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Improving cardiometabolic and mental health in women with gestational diabetes mellitus and their offspring: study protocol for MySweetHeart Trial, a randomised controlled trial.

ABSTRACT: INTRODUCTION:Gestational diabetes mellitus (GDM) carries prenatal and perinatal risk for the mother and her offspring as well as longer-term risks for both the mother (obesity, diabetes, cardiovascular disease) and her child (obesity, type 2 diabetes). Compared with women without GDM, women with GDM are twice as likely to develop perinatal or postpartum depression. Lifestyle interventions for GDM are generally limited to physical activity and/or nutrition, often focus separately on the mother or the child and take place either during or after pregnancy, while their results are inconsistent. To increase efficacy of intervention, the multifactorial origins of GDM and the tight link between mental and metabolic as well as maternal and child health need to be heeded. This calls for an interdisciplinary transgenerational approach starting in, but continuing beyond pregnancy. METHODS AND ANALYSIS:This randomised controlled trial will assess the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention aimed at improving the metabolic and mental health of 200 women with GDM and their offspring. Women with GDM at 24-32 weeks gestational age who understand French or English, and their offspring and partners can participate. The intervention components will be delivered on top of usual care during pregnancy and the first year postpartum. Metabolic and mental health outcomes will be measured at 24-32 weeks of pregnancy, shortly after birth and at 6-8 weeks and 1 year after childbirth. Data will be analysed using intention-to-treat analyses. The MySweetHeart Trial is linked to the MySweetHeart Cohort (clinicaltrials.gov/ct2/show/NCT02872974). ETHICS AND DISSEMINATION:We will disseminate the findings through regional, national and international conferences and through peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT02890693; Pre-results.

SUBMITTER: Horsch A

PROVIDER: S-EPMC5855393 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Improving cardiometabolic and mental health in women with gestational diabetes mellitus and their offspring: study protocol for <i>MySweetHeart Trial</i>, a randomised controlled trial.

Horsch Antje A Gilbert Leah L Lanzi Stefano S Gross Justine J Kayser Bengt B Vial Yvan Y Simeoni Umberto U Hans Didier D Berney Alexandre A Scholz Urte U Barakat Ruben R Puder Jardena J JJ

BMJ open 20180227 2

<h4>Introduction</h4>Gestational diabetes mellitus (GDM) carries prenatal and perinatal risk for the mother and her offspring as well as longer-term risks for both the mother (obesity, diabetes, cardiovascular disease) and her child (obesity, type 2 diabetes). Compared with women without GDM, women with GDM are twice as likely to develop perinatal or postpartum depression. Lifestyle interventions for GDM are generally limited to physical activity and/or nutrition, often focus separately on the m ...[more]

PMID: 29487077

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Project description:ObjectiveTo test the effect of a complex, interdisciplinary, lifestyle and psychosocial intervention on metabolic and mental health outcomes in women with gestational diabetes mellitus during pregnancy and in the post partum.DesignSingle centred, single blinded, randomised, controlled trial (the MySweetheart trial).SettingLausanne University Hospital, Switzerland, from 2 September 2016 to 25 October 2021.Participants211 women aged at least 18 years with a diagnosis of gestational diabetes mellitus at 24-32 gestational weeks were randomly assigned (1:1) to the intervention (n=105) or to usual care (n=106).InterventionsIn addition to a comparator based on active guidelines for prepartum and postpartum usual care, the intervention consisted of four individual lifestyle visits during pregnancy and four interdisciplinary visits in the postpartum group, a peer support group workshop in pregnancy and post partum, and a bimonthly lifestyle coach support through telemedicine. The intervention focused on tailored behavioural and psychosocial strategies to improve diet, physical activity, mental health, social support, and adherence to gestational weight gain during pregnancy and weight retention recommendations.Main outcome measuresPrimary outcomes were between-group differences in the decrease in maternal weight and depression symptom scores between baseline and one year post partum. Secondary outcomes included changes in total and central body fat, anxiety, wellbeing, glycaemic parameters (homeostatic model assessment for insulin resistance (known as HOMA-IR) and Matsuda indices), aerobic fitness (maximal oxygen uptake), gestational weight gain, and weight retention. Assessors were blinded to primary and secondary outcomes.Results84 (80%) of 105 women in the intervention and 95 (90%) of 106 in the usual care completed the study. There was not enough evidence of a difference in the decrease in weight (mean difference -0.38 kg (95% confidence interval -2.08 to 1.30)) or depression scores (-0.67 (-1.84 to 0.49)). The intervention led to an increase in fat-free mass (0.02 kg (0.01 to 0.03)). The intervention also decreased gestational weight gain since the first gestational diabetes mellitus visit (-1.20 kg (-2.14 to -0.26)) and weekly weight gain throughout the entire pregnancy (-0.14 kg (-0.25 to -0.03)), and led to a higher proportion of women without weight retention at one year post partum (34.1% (28/82) v 20.8% (20/96), P=0.034).ConclusionsCompared with active usual care based on guidelines, there was not enough evidence to conclude that the intervention led to decrease in weight or depression symptoms. However, the intervention decreased gestational weight gain and increased the proportion of women without weight retention.Trial registrationClinicaltrials.gov NCT02890693.

