Search

Background: Transmission of obesity across generations is of concern. Offspring of obese women have short- and long-term increased morbidities. A high intake of carbohydrate during pregnancy combined with impaired glucose tolerance is postulated to result in high birth weight, which is linked to subsequent metabolic disease. Objective: The objective was to examine the association between carbohydrate intake in obese pregnant women and their offspring's body composition. Design: Secondary analyses were performed in an observational setting of 222 pregnant women with a pregestational BMI (in kg/m²) ≥30 participating in a randomized controlled trial. Diet was assessed at gestational weeks 11-14 and 36-37 by using a semiquantitative food-frequency questionnaire. Body composition in the offspring was assessed at birth by dual-energy X-ray absorptiome-try. Relative fat mass (%) was the primary outcome. Absolute measures (total fat, abdominal fat, and lean body mass) were secondary outcomes. Results: Mean ± SD weight and absolute and relative fat mass in the offspring at birth were 3769 ± 542 g, 436 ± 214 g, and 11% ± 4%, respectively. Maternal intake of digestible carbohydrates was associated with the offspring's relative fat mass in late (P-trend = 0.006) but not early (P-trend = 0.15) pregnancy. A comparison of mothers in the highest (median: 238 g/d) compared with the lowest (median: 188 g/d) quartile of digestible carbohydrate intake showed a mean adjusted higher value in the offspring's relative fat mass of 2.1% (95% CI: 0.6%, 3.7%), which corresponded in absolute terms to a 103-g (95% CI: 27, 179-g) higher fat mass. Abdominal fat mass was also higher. In a strata of women with well-controlled glucose (2-h glucose values ≤6.6 mmol/L), no association between carbohydrate intake and offspring fat mass was observed, but the associations became significant and increased in strength with higher intolerance (strata with 2-h glucose values between 6.7-7.7 and ≥7.8 mmol/L). Conclusion: In obese women, even those without gestational diabetes but with impaired glucose tolerance, a lower carbohydrate intake at moderate levels in late gestation is associated with a lower fat mass in their offspring at birth. The TOP study was registered at clinicaltrials.gov as NCT01345149. [ABSTRACT FROM AUTHOR]

Dual-energy X-ray absorptiometry (DXA) has been hailed as a golden standard for measuring body composition in adults but remains to be fully assessed for the infant population. A total of 64 newborn infants were allocated to 1 of 3 groups. All underwent 2 Hologic Discovery A DXA scans. Suboptimal scans were reconstructed, and an investigation into the success of adjustment was carried out. Depending on group, the factors of weight change and repositioning were investigated. Test-retest variation and coefficients of variation for DXA body composition estimates were calculated. Furthermore, the effects of flannel sheets and breast milk were investigated using a pediatric phantom. Reconstruction of suboptimal scans resulted in more accurate body weight estimates. Moderate weight change and repositioning had no significant effect on the variation between scans. No significant body composition changes occurred between scans. The test-retest variation varied between 6.3% and 11.8%. Flannel sheets and breast milk affected DXA results significantly. High precision of DXA measurements was obtained in our newborn population. Reconstructing scans is a viable way of correcting minor movement artifacts. Moderate weight changes and repositioning have no significant effect on DXA results, whereas flannel sheets and milk do. [ABSTRACT FROM AUTHOR]

Background: Obese women often have difficulties breastfeeding. Objective: We evaluated whether telephone-based support could increase the duration of breastfeeding in obese women and, thereby, reduce offspring growth. Design: We recruited 226 dyads of obese mothers and their singleton, healthy, term infants. The women were randomly assigned to 6 mo of breastfeeding support or standard care controls. At 6 mo, there were 207 dyads in the study; 105 dyads received support, and 102 dyads were control subjects. One International Board Certified Lactation Consultant carried out the intervention, which was based on structured interviews and consisted of encouraging telephone calls. Results: The support group breastfed exclusively for a median of 120 d (25th-75th percentiles: 14-142 d) compared with 41 d (3-133 d) for control subjects (P = 0.003). Any breastfeeding was maintained for a median of 184 d (92-185 d) for the support group compared with 108 d (16-185 d) for control subjects (P = 0.002). Support increased the adjusted ORs for exclusive breastfeeding at 3 mo and the ratios for partial breastfeeding at 6 mo to 2.45 (95% CI: 1.36, 4.41; P = 0.003) and 2.25 (95% CI: 1.24, 4.08; P = 0.008, respectively). Although the duration of exclusive breastfeeding was inversely associated with infant weight (b = 24.39 g/d; 95% CI: 20.66, 28.11 g/d; P = 0.021) and infant length at 6 mo (b = 20. 012 cm/d; 95% CI: 20.004, 20.02 cm/d; P = 0.004), the breastfeeding support did not achieve a significant effect on infant growth at 6 mo (n = 192). Conclusions: Telephone-based advisory support was very effective in prolonging breastfeeding in obese mothers who often terminate the breastfeeding of their infants prematurely. A longer duration of breastfeeding may decrease risk of noncommunicable diseases in these infants. This trial was registered at clinicaltrials.gov as NCT01235663. [ABSTRACT FROM AUTHOR]

