The IRIS clinic: A Protocol for a mixed-methods study evaluating the management of Hyperemesis Gravidarum.

Background: Hyperemesis Gravidarum (HG) is a severe form of nausea and vomiting in pregnancy that affects 0.3-3% of women and has profound nutritional, physical and psychological consequences. Research is lacking regarding the most effective management of the condition. In response to patient feedback, a multidisciplinary HG day-case service (IRIS Clinic) was launched in 2020 at The National Maternity Hospital, Ireland. The clinic provides routine, day-case care in a comfortable space with pre-booked appointments. The MDT involves midwives, dietitians, perinatal mental health, obstetrics and pharmacy, and the nature of the clinic enables peer-to-peer support. As this clinic is the first of its kind in Ireland, we aim to assess its effectiveness and feasibility, and suggest recommendations for improvement. Methods: This is a sequential, mixed-methods study that commenced in August 2021. The prospective arm of the study is ongoing and involves enrolling women (n = 50) who are attending the IRIS clinic. Data are collected on first admission (pre-intervention) and approximately 8 weeks' later (post-intervention) relating to symptoms of HG, well-being, food tolerances, quality of life and nutritional intake. Qualitative, semi-structured interviews will be conducted to evaluate women's experiences of attending the clinic. The retrospective arm of the study will be a chart review (n = 200) of women diagnosed with HG to describe assessments, treatments and pregnancy and birth outcomes. Conclusion: The IRIS clinic has the potential to improve pregnancy outcomes and nutritional status among women with HG. If found to be effective and feasible, the model for this clinic could be replicated elsewhere.

Impact of previous pregnancy and BMI on cellular and serum immune activity from early to late pregnancy.

Immunological adaptions during pregnancy play a crucial role in healthy fetal development. Aberrant immune modifications however contribute to adverse pregnancy outcomes, which may be driven by maternal factors such as previous pregnancies and BMI. This secondary analysis of the MicrobeMom2 RCT investigates the changes to maternal inflammatory biomarkers derived from serum and stimulated peripheral blood mononuclear cells (PBMCs) during pregnancy, and the effects of previous pregnancies (parity) and BMI on maternal immune responses. Changes in immune and metabolic biomarkers from early (11-15 weeks' gestation) to late (28-32 weeks' gestation) pregnancy were compared using paired t-tests. Participants were then split by parity (nulliparous, parous) and BMI (BMI < 25, BMI > = 25), and the relationship between parity and BMI with immune biomarker levels was examined using independent t-tests, paired t-tests, ANCOVA, and linear regression. Equivalent non-parametric tests were used for skewed data. Recruited women (n = 72) were on average 31.17 (SD ± 4.53) years of age and 25.11 (SD ± 3.82) BMI (kg/m2). Of these, 51 (70.8%) had a previous term pregnancy. Throughout gestation, PBMC cytokines displayed contrasting trends to serum, with a dampening of immune responses noted in PBMCs, and enhanced production of cytokines observed in the serum. Significant decreases in PBMC derived TNF-α, IL-10 and IFN-γ were seen from early to late pregnancy. Serum C3, IL-17A, IL-6, TNF-α, CD163, GDF-15 and leptin increased throughout gestation. First pregnancy was associated with higher levels of leptin in late pregnancy, while parous women showed significant decreases in PBMC derived TNF-α, IL10, and IFN-γ with gestation. Differences in levels of C3, IL-17A, TNF-α, GDF-15 and leptin were observed across BMI groups. Overall, serum-derived cytokines exhibit contrasting levels to those derived from stimulated PBMCs. Maternal immune responses undergo significant changes from early to late pregnancy, which are influenced by parity and BMI. These differences aid our understanding as to why first-time mothers are at greater risk of placental disease such as pre-eclampsia and fetal growth restriction.

Recommendations on self-management interventions for adults living with obesity: COMPAR-EU project.

