Are pre- and early pregnancy lifestyle factors associated with the risk of preterm birth? A secondary cohort analysis of the cluster-randomised GeliS trial.

BACKGROUND: Maternal lifestyle is discussed as a modifiable determinant in the prevention of preterm birth. However, previous research on associations between individual lifestyle factors and preterm birth risk is inconclusive. In this secondary analysis, we investigated the associations between several modifiable antenatal lifestyle factors and the odds of preterm birth. METHODS: This secondary cohort analysis used data from the cluster-randomised controlled "healthy living in pregnancy" (GeliS) trial. Data were collected from early pregnancy to birth with maternity records, validated questionnaires and birth protocols. Women with complete datasets for all covariates were eligible for analysis. Multivariate logistic regression models, adjusted for recognised risk factors, were fitted to determine whether dietary quality, assessed with a healthy eating index (HEI), physical activity (PA) levels and antenatal anxiety/distress influenced the odds of preterm birth. Moreover, the combined association between pre-pregnancy body mass index (BMI) and HEI on the odds of preterm birth was explored. The independent associations of individual dietary components and types of PA on prematurity were assessed by adjusted logistic regression models. RESULTS: Overall, 1738 women were included in the analysis. A low HEI significantly increased the odds of preterm birth (OR 1.54 (CI 1.04 - 2.30), p = 0.033), while no associations with either low PA levels or antenatal anxiety/distress were observed. BMI significantly interacted with HEI on the association with prematurity (p = 0.036). Energy % from protein and the intake of average portions of vegetables and cereals were significantly negatively associated with the odds of preterm birth. There was no significant evidence of an association between different types of PA and prematurity. CONCLUSIONS: This cohort analysis revealed that low dietary quality in early pregnancy may increase the chance of giving birth prematurely, while healthier dietary choices may help to prevent preterm birth. More research on pre- and early pregnancy modifiable lifestyle factors is warranted. TRIAL REGISTRATION: This trial is registered with the Clinical Trial Registry ClinicalTrials.gov ( NCT01958307 ). Registration date 09 October 2013, retrospectively registered.

Associations between lifestyle interventions during pregnancy and childhood weight and growth: a systematic review and meta-analysis.

BACKGROUND: Maternal health and lifestyle during pregnancy may be critical for the onset and progression of childhood obesity. Prenatal lifestyle interventions have been shown to positively affect maternal behaviors, gestational weight gain, and anthropometric outcomes in infants at birth. The influence of such interventions on child weight or growth beyond birth is unknown. We therefore examined the association between lifestyle interventions during pregnancy and anthropometric outcomes during childhood. METHODS: A systematic literature search was conducted in three electronic databases, two clinical trial registers and further sources, without language or publication status restrictions. Additionally, 110 study authors were contacted to obtain unpublished data. Randomized controlled trials comparing any antenatal lifestyle or behavioral intervention to standard prenatal care, in women of any body mass index (BMI), with offspring anthropometric data at 1 month of age or older, were considered. Two reviewers independently extracted data and assessed the risk of bias using the Cochrane Collaboration's updated tool. Data on weight, length, and BMI, and corresponding z-scores, were stratified into six age ranges and weighted mean differences (WMD) with 95% confidence intervals (CI) were calculated in univariate and multivariate random-effects meta-analytical models. RESULTS: Twenty trials comprising 11,385 women were included in this systematic review, of which 19 were combined in meta-analyses. Overall, lifestyle interventions during pregnancy were not associated with differences in weight, length, BMI, or corresponding z-scores, in children aged 1 month to 7 years (e.g. weight in 5 to 6 month old children, WMD: 0.02 kg; 95% CI: - 0.05 to 0.10 kg, I2 = 38%; 13 studies, 6667 participants). Findings remained consistent when studies were stratified by maternal baseline BMI or other risk factors, and intervention content and duration. Based on the GRADE criteria, the strength of the body of evidence was considered moderate. CONCLUSION: Prenatal lifestyle interventions were not shown to influence childhood weight or growth. Nevertheless, women should be encouraged to pursue a healthy lifestyle during pregnancy. Further efforts to establish early prevention strategies for childhood obesity are urgently needed. Thus, large, high-quality studies with pre-planned, long-term follow-ups are warranted. TRIAL REGISTRATION: PROSPERO CRD42018118678 .