Objective: The objective of the study was to assess physical activity intervention assessed by a pedometer with or without dietary intervention on gestational weight gain (GWG) in obese pregnant women by comparing with a control group. Study Design: This study was a randomized controlled trial of 425 obese pregnant women comparing 3 groups: (1) PA plus D, physical activity and dietary intervention (n = 142); (2) PA, physical activity intervention (n = 142); and (3) C, a control group receiving standard care (n = 141). All participants routinely in gestational weeks 11-14 had an initial dietary counseling session and were advised to limit GWG to less than 5 kg. Physical activity intervention included encouragement to increase physical activity, aiming at a daily step count of 11,000, monitored by pedometer assessment on 7 consecutive days every 4 weeks. Dietary intervention included follow-up on a hypocaloric Mediterranean-style diet. Instruction was given by a dietician every 2 weeks. The primary outcome measure was GWG, and the secondary outcome measures were complications of pregnancy and delivery and neonatal outcome. Results: The study was completed by 389 patients (92%). Median values of GWG (ranges) were lower in each of the intervention groups (PA plus D, 8.6 [–9.6 to 34.1] kg, and group PA, 9.4 [–3.4 to 28.2] kg) compared with the control group (10.9 [–4.4 to 28.7] kg [PA+D vs C]; P = .01; PA vs C; P = .042). No significant difference was found between the 2 intervention groups. In a multivariate analysis, physical activity intervention decreased GWG by a mean of 1.38 kg (P = .040). The Institute of Medicine's recommendations for GWG were more frequently followed in the intervention groups. Conclusion: Physical activity intervention assessed by pedometer with or without dietary follow-up reduced GWG compared with controls in obese pregnant women. [ABSTRACT FROM AUTHOR]

The Bacille Calmette-Guérin (BCG) vaccine against tuberculosis (TB) may have beneficial non-specific effects (NSEs) beyond the protection against TB. This may be related to modifications of the innate immune system. We investigated the effect of BCG at birth on differential white blood cell (WBC) count in healthy, Danish infants. The Danish Calmette Study randomised newborns to BCG at birth (Danish strain 1331, Statens Serum Institut) or no intervention. A sub-group of infants had blood samples collected 4 days after randomisation (n = 161), and at age 3 months (n = 152) and 13 months (n = 300). We evaluated the effect of BCG on WBC differential count (total leucocytes, lymphocytes, monocytes, eosinophil, neutrophil and basophil granulocytes (109 cells/L)) measured in peripheral blood. Overall, we found no effect of BCG on differential WBC counts at any time point. BCG at birth did not affect WBC count in our cohort of healthy, Danish infants. [ABSTRACT FROM AUTHOR]

Introduction BCG vaccination has been associated with beneficial non-specific effects on child health. Some immunological studies have reported heterologous effects of vaccines on antibody responses to heterologous vaccines. Within a randomised clinical trial of Bacille Calmette-Guérin (BCG) vaccination at birth, The Danish Calmette Study, we investigated the effect of BCG at birth on the antibody response to the three routine vaccines against DiTeKiPol/Act-Hib and Prevenar 13 in a subgroup of participants. Methods Within 7 days after birth, children were randomised 1:1 to BCG vaccination or to the control group (no intervention). After three routine vaccinations given at age 3, 5 and 12 months, antibodies against DiTeKiPol/Act-Hib and Prevenar 13 ( Streptococcus pneumoniae serotype type 4, 6B, 9V, 14, 18C, 19F and 23F) were measured 4 weeks after the third vaccine dose. Results Among the 300 included children (178 BCG; 122 controls), almost all children (>96%) had antibody responses above the protective levels. Overall BCG vaccination at birth did not affect the antibody level. When stratifying by ‘age at randomisation' we found a possible inducing effect of BCG on antibodies against B. pertussis and all pneumococcal serotypes, when BCG was given after the first day of life. Girls had significantly higher antibody levels for Haemophilus influenza type b and pneumococcus than boys. Conclusions and relevance Three routine vaccinations with DiTeKiPol/Act-Hib and Prevenar 13 induced sero-protective levels in almost all children. No overall effect of neonatal BCG vaccination was observed. [ABSTRACT FROM AUTHOR]

