%). The findings offer insight into what adolescents with T1D and their health care professionals see as the shared advantages of COMPASS and desired future additions, such as personalization (mentioned by all 19 adolescents), self-management support (mentioned by 13/19, 68% of adolescents), clinical utility (mentioned by all 11 health care professionals), and breadth and flexibility of tools (mentioned by 10/11, 91% of health care professionals). CONCLUSIONS: Early data suggest that COMPASS is acceptable, is relevant to common difficulties, and has clinical utility during the COVID-19 pandemic. However, shared desired features among both groups, including problem-solving and integration with diabetes technology to support self-management; creating a safe peer-to-peer sense of community; and broadening the representation of cultures, lived experience stories, and diabetes challenges, could further improve the potential of the chatbot. On the basis of these findings, COMPASS is currently being improved to be tested in a feasibility study.

Bariatric Surgery and Psychological Health: A Randomised Clinical Trial in Patients with Obesity and Type 2 Diabetes.

PURPOSE: This study investigated the impact of either Roux-en-Y gastric bypass with silastic ring (SR-RYGB) or sleeve gastrectomy (SG) types of bariatric surgery on psychological health and explored the role of pre-existing depressive symptoms on weight loss. MATERIALS AND METHODS: A total of 114 participants with obesity and type 2 diabetes were randomized to receive SR-RYGB or SG at a single centre. Data from the Hospital Anxiety and Depression Scale (HADS), RAND 36-item Health Survey and body weight were collected before surgery and annually for 5 years. RESULTS: Sixteen patients were lost to follow-up at 5 years. Of the 98 patients who completed 5-year psychological follow-up assessments, 13 had mild to severe depressive symptoms (SR-RYGB n = 6, SG n = 7). SR-RYGB and SG resulted in similar psychological health improvement but percent weight loss at 5 years was greater for SR-RYGB by 10.6% (95% CI: 7.2 to 14.0, P < 0.0001). Scores for depressive symptoms and most RAND-36 domains improved significantly from baseline to 5 years in both groups. Patients with pre-existing depressive symptoms had similar percent weight loss at 5 years compared to patients without depressive symptoms, irrespective of procedural type. CONCLUSION: Patients receiving either SR-RYGB or SG had comparable psychosocial functioning, which was maintained to 5 years post-surgery. Pre-existing depressive symptoms did not affect weight loss achieved at 5 years. These findings confirm previous longitudinal studies demonstrating that bariatric surgery is generally associated with improved psychosocial functioning.

Self-compassion, Stress, and Eating Behaviour: Exploring the Effects of Self-compassion on Dietary Choice and Food Craving After Laboratory-Induced Stress.

BACKGROUND: Stress has been linked to high-fat and high-sugar food consumption. Self-compassion is associated with better emotional and physiological responses to stress. The current study explored whether trait self-compassion or induced state self-compassion could improve dietary choice and food craving after a stress induction. METHOD: Fifty-three university students completed an online survey assessing self-compassion, eating restraint, and general perceived stress before attending a laboratory visit. In the laboratory, participants were randomised to a neutral writing control or a self-compassion letter writing condition before a stress induction. Measures of heart rate, heart rate variability, state self-compassion, dietary choice, and state food cravings were taken. RESULTS: The brief self-compassion intervention did not sufficiently increase state self-compassion in the intervention group compared to the neutral writing condition. There was no effect of the written self-compassion intervention on heart rate, heart rate variability, dietary choice, or food craving. However, higher trait self-compassion was associated with healthier dietary choices (F(1, 49) = 5.35, p = .025, R2 = .098). CONCLUSION: Results suggest that higher trait self-compassion improved dietary choice after stress in a controlled environment in a university population. Further research is warranted to explore whether brief self-compassion interventions can improve state self-compassion and thereby influence dietary choices and food cravings after a stress induction.

Mindfulness and Relaxation-Based Interventions to Reduce Parental Stress, Anxiety and/or Depressive Symptoms in the Neonatal Intensive Care Unit: A Systematic Review.