Evaluation of antenatal risk factors for postpartum depression: a secondary cohort analysis of the cluster-randomised GeliS trial.

BACKGROUND: Maternal weight variables are important predictors of postpartum depression (PPD). While preliminary evidence points to an association between pre-pregnancy obesity and PPD, the role of excessive gestational weight gain (GWG) on PPD is less studied. In this secondary cohort analysis of the German 'healthy living in pregnancy' (GeliS) trial, we aimed to investigate associations between weight-related variables and PPD and to assess the influence of GWG on the risk for PPD. METHODS: We included women with normal weight, overweight, and obesity (BMI 18.5-40.0 kg/m2). Symptoms of PPD were assessed 6-8 weeks postpartum using the Edinburgh Postnatal Depression Scale. Pre-pregnancy BMI was self-reported. During the course of pregnancy, weight was measured at gynaecological practices within regular check-ups. GWG was defined as the difference between the last measured weight before delivery and the first measured weight at the time of recruitment (≤ 12th week of gestation). Excessive GWG was classified according to the Institute of Medicine. Multiple logistic regression analyses were used to estimate the odds of PPD in relation to pre-pregnancy BMI, GWG, and excessive GWG adjusting for important confounders. RESULTS: Of the total 1583 participants, 45.6% (n = 722) showed excessive GWG and 7.9% (n = 138) experienced PPD. Pre-pregnancy BMI (per 5-unit increase; OR = 1.23, 95% CI 1.08-1.41, p = 0.002) and pre-pregnancy overweight or obesity were significantly positively associated with the odds of developing PPD, particularly among women with an antenatal history of anxiety or depressive symptoms (overweight: OR = 1.93, 95% CI = 1.15-3.22, p = 0.01; obesity: OR = 2.11, 95% CI = 1.13-3.96, p = 0.02). Sociodemographic or lifestyle factors did not additively influence the odds of having PPD. In fully adjusted models, there was no significant evidence that GWG or the occurrence of excessive GWG increased the odds of experiencing PPD (excessive vs. non-excessive: OR = 3.48, 95% CI 0.35-34.94; GWG per 1 kg increase: OR = 1.16, 95% CI 0.94-1.44). CONCLUSION: Pre-pregnancy overweight or obesity is associated with PPD independent of concurrent risk factors. History of anxiety or depressive symptoms suggests a stress-induced link between pre-pregnancy weight and PPD. TRIAL REGISTRATION: NCT01958307 , ClinicalTrials.gov, retrospectively registered on 9 October 2013.

Effects of a lifestyle intervention during pregnancy to prevent excessive gestational weight gain in routine care - the cluster-randomised GeliS trial.

BACKGROUND: Excessive gestational weight gain (GWG) leads to obstetric complications, maternal postpartum weight retention and an increased risk of offspring obesity. The GeliS study examines the effect of a lifestyle intervention during pregnancy on the proportion of women with excessive GWG and pregnancy and obstetric complications, as well as the long-term risk of maternal and infant obesity. METHODS: The GeliS study is a cluster-randomised multicentre controlled trial including 2286 women with a pre-pregnancy BMI between 18.5 and 40.0 kg/m2 recruited from gynaecological and midwifery practices prior to the end of the 12th week of gestation in five Bavarian regions. In the intervention regions, four lifestyle counselling sessions covering a balanced healthy diet, regular physical activity and self-monitoring of weight gain were performed by trained healthcare providers alongside routine pre- and postnatal practice visits. In the control regions, leaflets with general recommendations for a healthy lifestyle during pregnancy were provided. RESULTS: The intervention did not result in a significant reduction of women showing excessive GWG (adjusted OR 0.95, 95% CI 0.66-1.38, p = 0.789), with 45.1% and 45.7% of women in the intervention and control groups, respectively, gaining weight above the Institute of Medicine recommendations. Gestational diabetes mellitus was diagnosed in 10.8% and 11.1% of women in the intervention and control groups, respectively (p = 0.622). Mean birth weight and length were slightly lower in the intervention group (3313 ± 536 g vs. 3363 ± 498 g, p = 0.020; 51.1 ± 2.7 cm vs. 51.6 ± 2.5 cm, p = 0.001). CONCLUSION: In the setting of routine prenatal care, lifestyle advice given by trained healthcare providers was not successful in limiting GWG and pregnancy complications. Nevertheless, the potential long-term effects of the intervention remain to be assessed. TRIAL REGISTRATION: NCT01958307 , ClinicalTrials.gov, retrospectively registered October 9, 2013.

