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Introduction Middle-aged multidomain risk reduction interventions targeting modifiable risk factors for dementia may delay or prevent a third of dementia cases in later life. We describe the protocol of a cluster randomised controlled trial (cRCT), HAPPI MIND (Holistic Approach in Primary care for PreventIng Memory Impairment aNd Dementia). HAPPI MIND will evaluate the efficacy of a multidomain, nurse-led, mHealth supported intervention for assessing dementia risk and reducing associated risk factors in middle-aged adults in the Australian primary care setting.Methods and analysis General practice clinics (n≥26) across Victoria and New South Wales, Australia, will be recruited and randomised. Practice nurses will be trained to implement the HAPPI MIND intervention or a brief intervention. Patients of participating practices aged 45–65 years with ≥2 potential dementia risk factors will be identified and recruited (approximately 15 patients/clinic). Brief intervention participants receive a personalised report outlining their risk factors for dementia based on Australian National University Alzheimer’s Disease Risk Index (ANU-ADRI) scores, education booklet and referral to their general practitioner as appropriate. HAPPI MIND participants receive the brief intervention as well as six individualised dementia risk reduction sessions with a nurse trained in motivational interviewing and principles of behaviour change, a personalised risk reduction action plan and access to the purpose-built HAPPI MIND smartphone app for risk factor self-management. Follow-up data collection will occur at 12, 24 and 36 months. Primary outcome is ANU-ADRI score change at 12 months from baseline. Secondary outcomes include change in cognition, quality of life and individual risk factors of dementia.Ethics and dissemination Project approved by Monash University Human Research Ethics Committee (ID: 28273). Results will be disseminated in peer-reviewed journals and at healthcare conferences. If effective in reducing dementia risk, the HAPPI MIND intervention could be integrated into primary care, scaled up nationally and sustained over time.Trial registration number ACTRN12621001168842.

BackgroundWomen with overweight and obesity are at higher risk of developing complications in pregnancy such as gestational diabetes and longer-term chronic conditions. Research concerning health behavior change interventions during pregnancy and postpartum shows promising effects, but implementation into routine services is sparsely investigated. Most interventions focus on the antenatal or postpartum life stages, failing to meet the needs of women. IMPACT DIABETES Bump2Baby is a multicenter project across 4 high-income countries developed to test the implementation of an antenatal and postpartum evidence-based mobile health (mHealth) coaching intervention called Bump2Baby and Me (B2B&Me) designed to sit alongside usual care in the perinatal period. ObjectiveWe aim to explore the feasibility and implementation of the B2B&Me intervention and investigate the effectiveness of this intervention in women at risk of gestational diabetes. MethodsIMPACT DIABETES Bump2Baby is a hybrid type 2 effectiveness-implementation study, which integrates an evidence-based mHealth coaching app that includes personalized health behavior change coaching provided by health care professionals alongside antenatal care from the first antenatal visit to 12 months postpartum. The mHealth app offers the possibility of synchronous calls, asynchronous contact (including coach-participant text and video messaging exchanges tailored to the participant’s needs), and ongoing access to an extensive library of bespoke intervention materials. Participants will interact asynchronously with their health coach throughout the intervention via the app. This randomized controlled trial across 4 clinical sites within Ireland, the United Kingdom, Spain, and Australia will recruit 800 women in early pregnancy to evaluate the effectiveness on postpartum weight. The Exploration, Preparation, Implementation, and Sustainment implementation framework is the theoretical underpinning of the study. The implementation evaluation will be assessed at the individual, hospital staff, and broader community levels using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. Data sources for the RE-AIM evaluation will include app and platform analytics, screening and training records, participant medical records, key informant interviews, participant and partner exit interviews, cost data, study questionnaires, staff surveys, and blood sample analyses. ResultsThe study was approved and registered with the Australian New Zealand Clinical Trials Registry on November 19, 2020. Recruitment commenced on February 9, 2021, and data collection is ongoing. Publication of the results is expected in 2024. ConclusionsThis is the first hybrid effectiveness-implementation study of an 18-month mHealth coaching intervention in at-risk women that we are aware of. As research aims to move toward real-world implementable solutions, it is critical that hybrid studies are conducted. The data from this large multicenter study will be useful in planning the potential implementation and scale-up of evidence-based perinatal health behavior change interventions. Trial RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12620001240932; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380020&isReview=true International Registered Report Identifier (IRRID)DERR1-10.2196/51431