Self-management interventions (SMIs) may improve disease management in adults living with obesity. We formulated evidence-based recommendations for SMIs within the context of the COMPAR-EU project. The multidisciplinary panel selected critical outcomes based on the COMPAR-EU core outcome set and established decision thresholds for each outcome. Recommendations were informed by systematic reviews of effects, cost-effectiveness, and a contextual assessment. To assess the certainty of the evidence and formulate the recommendations, we used the GRADE approach guidance. Overall, SMIs were deemed to have a small impact, but the absence of harmful effects and potential cumulative benefits indicated a favourable balance of effects, despite low certainty. SMIs showed variations in structure, intensity, and resource utilisation, but overall are likely to be cost-effective. Adapting SMIs to local contexts would enhance equity, acceptability, and feasibility, considering patients' values, and availability of resources and teamwork. Consequently, the panel made conditional recommendations favouring SMIs over usual care. The rigorous and explicit recommendations demonstrated the effectiveness of SMIs for adults living with obesity. However, the gaps in the literature influenced the panel to make only conditional recommendations in favour of SMIs. Further research is needed to strengthen the evidence base and improve recommendations' certainty and applicability.

Stability of child appetitive traits and association with diet quality at 5 years and 9-11 years old: Findings from the ROLO longitudinal birth cohort study.

BACKGROUND: We explored change in child appetitive traits from 5 to 9-11 years old and examined associations between appetitive traits at both timepoints and child diet quality. METHODS: This is secondary analyses of the ROLO longitudinal birth cohort study, including mother-child dyads from the 5 and 9-11-year old follow-up. The Children's Eating Behaviour Questionnaire measured child appetitive traits, with 167 children having matched data for both timepoints. The Healthy Eating Index (HEI) measured diet quality. Linear mixed models and multiple linear regression were completed. RESULTS: Mean (SD) score for 'Emotional Overeating' (1.63 (0.51) vs. 1.99 (0.57), p = <0.001) and 'Enjoyment of Food' (3.79 (0.72) vs. 3.98 (0.66), p = <0.001) increased from 5 to 9-11 years. Mean score for 'Desire to Drink' (2.63 (0.94) vs. 2.45 (0.85), p = 0.01), 'Satiety Responsiveness (3.07 (0.66) vs. 2.71 (0.66), p = <0.001), 'Slowness Eating' (3.02 (0.77) vs. 2.64 (0.78), p = <0.001), and 'Food Fussiness' (3.00 (1.04) vs. 2.81 (0.96), p = 0.001) decreased. At 5-years-old, 'Food Responsiveness' and 'Enjoyment of Food' were positively associated with HEI and 'Desire to Drink', 'Satiety Responsiveness' and 'Food Fussiness' were negatively associated with HEI. At 9-11-years, 'Enjoyment of Food' was positively and 'Desire to Drink' and 'Food 'Fussiness' were negatively associated with HEI. CONCLUSIONS: Food approach appetitive traits increased over time, whereas food avoidant appetitive traits tended to decrease. At both time points 'Food Fussiness' and 'Desire to Drink" were inversely associated with HEI. Further research on how appetitive traits track over childhood and how this relates to dietary quality and weight is warranted.

Diet quality and blood pressure among pregnant women with overweight or obesity: A secondary analysis of two randomized controlled trials.

INTRODUCTION: Maternal obesity is a significant risk factor for hypertensive disorders of pregnancy. High diet quality may protect against this, yet data regarding the relationship between diet quality and blood pressure among pregnant women with raised body mass index (BMI) is limited. MATERIAL AND METHODS: This is a secondary analysis (n = 543) of women with BMI ≥25 kg/m2 from two randomized controlled trials; PEARS (Pregnancy Exercise and nutrition Research Study with smartphone application support) and ROLO (Randomized cOntrol trial of LOw glycemic index diet to prevent macrosomia in euglycemic women). Blood pressure was measured at 10-18 weeks and 28 weeks of pregnancy. Mean arterial pressure was calculated as (diastolic blood pressure + 1 3 × [systolic blood pressure - diastolic blood pressure]). Diet quality was assessed using 3-day food diaries, and Alternative Healthy Eating Index for Pregnancy (AHEI-P) scores were generated, quantifying alignment of food intakes with dietary guidelines in first and early third trimesters. The cohort was divided based on AHEI-P tertiles to explore differences at an alpha significance value of <0.05. RESULTS: The mean age of the group was 32.21 ± 4.39 years with a median body mass index (BMI) of 28.13 (IQR 3.47) kg/m2. Mean arterial pressures in the first and third trimesters were 81.07 ± 9.00 mmHg and 82.33 ± 7.53 mmHg, respectively. Rates of elevated blood pressure (≥120/80 mmHg) were 22.33% in trimester 1 and 24.48% in early trimester 3. Mean AHEI-P scores in trimester 1 and early trimester 3 were 53.90 ± 10.43 and 54.05 ± 10.76, respectively. There was no correlation between AHEI-P score and blood pressure and no differences in blood pressure between AHEI-P tertiles at either timepoint (all P-values <0.05). A higher proportion of those with elevated early third trimester blood pressure had a BMI of ≥30 kg/m2 compared with those with normal blood pressure (40.31% vs 28.64%, P = 0.016). CONCLUSIONS: While diet remains an important factor in maternal health and wellbeing, we did not find a relationship between diet quality as measured by AHEI-P and blood pressure among pregnant women with BMI ≥25 kg/m2. High BMI remains a risk factor for hypertensive disorders of pregnancy.