Effects of a lifestyle intervention in routine care on prenatal physical activity - findings from the cluster-randomised GeliS trial.

BACKGROUND: Excessive gestational weight gain (GWG) is associated with an increased risk of pregnancy and obstetric complications. The "healthy living in pregnancy" (GeliS) study was performed in a routine care setting with the aim of limiting excessive GWG. The purpose of this secondary analysis is to evaluate the effect of the intervention on physical activity (PA) behaviour and to assess the impact of PA intensities on GWG. METHODS: The cluster-randomised, multicentre GeliS trial was performed in a routine care setting alongside scheduled prenatal visits. Pregnant women with a pre-pregnancy BMI between 18.5 and 40.0 kg/m2 were either assigned to the control group receiving usual care or to the intervention group. Participants in the intervention group attended three antenatal counselling sessions on diet and PA and one additional postpartum session. Data on PA behaviour were collected twice, before the end of the 12th (baseline) and after the 29th week of gestation using the Pregnancy Physical Activity Questionnaire. RESULTS: PA data were available for 1061 (93%) participants in the intervention and 1040 (93%) in the control group. Women in the intervention group reported significant improvements in the levels of total PA (p < 0.001), total PA of light intensity and above (p < 0.001), moderate-intensity (p = 0.024) and vigorous-intensity activities (p = 0.002) as well as sport activities (p < 0.001) in late pregnancy compared to the control group. The proportion of women meeting the international PA recommendations in late pregnancy was significantly higher in the intervention (64%) versus the control group (49%, p < 0.001). Activities of light-intensity and above (p = 0.006), light-intensity (p = 0.002) and vigorous-intensity (p = 0.014) in late pregnancy were inversely associated with total GWG. CONCLUSION: We found significant evidence of improvements in the PA pattern of pregnant women receiving lifestyle counselling within the framework of routine care. Most PA intensities were inversely associated with total GWG which indicates that PA across different intensities should be promoted. TRIAL REGISTRATION: NCT01958307, ClinicalTrials.gov, retrospectively registered 9 October, 2013.

Correction To: Effects of a lifestyle intervention in routine care on prenatal physical activity - findings from the cluster-randomised GeliS trial.

Following publication of the original article [1], the author notified us about incorrectly formatted of Table 2 and Table 3.

Identification of the activating cytotoxicity receptor NKG2D as a senescence marker in zero-hour kidney biopsies is indicative for clinical outcome.

The definition of biological donor organ age rather than chronological age seems obvious for the establishment of a valid pre-transplant risk assessment. Therefore, we studied gene expression for candidate markers in 60 zero-hour kidney biopsies. Compared with 29 younger donors under age 55, 31 elderly donors age 55 and older had significant mRNA expression for immunoproteasome subunits (PSMB8, PSMB9 and PSMB10), HLA-DRB, and transcripts of the activating cytotoxicity receptor NKG2D. Gene expression was validated in an independent donor cohort consisting of 37 kidneys from donors 30 years and under (Group I), 75 kidneys from donors age 31-54 years (Group II) and 75 kidneys from donors age 55 and older (Group III). Significant gene induction was confirmed in kidneys from Group III for PSMB9 and PSMB10. Strikingly, transcripts of NKG2D had the significantly highest gene induction in Group III versus Group II and Group I. Similar results were obtained for CDKN2A, but not for telomere length. Both NKG2D and CDKN2A mRNA expression were significantly correlated with creatinine levels at 24 months after transplantation. Univariate regression analysis showed significant predictive power regarding graft function at 6 and 12 months for NKG2D and CDKN2A. However, only NKG2D remained significantly predictive in the multivariate model at 12 months. Thus, our results reveal novel candidate markers in aged renal allografts, which could be helpful in the assessment of organ quality.