BackgroundThe COVID-19 pandemic has had a negative impact on the mental health of people globally. Significant concerns about health and access to services among women of reproductive age considering pregnancy may cause psychological distress, and in turn increase health risks during and after pregnancy for mothers and offspring.ObjectivesTo examine the association between pregnancy intention and psychological distress during the COVID-19 pandemic in Australia, and explore if this association differed based on local viral transmission rates and corresponding levels of pandemic restrictions.MethodsA nationwide online survey was completed by 849 non-pregnant women aged 18-50 years between 15 October and 7 November 2020. Women were asked about their intention to become pregnant, and psychological distress was assessed using the Kessler Psychological Distress Scale (K10). Multivariable regression analysis examined associations between pregnancy intention and psychological distress. An interaction term was added to the model to examine differences in associations by level of viral transmission rates and lockdown restrictions which was determined based on postcode.ResultsPregnancy intention was not associated with experiencing (very) high psychological distress in the overall study population (odds ratio (OR) 1.42, 95% CI 0.94, 2.11). The interaction term (p = 0.09) suggested potential differences by level of restrictions and viral transmission rates. In stratified analysis among women living in a location with strict lockdown restrictions and high viral transmission rates leading up to and during the study, those planning to become pregnant were more likely to experience (very) high psychological distress (OR 3.39, 2.04, 5.65) compared with women not planning to become pregnant. Pregnancy intention was not associated with psychological distress among women exposed to lower levels of pandemic restrictions and viral transmission rates (OR 1.17, 0.74, 1.85).ConclusionsOur findings highlight the need to identify and support women planning pregnancy during a public health crisis to mitigate potential short- and long-term intergenerational negative health outcomes associated with psychological distress.

BackgroundGestational diabetes mellitus (GDM) is an increasingly prevalent risk factor for type 2 diabetes. We evaluated the effectiveness of a group-based lifestyle modification program in mothers with prior GDM within their first postnatal year.Methods and findingsIn this study, 573 women were randomised to either the intervention (n = 284) or usual care (n = 289). At baseline, 10% had impaired glucose tolerance and 2% impaired fasting glucose. The diabetes prevention intervention comprised one individual session, five group sessions, and two telephone sessions. Primary outcomes were changes in diabetes risk factors (weight, waist circumference, and fasting blood glucose), and secondary outcomes included achievement of lifestyle modification goals and changes in depression score and cardiovascular disease risk factors. The mean changes (intention-to-treat [ITT] analysis) over 12 mo were as follows: -0.23 kg body weight in intervention group (95% CI -0.89, 0.43) compared with +0.72 kg in usual care group (95% CI 0.09, 1.35) (change difference -0.95 kg, 95% CI -1.87, -0.04; group by treatment interaction p = 0.04); -2.24 cm waist measurement in intervention group (95% CI -3.01, -1.42) compared with -1.74 cm in usual care group (95% CI -2.52, -0.96) (change difference -0.50 cm, 95% CI -1.63, 0.63; group by treatment interaction p = 0.389); and +0.18 mmol/l fasting blood glucose in intervention group (95% CI 0.11, 0.24) compared with +0.22 mmol/l in usual care group (95% CI 0.16, 0.29) (change difference -0.05 mmol/l, 95% CI -0.14, 0.05; group by treatment interaction p = 0.331). Only 10% of women attended all sessions, 53% attended one individual and at least one group session, and 34% attended no sessions. Loss to follow-up was 27% and 21% for the intervention and control groups, respectively, primarily due to subsequent pregnancies. Study limitations include low exposure to the full intervention and glucose metabolism profiles being near normal at baseline.ConclusionsAlthough a 1-kg weight difference has the potential to be significant for reducing diabetes risk, the level of engagement during the first postnatal year was low. Further research is needed to improve engagement, including participant involvement in study design; it is potentially more effective to implement annual diabetes screening until women develop prediabetes before offering an intervention.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12610000338066.