Multicomponent perinatal breastfeeding support in women with BMI >25: The Latch On multi-centre randomised trial.

OBJECTIVE: To investigate the effectiveness of a multicomponent breastfeeding support intervention on breastfeeding prevalence at 3 months among women with a body mass index (BMI) >25 kg/m2. DESIGN: Multicentre multicomponent randomised controlled trial. SETTING: Four maternity centres in Ireland. POPULATION: A total of 225 primiparous women and their nominated support partners. Participants were aged 18 years and over, with BMI ≥25 kg/m2, carrying a singleton pregnancy and without contraindication for breastfeeding. METHODS: The intervention included an antenatal group breastfeeding education session for participants and their support partners, followed by a planned postnatal breastfeeding assessment and telephone support for up to 6 weeks by a lactation consultant. MAIN OUTCOME MEASURES: Any breastfeeding at 3 months postpartum. RESULTS: Any breastfeeding prevalence was 68.7% (n = 68) in the intervention group and 62.1% (n = 59) in the control group at 3 months postpartum (odds ratio 1.33, 95% confidence interval 0.72-2.46, p = 0.36). Any and exclusive breastfeeding rates did not significantly differ at any other time point. More women in the control group accessed support from private lactation consultants (intervention 23.5% [n = 12], control 45.3% [n = 24], p = 0.02). CONCLUSIONS: The control group had higher than expected breastfeeding rates, and the study found no evidence of effect on the primary outcome. Providing comprehensive education and support for women intending to breastfeed remains of paramount importance.

Impact of Bifidobacterium longum1714® on maternal cytokine response in peripheral blood mononuclear cells.

PURPOSE: The maternal immune system is implicated in adverse pregnancy outcomes. Manipulation of maternal immune response by probiotics holds potential to reduce pregnancy complications. The MicrobeMom2 study investigates the impact of probiotic supplementation on maternal immune responses to pathogen associated molecular patterns (PAMPs) in peripheral blood mononuclear cells (PBMCs) during pregnancy. METHODS: This double-blinded randomised-controlled trial involved oral supplementation of Bifidobacterium longum subsp. longum 1714® (B. longum 1714; daily ingestion of a minimum of 1x109 colony forming units) or placebo from 16 to 20-weeks' gestation until delivery in healthy pregnant women. The primary outcome was a change in IL-10 production, after stimulation with Lipopolysaccharide (LPS) or anti-CD3/28/2, in PBMCs isolated from blood samples taken at baseline (11-15 weeks' gestation) and late pregnancy (28-32 weeks' gestation) after 48 h incubation. 68 subjects were needed (34ineachgroup) for 80 % power at an alpha significance of 0.05 to detect differences in IL10. RESULTS: 72 women (mean ± SD age 33.17 ± 4.53 years and median (25th, 75th centile) body mass index 24.93 (21.93, 27.57 kg/m2)) were recruited with primary outcome data. Using LPS, late pregnancy fold change in IL-10 in PBMCs after 48 h incubation was median (25th, 75th centile) 88.45 (4.88, 488.78) in the intervention, 24.18 (6.36, 141.17) in the control group, p = 0.183. Using anti-CD3/28/2, values were 189.69 (425.96, 866.57),148.74 (31.67, 887.03) in intervention and control groups, respectively, p = 0.506. No significant differences were observed between the two groups. CONCLUSION: Maternal antenatal supplementation with B. longum 1714 did not alter cytokine production by maternal PBMCs in response to PAMPs or anti-CD3/28/2. TRIAL REGISTRATION NUMBER: ISRCTN registry ISRCTN43013285.