Deletion of the activating NK cell receptor NKG2D accelerates rejection of cardiac allografts.

It has already been shown that neutralization of the activating NK cell receptor NKG2D in combination with co-stimulation blockade prolongs graft survival of vascularized transplants. In order to clarify the underlying cellular mechanisms, we transplanted complete MHC-disparate BALB/c-derived cardiac grafts into C57BL/6 wildtypes or mice deficient for NKG2D (Klrk1-/- ). Although median survival was 8 days for both recipient groups, we detected already at day 5 posttransplantation significantly greater intragraft frequencies of NKp46+ NK cells in Klrk1-/- recipients than in wildtypes. This was followed by a significantly greater infiltration of CD4+ , but a lesser infiltration of CD8+ T cell frequencies. Contrary to published observations, co-stimulation blockade with CTLA4-Ig resulted in a significant acceleration of cardiac rejection by Klrk1-/- recipients, and this result was confirmed by applying a neutralizing antibody against NKG2D to wildtypes. In both experimental setups, grafts derived from Klrk1-/- recipients were characterized by significantly higher levels of interferon-γ mRNA, and both CD4+ and CD8+ T cells displayed a greater capacity for degranulation and interferon-γ production. In summary, our results clearly illustrate that NKG2D expression in the recipient is important for cardiac allograft survival, thus supporting the hypothesis that impairment of NK cells prevents the establishment of graft acceptance.

The Epidermal Growth Factor Receptor (EGFR) Inhibitor Gefitinib Reduces but Does Not Prevent Tumorigenesis in Chemical and Hormonal Induced Hepatocarcinogenesis Rat Models.

Activation of the epidermal growth factor receptor (EGFR) signaling pathway promotes the development of hepatocellular adenoma (HCA) and carcinoma (HCC). The selective EGFR inhibitor Gefitinib was found to prevent hepatocarcinogenesis in rat cirrhotic livers. Thus, Gefitinib might reduce progression of pre-neoplastic liver lesions to HCC. In short- and long-term experiments, administration of N-Nitrosomorpholine (NNM) or intrahepatic transplantation of pancreatic islets in diabetic (PTx), thyroid follicles in thyroidectomized (TTx) and ovarian fragments in ovariectomized (OTx) rats was conducted for the induction of foci of altered hepatocytes (FAH). Gefitinib was administered for two weeks (20 mg/kg) or three and nine months (10 mg/kg). In NNM-treated rats, Gefitinib administration decreased the amount of FAH when compared to controls. The amount of HCA and HCC was decreased, but development was not prevented. Upon all transplantation models, proliferative activity of FAH was lower after administration of Gefitinib in short-term experiments. Nevertheless, the burden of HCA and HCC was not changed in later stages. Thus, EGFR inhibition by Gefitinib diminishes chemical and hormonal also induced hepatocarcinogenesis in the initiation stage in the non-cirrhotic liver. However, progression to malignant hepatocellular tumors was not prevented, indicating only a limited relevance of the EGFR signaling cascade in later stages of hepatocarcinogenesis.

Lifestyle intervention to prevent excessive maternal weight gain: mother and infant follow-up at 12 months postpartum.