Abstract Background Breastfeeding self-efficacy is a woman’s self-belief and confidence in her perceived ability to breastfeed. This modifiable determinant is strongly associated with breastfeeding initiation, exclusivity, and duration. It is unclear how important the timing of breastfeeding self-efficacy measurement and interventions are. The prenatal period appears underexplored in the literature and yet a prenatal focus provides increased opportunity for breastfeeding self-efficacy enhancement and further potential improvement in breastfeeding outcomes. This scoping review aims to synthesise the evidence on prenatal breastfeeding self-efficacy, describing for the first time the theoretical frameworks, measurement tools, and interventions used in the prenatal period. Methods 8 databases were searched using the PCC framework (Problem: breastfeeding, Concept: self-efficacy, Context: prenatal period). From 4,667 citations and 156 additional sources identified through grey literature and snowballing, data were extracted from 184 studies and 2 guidance documents. All were summarised descriptively and narratively. Results Just over half (57%) of included studies stated their theoretical underpinning, with Bandura’s Self-Efficacy Theory / Dennis’ Breastfeeding Self-Efficacy Framework predominant. Only half of intervention studies incorporated theory in their design. More intervention studies were undertaken in the past decade than previously, but the level of theoretical underpinning has not improved. Prenatal interventions incorporating theory-led design and using components addressing the breadth of theory, more frequently reported improving breastfeeding self-efficacy and breastfeeding outcomes than those not theory-led. Intervention components used less frequently were vicarious or kinaesthetic learning (52.5%) and involvement of social circle support (26%). The Breastfeeding Self-Efficacy Scales were the most common measurement tool, despite being designed for postpartum use. Overall, issues were identified with the late prenatal timing of breastfeeding self-efficacy investigation and the design, content and phraseology of measurements and interventions used in the prenatal period. Conclusion This review provides novel insights for consideration in the design and conduct of breastfeeding self-efficacy studies in the prenatal period. Future research should aim to be theory-led, commence earlier in pregnancy, and embed the breadth of self-efficacy theory into the design of interventions and measurement tools. This would provide more robust data on prenatal breastfeeding self-efficacy’s role in impacting breastfeeding outcomes.

Abstract Background Individual differences in children eating behaviours have been linked with childhood overweight and obesity. The determinants of childhood eating behaviours are influenced by a complex combination of hereditary and ecological factors. This study examines if key ecological predictors of childhood overweight; maternal socio-economic status (SES), children’s screen time, and childcare arrangements, are associated with eating behaviours in children aged 5-years-old. Methods This is secondary, cross-sectional analysis of the ROLO (Randomized COntrol Trial of LOw glycemic diet in pregnancy) study, using data from the 5-year follow-up (n = 306). Weight, height, and body mass index (BMI) were obtained from mothers and children at the 5-year follow-up. Children’s BMI z-scores were calculated. SES was determined using maternal education level and neighborhood deprivation score. Information on children’s screen time and childcare arrangements were collected using lifestyle questionnaires. Children’s eating behaviours were measured using the Children’s Eating Behaviour Questionnaire (CEBQ). Multiple linear regression, adjusted for potential confounders, assessed associations between maternal SES, screen time and children’s eating behaviours. One-way ANOVA, independent sample t-tests and Spearman’s correlation examined childcare exposure and children’s eating behaviour. Results Mothers in the lowest SES group had higher BMI and were younger than those in the highest SES group (p =

Background: Excessive inflammation during pregnancy has been linked to adverse long-term health outcomes for both mothers and their children. One such outcome is maternal cardiometabolic dysfunction. The Energy-Adjusted Dietary Inflammatory Index is a method of scoring the overall inflammatory potential of the diet. Research on how the inflammatory potential of the maternal diet during pregnancy affects maternal cardiometabolic factors is limited. Objective: We investigated if the maternal Energy-Adjusted Dietary Inflammatory Index was associated with maternal cardiometabolic factors during pregnancy. Study design: This is a secondary analysis of 518 individuals who participated in the ROLO (Randomized cOntrol trial of a LOw glycemic index diet in pregnancy) study. Maternal Energy-Adjusted Dietary Inflammatory Index scores were calculated in early (12–14 weeks’ gestation) and late pregnancy (34 weeks’ gestation) using data collected from 3-day food diaries. Body mass index, blood pressure, fasting lipid profiles, glucose levels, and HOMA1-IR were obtained in early and late pregnancy. Multiple linear regression examined associations between early-pregnancy Energy-Adjusted Dietary Inflammatory Index and early and late maternal cardiometabolic markers. In addition, the relationship between late-pregnancy Energy-Adjusted Dietary Inflammatory Index and late cardiometabolic factors was explored. Regression models were adjusted for maternal ethnicity, maternal age at delivery, education level, smoking status, and original randomized control trial group allocation. In regression models examining late-pregnancy Energy-Adjusted Dietary Inflammatory Index with late lipids, change in lipid level from early to late pregnancy was also adjusted for. Results: Women's mean (standard deviation) age at delivery was 32.8 (±4.01) years, with median (interquartile range) body mass index of 24.45 (23.34–28.20) kg/m2. Mean (standard deviation) Energy-Adjusted Dietary Inflammatory Index was 0.59 (±1.60) in early pregnancy and 0.67 (±1.59) in late pregnancy. In adjusted linear regression analysis, first-trimester maternal Energy-Adjusted Dietary Inflammatory Index was positively associated with maternal body mass index (B=0.007; 95% confidence interval, 0.003–0.011; P=.001), early-pregnancy cardiometabolic markers including total cholesterol (B=0.155; 95% confidence interval, 0.061–0.249; P=.001), triglycerides (B=0.043; 95% confidence interval, 0.005–0.080; P=.03), low-density lipoproteins (B=0.129; 95% confidence interval, 0.049–0.209; P=.002), and diastolic blood pressure (B=0.538; 95% confidence interval, 0.070–1.006; P=.02), and late-pregnancy cardiometabolic markers including total cholesterol (B=0.127; 95% confidence interval, 0.012–0.243; P=.01) and low-density lipoproteins (B=0.110; 95% confidence interval, 0.010–0.209; P=.03). In the third trimester, Energy-Adjusted Dietary Inflammatory Index was associated with late-pregnancy diastolic blood pressure (B=0.624; 95% confidence interval, 0.103–1.145; P=.02), HOMA1-IR (B=0.030; 95% confidence interval, 0.005–0.054; P=.02), and glucose (B=0.003; 95% confidence interval, 0.003–0.034; P=.03). No associations were observed between third-trimester Energy-Adjusted Dietary Inflammatory Index and late-pregnancy lipid profiles. Conclusion: Maternal diets with a higher Energy-Adjusted Dietary Inflammatory Index, which were low in anti-inflammatory foods and rich in proinflammatory foods, were associated with increased levels of cardiometabolic health risk factors in pregnancy. Promoting dietary intakes that have a lower inflammatory potential may support more favorable maternal cardiometabolic profiles during pregnancy.

