Antibiotic Treatment During Pregnancy and the First Six Months Postpartum - a Secondary Analysis of the "Healthy Living in Pregnancy" (GeliS) Study.

Introduction: Antibiotic therapies for the treatment of bacterial infections pose a particular challenge during pregnancy and breastfeeding. For Germany, there is hardly any information on the frequency of antibiotic use during this phase. Our analysis uses data from the "Healthy Living in Pregnancy" (GeliS) study to describe antibiotic treatments during pregnancy and in the first six months after birth (postpartum), and to compare their use with existing recommendations. Methods: This is a retrospective secondary analysis of the GeliS study. In the cluster randomized lifestyle intervention study, detailed information on antibiotic therapies during pregnancy and postpartum was collected using surveys. Chi-square tests and generalized estimating equations were used for evaluation. Results: Of the 1636 women included in the analysis, 21% reported antibiotic treatment at least once during pregnancy (14%) or in the first six months postpartum (7%). During pregnancy, the antibiotic therapies of women increased from 1.7% in the first trimester to 6.5% in the third trimester. Common reasons for treatment were urinary tract infections (7.3% of women), ear, nose, throat (ENT) infections (3.6%), and birth complications (2.6%). The information on the prescribed preparations corresponded to the current recommendations. A significant increase in the frequency of treatment with antibiotics was observed in the lifestyle intervention group (p < 0.001), in participants without a partner (p < 0.001), and in women who breastfed their children (p = 0.005) or gave birth by caesarean section (p = 0.003) or prematurely (p = 0.012). Other socioeconomic or lifestyle factors were not significant. Conclusion: Approximately one in five women receives at least one antibiotic treatment during pregnancy and breastfeeding that meets current treatment recommendations. Treatment with antibiotics is more common in premature births, caesarean sections, and breastfeeding women.

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.

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.

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.

Effects of a Prenatal Lifestyle Intervention in Routine Care on Maternal Health Behaviour in the First Year Postpartum-Secondary Findings of the Cluster-Randomised GeliS Trial.

Lifestyle interventions during pregnancy were shown to beneficially influence maternal dietary behaviour and physical activity, but their effect on health behaviour after delivery is unclear. The objective of this secondary analysis was to investigate the sustained effect of a lifestyle intervention in routine care on maternal health behaviour during the first year postpartum. The cluster-randomised controlled "Healthy living in pregnancy" (GeliS) study included 2286 pregnant women. Data on maternal health behaviour were collected at 6-8 weeks (T1pp) and one year postpartum (T2pp) using validated questionnaires. The intervention group showed a lower mean intake of fast food (T1pp: p = 0.016; T2pp: p < 0.001) and soft drinks (T1pp: p < 0.001), a higher mean intake of vegetables (T2pp: p = 0.015) and was more likely to use healthy oils for meal preparation than the control group. Dietary quality rated by a healthy eating index was higher in the intervention group (T1pp: p = 0.093; T2pp: p = 0.043). There were minor trends towards an intervention effect on physical activity behaviour. The proportion of smokers was lower in the intervention group (p < 0.001, both time points). The lifestyle intervention within routine care modestly improved maternal postpartum dietary and smoking behaviours.

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.

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.

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.

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.

Associations between Prenatal Physical Activity and Neonatal and Obstetric Outcomes-A Secondary Analysis of the Cluster-Randomized GeliS Trial.

Prenatal physical activity (PA) was discussed to decrease the incidence of obstetric and neonatal complications. In this secondary cohort analysis of the cluster-randomized GeliS ("healthy living in pregnancy") trial, associations between prenatal PA and such outcomes were investigated. PA behavior was assessed twice, before or during the 12th week (baseline, T0) and after the 29th week of gestation (T1), using the self-reported Pregnancy Physical Activity Questionnaire. Obstetric and neonatal data were collected in the routine care setting. Data were available for 87.2% (n = 1994/2286) of participants. Significant differences between the offspring of women who adhered to PA recommendations at T1 and offspring of inactive women were found in birth weight (p = 0.030) but not in other anthropometric parameters. Sedentary behavior was inversely associated with birth weight at T1 (p = 0.026) and, at both time points, with an increase in the odds of low birth weight (T0: p = 0.004, T1: p = 0.005). Light-intensity PA at T0 marginally increased the odds of caesarean section (p = 0.032), but neither moderate-intensity nor vigorous-intensity activity modified the risk for caesarean delivery at any time point. The present analyses demonstrated associations between prenatal PA and some neonatal and obstetric outcomes.

