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Aims/hypothesis: The aim of this systematic review was to develop core outcome sets (COSs) for trials evaluating interventions for the prevention or treatment of gestational diabetes mellitus (GDM). Method(s): We identified previously reported outcomes through a systematic review of the literature. These outcomes were presented to key stakeholders (including patient representatives, researchers and clinicians) for prioritisation using a three-round, e-Delphi study. A priori consensus criteria informed which outcomes were brought forward for discussion at a face-to-face consensus meeting where the COS was finalised. Result(s): Our review identified 74 GDM prevention and 116 GDM treatment outcomes, which were presented to stakeholders in round 1 of the e-Delphi study. Round 1 was completed by 173 stakeholders, 70% (121/173) of whom went on to complete round 2; 84% (102/121) of round 2 responders completed round 3. Twenty-two GDM prevention outcomes and 30 GDM treatment outcomes were discussed at the consensus meeting. Owing to significant overlap between included prevention and treatment outcomes, consensus meeting stakeholders agreed to develop a single prevention/treatment COS. Fourteen outcomes were included in the final COS. These consisted of six maternal outcomes (GDM diagnosis, adherence to the intervention, hypertensive disorders of pregnancy, requirement and type of pharmacological therapy for hyperglycaemia, gestational weight gain and mode of birth) and eight neonatal outcomes (birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, neonatal hypoglycaemia, neonatal death and stillbirth). Conclusions/interpretation: This COS will enable future GDM prevention and treatment trials to measure similar outcomes that matter to stakeholders and facilitate comparison and combination of these studies. Trial registration: This study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (

Background: High Body Mass Index (BMI) and gestational weight gain (GWG) affect an increasing number of pregnancies. The Institute of Medicine (IOM) has issued recommendations on the optimal GWG for women according to their pre-pregnancy BMI (healthy, overweight or obese). It has been shown that pregnant women rarely met the recommendations; however, it is unclear by how much. Previous studies also adjusted the analyses for various women's characteristics making their comparison challenging. Method(s): We analysed individual participant data (IPD) of healthy women with a singleton pregnancy and a BMI of 18.5 kg/m2 or more from the control arms of 36 randomised trials (16 countries). Adjusted odds ratios (aOR) and 95% confidence intervals (CI) were used to describe the association between GWG outside (above or below) the IOM recommendations (2009) and risks of caesarean section, preterm birth, and large or small for gestational age (LGA or SGA) infants. The association was examined overall, within the BMI categories and by quartile of GWG departure from the IOM recommendations. We obtained aOR using mixed-effects logistic regression, accounting for the within-study clustering and a priori identified characteristics. Result(s): Out of 4429 women (from 33 trials) meeting the inclusion criteria, two thirds gained weight outside the IOM recommendations (1646 above; 1291 below). The median GWG outside the IOM recommendations was 3.1 kg above and 2.7 kg below. In comparison to GWG within the IOM recommendations, GWG above was associated with increased odds of caesarean section (aOR 1.50; 95%CI 1.25, 1.80), LGA (2.00; 1.58, 2.54), and reduced odds of SGA (0.66; 0.50, 0.87); no significant effect on preterm birth was detected. The relationship between GWG below the IOM recommendation and caesarean section or LGA was inconclusive; however, the odds of preterm birth (1.94; 1.31, 2.28) and SGA (1.52; 1.18, 1.96) were increased. Conclusion(s): Consistently with previous findings

Objective: Does ovarian hyperstimulation and/or the in vitro procedure of assisted reproduction affect neurodevelopmental and physical health of the offspring? Study design: Infertile couples were randomly allocated to intrauterine insemination with controlled ovarian hyperstimulation (IUI-COH), modified natural cycle in vitro fertilization (IVF-MNC) or single embryo transfer IVF (IVF-SET). We compared neurodevelopmental and physical health in childhood (4-7 years). We used age-appropriate questionnaires to assess behavioral problems (Child Behavior Check List (CBCL)) and executive functioning (Behavior Rating Inventory of Executive Function (BRIEF)). We measured body mass index Z-score, waist- and hip-circumference, body fat percentage, blood pressure Z-scores, pulse wave velocity, glucose, insulin, insulin resistance, total cholesterol, high- and low-density lipoprotein cholesterol, triglycerides, and high sensitivity c-reactive protein. We compared groups by analysis of variance. Result(s): We examined 191 (57%) of the 333 children born in the study at a mean age of 5.5 years (range 4.0-7.6 years). We found no statistically significant differences between randomization groups in children's neurodevelopmental or physical health indices (all p-values > 0.05). Comparing the outcomes between actual method of conception, including a naturally conceived group, also did not show statistically significant differences. Conclusion(s): Although this follow-up study was not powered on childhood outcomes and limited power due to attrition may have hampered detection of subtle effects, we found no indications of differences in neurodevelopmental and physical health between ovarian hyperstimulation and/or the in vitro procedure of assisted reproduction. Future trials should be powered on child outcomes, and aim to optimize follow-up rates to provide answers that are more definitive.Copyright © 2019 Elsevier B.V.

