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.

Healthy living in pregnancy: a cluster-randomized controlled trial to prevent excessive gestational weight gain - rationale and design of the GeliS study.

BACKGROUND: Recent studies suggest that excessive gestational weight gain (GWG) leads to adverse maternal and fetal outcomes including weight retention in the mother and an increased risk of childhood obesity in the offspring.The aim of the GeliS study is to examine the effect of a lifestyle intervention programme during pregnancy to avoid excessive GWG and, hence, to reduce pregnancy and obstetric complications as well as the risk of maternal and offspring obesity. METHODS AND DESIGN: The GeliS study is a multicentre cluster-randomized controlled trial. A total number of 2500 pregnant women (singleton pregnancy) with a pre-pregnancy BMI ≥ 18.5 kg/m2 and ≤ 40 kg/m2 will be recruited in practices of gynaecologists and midwives in ten Bavarian regions. The intervention comprises three structured and individualised counselling sessions on a healthy diet, regular physical activity as well as weight monitoring during pregnancy and one session after delivery, respectively. The counselling sessions are attached to routine pre- and postnatal visits using standardised materials and procedures. In the control regions, general recommendations for a healthy lifestyle are given. An oral glucose tolerance test is offered to all participants.The primary outcome is the proportion of participants with excessive GWG. Secondary outcomes include pregnancy and obstetric complications such as frequency of gestational diabetes, preeclampsia and caesarean sections as well as weight retention in the mothers and BMI and other health variables in the offspring. A 5-year follow-up of both mothers and their infants is planned. DISCUSSION: The GeliS lifestyle intervention programme has been adapted to the existing routine health care system for pregnant women. If shown to be effective, it could be immediately implemented in routine care. TRIAL REGISTRATION: The study protocol is registered at the ClinicalTrials.gov Protocol Registration System (NCT01958307).

Weight gain and dietary intake during pregnancy in industrialized countries--a systematic review of observational studies.

BACKGROUND: Gestational weight gain (GWG) above the recently recommended ranges is likely to be related to adverse pregnancy outcomes and therefore a challenge in industrialized countries. AIMS: We conducted a systematic review on observational studies in order to gain more evidence on whether diets with lower caloric/protein content or other diets might be associated with lower GWG. METHODS: We searched in MEDLINE and EMBASE for observational studies written in English or German reporting associations between diet and GWG in singleton pregnancies of healthy women in industrialized countries. RESULTS: We identified 12 studies which met the inclusion criteria. Five studies suggested significant positive associations between energy intake and GWG, whereas three found no significant association. Further significant positive associations of GWG were reported with respect to protein intake, animal lipids, energy density and a number of different food servings per day, whereas intake of carbohydrates and vegetarian diet were associated with less GWG. CONCLUSIONS: We suggest that GWG might be reduced by lower energy intake in pregnancy.

Infant formula supplementation with long-chain polyunsaturated fatty acids has no effect on Bayley developmental scores at 18 months of age--IPD meta-analysis of 4 large clinical trials.

OBJECTIVES: To find out whether supplementation of formula milk by long-chain polyunsaturated fatty acids (LCPUFA) affects neurodevelopment at 18 months of age in term or preterm infants by an individual patient data (IPD) meta-analysis. MATERIALS AND METHODS: Data of 870 children from 4 large randomised clinical trials for formula milk with and without LCPUFAs allowed for assessing the effect of LCPUFA with adjustment for potential confounders and extensive subgroup analysis on prematurity, LCPUFA source, and dosage. Any additional clinical trials examining the effect of LCPUFA supplementation on Bayley Scales of Infant Development at 18 months were regarded as relevant. Two relevant studies were identified by MEDLINE, but were not available to us. An IPD meta-analysis was performed with subgroup analyses by preterm delivery, very low birth weight (<1500 g), trials with higher amounts of docosahexaenoic acid (DHA) and arachidonic acid (AA), and specific sources of LCPUFA. The sample size of 870 children was sufficient to detect clinically relevant differences in Bayley Scales even in subgroups. RESULTS: There were no significant differences in mental or psychomotor developmental indexes between LCPUFA-supplemented and control groups for all children or in subgroups. This was confirmed with adjustment for the possible confounders: sex, gestational age, birth weight, maternal age, and maternal smoking. The adjusted mean differences in mental developmental index and psychomotor developmental index for all of the children were -0.8 (95% confidence interval -2.8 to 1.2) and -1.0 (-2.7 to 0.7), respectively. CONCLUSIONS: These data based on considerable sample size provide substantial evidence that LCPUFA supplementation of infant formula does not have a clinically meaningful effect on the neurodevelopment as assessed by Bayley scores at 18 months. Inclusion of all relevant data should not have led to differing conclusions except, possibly, for very-low-birth-weight infants.