Associations between the Prenatal Diet and Neonatal Outcomes-A Secondary Analysis of the Cluster-Randomised GeliS Trial.

The prenatal lifestyle, including maternal dietary behaviour, is an important determinant of offspring health. This secondary cohort analysis of the GeliS ("healthy living in pregnancy") trial investigated associations between antenatal dietary factors and neonatal weight parameters. The cluster-randomised GeliS trial included 2286 pregnant women. Dietary information was collected with food frequency questionnaires before or in the 12th (T0) and after the 29th week of gestation (T1). Consumption of vegetables (41.28 g per portion at T0, p = 0.001; 36.67 g per portion at T1, p = 0.001), fruit (15.25 g per portion at T1, p = 0.010) and dietary quality, measured with a Healthy Eating Index (39.26 g per 10 points at T0, p = 0.004; 42.76 g per 10 points at T1, p = 0.002) were positively associated with birth weight. In contrast, sugar-sweetened beverages (10.90 g per portion at T0, p = 0.003; 8.19 g per portion at T1, p = 0.047), higher sugar consumption at T0 (8.27 g per 10 g, p = 0.032) and early pregnancy alcohol intake (15.32 g per g, p = 0.039) were inversely associated with birth weight. Most other dietary factors were not associated with neonatal weight. Some components reflecting a healthy maternal diet were associated with a modest increase in offspring birth weight, whereas some unhealthy components slightly reduced neonatal weight.

Effects of a Lifestyle Intervention in Routine Care on Prenatal Dietary Behavior-Findings from the Cluster-Randomized GeliS Trial.

The antenatal lifestyle and excessive gestational weight gain (GWG) modify the risk of obstetric complications, maternal weight retention, and the risk of obesity for the next generation. The cluster-randomized controlled "Healthy living in pregnancy" (GeliS) study, recruiting 2286 women, was designed to examine whether a lifestyle intervention reduced the proportion of women with excessive GWG. Trained healthcare providers gave four counseling sessions covering a healthy diet, regular physical activity, and self-monitoring of GWG in the intervention group. In this secondary analysis, the effect on maternal dietary behavior was analyzed. Dietary behavior was assessed by means of a 58-item food frequency questionnaire in early and late pregnancy. The intervention resulted in a significant reduction in soft drink intake (p < 0.001) and an increase in the consumption of fish (p = 0.002) and vegetables (p = 0.023). With the exception of higher percentage energy from protein (p = 0.018), no effects of the intervention on energy and macronutrient intake were observed. There was no evidence for an overall effect on dietary quality measured with a healthy eating index. Some dietary variables were shown to be associated with GWG. In a routine prenatal care setting in Germany, lifestyle advice modified single aspects of dietary behavior, but not energy intake or overall dietary quality.

Effects of a Lifestyle Intervention in Routine Care on Short- and Long-Term Maternal Weight Retention and Breastfeeding Behavior-12 Months Follow-up of the Cluster-Randomized GeliS Trial.

Postpartum weight retention (PPWR) is associated with an increased risk for maternal obesity and is discussed to be influenced by breastfeeding. The objective was to evaluate the effect of a lifestyle intervention delivered three times during pregnancy and once in the postpartum period on PPWR and on maternal breastfeeding behavior. In total, 1998 participants of the cluster-randomized "healthy living in pregnancy" (GeliS) trial were followed up until the 12th month postpartum (T2pp). Data were collected using maternity records and questionnaires. Data on breastfeeding behavior were collected at T2pp. At T2pp, mean PPWR was lower in women receiving counseling (IV) compared to the control group (C) (-0.2 ± 4.8 kg vs. 0.6 ± 5.2 kg), but there was no significant evidence of between-group differences (adjusted p = 0.123). In the IV, women lost more weight from delivery until T2pp compared to the C (adjusted p = 0.008) and showed a slightly higher rate of exclusive breastfeeding (IV: 87.4%; C: 84.4%; adjusted p < 0.001). In conclusion, we found evidence for slight improvements of maternal postpartum weight characteristics and the rate of exclusive breastfeeding in women receiving a lifestyle intervention embedded in routine care, although the clinical meaning of these findings is unclear.