Parents with infants in the neonatal intensive care unit (NICU) experience high levels of stress, anxiety, and depression. Mindfulness and relaxation-based interventions are effective in reducing distress in the general postpartum population. The aim of this systematic review was to evaluate whether mindfulness and/or relaxation-based interventions reduce stress, anxiety, and depression in NICU parents. A total of five studies met the inclusion criteria and were assessed for quality using the Downs & Black Checklist. The most consistent results in this review suggest that mindfulness and/or relaxation-based interventions may be effective at reducing anxiety symptoms in NICU parents, with moderate to large effect sizes, and show promise in reducing depressive symptoms. The findings show limited potential benefits on parental stress. Methodological weaknesses, heterogeneous intervention factors (including format and length), and varying participant adherence hinder the ability to make strong conclusions. Directions for future research are discussed.

Rethinking weight: Finding self-compassion for 'weight management'.

Conventional weight management approaches emphasize engaging in health behaviours, such as healthy eating and physical activity, to control body weight and promote favourable health outcomes (e.g., lower blood pressure). However, weight management is a multi-faceted, complex process influenced by numerous factors that limit the impact of behaviour change on weight. Self-compassion, treating oneself kindly in times of increased distress or difficulty, may offer a way for individuals to cope with the challenges of managing weight. The objectives of this perspective paper are threefold: (1) to conceptualize weight management, (2) to describe the problem that arises when focusing solely on weight loss, and (3) to explore the theoretical rationale for integrating self-compassion into weight management interventions. To support individual health and well-being, there is a need to reframe measures of success and provide innovative ways to cope with the challenges of managing body weight. Continued research is needed to investigate whether self-compassion can support health outcomes for those with weight management goals. This manuscript provides a proposed research agenda and implications for future practice.

Utility and Acceptability of a Brief Type 2 Diabetes Visual Animation: Mixed Methods Feasibility Study.

BACKGROUND: Visualizations of illness and treatment processes are promising interventions for changing unhelpful perceptions and improving health outcomes. However, these are yet to be tested in patients with type 2 diabetes mellitus (T2DM). OBJECTIVE: This study assesses the cross-cultural acceptability and potential effectiveness of a brief visual animation of T2DM at changing unhelpful illness and treatment perceptions and self-efficacy among patients and family members in 2 countries, New Zealand and Saudi Arabia. Health care professionals' views on visualization are also explored. METHODS: A total of 52 participants (n=39, 75% patients and family members and n=13, 25% health care professionals) were shown a 7-minute T2DM visual animation. Patients and family members completed a questionnaire on illness and treatment perceptions and self-efficacy before and immediately after the intervention and completed semistructured interviews. Health care professionals completed written open-ended questions. Means and 95% CIs are reported to estimate potential effectiveness. Inductive thematic analysis was conducted on qualitative data. RESULTS: All participants rated the visual animation as acceptable and engaging. Four main themes were identified: animation-related factors, impact of the animation, animation as an effective format for delivering information, and management-related factors. Effect sizes (ranged from 0.10 to 0.56) suggested potential effectiveness for changing illness and treatment perceptions and self-efficacy among patients and family members. CONCLUSIONS: Visualizations are acceptable and may improve the perceptions of patients' with diabetes in a short time frame. This brief visual animation has the potential to improve current T2DM education. A subsequent randomized controlled trial to investigate the effects on illness and treatment perceptions, adherence, glycemic control, and unplanned hospital admission is being prepared.

Well-being app to support young people during the COVID-19 pandemic: randomised controlled trial.