BACKGROUND: Excessive gestational weight gain (GWG) is associated with elevated weight retention in mothers and might be related to adiposity of their offspring. Little is known if lifestyle intervention during pregnancy has beneficial effects for mothers and children beyond gestation. METHODS: A cluster-randomized controlled intervention trial was performed with 250 pregnant women in 8 gynaecological practices. Lifestyle intervention was carried out twice with individual counselling sessions on nutrition, physical activity and weight monitoring. Participants in the control group received routine prenatal care and an information leaflet. Follow-up data of women and their offspring were collected one year postpartum (pp) by phone call and/or via e-mail using a structured questionnaire. Maternal weight retention at 12 months pp and weight development of the children in their first year of life was compared between groups using linear regression. The association between energy and macronutrient intake during pregnancy with maternal weight retention and children weight development was also assessed. RESULTS: The intervention resulted in a trend towards lower mean weight retention 12 months pp (0.2 vs. 0.8 kg), but was not statistically significant (p = 0.321). Among women receiving lifestyle counselling, only 8% retained more than 5 kg weight while 17% in the control group retained >5 kg (OR: 0.40 (95% CI: 0.16, 0.97)). For the whole study cohort, an association between higher GWG and increased 12 month weight retention was found (0.4 kg weight retention per 1 kg increase in GWG, p < 0.001). Weight development of the infants did not differ between groups in the first months after birth. At the 10th-12th month weight measurement, infants born to mothers in the intervention group tended towards lower body weights. Both energy intake and macronutrient composition of the diet during pregnancy did not affect maternal weight retention and weight development of the infants. CONCLUSIONS: Lifestyle counselling during pregnancy to avoid GWG had a rather modest effect on maternal pp weight retention and weight development of the infants. However, larger intervention studies and longer follow-up are required to be able to draw definite conclusions. TRIAL REGISTRATION: German Clinical Trials Register DRKS00003801.

Report of the joint ESOT and TTS basic science meeting 2013: current concepts and discoveries in translational transplantation.

A joint meeting organized by the European (ESOT) and The Transplantation (TTS) Societies for basic science research was organized in Paris, France, on November 7-9, 2013. Focused on new ideas and concepts in translational transplantation, the meeting served as a venue for state-of-the-art developments in basic transplantation immunology, such as the potential for tolerance induction through regulation of T-cell signaling. This meeting report summarizes important insights which were presented in Paris. It not only offers an overview of established aspects, such as the role of Tregs in transplantation, presented by Nobel laureate Rolf Zinkernagel, but also highlights novel facets in the field of transplantation, that is cell-therapy-based immunosuppression or composite tissue transplantation as presented by the emotional story given by Vasyly Rohovyy, who received two hand transplants. The ESOT/TTS joint meeting was an overall productive and enjoyable platform for basic science research in translational transplantation and fulfilled all expectations by giving a promising outlook for the future of research in the field of immunological transplantation research.

Efficacy and safety of a synbiotic infant formula for the prevention of respiratory and gastrointestinal infections: a randomized controlled trial.

BACKGROUND: Early life nutrition is crucial for the development of the gut microbiota that, in turn, plays an essential role in the maturation of the immune system and the prevention of infections. OBJECTIVES: The aim of this study was to investigate whether feeding synbiotic infants and follow-on formulas during the first year of life reduces the incidence rate (IR) of infectious diarrhea compared with standard formulas. Secondary endpoints included the IR of other infectious diseases as well as fecal milieu parameters. METHODS: In this double-blind, controlled trial, 460 healthy, 1-mo-old infants were randomly assigned to receive a synbiotic [galacto-oligosaccharides (GOS)/Limosilactobacillus fermentum CECT 5716] (IF, n = 230) or a control formula (CF, n = 230) until 12 mo of age. A reference group of breastfed infants (HM, n = 80) was included. Data on infections were recorded throughout the study period and stool samples were collected at 4 and 12 mo of age. RESULTS: IR of infectious diarrhea during the first year of life was 0.60 (CF), 0.56 (IF), and 0.29 (HM), with no statistically significant difference between groups. The IR of lower respiratory tract infections, 1 of the secondary endpoints, however, was lower in IF than in CF [0.79 compared with 1.01, IR ratio = 0.77 (0.60-1.00)]. Additionally, fecal pH was significantly lower at 4 mo (P < 0.0001), whereas secretory IgA was significantly higher at 12 mo of age (P = 0.015) in IF compared with CF. CONCLUSIONS: Although no difference is observed in the incidence of diarrhea, consumption of a synbiotic formula containing L. fermentum CECT5716 and GOS in infancy may reduce the incidence of lower respiratory tract infections and affect the immune system and fecal milieu. Additional research is warranted to further investigate the potential interaction of the gut-lung axis. This trial was registered at clinicaltrials.gov as NCT02221687.