The impact of macrosomia on cardiometabolic health in preteens: findings from the ROLO longitudinal birth cohort study.

BACKGROUND: Macrosomia (birthweight ≥ 4 kg or ≥ 4.5 kg) is strongly associated with a predisposition to childhood obesity, which in turn is linked with adverse cardiometabolic health. Despite this, there is a lack of longitudinal investigation on the impact of high birthweight on cardiometabolic outcomes in youth. The preteen period represents an important window of opportunity to further explore this link, to potentially prevent cardiometabolic profiles worsening during puberty. METHODS: This is a secondary analysis of 9-11-year-olds (n = 405) born to mothers in the ROLO longitudinal birth cohort study, who previously delivered an infant with macrosomia. Preteens were dichotomised into those born with and without macrosomia, using two common cut-off criteria (birthweight ≥ 4 kg (n = 208) and < 4 kg; ≥ 4.5 kg (n = 65) and < 4.5 kg). Cardiometabolic health was assessed using anthropometry, dual-energy x-ray absorptiometry, blood pressure, heart rate, cardiorespiratory endurance (20-m shuttle run test), and non-fasting serum biomarkers for a subgroup (n = 213). Statistical comparisons between the two groups were explored using independent t-tests, Mann-Whitney U tests, and Chi-square tests. Crude and adjusted linear regression models investigated associations between macrosomia and preteen cardiometabolic outcomes. RESULTS: In total, 29.3% (n = 119) of preteens had overweight/obesity based on their BMI z-score. Preteens born ≥ 4 kg had lower median (IQR) C3 concentrations (1.38 (1.22, 1.52) g/L vs. 1.4 (1.26, 1.6) g/L, p = 0.043) and lower median (IQR) ICAM-1 concentrations (345.39 (290.34, 394.91) ng/mL vs. 387.44 (312.91, 441.83) ng/mL, p = 0.040), than those born < 4 kg. Those born ≥ 4.5 kg had higher mean (SD) BMI z-scores (0.71 (0.99) vs. 0.36 (1.09), p = 0.016), and higher median (IQR) lean mass (24.76 (23.28, 28.51) kg vs. 23.87 (21.9, 26.79) kg, p = 0.021), than those born < 4.5 kg. Adjusted linear regression analyses revealed birthweight ≥ 4 kg was negatively associated with C3 concentration (g/L) (B = - 0.095, 95% CI = - 0.162, - 0.029, p = 0.005) and birthweight ≥ 4.5 kg was positively associated with weight z-score (B = 0.325, 95% CI = 0.018, 0.633, p = 0.038), height z-score (B = 0.391, 95% CI = 0.079, 0.703, p = 0.014), lean mass (kg) (B = 1.353, 95% CI = 0.264, 2.442, p = 0.015) and cardiorespiratory endurance (B = 0.407, 95% CI = 0.006, 0.808, p = 0.047). CONCLUSION: This study found no strong evidence to suggest that macrosomia is associated with adverse preteen cardiometabolic health. Macrosomia alone may not be a long-term cardiometabolic risk factor. Trial registration ISRCTN54392969 registered at  www.isrctn.com .

Maternal breastfeeding is associated with offspring microbiome diversity; a secondary analysis of the MicrobeMom randomized control trial.