There is increasing evidence linking maternal diet and physical activity before and during pregnancy with offspring's cardiovascular health. Although many studies examined this association, the evidence has not been reviewed systematically. We therefore undertook a systematic review to synthesize evidence examining the association of maternal diet and physical activity before and during pregnancy with offspring's blood pressure and vascular health. We systematically searched the databases MEDLINE and EMBASE from inception to June 30, 2017. Eligibility screening, data extraction and quality assessment were performed by two independent reviewers. A total of 19 articles were included comprising three randomized controlled trials and 16 observational studies. Of the studies that examined the association of interest, 60% (three out of five studies) showed that high maternal carbohydrate intake was associated with higher offspring's blood pressure. Maternal protein intake during pregnancy was negatively associated with offspring carotid intima-media thickness in two out of two studies. No consistent findings for maternal fatty acid intake were found. There were too few studies to draw conclusions on energy intake, fibre intake, protein/carbohydrate ratio, specific foods, dietary patterns and maternal physical activity. Heterogeneity in exposure and outcome assessment hampered pooling. Also, owing to the observational nature of most studies, causality cannot be established. Harmonization of valid exposure and outcome measurements, and the development of core outcome sets are needed to enable more robust conclusions.

Background: The preconceptional period may be an optimal window of opportunity to improve lifestyle. We previously showed that a 6 month preconception lifestyle intervention among women with obesity and infertility was successful in decreasing the intake of high caloric snacks and beverages, increasing physical activity and in reducing weight in the short term. We now report the effects of the preconception lifestyle intervention on diet, physical activity and body mass index (BMI) at 5.5 years (range = 3.7-7.0 years) after the intervention. Methods: We followed women who participated in the LIFEstyle study, a multicentre RCT in which women with obesity and infertility were assigned to a six-month lifestyle intervention program or prompt infertility treatment (N = 577). Diet and physical activity 5.5 years later were assessed with an 173-item food frequency questionnaire (N = 175) and Actigraph triaxial accelerometers (N = 155), respectively. BMI was calculated from self-reported weight and previously measured height (N = 179). Dietary intake, physical activity, and BMI in the intervention and control group were compared using multivariate regression models. Additionally, dietary intake, physical activity and BMI of women allocated to the intervention arm with successful weight loss during the intervention (i.e. BMI < 29 kg/m2 or ≥ 5% weight loss), unsuccessful weight loss and the control group were compared with ANCOVA. Results: Although BMI did not differ between the intervention and control group 5.5 years after the intervention (- 0.5 kg/m2 [- 2.0;1.1]; P = 0.56), the intervention group did report a lower energy intake (- 216 kcal/day [- 417;-16]; P = 0.04). Women in the intervention arm who successfully lost weight during the intervention had a significantly lower BMI at follow-up compared to women in the intervention arm who did not lose weight successfully (- 3.4 kg/m2 [- 6.3;-0.6]; P = 0.01), and they reported a significantly lower energy intake compared to

Aims/hypothesis: Accurate prevalence estimates for gestational diabetes mellitus (GDM) among pregnant women in Europe are lacking owing to the use of a multitude of diagnostic criteria and screening strategies in both high-risk women and the general pregnant population. Our aims were to report important risk factors for GDM development and calculate the prevalence of GDM in a cohort of women with BMI ≥29 kg/m2 across 11 centres in Europe using the International Association of the Diabetes and Pregnancy Study Groups (IADPSG)/WHO 2013 diagnostic criteria. Methods: Pregnant women (n = 1023, 86.3% European ethnicity) with a BMI ≥29.0 kg/m2 enrolled into the Vitamin D and Lifestyle Intervention for GDM Prevention (DALI) pilot, lifestyle and vitamin D studies of this pan-European multicentre trial, attended for an OGTT during pregnancy. Demographic, anthropometric and metabolic data were collected at enrolment and throughout pregnanc

Background: The prevalence of gestational diabetes mellitus (GDM) is increasing worldwide. GDM and the risks associated with GDM lead to increased health care costs and losses in productivity. The objective of this study is to evaluate whether the FitFor2 exercise program during pregnancy is cost-effective from a societal perspective as compared to standard care.Methods: A randomised controlled trial (RCT) and simultaneous economic evaluation of the FitFor2 program were conducted. Pregnant women at risk for GDM were randomised to an exercise program to prevent high maternal blood glucose (n = 62) or to standard care (n = 59). The exercise program consisted of two sessions of aerobic and strengthening exercises per week. Clinical outcome measures were maternal fasting blood glucose levels, insulin sensitivity and infant birth weight. Quality of life was measured using the EuroQol 5-D and quality-adjusted life-years (QALYs) were calculated. Resource utilization and sick leave data were collected by questionnaires. Data were analysed according to the intention-to-treat principle. Missing data were imputed using multiple imputations. Bootstrapping techniques estimated the uncertainty surrounding the cost differences and incremental cost-effectiveness ratios.Results: There were no statistically significant differences in any outcome measure. During pregnancy, total health care costs and costs of productivity losses were statistically non-significant (mean difference €1308; 95%CI €-229 - €3204). The cost-effectiveness analyses showed that the exercise program was not cost-effective in comparison to the control group for blood glucose levels, insulin sensitivity, infant birth weight or QALYs.Conclusion: The twice-weekly exercise program for pregnant women at risk for GDM evaluated in the present study was not cost-effective compared to standard care. Based on these results, implementation of this exercise program for the prevention of GDM cannot be recommended.Trial regist

