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Background: Gestational diabetes mellitus (GDM) is associated with perinatal health risks to both mother and offspring, and represents a large economic burden. The DALI study is a multicenter randomized controlled trial, undertaken to add to the knowledge base on the effectiveness of interventions for pregnant women at increased risk for GDM. The purpose of this study was to evaluate the cost-effectiveness of the healthy eating and/or physical activity promotion intervention compared to usual care among pregnant women at increased risk of GDM from a societal perspective.Methods: An economic evaluation was performed alongside a European multicenter-randomized controlled trial. A total of 435 pregnant women at increased risk of GDM in primary and secondary care settings in nine European countries, were recruited and randomly allocated to a healthy eating and physical activity promotion intervention (HE + PA intervention), a healthy eating promotion intervention (HE intervention), or a physical activity promotion intervention (PA intervention). Main outcome measures were gestational weight gain, fasting glucose, insulin resistance (HOMA-IR), quality adjusted life years (QALYs), and societal costs.Results: Between-group total cost and effect differences were not significant, besides significantly less gestational weight gain in the HE + PA group compared with the usual care group at 35–37 weeks (−2.3;95%CI:-3.7;-0.9). Cost-effectiveness acceptability curves indicated that the HE + PA intervention was the preferred intervention strategy. At 35–37 weeks, it depends on the decision-makers' willingness to pay per kilogram reduction in gestational weight gain whether the HE + PA intervention is cost-effective for gestational weight gain, whereas it was not cost-effective for fasting glucose and HOMA-IR. After delivery, the HE + PA intervention was cost-effective for QALYs, which was predominantly caused by a large reduction in delivery-related costs.Conclusions: Healthy eating and physical activity promotion was found to be the preferred strategy for limiting gestational weight gain. As this intervention was cost-effective for QALYs after delivery, this study lends support for broad implementation.Trial registration: ISRCTN ISRCTN70595832. Registered 2 December 2011.

Background: Process evaluation is an essential part of designing and assessing complex interventions. The vitamin D and lifestyle intervention study (DALI) study is testing different strategies to prevent development of gestational diabetes mellitus among European obese pregnant women with a body mass index ≥29 kg/m2. The intervention includes guidance on physical activity and/or healthy eating by a lifestyle coach trained in motivational interviewing (MI). The aim of this study was to assess the process elements: reach, dose delivered, fidelity and satisfaction and to investigate whether these process elements were associated with changes in gestational weight gain (GWG).Methods: Data on reach, dose delivered, fidelity, and satisfaction among 144 participants were collected. Weekly recruitment reports, notes from meetings, coach logs and evaluation questionnaires (n = 110) were consulted. Fidelity of eight (out of twelve) lifestyle coach practitioners was assessed by analysing audio recorded counselling sessions using the MI treatment integrity scale. Furthermore, associations between process elements and GWG were assessed with linear regression analyses.Results: A total of 20% of the possible study population (reach) was included in this analysis. On average 4.0 (of the intended 5) face-to-face sessions were delivered. Mean MI fidelity almost reached 'expert opinion' threshold for the global scores, but was below 'beginning proficiency' for the behavioural counts. High variability in quality of MI between practitioners was identified. Participants were highly satisfied with the intervention, the lifestyle coach and the intervention materials. No significant associations were found between process elements and GWG.Conclusion: Overall, the intervention was well delivered and received by the study population, but did not comply with all the principles of MI. Ensuring audio recording of lifestyle sessions throughout the study would facilitate provision of individualized feedback to improve MI skills. A larger sample size is needed to confirm the lack of association between process elements and GWG.Trial registration: ISRCTN registry: ISRCTN70595832; Registered 12 December 2011.

Altres ajuts: The project described has received funding from the European Community's 7th Framework Programme (FP7/2007-2013) under grant agreement no. 242187. In the Netherlands, additional funding was provided by the Netherlands Organization for Health Research and Development (ZonMw) (grant no. 200310013). In Poland, additional funding was obtained from Polish Ministry of Science (grant no. 2203/7. PR/2011/2). In Denmark, additional funding was provided by the Odense University Free Research Fund. In the United Kingdom, the DALI team acknowledge the support received from the NIHR Clinical Research Network: Eastern, especially the local diabetes clinical and research teams based in Cambridge. In Spain, additional funding was provided by CAIBER 1527-B-226. The funders had no role in any aspect of the study beyond funding. A better understanding of what drives behaviour change in obese pregnant overweight women is needed to improve the effectiveness of lifestyle interventions in this group at risk for gestational diabetes (GDM). Therefore, we assessed which factors mediated behaviour change in the Vitamin D and Lifestyle Intervention for GDM Prevention (DALI) Lifestyle Study. A total of 436 women, with pre-pregnancy body mass index ≥29 kg/m , ≤19 + 6 weeks of gestation and without GDM, were randomised for counselling based on motivational interviewing (MI) on healthy eating and physical activity, healthy eating alone, physical activity alone, or to a usual care group. Lifestyle was measured at baseline, and at 24-28 and 35-37 weeks of gestation. Outcome expectancy, risk perception, task self-efficacy and social support were measured at those same time points and considered as possible mediators of intervention effects on lifestyle. All three interventions resulted in increased positive outcome expectancy for GDM reduction, perceived risk to the baby and increased task self-efficacy. The latter mediated intervention effects on physical activity and reduced sugared drink consumption. In conclusion, our MI intervention was successful in increasing task self-efficacy, which was related to improved health behaviours.