Variability in COVID-19 Symptom Presentation During Pregnancy and its Impact on Maternal and Infant Outcomes Across the Pandemic.

BACKGROUND: With the dominance of different SARS-CoV-2 variants, the severity of COVID-19 has evolved. We aimed to investigate the difference in symptom prevalence and the association between symptoms and adverse pregnancy outcomes during the dominance of Wild-type/Alpha, Delta, and Omicron. METHODS: COVID-19 related symptom prevalence, maternal and specific neonatal outcomes of 5431 pregnant women registered in this prospective study were compared considering the dominant virus variant. Logistic regression models analyzed the association between specific symptoms and intensive care unit (ICU) admission or preterm birth. RESULTS: Infection with the Delta variant led to an increase in the symptom burden compared to the Wild-type/Alpha variant and the highest risk for respiratory tract symptoms, feeling of sickness, headache, and dizziness/drowsiness. An infection with the Omicron variant was associated with the lowest risk of dyspnea and changes in smell/taste but the highest risk for nasal obstruction, expectoration, headaches, myalgia, and fatigue compared to the Wild-type/Alpha and Delta variant dominant periods. With the progression of the Wild-type/Alpha to the Delta variant neonatal outcomes worsened. Dyspnea and fever were strong predictors for maternal ICU admission and preterm birth independent of vaccination status or trimester of infection onset. CONCLUSION: The symptom burden increased during the Delta period and was associated with worse pregnancy outcomes than in the Wild-type/Alpha area. During the Omicron dominance there still was a high prevalence of less severe symptoms. Dyspnea and fever can predict a severe maternal illness.

Gastrointestinal Tolerance of an Infant Formula Manufactured from Extensively Hydrolysed Protein in Healthy Term Infants.

The evaluation of secondary parameters of a prospective, randomised, controlled, multicentre intervention trial aimed to analyse gastrointestinal tolerance of an infant formula manufactured from extensively hydrolysed whey protein (eHF) compared to intact cow's milk protein (control formula, CF) in healthy term infants. Infants ≤ 25 days of age, who were exclusively formula-fed, were randomised to receive eHF or CF for at least three months up to 120 days of age. An exclusively breastfed reference group (BF) was included for descriptive comparison. Infants' gastrointestinal tolerance was evaluated based on stool parameters, the Amsterdam Infant Stool Scale (AISS), the Infant Gastrointestinal Symptom Questionnaire (IGSQ), and sleeping patterns. Of 359 infants included, 297 randomised (eHF: n = 149, CF: n = 148) and 41 BF infants completed the study per protocol. All tolerance parameters were comparable between eHF and CF. Stool was predominantly soft and yellow in colour. Stool was more frequently green in eHF than CF. BF infants had more frequent stools, which were mainly watery or soft and yellow, and comparable IGSQ scores (descriptive). Irrespective of group, all gastrointestinal and sleep parameters showed signs of maturation with increasing age. In conclusion, eHF showed gastrointestinal tolerance as good as CF in healthy infants. Both formulae were well-tolerated.

eHealth education of professionals in the Baltic Sea Area.