Background: In 2006, the Dutch government initiated Hello World, an email-based program promoting healthy lifestyles among pregnant women through quizzes with pregnancy-related questions. In 2008, an updated version was released. The present study aimed to (1) examine the reach of Hello World and the representativeness of its users for all pregnant women in the Netherlands, (2) explore the relationship between program engagement and lifestyle characteristics, and (3) explore the relationship between the program content participants accessed (content on smoking, physical activity, and nutrition) and their lifestyle characteristics. Methods. Data from 4,363 pregnant women were included. After registration, women received an online questionnaire with demographic and lifestyle questions. To evaluate their representativeness, their demographic characteristics were compared with existing data for Dutch (pregnant) women. Women were classified on the following lifestyle characteristics: smoking, nutrition, physical activity, and pre-pregnancy weight status. Program use was tracked and the relationships between lifestyle characteristics, program engagement, and the percentage of smoking, physical activity, and nutrition questions accessed after opening a quiz were explored using Mann-Whitney U tests and Kruskal-Wallis tests. Results: Hello World reached 4% of its target population. Ten percent of participants were low educated and 22% immigrants. On average, women received 6.1 (SD:2.8) quiz emails and opened 32% of the associated quizzes (2.0, SD:2.1). A significant positive association was found between the number of quizzes opened and the number of healthy lifestyle characteristics. After opening a quiz, women accessed most smoking, nutrition, and physical activity questions. Significant relationships were found between several lifestyle characteristics and the percentage of smoking, physical activity, and nutrition questions accessed. However, between-group differences we

Background: Working women of childbearing age are a vital part of the population. Following childbirth, this group of women can experience a myriad of physical and mental health problems that can interfere with their ability to work. Currently, there is little known about cost-effective post-partum interventions to prevent work disability. The purpose of the study was to evaluate whether supervisor telephone contact (STC) during maternity leave is cost-effective from a societal perspective in reducing sick leave and improving quality-adjusted life years (QALYs) compared to common practice (CP). Methods. We conducted an economic evaluation alongside a randomized controlled trial. QALYs were measured by the EuroQol 5-D, and sick leave and presenteeism by the Health and work Performance Questionnaire. Resource use was collected by questionnaires. Data were analysed according to intention-to-treat. Missing data were imputed via multiple imputation. Uncertainty was estimated by 95% confidence intervals, cost-utility planes and curves, and sensitivity analyses. Results: 541 working women from 15 companies participated. Response rates were above 85% at each measurement moment. At the end of the follow-up, no statistically significant between-group differences in QALYs, mean hours of sick leave or presenteeism or costs were observed. STC was found to be less effective and more costly. For willingness-to-pay levels from 0 through 50,000, the probability that STC was cost-effective compared to CP was 0.2. Overall resource use was low. Mean total costs were 3678 (95% CI: 3386; 3951). Productivity loss costs represented 37% of the total costs and of these costs, 48% was attributable to sick leave and 52% to work presenteeism. The cost analysis from a company's perspective indicated that there was a net cost associated with the STC intervention. Conclusions: STC was not cost-effective compared to common practice for a healthy population of working mothers; therefore, implementat

The objective of this study was to examine the relationship between physical and psychological risk factors on the one hand, and the occurrence of new episodes of back pain on the other hand. A prospective study was conducted with 12 months follow-up by means of self-administered questionnaires. The study took place in the Cargo Department of a major Dutch airline company. The subjects for this study were 270 workers involved in heavy physical work. Only workers without back pain at baseline were included. Self-reported back pain and sick leave due to back pain during the follow-up period were measured. Of the 238 workers included in the analysis, 73 (31%) developed a new episode of back pain during the follow-up period, and 27 (11%) subjects reported sick leave due to back pain. Multiple logistic regression analysis showed that the history of back pain was the best predictor for the occurrence of a new episode of back pain during follow-up (OR 9.8; 95% CI 2.8-34.4 for subjects who had back pain more than twice in the past year). Low job satisfaction was also associated with an increased risk for the occurrence of back pain during follow-up (OR 1.2; 95% CI 1.01-1.4). Riding a forklift truck appeared to be a protective factor for the occurrence of back pain (OR 0.7; 95% CI 0.5-0.99). In this study the best predictors for the occurrence of back pain were the history of back complaints and low job satisfaction. Although it needs to be confirmed by future intervention studies, the results indicate that increasing job satisfaction may be a successful (co-)intervention for the prevention of back pain at the workplace. Copyright (C) 1998 International Association for the Study of Pain. Published by Elsevier Science B.V.