OBJECTIVES: To evaluate the efficacy and acceptability of 'Whitu: seven ways in seven days', a well-being application (app) for young people. DESIGN: Prospective randomised controlled trial of Whitu against waitlist control, with 45 participants in each arm. PARTICIPANTS: 90 New Zealand young people aged 16-30 recruited via a social media advertising campaign. SETTING: Participants' homes. INTERVENTIONS: Developed during the COVID-19 pandemic, and refined from a prototype version that was evaluated during a smaller qualitative study, 'Whitu: seven ways in seven days' is a well-being app that, as its name suggests, contains seven modules to help young people (1) recognise and rate emotions, (2) learn relaxation and mindfulness, (3) practice self-compassion and (4) gratitude, (5) connect with others, (6) care for their physical health and (7) engage in goal-setting. It can be completed within a week or as desired. MAIN OUTCOME MEASURES: Primary outcomes were changes in well-being on the WHO 5-item Well-Being Index and Short Warwick-Edinburgh Mental Well-Being Scale. Secondary outcomes were changes in depression on the Centre for Epidemiological Studies Depression Scale, anxiety on the Generalised Anxiety Disorder 7-item Scale, self-compassion on the Self Compassion Scale-Short Form, stress on the 10-item Perceived Stress Scale, sleep on the single-item Sleep Quality Scale and user engagement on the end-user version of the Mobile Application Rating Scale and via qualitative feedback during an online survey. Outcomes were evaluated at baseline, 4 weeks (primary study endpoint) and 3 months, and analysed using linear mixed models with group, time and a group-time interaction. RESULTS: At 4 weeks, participants in the Whitu group experienced significantly higher emotional (Mean difference (md) 13.19 (3.96 to 22.42); p=0.005) and mental (md 2.44 (0.27 to 4.61); p=0.027) well-being, self-compassion (md 0.56 (0.28 to 0.83); p<0.001) and sleep (md 1.13 (0.24 to 2.02); p=0.018), and significantly lower stress (md -4.69 (-7.61 to -1.76); p=0.002) and depression (md -5.34 (-10.14 to -0.53); p=0.030), compared with the waitlist controls. Group differences remained statistically significant at 3 months for all outcomes. Symptoms of anxiety were also lower in the intervention group at 4 weeks (p=0.096), with statistically significant differences at 3 months (md -2.31 (-4.54 to -0.08); p=0.042). Usability of Whitu was high (subjective ratings of 4.45 (0.72) and 4.38 (0.79) out of 5 at 4 weeks and 3 months, respectively) and qualitative feedback indicated individual and cultural acceptability of the app. CONCLUSIONS: Given the evolving psychological burden of the COVID-19 pandemic, Whitu could provide a clinically effective and scalable means of improving the well-being, mental health and resilience of young people. Replication of current findings with younger individuals and in other settings is planned. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12620000516987).

Investigating the effect of an online self-compassion for weight management (SC4WM) intervention on self-compassion, eating behaviour, physical activity and body weight in adults seeking to manage weight: protocol for a randomised controlled trial.

INTRODUCTION: Individual weight management, defined as engaging in behaviours to maintain or lose weight, can improve health and well-being. However, numerous factors influence weight management outcomes, such as genetics, biology, stress, the social and physical environment. Consequently, weight management can be hard. Self-compassion, described as treating oneself kindly in times of failure or distress, has shown promise in improving weight management outcomes. The objectives of this study are twofold: (1) to examine the efficacy of an online self-compassion for weight management (SC4WM) intervention coupled with an online commercial weight management programme (WW Weight Watchers reimagined) with increasing self-compassion and improving weight management outcomes (eating behaviour, physical activity and body weight) in comparison with the WW programme only and (2) to explore whether improvements in weight management outcomes are moderated by eating restraint, weight self-stigma, perceived stress and psychological coping. METHODS AND ANALYSIS: To achieve these objectives, 240 participants seeking to manage their weight were randomised to either an online behavioural commercial weight management programme (WW) or the online WW +SC4 WM intervention. Validated measures of self-compassion, stress, weight self-stigma, eating restraint, psychological coping and weight management outcomes were administered online at baseline, 4 weeks and at a 12-week follow-up. ETHICS AND DISSEMINATION: Ethics has been granted by the University of Auckland Health Research Ethics committee. Results will be communicated in peer-review journals, conferences and a doctoral thesis. If effective in increasing self-compassion and improving weight management outcomes, the intervention could be made more widely available to supplement behavioural weight management programmes. TRIAL REGISTRATION NUMBER: ACTRN12621000580875; Pre-results.

The role of protective psychological factors, self-care behaviors, and HbA1c in young adults with type 1 diabetes.

