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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: Anxiety and depression levels are higher in obese compared to those in normal weight pregnant women. The aims of this study are to examine anxiety and depression in pregnancy following bariatric surgery and to compare with obese pregnant controls considering the dietary intake of polyunsaturated fatty acids (PUFA), folate, and vitamin B12. METHODS: Anxiety (State-Trait Anxiety Inventory) and depression (Edinburgh Postnatal Depression Scale) were examined in the first (T1) and third (T3) pregnancy trimester in 54 women with bariatric surgery and 25 obese. T1 and T3 dietary intake of PUFA, folate, and vitamin B12 intake was assessed using a 3-day food record. Mixed models with a compound symmetry covariance structure and regression models were applied. RESULTS: About half of the women with surgery had high state and trait anxiety scores (≥ 40), which did not significantly change during pregnancy. Every 10-kg postoperative weight loss was associated with an increase in T1 state and trait anxiety with respectively 2.7 and 2.3 points. A smoking woman had a 8.6-point higher state anxiety score than a non-smoking woman in T1. In T3, every additional hour of sleep was associated with a decrease in trait anxiety score with 1.59 points. Anxiety and depression scores were not associated with and could not be explained by inadequate PUFAs, folate, and vitamin B12 intakes. Anxiety scores were higher following surgery than those in untreated obesity at both time points. CONCLUSION: Pregnancy following bariatric surgery induces high levels of anxiety that are not associated with an inadequate maternal diet. ispartof: Obesity Surgery vol:28 issue:6 pages:1629-1635 ispartof: location:United States status: published

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.

OBJECTIVE: Self-management is a core theme within chronic care and several evidence-based interventions (EBIs) exist to promote self-management ability. However, these interventions cannot be adapted in a mere copy-paste manner. The current study describes and demonstrates a planned approach in adapting EBI's in order to promote self-management in community-dwelling people with chronic conditions. METHODS: We used Intervention Mapping (IM) to increase the intervention's fit with a new context. IM helps researchers to take decisions about whether and what to adapt, while maintaining the working ingredients of existing EBI's. RESULTS: We present a case study in which we used IM to adapt EBI's to the Flemish primary care context to promote self-management in people with one or more chronic disease. We present the reader with a contextual analysis, intervention aims, and content, sequence and scope of the resulting intervention. CONCLUSION: IM provides an excellent framework in providing detailed guidance on intervention adaption to a new context, while preserving the essential working ingredients of EBI's. PRACTICE IMPLICATIONS: The case study is exemplary for public health researchers and practitioners as a planned approach to seek and find EBI's, and to make adaptations. Query date: 2019-12-23 16:38:43 https://www.sciencedirect.com/science/article/pii/S0738399119304379?via%3Dihub ispartof: Patient Education And Counseling vol:103 issue:3 pages:589-596 ispartof: location:Ireland status: published

Altres ajuts: Funding 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 Organisation for Health Research and Development (ZonMw) (grant no. 200310013). In Poland, additional funding was obtained from the Polish Ministry of Science (grant no. 2203/7, PR/2011/2). In Denmark, additional funding was provided by Odense University Free Research Fund. In the UK, the DALI team acknowledges the support received from the National Institute for Health Research Clinical Research Network Eastern, especially the local diabetes clinical and research teams based in Cambridge. In Spain, additional funding was provided by CAIBER (Consorcio de Apoyo a la Investigación Biomédica en Red; 1527-B-226). The funders had no role in any aspect of the study beyond funding. Aims/hypothesis: Offspring of obese women are at increased risk of features of the metabolic syndrome, including obesity and diabetes. Lifestyle intervention in pregnancy might reduce adverse effects of maternal obesity on neonatal adiposity. Methods: In the Vitamin D And Lifestyle Intervention for Gestational Diabetes Mellitus (GDM) Prevention (DALI) lifestyle trial, 436 women with a BMI ≥29 kg/m were randomly assigned to counselling on healthy eating (HE), physical activity (PA) or HE&PA, or to usual care (UC). In secondary analyses of the lifestyle trial, intervention effects on neonatal outcomes (head, abdominal, arm and leg circumferences and skinfold thicknesses, estimated fat mass, fat percentage, fat-free mass and cord blood leptin) were assessed using multilevel regression analyses. Mediation of intervention effects by lifestyle and gestational weight gain was assessed. Results: Outcomes were available from 334 neonates. A reduction in sum of skinfolds (−1.8 mm; 95% CI −3.5, −0.2; p = 0.03), fat mass (−63 g; 95% CI −124, −2; p = 0.04), fat percentage (−1.2%; 95% CI −2.4%, −0.04%; p = 0.04) and leptin (−3.80 μg/l; 95% CI −7.15, −0.45; p = 0.03) was found in the HE&PA group, and reduced leptin in female neonates in the PA group (−5.79 μg/l; 95% CI −11.43, −0.14; p = 0.05) compared with UC. Reduced sedentary time, but not gestational weight gain, mediated intervention effects on leptin in both the HE&PA and PA groups. Conclusions/interpretation: The HE&PA intervention resulted in reduced adiposity in neonates. Reduced sedentary time seemed to drive the intervention effect on cord blood leptin. Implications for future adiposity and diabetes risk of the offspring need to be elucidated. Trial registration: ISRCTN70595832.