Project description:BackgroundHyperglycaemic disorders of pregnancy are associated with offspring cardiovascular alterations.MethodsMySweetHeart cohort study aimed to assess the effect of maternal gestational diabetes (GDM) on offsprings' cardiovascular health. Newborns underwent clinical and echocardiographic examinations between 2016 and 2020.ResultsCompared to mothers without GDM (n = 141), mothers with GDM (n = 123) were more likely to have had GDM in previous pregnancies and had higher weight, BMI, blood glucose, and HbA1c. Newborns of both groups showed similar clinical characteristics. Echocardiography was performed on the 3rd (interquartile range, IQR, 2nd-4th) day of life in 101 offsprings of mothers without and 116 offsprings of mothers with GDM. Left ventricular (LV) mass was similar. Children born to mothers with GDM had a thicker posterior LV wall (z-score +0.15, IQR -0.38/0.62, versus +0.47, IQR -0.11/+1.1, p = 0.004), a smaller end-systolic (1.3 mL, IQR 1.0-1.5 mL, versus 1.4 mL, IQR 1.2-1.8 mL, p = 0.044) but a similar end-diastolic LV volume. They also had shorter tricuspid valve flow duration and aortic valve ejection time, lower tricuspid E-wave and pulmonary valve velocities.ConclusionsNewborns of mothers with or without GDM had similar clinical characteristics and LV mass. However, some echocardiographic differences were detected, suggesting an altered myocardial physiology among infants of mothers with GDM.RegistrationClinicalTrials.gov (NCT02872974).ImpactHyperglycaemic disorders of pregnancy are known to be associated with offspring cardiovascular alterations. Clinical characteristics and estimated left ventricular (LV) mass were similar in children issued from mothers with and without gestational diabetes (GDM). Children born to mothers with GDM had a thicker posterior LV wall and a smaller end-systolic LV volume. Although LV mass is not different, myocardial physiology may be altered in these infants. Further studies should investigate the endothelial function of this population and the cardiovascular evolution of these children over time.

Project description:IntroductionGestational diabetes mellitus (GDM) is a state of glucose intolerance with onset during pregnancy. GDM carries prenatal and perinatal risks as well as long-term risks for the mother and her child. GDM may be involved in the foetal programming of long-term cardiovascular health. However, evidence is sparse and the effect of GDM on cardiovascular health is unknown. To address these issues, we will conduct MySweetHeart Cohort study. The objectives are to assess the effect of GDM on offspring's cardiovascular health early in life by using surrogate markers of cardiovascular disease and atherosclerosis.Methods and analysisThis is a cohort study of 100 offspring of women with GDM and 100 offspring of women without GDM. At inclusion, a baseline assessment of the mothers will be conducted through means of self-report questionnaires, a researcher-administrated interview, blood pressure and anthropometric measurements, and a maternal blood sampling. Between the 30th and 34th weeks of gestation, a foetal echography will be performed to assess the foetal cardiac structure and function, the fetomaternal circulation and the hepatic volume. At birth, maternal and neonatal characteristics will be assessed. An echocardiography will be performed to assess cardiac structure and function 2-7 days after birth; carotid intima-media thickness will be also measured to assess vascular structure. MySweetHeart Cohort is linked to MySweetHeart Trial (clinicaltrials.gov/ct2/show/NCT02890693), a randomised controlled trial assessing the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention to improve the cardiometabolic and mental health of women with GDM and their offspring. A long-term follow-up of children is planned.Ethics and disseminationEthical approval has been obtained through the state Human Research Ethics Committee of the Canton de Vaud (study number 2016-00745). We aim to disseminate the findings through regional, national and international conferences and through peer-reviewed journals.Trial registration numberClinicalTrials.gov (clinicaltrials.gov/ct2/show/NCT02872974).