OBJECTIVE: To investigate whether protective psychological factors in young adults with type 1 diabetes are associated with more optimal self-care behaviors and HbA1c, and to explore possible mediators between protective psychological factors and HbA1c. RESEARCH DESIGN AND METHODS: This cross-sectional study examined the associations between protective psychological factors (optimism, positive efficacy expectancies, and self-compassion), maladaptive psychological factors (depression, anxiety, and stress), self-care behaviors, and HbA1c in 113 young adults (17-25 years) with type 1 diabetes in Auckland, New Zealand. Pearson's correlations, multiple linear regressions, and multiple mediation analyses were used to examine associations and mediators. RESULTS: Higher positive efficacy expectancies (beliefs about coping with difficulties) were associated with more optimal HbA1c (ß = -0.26, 95% CI: -1.99 to -0.45) and more optimal self-care behaviors (ß = 0.33, 95% CI: 0.28 to 0.92) in the adjusted models. Higher levels of self-compassion were associated with more optimal self-care behaviors (ß = 0.27, 95% CI: 0.09 to 0.43). Depression was associated with less optimal self-care behaviors (ß = -0.35, 95% CI: -1.33 to -0.43) and stress was associated with less optimal HbA1c (ß = 0.26, 95% CI: 0.27 to 1.21). Mediation results suggested that self-care behaviors mediated the relationship between all three of the protective psychological factors and more optimal HbA1c, and that lower stress also mediated the relationship between higher self-compassion and more optimal HbA1c. CONCLUSIONS: This study adds to the emerging literature that protective psychological factors may play an adaptive role in improving health outcomes in young adults with type 1 diabetes. Interventions targeting protective psychological factors present a promising approach to optimizing wellbeing and self-care in youth with type 1 diabetes.

Longitudinal Associations Between Illness Perceptions and Glycemic Control in Type 2 Diabetes.

BACKGROUND: Cross-sectional research demonstrates associations between illness perceptions and glycemic control in people with type 2 diabetes (T2D). Prospective studies are limited and show mixed findings. This study aimed to investigate (1) whether baseline illness perceptions predicted glycemic control (HbA1c levels) at 6-12-month follow-up and (2) possible differences in baseline illness perceptions between individuals who completed at least one HbA1c blood test during the 12-month follow-up and those who did not. METHODS: A total of 115 individuals with T2D were recruited from an outpatient clinic. Demographic and clinical information and illness perceptions were assessed at baseline. HbA1c was assessed at baseline and 12 months later from clinical records. Hierarchical multiple linear regression examined associations between baseline illness perceptions and HbA1c levels at 6-12-month follow-up, controlling for age, sex, education, types of diabetes medication, and baseline HbA1c. RESULTS: Univariate analysis showed perceived weight management effectiveness at baseline was associated with lower HbA1c at follow-up (rho = -.25, p = .04, n = 67). Adjusted multiple regression showed that HbA1c at baseline was the only significant predictor of HbA1c at 6-12-month follow-up (ß = 0.51, p < .001). There were no significant differences in baseline illness perceptions between individuals who completed HbA1c blood tests during follow-up (n = 78) and those who did not (n = 34), p > .05. CONCLUSION: Illness perceptions at baseline did not predict longitudinal HbA1c in adjusted analyses, nor completion of HbA1c tests. Results may be due to temporal variability in HbA1c and barriers to accessing blood tests.

Digital health interventions for improving mental health outcomes and wellbeing for youth with type 1 diabetes: A systematic review.

Digital health interventions are a promising alternative to face-to-face psychosocial interventions that may improve psychological outcomes in youth with diabetes. Several reviews have explored the efficacy of digital health interventions for adults and youth with some chronic health conditions; however, their efficacy among youth with type 1 diabetes is not known. This systematic review aims to assess digital health interventions targeting both psychological and physical health outcomes in youth with type 1 diabetes as well as to evaluate study quality and efficacy, and provide directions for future research in this area. Relevant studies were identified through searches conducted in MEDLINE, Embase, APA PsycInfo, Scopus, Cochrane Central, and CINAHL Plus up until February 2021. Studies were included if they were randomized; reported at least one psychological outcome that was assessed at ≥2 time points; included a digital health intervention; and were conducted in youth aged 5 to 25 years with type 1 diabetes. The revised Cochrane risk-of-bias (RoB 2) tool was used to assess risk of bias. Of the 5159 articles found, 15 met the inclusion criteria and were included in the review. Self-efficacy improved in 2 of the 3 studies which assessed self-efficacy; however, no consistent improvements were found for other psychological, behavioral, or physical outcomes. All studies showed some risk of bias concerns. More research is needed to make firm conclusions on the efficacy of digital health interventions for youth with diabetes. More specifically, interventions based on psychological theories are needed and studies of higher quality methodologies.