Background: Microbial dysbiosis in infancy can influence long-term health outcomes such as childhood obesity. The aim of this study is to explore relationships among maternal well-being during pregnancy, breastfeeding, and the infant gut microbiome. Methods: This is a secondary analysis of healthy pregnant women from the MicrobeMom study, a double-blind randomized control trial of maternal probiotic supplementation (Bifidobacterium breve 702258) versus placebo antenatally and up to 3 months postpartum. Maternal well-being was assessed using the WHO-5 well-being index at 16 weeks' and 34 weeks' gestation. Breastfeeding practices were recorded at discharge from hospital and at 1 month postpartum. Infant stool samples were obtained at 1 month of age. Next generation shotgun sequencing determined infant microbial diversity. Independent sample t-tests and Mann-Whitney U tests informed adjusted regression analysis, which was adjusted for delivery mode, antibiotics during delivery, maternal age and body mass index (BMI), and probiotic vs. control study group. Results: Women (n = 118) with at least one measure of well-being were on average 33 years (SD 3.93) of age and 25.09 kg/m2 (SD 3.28) BMI. Exclusive breastfeeding was initiated by 65% (n = 74). Any breastfeeding was continued by 69% (n = 81) after 1 month. In early and late pregnancy, 87% (n = 97/111) and 94% (n = 107/114) had high well-being scores. Well-being was not associated with infant microbial diversity at 1 month. In adjusted analysis, exclusive breastfeeding at discharge from hospital was associated with infant microbial beta diversity (PC2; 0.254, 95% CI 0.006, 0.038). At 1 month postpartum, any breastfeeding was associated with infant microbial alpha diversity (Shannon index; -0.241, 95% CI -0.498, -0.060) and observed species; (-0.325, 95% CI -0.307, -0.060), and infant microbial beta diversity (PC2; 0.319, 95% CI 0.013, 0.045). Exclusive breastfeeding at 1 month postpartum was associated with infant alpha diversity (Shannon index -0.364, 95% CI -0.573, -0.194; Simpson index 0.339, 95% CI 0.027, 0.091), and infant's number of observed microbial species (-0.271, 95% CI -0.172, -0.037). Conclusion: Breastfeeding practices at 1 month postpartum were associated with lower microbial diversity and observed species in infants at 1 month postpartum, which is potentially beneficial to allow greater abundance of Bifidobacterium. Clinical trial registration: ISRCTN53023014.

Women's experiences of Hyperemesis Gravidarum (HG) and of attending a dedicated multi-disciplinary hydration clinic.

PROBLEM: Hyperemesis Gravidarum (HG) is a severe form of nausea and vomiting in pregnancy that affects 1-3 % of women and has profound nutritional, physical and psychological consequences. Previous research identified that women with HG report inadequate infrastructure for day case management. INTRODUCTION: A multi-disciplinary HG day case service (IRIS Hydration Clinic) was launched and provides routine care for women with HG in a dedicated unit. The multi-disciplinary team involves midwives, dietitians, obstetricians and perinatal mental health. AIMS: To explore women's experiences of HG and of attending the dedicated clinic. METHODS: Ten interviews were conducted with women who attended the clinic. Data were transcribed and analysed using Reflexive Thematic Analysis. FINDINGS: The physical and psychological impact of HG was captured. The appreciation for the dedicated clinic was a common theme, regarding having somewhere specific for treatment rather than ad-hoc treatment. 'Relationships' was a significant theme - women described the benefits of continuity of care and the positive impact of peer support. Areas for improvement were explored, such as expansion and extra sensitivity around some women's issues around weight gain/loss. DISCUSSION: HG causes significant ill-health and its impact remains undervalued. Women had highly positive experiences of attending the dedicated HG clinic. The impact of continuity and individualized care in a day-case setting improved women's experiences of this condition. CONCLUSION: The dedicated HG clinic was highly valued by women experiencing the condition. The IRIS clinic provides much-needed validation for a medical condition with little understanding from the general public or many healthcare professionals.

Energy-Adjusted Dietary Inflammatory Index in pregnancy and maternal cardiometabolic health: findings from the ROLO study.

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.

Detailed mapping of Bifidobacterium strain transmission from mother to infant via a dual culture-based and metagenomic approach.

A significant proportion of the infant gut microbiome is considered to be acquired from the mother during and after birth. Thus begins a lifelong and dynamic relationship with microbes that has an enduring impact on host health. Based on a cohort of 135 mother-infant (F = 72, M = 63) dyads (MicrobeMom: ISRCTN53023014), we investigated the phenomenon of microbial strain transfer, with a particular emphasis on the use of a combined metagenomic-culture-based approach to determine the frequency of strain transfer involving members of the genus Bifidobacterium, including species/strains present at low relative abundance. From the isolation and genome sequencing of over 449 bifidobacterial strains, we validate and augment metagenomics-based evidence to reveal strain transfer in almost 50% of dyads. Factors important in strain transfer include vaginal birth, spontaneous rupture of amniotic membranes, and avoidance of intrapartum antibiotics. Importantly, we reveal that several transfer events are uniquely detected employing either cultivation or metagenomic sequencing, highlighting the requirement for a dual approach to obtain an in-depth insight into this transfer process.