Background: Bacillus Calmette-Guérin vaccine (BCG) induces a complex, pro-inflammatory immune response. Obesity is associated with low-grade inflammation.Aims: The purpose of the study was to test whether BCG at birth has effects on infant growth and body composition.Study Design, Subjects, and Outcome Measures: The Danish Calmette Study is a randomized, clinical trial. The study was conducted at three university hospitals and randomized 4262 children of gestational age ≥32weeks to receive BCG within seven days of birth or to a no-intervention control group. Follow-up consisted of clinical examinations. Outcome measures were weight and length at 3months, and weight, length, mid upper-arm circumference, and triceps and subscapular skinfold at 13months. Data collectors were blinded to allocation. Anthropometric measurements were converted to z-scores using WHO reference population.Results: Follow-up was 94% complete at 3 and 13months after birth. The children were bigger than the WHO reference population. There was no effect of BCG on weight z-score at 13months (-0.028 [95% confidence interval: -0.085 to 0.029], p=0.34). There was no effect on weight and length at 3months, or length, mid-upper-arm circumference, or triceps and subscapular skinfold at 13months.Conclusion: In this study, vaccination with BCG at birth did not have effects on child growth or body composition at 13months.Trial Registration: www.clinicaltrials.gov, registration number NCT01694108. [ABSTRACT FROM AUTHOR]

Objective To evaluate adverse reactions of the Bacillus Calmette–Guérin (BCG) Statens Serum Institut (SSI) (Danish strain 1331) used as intervention in a randomized clinical trial. Design A randomized clinical multicenter trial, The Danish Calmette Study, randomizing newborns to BCG or no intervention. Follow-up until 13 months of age. Setting Pediatric and maternity wards at three Danish university hospitals. Participants All women planning to give birth at the three study sites ( n = 16,521) during the recruitment period were invited to participate in the study. Four thousand one hundred and eighty four families consented to participate and 4262 children, gestational age 32 weeks and above, were randomized: 2129 to BCG vaccine and 2133 to no vaccine. None of the participants withdrew because of adverse reactions. Main outcome and measure Trial-registered adverse reactions after BCG vaccination at birth. Follow-up at 3 and 13 months by telephone interviews and clinical examinations. Results Among the 2118 BCG-vaccinated children we registered no cases of severe unexpected adverse reaction related to BCG vaccination and no cases of disseminated BCG disease. Two cases of regional lymphadenitis were hospitalized and thus classified as serious adverse reactions related to BCG. The most severe adverse reactions were 10 cases of suppurative lymphadenitis. This was nearly a fivefold increase compared to what was expected based on the summary of product characteristics of the vaccine. All cases were treated conservatively and recovered. Six of 10 (60%) families of children experiencing suppurative lymphadenitis compared to 117/2071 (6%) of those with no lymphadenitis indicated that the vaccine had more adverse effects than expected ( p -value <0.001). Conclusions and relevance BCG vaccination was associated with only mild morbidity and no mortality. A higher incidence of suppurative lymphadenitis than expected was observed. All children were treated conservatively without sequelae or complications. Trial registration Trial registration number NCT01694108 at www.clinicaltrials.gov [ABSTRACT FROM AUTHOR]

Background Studies from low-income countries report positive non-specific effects of early Bacillus Calmette-Guérin (BCG) immunisation on childhood health and survival. Neonatal immunisation with BCG may prime the immune system and offer partial protection against other infectious and possibly allergic diseases. The potential clinical value of these non-specific effects has not yet been examined in a large randomised trial in high-income countries. Methods The Danish Calmette Study is a multicentre randomised clinical trial conducted between October 2012 and November 2015. Within the first 7 days of life, infants were randomly assigned to intra-dermal vaccination with BCG or no intervention. At 3 and 13 months of age structured telephone interviews and clinical examinations of the children were conducted. In a subgroup of children blood samples were drawn and stool samples collected at age 4 days, 3 and 13 months. Thymus index was assessed by ultrasound in a subgroup at randomisation and at 3 months. The primary study outcome is hospitalisation within the first 15 months of life as assessed in Danish health registers. Secondary outcomes include infectious disease hospitalisations, wheezing, eczema, use of prescribed medication, growth, development, thymus index, T- and B-cell subpopulations assessed by flow cytometry, in vitro cytokine responses and specific antibody responses to other vaccines. Adverse reactions were registered. Discussion With participation of 4184 families and more than 93% adherence to clinical follow-up at 3 and 13 months, this randomised clinical trial has the potential to create evidence regarding non-specific effects of BCG vaccination in a high-income setting. [ABSTRACT FROM AUTHOR]