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.

To assess maternal and fetal outcomes of pregnancies complicated by internal herniation after Roux-en-Y gastric bypass.Articles were identified through searches in online databases (ClinicalTrials.gov, MEDLINE, EMBASE, PubMed, and Google Scholar) from January 1980 to March 2015 for the following terms: [gastric bypass OR bariatric surgery] AND [pregnancy] AND [complication OR herniation OR obstruction]. Reference lists of relevant articles were hand-searched. Additionally, we searched our own hospital's obstetric database for cases of internal herniation after Roux-en-Y gastric bypass.Only articles in English and studies in humans were selected. Cases of internal herniation outside of pregnancy or internal herniation without a history of Roux-en-Y gastric bypass were excluded. Of 384 articles identified by the initial search, 22 were retained for further analysis.All retrieved articles were case reports or case series. There were no interventional studies. We retrieved 47 cases from the literature and five cases from our own database. The mean gestational age at diagnosis was 28.4±7.3 weeks. All women presented with abdominal pain. Nausea and vomiting were present in only 65%. Ultrasonography and laboratory results are usually noninformative, and computed tomography or magnetic resonance imaging confirmed the diagnosis in only 75% of cases. Nine of 52 women (17.3%) required bowel resections. There were two maternal deaths and three perinatal deaths, all in women treated later than 48 hours after onset of the symptoms.Internal herniation complicating pregnancy after Roux-en-Y gastric bypass typically presents with subtle signs in the third trimester of pregnancy. Timely recognition and early surgical intervention are associated with a reduced risk of bowel ischemia and maternal and fetal adverse outcomes.

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.

Unit costs used for valuing resource use in the main analysis. (DOCX 493 kb)

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.

Background: The breast-milk composition in the first 6 wk postpartum of women who have undergone bariatric surgery (BS) is unknown. Objective: The aim of this study was to examine 1) the breast-milk macronutrient and vitamin A composition in women who had and who had not undergone BS and 2) the impact of maternal diet on the breast-milk composition. We hypothesized that the milk of women who had undergone BS would be less energy dense and have a lower vitamin A concentration than that of other women. Methods: A multicenter prospective substudy was conducted at 2 university hospitals. Breast-milk samples were collected from 24 normal-weight [NW; mean ± SD body mass index (BMI; kg/m2): 21.5 ± 1.7; mean ± SD age: 29 ± 6 y], 39 overweight (OW; BMI: 26.9 ± 1.5; aged 29 ± 5 y), and 12 obese women (BMI: 35.0 ± 5.7; aged 29 ± 5 y) as well as from 11 women who had undergone BS (BMI: 28.0 ± 4.4; aged 30 ± 4 y) from day 3 until week 6 of lactation. Milk energy and macronutrients (Human Milk Analyzer; Miris) and vitamin A concentrations (iCheck Fluoro; BioAnalyt) were determined at the end of each week. Maternal diet (food-frequency questionnaire) and physical activity (Kaiser Physical Activity Survey) were measured during the third trimester of pregnancy and on day 3 or 4 and during week 6 of lactation. Statistical analyses include 1-factor ANOVA, Spearman and Pearson correlations, and multiple linear regression. Results: In all women, a weekly increase in milk energy, total fat, and total carbohydrates was seen, whereas a weekly decrease in proteins and vitamin A was found during the first 2 wk of lactation, followed by a stable concentration of all nutrients. At week 4, milk protein concentrations were higher in women who had undergone BS (14 g/L) compared with NW (8 g/L; P = 0.005) and OW (9 g/L; P = 0.019) women. At week 5, milk carbohydrate concentrations were higher in women who had undergone BS (74 g/L) compared with NW women (68 g/L; P = 0.042). Conclusions: Breast milk of women who have undergone BS appears to be adequate in energy, macronutrients, and vitamin A during the first 6 wk of lactation. This supports the conclusion that breast feeding should not be discouraged in this group of women. This trial was registered at http://www.clinicaltrials.gov as NCT02515214. ispartof: The Journal of Nutrition vol:148 issue:7 pages:1096-1102 ispartof: location:United States status: Published online

Lifestyle process evaluation questionnaire. Process evaluation questions to gather reasons for participation and satisfaction with the DALI lifestyle study. (PDF 137Â kb)

The spelling of author name Jill Shawe was incorrect in the original article. It is correct here.