In this paper we present a study on the extent, level and content of e-Health in existing formal educational systems in Lithuania, Germany, Finland, Norway and Denmark with the objectives of identifying future educational needs within this area. The study was carried out as a desk-top study and took place within the context of the ICT for Health project. The results of the study on the one hand revealed a wide range of programs and courses that included e-Health, but on the other hand also showed that in the educations of health care professionals (physicians, nurses etc.) the integration of e-Health elements are often marginal or non-existing. Thus the study indicates that there is a need for a higher integration of e-Health in the education of health care professionals. We discuss what kind of knowledge of e-Health is needed and how it could or should be integrated in these educations. We argue that providing possibilities for applying and experimenting with e-Health system in a concrete and tangible manner is central in order to raise the acceptance and capabilities of health care professionals to use e-Health systems.

Drug survival of secukinumab, ustekinumab, and certolizumab pegol in psoriasis: a 2-year, monocentric, retrospective study.

OBJECTIVE: To investigate the drug survival of secukinumab (SEC), ustekinumab (UST), and certolizumab pegol (CZP) in real-world conditions and to identify the predictors and reasons for treatment discontinuation. METHODS: We performed a 2-year retrospective single-center analysis of 110 treatment courses in 98 patients with moderate to severe plaque-type psoriasis and/or psoriatic arthritis (SEC n = 68; UST n = 29; and CZP n = 13). Drug survival was examined using the Kaplan-Meier analysis and the influence of demographic factors on drug survival with Cox regression analysis. RESULTS: Drug survival rates at 12 and 18 months were respectively 68.5% and 59% for the entire study population, 85% and 69% for UST, 68% and 59% for SEC, and 34% for CZP. Both UST and SEC showed a significantly longer survival rate compared to CZP (p<.05), but not between each other. A total of 30 treatment discontinuations were observed, predominantly due to loss of efficacy and adverse events. Treatment selection predicted the survival rate. Other predictors could not be identified. CONCLUSIONS: Drug survival is the resultant of many factors such as long-term effectiveness, safety, compliance, and convenience of use. UST and SEC had higher retention rates in comparison with CZP.

Dietary Supplementation Before, During and After Pregnancy: Results of the Cluster-Randomized GeliS Study.

Introduction The nutritional status of women before, during, and after pregnancy plays an important role in the health of mother and child. In addition to a balanced mixed diet, the increased need for folic acid and iodine should be met and ensured with supplements. The aim of this study was to assess dietary supplementation in the context of pregnancy and to investigate the effect of targeted counselling on supplementation behavior during and after pregnancy. Methods In the context of the "Gesund leben in der Schwangerschaft" (GeliS; "Healthy living in pregnancy") trial, women in the intervention group (IG) received four structured lifestyle counselling sessions during pregnancy as well as postpartum, during which they were informed about appropriate dietary supplementation. The women in the control group (CG) received routine prenatal care. The intake of dietary supplements was recorded at different points using a questionnaire. Results In total, 2099 women were included in the analysis. Prior to conception, 31.3% of the women in the IG and 31.4% of the women in the CG took folic acid supplements. Prenatally, about half of the women took folic acid (IG: 54.1%; CG: 52.0%) and iodine (IG: 50.2%; CG: 48.2%). Statistically significant differences between the groups with regard to supplementation behavior could not be observed, neither prior to inclusion in the study nor during the intervention. During pregnancy, 23.0% of all women took docosahexaenoic acid (DHA) supplements and 21.8% iron supplements. 49.4% of the women additionally took vitamin D supplements. A higher educational level (p < 0.001), advanced age (p < 0.001), primiparity (p < 0.001), and a vegetarian diet (p = 0.037) were all associated with a higher level of dietary supplementation. Conclusion The GeliS lifestyle counselling did not significantly improve the supplementation behavior of women during and after pregnancy. Women should be informed about adequate dietary supplementation early on within the scope of gynecological prenatal care.

Child Anthropometrics and Neurodevelopment at 2 and 3 Years of Age Following an Antenatal Lifestyle Intervention in Routine Care-A Secondary Analysis from the Cluster-Randomised GeliS Trial.