IPD meta-analysis shows no effect of LC-PUFA supplementation on infant growth at 18 months.

AIM: Clinical trials on the effects of long-chain polyunsaturated fatty acids (LC-PUFA) supplementation of formula milk on growth of term and preterm children have shown conflicting results. We examined the effects of LC-PUFAs-- especially docosahexaenoic acid (DHA) and arachidonic acid (AA)--on growth at 18 months. METHODS: We performed a meta-analysis based on individual patient data (IPD) of 901 children from four large, randomised clinical trials of formula milk with and without LC-PUFAs. Anthropometrics were assessed by z-scores based on weight for age, length for age, head circumference for age and body mass index (BMI) for age at 18 months. The studies differed in LC-PUFA composition and infant characteristics (two studies on preterm children, two on term children). RESULTS: Multivariate regression analyses including the possible confounders, sex, gestational age, birth weight, smoking in the last trimester and maternal age, as well as interaction terms showed no significant effects of LC-PUFA supplementation on any z-score. Subgroup analyses on trials with high amounts of DHA and on studies with duration of supplementation of at least 6 months yielded the same result. These findings cannot be explained by the lack of power. CONCLUSION: Our IPD meta-analysis shows no evidence that LC-PUFA supplementation affects children's growth at 18 months of age.

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.

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.

The burden of varicella complications before the introduction of routine varicella vaccination in Germany.

BACKGROUND: The true burden of varicella complications in Germany is not known. We investigated the incidence and pattern of varicella complications in children and adolescents using 3 independent surveillance sources. METHODS: Prospective nationwide surveillance in all pediatric hospitals through the German Pediatric Surveillance Unit [Erhebungseinheit für Seltene Pädiatrische Erkrankungen in Deutschland (ESPED)] was used to ascertain hospitalized varicella cases in children

Reliability of physical activity measures from accelerometry among preschoolers in free-living conditions.

BACKGROUND & AIMS: Physical activity (PA) is a major determinant of obesity. Accelerometers have been reported to provide valid measures among adults. However, studies among preschoolers rarely report positive findings. To assess the day-to-day variability of accelerometers in preschoolers. METHODS: Uni-axial accelerometer (Actigraph monitor AM 7164-2.2) counts including one weekend from the time of getting up in the morning until bedtime. RESULTS: On average, boys showed 899 counts per minute (cpm) compared to 764 for girls (p<0.01; overall mean 828 cpm). Intra-individual correlation for accelerometry data between single days of examination was low with Pearson correlation coefficients between r=0.31 and 0.51. Furthermore, child's body mass index (BMI) and accelerometer measures were not related to each other (Pearson's correlation coefficient r=-0.06). Subsequent analyses showed higher measures (+50%cpm; p<0.01) for instruments placed in front of the umbilicus compared to instruments placed at the right hip. CONCLUSIONS: Measurements of uni-axial accelerometers showed a low reliability among preschoolers. Uni-axial accelerometers placed on elastic belts might measure PA with low precision among preschoolers under free-living conditions possibly due to slipping instruments. This might explain lacking findings of an association between PA and obesity in studies among preschoolers.

Immunocompetent children account for the majority of complications in childhood herpes zoster.

In a 2-year-long active surveillance conducted in all German pediatric hospitals, the incidence of hospitalization because of herpes zoster and the clinical picture of complications in children were assessed. Herpes zoster resulted in hospitalization of 244 children, 78 of whom were considered to be immunocompromised. Zoster ophthalmicus (n=29), meningoencephalitis (n=22), and zoster oticus (n=23) (11 cases had Ramsay Hunt syndrome) accounted for 59% of all complications (n=115). The incidence of hospitalization suggests that at least 1 in every 100 children with herpes zoster is hospitalized and that at least 1 in every 250 immunocompetent children with herpes zoster is hospitalized with complications.