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. AURORA is a multicenter prospective cohort study. The main objective is to collect long-term data on reproductive outcomes before and after bariatric surgery and in a subsequent pregnancy. Women aged 18–45 years are invited to participate at 4 possible inclusion moments: 1) before surgery, 2) after surgery, 3) before 15 weeks of pregnancy and 4) in the immediate postpartum period (day 3–4). Depending on the time of inclusion, data are collected before surgery (T1), 3 weeks and 3, 6, 12 or x months after surgery (T2-T5) and during the first, second and third trimester of pregnancy (T6-T8), at delivery (T9) and 6 weeks and 6 months after delivery (T10-T11). Online questionnaires are send on the different measuring moments. Data are collected on contraception, menstrual cycle, sexuality, intention of becoming pregnant, diet, physical activity, lifestyle, psycho-social characteristics and dietary supplement intake. Fasting blood samples determine levels of vitamin A, D, E, K, B-1, B-12 and folate, albumin, total protein, coagulation parameters, magnesium, calcium, zinc and glucose. Participants are weighted every measuring moment. Fetal ultrasounds and pregnancy course and complications are reported every trimester of pregnancy. Breastfeeding is recorded and breast milk composition in the postpartum period is studied. AURORA is a multicenter prospective cohort study extensively monitoring women before undergoing bariatric surgery until a subsequent pregnancy and postpartum period. Retrospectively registered (July 2015 - NCT02515214 )

OBJECTIVE Ways to prevent gestational diabetes mellitus (GDM) remain unproven. We compared the impact of three lifestyle interventions (healthy eating [HE], physical activity [PA], and both HE and PA [HE+PA]) on GDM risk in a pilot multicenter randomized trial. RESEARCH DESIGN AND METHODS Pregnant women at risk for GDM (BMI ≥29 kg/m2) from nine European countries were invited to undertake a 75-g oral glucose tolerance test before 20 weeks' gestation. Those without GDM were randomized to HE, PA, or HE+PA. Women received five face-to-face and four optional telephone coaching sessions, based on the principles of motivational interviewing. A gestational weight gain (GWG) RESULTS Among the 150 trial participants, 32% developed GDM by 35–37 weeks and 20% achieved GWG CONCLUSIONS An antenatal HE intervention is associated with less GWG and lower fasting glucose compared with PA alone. These findings require a larger trial for confirmation but support the use of early HE interventions in obese pregnant women.

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.

Context: Lifestyle approaches for preventing gestational diabetes mellitus (GDM) have produced mixed results. Objective: The aim of the present study was to compare the effectiveness of 3 lifestyle interventions [healthy eating (HE), physical activity (PA), and both HE and PA (HE+PA)] with usual care (UC) in reducing GDM risk. Design: The present study was a multicenter randomized controlled trial conducted from 2012 to 2014 [the DALI (vitamin D and lifestyle intervention for GDM prevention) lifestyle study]. Setting: The study occurred at antenatal clinics across 11 centers in 9 European countries. Patients: Consecutive pregnant women at,20 weeks of gestation with a body mass index (BMI) of >= 29 kg/m(2) and without GDM using the International Association of Diabetes and Pregnancy Study Group criteria (n = 436). For the intervention, women were randomized, stratified by site, to UC, HE, PA, or HE+PA. The women received 5 face-to-face and = 29 kg/m(2).

Background Gestational diabetes mellitus (GDM) is an increasing problem world-wide. Lifestyle interventions and/or vitamin D supplementation might help prevent GDM in some women. Methods/design Pregnant women at risk of GDM (BMI≥29 (kg/m2)) from 9 European countries will be invited to participate and consent obtained before 19+6 weeks of gestation. After giving informed consent, women without GDM will be included (based on IADPSG criteria: fasting glucose Discussion DALI is a unique Europe-wide randomised controlled trial, which will gain insight into preventive measures against the development of GDM in overweight and obese women. Trial registration ISRCTN70595832

Background Studies report frequent micronutrient deficiencies after bariatric surgery, but less is known about micronutrient levels of pregnant women after bariatric surgery. Objective To prospectively evaluate micronutrient levels and supplement intake in pregnancy following bariatric surgery. Design A multicenter prospective cohort study including women with restrictive or malabsorptive types of bariatric surgery. Nutritional deficiencies, together with supplement intake, were screened during pregnancy. Results The total population included 18 women in the restrictive and 31 in the malabsorptive group. Most micronutrients were depleted and declined significantly during pregnancy. The proportion of women with low vitamin A and B-1 levels increased to respectively 58 and 17% at delivery (P = 0.005 and 0.002). The proportion of women with vitamin D deficiency decreased from 14% at trimester 1 to 6% at delivery (P = 0.030). Mild anemia was found in respectively 22 and 40% of the women at trimester 1 and delivery. In the first trimester, most women took a multivitamin (57.1%). In the second and third trimester, the majority took additional supplements (69.4 and 73.5%). No associations were found between supplement intake and micronutrient deficiencies. Conclusion Pregnant women with bariatric surgery show frequent low micronutrient levels. Supplementation partially normalizes low levels of micronutrients.

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.

Results of the sensitivity analyses. (DOCX 116 kb)

CONSORT 2010 checklist of information to include when reporting a randomized trial. (DOC 217 kb)

TIDieR (Template for Intervention Description and Replication) Checklist. (DOCX 39 kb)

CONSORT 2010 checklist of information to include when reporting a randomized trial. (DOC 217 kb)

TIDieR (Template for Intervention Description and Replication) Checklist. (DOCX 39 kb)

Results of the sensitivity analyses. (DOCX 116 kb)