Ability of Bifidobacterium breve 702258 to transfer from mother to infant: the MicrobeMom randomized controlled trial.

BACKGROUND: The composition of the infant microbiome can have a variety of short- and long-term implications for health. It is unclear if maternal probiotic supplementation in pregnancy can affect the infant gut microbiome. OBJECTIVE: This study aimed to investigate if maternal supplementation of a formulation of Bifidobacterium breve 702258 from early pregnancy until 3 months postpartum could transfer to the infant gut. STUDY DESIGN: This was a double-blinded, placebo-controlled, randomized controlled trial of B breve 702258 (minimum 1 × 109 colony-forming units) or placebo taken orally from 16 weeks' gestation until 3 months postpartum in healthy pregnant women. The primary outcome was presence of the supplemented strain in infant stool up to 3 months of life, detected by at least 2 of 3 methods: strain-specific polymerase chain reaction, shotgun metagenomic sequencing, or genome sequencing of cultured B breve. A total of 120 individual infants' stool samples were required for 80% power to detect a difference in strain transfer between groups. Rates of detection were compared using the Fisher exact test. RESULTS: A total of 160 pregnant women with average age of 33.6 (3.9) years and mean body mass index of 24.3 (22.5-26.5) kg/m2, of whom 43% were nulliparous (n=58), were recruited from September 2016 to July 2019. Neonatal stool samples were obtained from 135 infants (65 in intervention and 70 in control group). The presence of the supplemented strain was detected through at least 2 methods (polymerase chain reaction and culture) in 2 infants in the intervention group (n=2/65; 3.1%) and none in the control group (n=0; 0%; P=.230). CONCLUSION: Direct mother-to-infant strain transfer of B breve 702258 occurred, albeit infrequently. This study highlights the potential for maternal supplementation to introduce microbial strains into the infant microbiome.

Pregnancy Nutrition Core Outcome Set (PRENCOS): A core outcome set development study.

OBJECTIVE: To develop a core outcome set for pregnancy nutrition. DESIGN: Mixed-methods core outcome set development study. SETTING: Online. POPULATION: Healthcare professionals, researchers and women with experience of pregnancy. METHODS: Candidate outcomes were identified from a systematic review of intervention and observational studies. One-to-one semi-structured interviews with women with experience of pregnancy (n = 26) were transcribed and analysed using inductive thematic analysis. Outcomes were consolidated, organised into domains and categorised using the Core Outcome Measures in Effectiveness Trials taxonomy. A two-round, modified Delphi survey (May-August 2021) was conducted. Participants voted on how critical each outcome was to include using a nine-point Likert scale. All outcomes that did not reach consensus were discussed at a consensus meeting. MAIN OUTCOME MEASURES: Critical outcomes to include in the core outcome set. RESULTS: A total of 53 091 articles were identified. Outcomes were extracted from 427 articles. The qualitative data yielded 45 outcomes. An additional 24 outcomes came from the literature. In round one, 82 participants ranked 30 outcomes. One new outcome was included in round two, during which participants (n = 60) voted 12/31 outcomes as critical to include. The remaining 20 outcomes were discussed at the consensus meeting and two outcomes were included. Maternal outcomes included: pregnancy complications; delivery complications; maternal wellbeing; gestational weight change; maternal vitamin and mineral status; mental health; diet quality; nutritional intakes; need for treatments, interventions, medications and supplements; pregnancy loss or perinatal death; birth defects or congenital anomalies; neonatal complications; and newborn anthropometry and body composition. CONCLUSIONS: The use of the Pregnancy Nutrition Core Outcome Set (PRENCOS) will ensure researchers measure what matters most from the perspective of key stakeholders.

Integrating nutrition and mental health screening, risk identification and management in prenatal health programs in India.