A comparison of FreeStyle Libre 2 to self-monitoring of blood glucose in children with type 1 diabetes and sub-optimal glycaemic control: a 12-week randomised controlled trial protocol.

PURPOSE: Frequent glucose monitoring is necessary for optimal glycaemic control. Second-generation intermittently scanned glucose monitoring (isCGM) systems inform users of out-of-target glucose levels and may reduce monitoring burden. We aim to compare FreeStyle Libre 2 (Abbott Diabetes Care, Witney, U.K.) to self-monitoring of blood glucose in children with type 1 diabetes and sub-optimal glycaemic control. METHODS: This open-label randomised controlled trial will enrol 100 children (4-13 years inclusive, diagnosis of type 1 diabetes ≥ 6 months, HbA1c 58-110 mmol/mol [7.5-12.2%]), from 5 New Zealand diabetes centres. Following 2 weeks of blinded sensor wear, children will be randomised 1:1 to control or intervention arms. The intervention (duration 12 weeks) includes second-generation isCGM (FreeStyle Libre 2) and education on using interstitial glucose data to manage diabetes. The control group will continue self-monitoring blood glucose. The primary outcome is the difference in glycaemic control (measured as HbA1c) between groups at 12 weeks. Pre-specified secondary outcomes include change in glucose monitoring frequency, glycaemic control metrics and psychosocial outcomes at 12 weeks as well as isCGM acceptability. DISCUSSION: This research will investigate the effectiveness of the second-generation isCGM to promote recommended glycaemic control. The results of this trial may have important implications for including this new technology in the management of children with type 1 diabetes. TRIAL REGISTRATION: This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry on 19 February 2020 (ACTRN12620000190909p) and the World Health Organization International Clinical Trials Registry Platform (Universal Trial Number U1111-1237-0090).

Pilot study of a well-being app to support New Zealand young people during the COVID-19 pandemic.

BACKGROUND: Well-being apps represent a promising and scalable approach for improving mental health outcomes in youth, especially during a global pandemic when access to face-to-face interventions may be limited. Whitu (meaning 7 in the New Zealand Maori language Te Reo) is a newly developed well-being app with 7 modules that support young people to learn and practice evidence-based coping skills, including relaxation, mindfulness, self-compassion, and goal-setting. OBJECTIVE: During this pilot, we explored the acceptability, usability, and preliminary efficacy of Whitu before refining the app for a randomized controlled trial (RCT). METHODS: We recruited 20 New Zealand young people aged 16-25 years via social media to trial the first prototype of the Whitu app over 6 weeks. Within-group differences from baseline to 2- and 6-weeks post intervention in self-reported well-being, depression, anxiety, stress, self-compassion, optimism and sleep quality were evaluated using repeated-measures ANOVA. A further 21 participants aged 16-30 years were recruited to participate in 4 focus groups to give feedback on the app's usability and cultural acceptability. Feedback was analysed using directed content analysis. RESULTS: Statistically significant improvements in anxiety (p = 0.024) and stress (p = 0.017) were observed from baseline to 2-weeks post intervention. Improvements in well-being (p = 0.021), depression (p = 0.031), anxiety (p = 0.005), and stress (p = 0.004) were also observed from baseline to 6-weeks. No statistically significant changes were seen in self-compassion, optimism, or sleep quality. Effect sizes (partial η2s) ranged from 0.25 (depression) to 0.42 (stress). Qualitative feedback comprised of five key themes, namely: factors affecting engagement, issues with functionality, preferences regarding aesthetics, effectiveness and adverse effects, and cultural acceptability. CONCLUSIONS: Our preliminary results suggest that Whitu may be an effective app for improving multiple dimensions of young people's well-being. Modifications to the look and feel, cultural content, and onboarding have been undertaken based on the qualitative feedback, and an RCT is currently underway.