Maternal characteristics around pregnancy may influence obesity risk and neurodevelopment in children. To date, the effect of antenatal lifestyle interventions on long-term child development is unclear. The objective was to investigate the potential long-term effects of an antenatal lifestyle intervention programme conducted alongside routine care on child anthropometrics and neurodevelopment up to 3 years of age. Mother-child pairs from the cluster-randomised GeliS trial were followed up to 3 years of age. Data on child anthropometrics in both groups were collected from routine health examinations. Neurodevelopment was assessed via questionnaire. Of the 2286 study participants, 1644 mother-child pairs were included in the analysis. Children from the intervention group were less likely to score below the cut-off in Fine motor (p = 0.002), and more likely to have a score below the cut-off in Problem-solving (p < 0.001) compared to the control group at 3 years of age. Mean weight, height, head circumference, body mass index, and the respective z-scores and percentiles were comparable between the groups at 2 and 3 years of age. We found no evidence that the lifestyle intervention affected offspring development up to 3 years of age. Further innovative intervention approaches are required to improve child health in the long-term.

How does antenatal lifestyle affect the risk for gestational diabetes mellitus? A secondary cohort analysis from the GeliS trial.

OBJECTIVES: We aimed to investigate the predictive potential of early pregnancy factors such as lifestyle, gestational weight gain (GWG) and mental well-being on gestational diabetes mellitus (GDM) beyond established risk factors. METHODS: GDM risk was investigated in the cohort of the German 'Gesund leben in der Schwangerschaft'/healthy living in pregnancy study. Women were recruited up to the 12th week of gestation. GDM was diagnosed with a 75 g oral glucose tolerance test between the 24th and 28th weeks of gestation. Pre-pregnancy age and weight, mental health and lifestyle were assessed via questionnaires. Maternal weight was measured throughout pregnancy. Early excessive GWG was defined based on the guidelines of the Institute of Medicine. The association between several factors and the odds of developing GDM was assessed using multiple logistic regression analyses. RESULTS: Of 1694 included women, 10.8% developed GDM. The odds increased with pre-pregnancy BMI and age (women with obesity: 4.91, CI 3.35-7.19, p < 0.001; women aged 36-43 years: 2.84, CI 1.45-5.56, p = 0.002). Early excessive GWG, mental health and general lifestyle ratings were no significant risk factors. A 31% reduction in the odds of GDM was observed when <30% of energy was consumed from fat (OR 0.69, CI 0.49-0.96, p = 0.026). Vigorous physical activity tended to lower the odds without evidence of statistical significance (OR 0.59 per 10 MET-h/week, p = 0.076). CONCLUSIONS: Maternal age and BMI stand out as the most important drivers of GDM. Early pregnancy factors like dietary fat content seem to be associated with GDM risk. Further evaluation is warranted before providing reliable recommendations.

Infant growth during the first year of life following a pregnancy lifestyle intervention in routine care-Findings from the cluster-randomised GeliS trial.

BACKGROUND: Lifestyle interventions in pregnancy may influence postpartum development and obesity risk in offspring. The impact of lifestyle interventions as health system-based approaches is unclear. OBJECTIVE: To evaluate the effect of an antenatal lifestyle intervention conducted as public health approach on infant development and feeding practices. METHODS: We followed offspring born to women participating in the cluster-randomised GeliS trial who received usual care (CG) or repeated lifestyle counselling (IG). We collected data on offspring development and complementary feeding until the 12th month postpartum. RESULTS: Of the 1998 mother-child pairs, 1783 completed the follow-up. Mean infant weight at 12 months was comparable between groups (IG: 9497.9 ± 1137.0 g; CG: 9433.4 ± 1055.2 g; P = .177). There was no significant evidence of differences in sex- and age-adjusted z-scores or in the odds of offspring being overweight. More infants in the IG received whole-grain products compared to the CG (95.6% vs. 90.8%; P = .003). Despite small differences in the timing of introducing solid foods, there were no further significant differences in the pattern of complementary feeding. CONCLUSIONS: The antenatal lifestyle intervention embedded in routine care did not substantially influence infant anthropometrics and is thus unlikely to impact future development.