Background Women with a history of bariatric surgery are recommended to avoid pregnancy at least 12 months after surgery. Evidence on the impact of bariatric surgery on contraception, menstrual cycle, and sexuality in the first year postoperative is therefore indispensable. Objectives The objective of this paper is to prospectively study changes in contraception, menstrual cycle and sexuality in women of reproductive age following bariatric surgery. Setting The study was conducted in two secondary medical centers and a tertiary academic medical center. Methods Women attending for bariatric surgery or who recently underwent bariatric surgery completed online questionnaires about contraception, menstrual cycle, and sexual behavior before surgery and 6 and 12 months after surgery. Results The study included data from 71 women, including 70 and 47 women at 6 and 12 months after bariatric surgery, respectively. Preoperatively, 43.6% (n = 31/71) used a short-acting hormonal contraceptive, the usage of which decreased significantly to, respectively, 32.8% (n = 23/70; p = .031) and 27.7% (n = 13/47; p = .022) 6 and 12 months post-surgery. Usage of long-acting contraceptive methods increased from 26.7% (n = 19/71) preoperatively to 38.6% (n = 27/70; p = .021) and 42.6% (n = 20/47; p = .004) at 6 and 12 months. Combined oral contraceptives (COC) remained used (39.4% preoperatively, 27.1 and 14.9% at 6 and 12 months postoperatively). Menstrual cycle (frequency, pattern, duration of the cycle, and the menstruation itself) and sexual behavior (intimate relationship, frequency of intercourse, and satisfaction) did not differ significantly before and after surgery. Conclusions Women undergoing bariatric surgery appear to switch their type of contraceptive from oral, short-acting hormonal contraceptives to non-oral, long-acting contraceptives. No changes in menstrual cycle and sexual behavior were shown.

Background: Depression during pregnancy is associated with higher maternal morbidity and mortality, and subsequent possible adverse effects on the cognitive, emotional and behavioral development of the child. The aim of the study was to identify maternal characteristics associated with poor mental health, in a group of overweight/obese pregnant women in nine European countries, and thus, to contribute to better recognition and intervention for maternal depression.Methods: In this cross-sectional observational study, baseline data from early pregnancy (< 20 weeks) of the DALI (Vitamin D and Lifestyle Intervention for gestational diabetes mellitus prevention) study were analyzed. Maternal mental health was assessed with the World Health Organization Well-Being Index (WHO–5). Women were classified as having a low (WHO–5 ≤ 50) or high wellbeing.Results.: A total of 735 pregnant women were included. The prevalence of having a low wellbeing was 27.2%, 95% CI [24.0, 30.4]. Multivariate analysis showed independent associations between low wellbeing and European ethnicity, OR = .44, 95% CI [.25, .77], shift work, OR = 1.81, 95% CI [1.11, 2.93], insufficient sleep, OR = 3.30, 95% CI [1.96, 5.55], self-efficacy, OR = .95, 95% CI [.92, .98], social support, OR = .94, 95% CI [.90, .99], and pregnancy-related worries (socioeconomic: OR = 1.08, 95% CI [1.02, 1.15]; health: OR = 1.06, 95% CI [1.01, 1.11]; relationship: OR = 1.17, 95% CI [1.05, 1.31]).Conclusions: Mental health problems are common in European overweight/obese pregnant women. The identified correlates might help in early recognition and subsequent treatment of poor mental health problems during pregnancy. This is important to reduce the unfavorable effects of poor mental health on pregnancy outcomes.Trial registration: ISRCTN70595832, 02.12.2011.

Pregnant and postpartum women with a history of bariatric surgery are at risk of micronutrient deficiencies as a result of the combination of physiologic changes related to pregnancy and iatrogenic postoperative alterations in the absorption and metabolism of crucial nutrients. This systematic review investigates micronutrient deficiencies and related adverse clinical outcomes in pregnant and postpartum women after bariatric surgery. A systematic approach involving critical appraisal was conducted independently by 2 researchers to examine deficiencies of phylloquinone, folate, iron, calcium, zinc, magnesium, iodide, copper, and vitamins A, D, and B-12 in pregnant and postpartum women after bariatric surgery, together with subsequent outcomes in the neonates. The search identified 29 relevant cases and 8 cohort studies. The quality of reporting among the case reports was weak according to the criteria based on the CARE (CAse REporting) guidelines as was that for the cohort studies based on the criteria from the Cohort Study Quality Assessment list of the Dutch Cochrane Center. The most common adverse neonatal outcomes related to maternal micronutrient deficiencies include visual complications (vitamin A), intracranial hemorrhage (phylloquinone), neurological and developmental impairment (vitamin B-12), and neural tube defects (folate). On the basis of the systematically collected information, we conclude that the evidence on micronutrient deficiencies in pregnant and postpartum women after bariatric surgery and subsequent adverse neonatal outcomes remains weak and inconclusive.

Background The expansion of the obesity epidemic is accompanied with an increase in bariatric procedures, in particular in women of reproductive age. The weight loss induced by the surgery is believed to reverse the negative impact of overweight and obesity on female reproduction, however, research is limited to in particular retrospective cohort studies and a growing number of small case-series and case-(control) studies.

Materials and methods A cross-sectional study was conducted at the maternity units of the University Hospital of Leuven, Belgium. Postpartum women, who delivered a term (≥37 weeks of gestation), did not smoke, were normoglycaemic and who were not on predefined medication, were invited to participate. Participants completed a 24 dietary recall and donated a breast milk sample of 1.5-2cl at day 4 post-delivery. The samples were collected during the first feeding in the morning by use of a vacuum pump. Each sample was analyzed for macronutrients (carbohydrates, protein, fats) and energy with the MIRIS Human Milk Analyzer. The prepregnancy weight and length were assessed from the online medical patient file to calculate the pre-pregnancy BMI. Further baseline characteristics included maternal age, ethnicity and parity. Pregnancy outcomes included delivery mode, the use of combined spinal epidural, gestational age, birth weight and gender of the baby.