IntroductionWomen with previous gestational diabetes mellitus (GDM) are at increased risk of type 2 diabetes (T2D). Guidelines recommend postnatal diabetes screening (oral glucose tolerance test or HbA1c) typically 6-12 weeks after birth, with screening maintained at regular intervals thereafter. Despite this, around half of women are not screened, representing a critical missed opportunity for early identification of prediabetes or type 2 diabetes. While policy and practice-level recommendations are comprehensive, those at the personal-level primarily focus on increasing screening knowledge and risk perception, potentially missing other influential behavioral determinants. We aimed to identify modifiable, personal-level factors impacting postpartum type 2 diabetes screening among Australian women with prior gestational diabetes and recommend intervention functions and behavior change techniques to underpin intervention content.Research design and methodsSemi-structured interviews with participants recruited via Australia’s National Gestational Diabetes Register, using a guide based on the Theoretical Domains Framework (TDF). Using an inductive-deductive approach, we coded data to TDF domains. We used established criteria to identify ‘important’ domains which we then mapped to the Capability, Opportunity, Motivation–Behavior (COM-B) model.ResultsNineteen women participated: 34 ± 4 years, 19 ± 4 months postpartum, 63% Australian-born, 90% metropolitan, 58% screened for T2D according to guidelines. Eight TDF domains were identified: ‘knowledge’, ‘memory, attention, and decision-making processes’, ‘environmental context and resources’, ‘social influences’, ‘emotion’, ‘beliefs about consequences’, ‘social role and identity’, and ‘beliefs about capabilities’. Study strengths include a methodologically rigorous design; limitations include low recruitment and homogenous sample.ConclusionsThis study identified numerous modifiable barriers and enablers to postpartum T2D screening for women with prior GDM. By mapping to the COM-B, we identified intervention functions and behavior change techniques to underpin intervention content. These findings provide a valuable evidence base for developing messaging and interventions that target the behavioral determinants most likely to optimize T2D screening uptake among women with prior GDM.