Pregnancy is a period of major physiologic, hormonal, and psychological change, increasing the risk of nutritional deficiencies and mental disorders. Mental disorders and malnutrition are associated with adverse pregnancy and child outcomes, with potential long-standing impact. Common mental disorders during pregnancy are more prevalent in low- and middle-income countries (LMICs). In India, studies suggest the prevalence of depression is 9.8%-36.7% and of anxiety is 55.7%. India has seen some promising developments in recent years such as increased coverage of the District Mental Health Program; integration of maternal mental health into the Reproductive and Child Health Program in Kerala; and the Mental Health Care Act 2017. However, mental health screening and management protocols have not yet been established and integrated into routine prenatal care in India. A five-action maternal nutrition algorithm was developed and tested for the Ministry of Health and Family Welfare, aiming to strengthen nutrition services for pregnant women in routine prenatal care facilities. In this paper, we present opportunities and challenges for integration of maternal nutrition and mental health screening and a management protocol at routine prenatal care in India, discuss evidence-based interventions in other LMICs including India, and make recommendations for public healthcare providers.

Including the child's voice in research from a longitudinal birth cohort: insights from the ROLO young person's advisory group.

BACKGROUND: Public and patient involvement (PPI) through Young Person's Advisory Groups (YPAG) enables children to provide guidance and insight into research activities. PPI is an important characteristic of research, however, to date, most collaboration has been with adults. Also, few YPAGs have been established within the Irish setting. The ROLO (Randomised cOntrol trial of a LOw glycaemic index diet in pregnancy to prevent macrosomia) YPAG was established in July 2020 to identify the research priorities of a group of healthy Irish children who are part of a longitudinal birth cohort. We aimed to describe this process and the key insights to date. METHODS: The ROLO study is a longitudinal birth cohort which has followed-up mother-child dyads at multiple timepoints over 10 years. Mothers actively involved in the study were contacted by the research team to invite their ROLO child and older sibling to participate in the YPAG. Meetings were conducted virtually between July 2020 and February 2022. Researchers encouraged free expression of views amongst the children regarding their research interests. Meetings were recorded, transcribed verbatim and analysed for themes based on the topics most frequently discussed and considered important to participants. RESULTS: In all, seven ROLO children and six older siblings attended four ROLO YPAG meetings. Participants were aged between nine to fifteen years old. Four key themes were identified; study children viewed their identity as part of a longitudinal birth cohort as positive and unique; study children considered the fitness test and body measurements as fun aspects related to their participation; all children considered the impact and use of social media as an important form of communication; and all participants expressed interest in attaining new health-related information and learning opportunities. Children suggested topics such as mental health, future viruses, organ transplants, cancer, and the effect of technology and chemicals on the body were important for future research. CONCLUSION: The ROLO YPAG offers promising scope for continued collaboration. The themes identified from the meetings contribute to a gap in the literature which will guide future research activities, particularly with children, in view of study design, relevance, and by communication strategies. Trial Details: ISRCTN54392969 registered at www.isrctn.com .

The ROLO pregnancy study took place in the National Maternity Hospital in Dublin Ireland. It started in 2007 and ended in 2011. The researchers recorded what women were eating. They also measured the weight of the baby at birth. Since then, ROLO mothers and their children were invited to come back to the study. Now the children of the study are 9­11 years of age.The researchers invited members of the ROLO study to speak with them. They wanted to know what research was important to them. They set up a group called the ROLO Family Advisory Committee in 2017. This group of parents and researchers meet once a year. The group thought it was important to include children as well. They made a new group called the ROLO Young Person's Advisory Group in 2020. The group has 7 ROLO children and 6 older siblings. The members are aged between 9 and 15-years-old. The children and researchers have met four times so far.The researchers found four key themes. Study children saw their identity as being part of a longitudinal birth cohort as positive and unique. Study children liked the fitness test and body measurements. All children thought that social media was an important form of communication. All children were interested in learning new information on how their bodies worked.Involving this group of children is important. It will make our research more relevant. Other researchers who want to involve children can learn from our experience.

Evaluating implementation of the FIGO Nutrition Checklist for preconception and pregnancy within the Bukhali trial in Soweto, South Africa.