Project description:OBJECTIVE:To assess the effect of the Pregnant+ app on the 2-hour glucose level of the routine postpartum oral glucose tolerance test (OGTT) among women with gestational diabetes mellitus (GDM). The Pregnant+ app was designed to provide information about GDM, and promote physical activity and a healthy diet. DESIGN:A multicentre, non-blinded randomised controlled trial. SETTING:Five diabetes outpatient clinics in the Oslo region. PARTICIPANTS:Women ≥18 years old with a 2-hour OGTT blood glucose level ≥9 mmol/L who owned a smartphone; understood Norwegian, Urdu or Somali; and were <33 weeks pregnant. A total of 238 women were randomised; 158 women completed the OGTT post partum. INTERVENTION:The Pregnant+ app and usual care, the control group received usual care. PRIMARY AND SECONDARY OUTCOMES:The primary outcome was the 2-hour blood glucose level of the routine postpartum OGTT. Secondary outcomes reported were mode of delivery, induction of labour, Apgar score, birth weight, transfer to the neonatal intensive care unit and breast feeding practice. Blood glucose levels during pregnancy, knowledge of diabetes, diet and physical activity are not reported. RESULTS:No difference was found for the 2-hour blood glucose level of the postpartum OGTT, with 6.7 mmol/L (95% CI 6.2 to 7.1) in the intervention group and 6.0 mmol/L (95% CI 5.6 to 6.3) in the control group. The significant difference in the proportion of emergency caesarean sections between the intervention group, 10 (8.8%) and the usual care group, 27 (22.1%), disappeared when adjusted for parity. There were no differences in birth weight, breast feeding practice, obstetric complications or transfer to the intensive neonatal care unit. No adverse events were registered. CONCLUSION:The Pregnant+ app had no effect on 2-hour glucose level at routine postpartum OGTT. After controlling for parity, the difference in emergency caesarean section was not statistically significant. TRIAL REGISTRATION NUMBER:NCT02588729.

Project description:IntroductionGestational diabetes mellitus (GDM) may negatively affect offspring outcomes. A lifestyle intervention may therefore not only improve maternal, but also offspring outcomes. The effects of lifestyle interventions on birth, anthropometric, and psychobehavioral outcomes in offspring of women with GDM need further evidence.DesignThe MySweetheart trial is a monocentric single-blind randomized controlled trial in 211 women with GDM. It tested the effect of a pre- and postpartum multidimensional interdisciplinary lifestyle and psychosocial intervention focusing on both the mothers and their infants and its effects on maternal (primary outcomes) and offspring (secondary outcomes) metabolic and psychobehavioral outcomes compared with guidelines-based usual-care. This paper focuses on offspring's birth, anthropometric, and maternal report of psychobehavioral outcomes at singular timepoints.MethodsWomen with GDM aged ≥18 years, between 24-32 weeks of gestation, speaking French or English were included and randomly allocated to either the intervention or to an active guidelines-based usual-care group using a 1:1 allocation ratio. The intervention lasted from pregnancy until 1 year postpartum and focused on improving diet, physical activity, and mental health in the mother. For the offspring it focused on supporting breastfeeding, delaying the timing of introduction of solid foods, reducing the consumption of sweetened beverages, increasing physical activity of the family, and improving parental responsiveness to infant distress, hunger, satiety and sleeping cues, and difficult behavior.ResultsAdverse birth and neonatal outcomes rarely occurred overall. There were no differences between groups in offspring birth, neonatal, anthropometric, or psychobehavioral outcomes up to one year. After adjustments for maternal age and the offspring's sex and age, there was a borderline significant between-group difference in birth length (β:-0.64, CI:-1.27; -0.01, p: 0.05), i.e., offspring of mothers in the intervention group were born 0.64 cm shorter compared to those in the usual-care group.ConclusionThis is the first pre- and postpartum multidimensional interdisciplinary lifestyle and psychosocial intervention in GDM focusing on both the mother and the offspring. It did not lead to a significant improvement in most birth, anthropometric, and psychobehavioral outcomes in offspring of women with GDM. ClinicalTrials.gov Identifier: NCT02890693.

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Improving cardiometabolic and mental health in women with gestational diabetes mellitus and their offspring: study protocol for MySweetHeart Trial, a randomised controlled trial.

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Improving cardiometabolic and mental health in women with gestational diabetes mellitus and their offspring: study protocol for <i>MySweetHeart Trial</i>, a randomised controlled trial.

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