Abstract Background Gestational diabetes (GDM) impacts 8–18% of pregnancies and greatly increases both maternal and child risk of developing non-communicable diseases such as type 2 diabetes and obesity. Whilst lifestyle interventions in pregnancy and postpartum reduce this risk, a research translation gap remains around delivering implementable interventions with adequate population penetration and participation. Impact Diabetes Bump2Baby is an implementation project of an evidence-based system of care for the prevention of overweight and obesity. Bump2Baby and Me is the multicentre randomised controlled trial investigating the effectiveness of a mHealth coaching programme in pregnancy and postpartum for women at high risk of developing GDM. Methods Eight hundred women will be recruited in early pregnancy from 4 clinical sites within Ireland, the UK, Spain, and Australia. Women will be screened for eligibility using the validated Monash GDM screening tool. Participants will be enrolled from 12 to 24 weeks’ gestation and randomised on a 1:1 basis into the intervention or control arm. Alongside usual care, the intervention involves mHealth coaching via a smartphone application, which uses a combination of synchronous and asynchronous video and text messaging, and allows for personalised support and goal setting with a trained health coach. The control arm receives usual care. All women and their children will be followed from early pregnancy until 12 months postpartum. The primary outcome will be a difference in maternal body mass index (BMI) of 0.8 kg/m2 at 12 months postpartum. Secondary maternal and infant outcomes include the development of GDM, gestational weight gain, pregnancy outcomes, improvements in diet, physical activity, sleep, and neonatal weight and infant growth patterns. The 5-year project is funded by the EU Commission Horizon 2020 and the Australian National Health and Medical Research Council. Ethical approval has been received. Discussion Previous interventions have not moved beyond tightly controlled efficacy trials into routine service delivery. This project aims to provide evidence-based, sustainable support that could be incorporated into usual care for women during pregnancy and postpartum. This study will contribute evidence to inform the early prevention of non-communicable diseases like obesity and diabetes in mothers and the next generation. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12620001240932 . Registered on 19 November 2020

Background: People with polycystic ovary syndrome (PCOS) have higher weight gain and psychological distress compared to those without PCOS. While COVID-19 restrictions led to population level adverse changes in lifestyle, weight gain and psychological distress, their impact on people with PCOS is unclear. The aim of this study was to investigate the impact the 2020 COVID-19 restrictions had on weight, physical activity, diet and psychological distress for Australians with PCOS. Methods: Australian reproductive-aged women participated in an online survey with assessment of weight, physical activity, diet and psychological distress. Multivariable logistic and linear regression were used to examine associations between PCOS and residential location with health outcomes. Results: On adjusted analysis, those with PCOS gained more weight (2.9%; 95% CI; 0.027–3.020; p = 0.046), were less likely to meet physical activity recommendations (OR 0.50; 95% CI; 0.32–0.79; p = 0.003) and had higher sugar-sweetened beverage intake (OR 1.74; 95% CI 1.10–2.75; p = 0.019) but no differences in psychological distress compared to women without PCOS. Conclusions: People with PCOS were more adversely affected by COVID-19 restrictions, which may worsen their clinical features and disease burden. Additional health care support may be necessary to assist people with PCOS to meet dietary and physical activity recommendations.

Introduction: Breastfeeding is associated with improved maternal and child outcomes. Women with a higher body mass index (BMI), who comprise about 50% of the population, are at increased risk of poorer breastfeeding practices and are a population who would benefit from breastfeeding. Methods: This protocol is for a multi-centre, randomised controlled trial of perinatal breastfeeding support among primiparous women with a BMI >25 kg/m2, using a previously-tested, multi-component intervention. The primary outcome is any breastfeeding at 3 months. The intervention will support mothers and their partners and spans from late pregnancy to six weeks postpartum. Intervention components include group antenatal breastfeeding education, individual face-to-face education in the immediate postnatal period, professional support to six weeks’ postpartum and weekly phone calls in the immediate postpartum period from an International Board Certified Lactation Consultant (IBCLC). The intervention will target attitudes towards breastfeeding, breastfeeding self-efficacy, and subjective norms around infant feeding with the aim to normalise the behaviour. Results: We anticipate that the intervention will be well-accepted and feasible to carry out within four maternity units in the East of Ireland. Furthermore, essential formative qualitative work has been conducted to inform the intervention design and to ensure that it is contextually appropriate. Conclusion: The proposed intervention will be invaluable to policy-makers in providing insights into what specific interventions are effective in improving breastfeeding rates for women with a raised BMI.

Type 2 Diabetes Mellitus (T2DM) and Gestational Diabetes (GDM) are important and escalating problems worldwide. GDM increases the risk of complications in pregnancy and birth, as well as a 1 in 2 chance of developing T2DM later in life. The burden of GDM extends to offspring, who have an increased risk of obesity and diabetes—further perpetuating the cycle of diabetes within families. Clinical trial evidence demonstrates T2DM incidence reduced by up to 50% for women with GDM with nutrition and physical activity changes and the economic modeling suggests cost effectiveness. The key diet-related changes to reduce T2DM risk are reviewed, in addition to breastfeeding. The difficulties associated with the delivery of dietary and lifestyle behaviour change to women after GDM are discussed and focus on: complex healthcare system interactions needed for care delivery; women finding postpartum self-care challenging; and low levels of awareness being present across the board. In addition, studies currently underway to improve care provision in this important area will be examined.