OBJECTIVE: To evaluate implementation of the FIGO Nutrition Checklist in a low/middle-income South African setting. METHODS: This is a mixed-methods study. Following administration of the FIGO Nutrition Checklist by a dietitian between July 2021 and May 2022, quantitative responses from pregnant (n = 96) and nonpregnant (n = 291) participants with overweight or obesity were analyzed, using logistic regression. Qualitative data from in-depth interviews with the dietitian and a subgroup of participants (n = 15) were analyzed using reflexive thematic analysis. RESULTS: Of 387 participants, 97.4% (n = 377) answered 'no' to at least one diet quality question on the FIGO Nutrition Checklist, indicative of an at-risk dietary practice. Food insecurity was positively associated with having more than three at-risk practices (OR 1.87; 95% CI, 1.10-3.18; P = 0.021). Themes from the dietitian interview included ease of use of the checklist; required adaptations to it, including explanation and translation; and benefits of the tool. Despite challenges to healthy nutrition, participant interviews identified that the checklist is acceptable and supported improved awareness of dietary intakes. CONCLUSION: Considering the high incidence of at-risk dietary practices identified by the FIGO Nutrition Checklist in this population, further research into use of the tool across South African healthcare settings is warranted.

Using FIGO Nutrition Checklist counselling in pregnancy: A review to support healthcare professionals.

The period before and during pregnancy is increasingly recognized as an important stage for addressing malnutrition. This can help to reduce the risk of noncommunicable diseases in mothers and passage of risk to their infants. The FIGO Nutrition Checklist is a tool designed to address these issues. The checklist contains questions on specific dietary requirements, body mass index, diet quality, and micronutrients. Through answering these questions, awareness is generated, potential risks are identified, and information is collected that can inform health-promoting conversations between women and their healthcare professionals. The tool can be used across a range of health settings, regions, and life stages. The aim of this review is to summarize nutritional recommendations related to the FIGO Nutrition Checklist to support healthcare providers using it in practice. Included is a selection of global dietary recommendations for each of the components of the checklist and practical insights from countries that have used it. Implementation of the FIGO Nutrition Checklist will help identify potential nutritional deficiencies in women so that they can be addressed by healthcare providers. This has potential longstanding benefits for mothers and their children, across generations.

Associations between maternal metabolic parameters during pregnancy and fetal and child growth trajectories from 20 weeks' gestation to 5 years of age: Secondary analysis from the ROLO longitudinal birth cohort study.

OBJECTIVE: To examine the association between maternal metabolic parameters in pregnancy and growth trajectories up to 5 years of age. METHODS: Data from mother-child pairs who participated in the ROLO study, a randomized trial examining the impact of a low glycaemic index diet on the recurrence of macrosomia, were analysed. Fetal and child growth trajectories were developed from longitudinal measurements from 20 weeks gestation up to 5 years of age. We examined associations between maternal fasting glucose, insulin, HOMA-IR and leptin, taken in early pregnancy (14-16 weeks) and late pregnancy (28 weeks), and weight (kg) and abdominal circumference (cm) trajectories using linear spline multilevel models. RESULTS: We found no strong evidence of associations between any maternal metabolic parameters and fetal to childhood weight and abdominal circumference trajectories from 20 weeks gestation to 5 years. CONCLUSION: In a cohort of women with obesity with infants at risk of macrosomia, maternal metabolic markers were not strongly associated with trajectories of weight or abdominal circumference from 20 weeks gestation to 5 years of age.

Recruiting and Engaging Women of Reproductive Age with Obesity: Insights from A Mixed-Methods Study within A Trial.

Engaging women with obesity in health-related studies during preconception is challenging. Limited data exists relating to their participation. The aim of this study is to explore the experiences and opinions of women participating in a weight-related, preconception trial. This is an explanatory sequential (quan-QUAL) mixed-methods Study Within A Trial, embedded in the GetGutsy randomized controlled trial (ISRCTN11295995). Screened participants completed an online survey of eight questions (single or multiple choice and Likert scale) on recruitment, motivations and opinions on study activities. Participants with abdominal obesity (waist circumference ≥ 80 cm) were invited to a subsequent semi-structured, online focus group (n = 2, 9 participants) that was transcribed and analyzed using inductive thematic analysis, with a pragmatic epistemological approach. The survey (n = 102) showed the main research participation motivations were supporting health research (n = 38, 37.3%) and wanting health screening (n = 30, 29.4%). Most participants were recruited via email (n = 35, 34.7%) or social media (n = 15, 14.7%). In the FGs, participants valued flexibility, convenience and. research methods that aligned with their lifestyles. Participants had an expanded view of health that considered emotional well-being and balance alongside more traditional medical assessments. Clinical trialists should consider well-being, addressing the interconnectedness of health and incorporate a variety of research activities to engage women of reproductive age with obesity.