mental health; postpartum screening; gestational diabetes intervention ; physical activity; biomarker; maternal health; child health; metabolic health; epigenetics; nutrition
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Background: Gestational diabetes mellitus (GDM) is one of the most frequent pregnancy complications (up to 20% of pregnancies) and increases the risk for non-communicable diseases such as obesity and type 2 diabetes in the mother and/or her child, as well as the risk for postpartum depression. GDM is also involved in the fetal programming of long-term metabolic health. GDM risk factors that are potentially modifiable during pregnancy include excessive pregnancy weight gain, high fat consumption, physical inactivity, psychosocial stress, depression, and lack of social support. Lifestyle interventions for the treatment of GDM are often limited to nutrition or physical activity. They usually treat the mother or the child separately, take place either only during or after pregnancy, and their results are inconsistent. The multifactorial origins of GDM and the tight link between metabolic and mental as well as maternal and child health call for an interdisciplinary intervention. Due to the complex nature and the transgenerational transmission of these non-communicable diseases, we aim to scale-up from the few existing interventions to a concerted complex, multidimensional interdisciplinary intervention: Aim: To test the effects of a complex, interdisciplinary lifestyle and psychosocial continuous pre-and postpartum intervention to improve metabolic and mental health outcomes in women with GDM and their children up to 1 year postpartum. Primary aim: We expect that the 1) the decrease in maternal weight between study enrolment after GDM diagnosis and maternal weight at 1 yr postpartum will be larger in the intervention group than in the control group and 2) that the decrease in maternal symptoms of the Edinburgh Postnatal Depression score (EPDS) during the same time period will be larger in the intervention group than in the control group. Secondary aims: We expect that the intervention will improve other indicators of maternal and offspring metabolic and mental health at enrolment, the peri- and postpartum period. We will also investigate longitudinal associations, thus increasing the understanding of the trajectories of maternal and child obesity, glucose intolerance and mental health problems. Maternal secondary outcomes are (1) fat mass, gestational weight gain and weight retention, lifestyle behaviours, aerobic fitness and strength, metabolic and epigenetic laboratory biomarkers and (2) other mental health indicators. Offspring secondary outcomes are (1) body composition, metabolic and epigenetic laboratory biomarkers and (2) mental health indicators, such as self-regulation. Method: Monocentric superiority open randomized controlled trial (RCT) in 200 women with GDM and their offspring randomly assigned (1:1) to either the intervention or the control group (treatment-as-usual). Patients will be recruited at 24-32 wks of gestation after GDM diagnosis. The intervention will take place during pregnancy and the first year postpartum. On top of usual care offered in the control group, the intervention consists of 7 individual interdisciplinary sessions with dieticians, physiotherapists, clinical psychologists, and two group sessions. The team will provide counseling regarding weight gain recommendations and focus on specific dietary aspects (reduction of total lipid intake, prioritization of higher quality fats and reduction of red or processed meats; mindful eating techniques, and regular structured eating). It will also provide encouragement for aerobic and resistance physical activity, screening for and treatment of depression using a stepped care approach and facilitated self-help, and social support offers including support from services, peers and partner. Treatment goals for the infant focus on diet (continuation of breastfeeding for at least 6 months, recognition of hunger and satiety cues and use of different soothing strategies), physical activity and mental health (self regulation capacity). Patients will be supported by a lifestyle coach. Assessors measuring the primary outcomes and other outcomes, such as biomarkers and questionnaires, and the statistician will be blind to group allocation. For the assessment of outcomes, validated online questionnaires and standardised devices, such as calibrated scales, accelerometer, bioimpedance, Dual energy X-ray absorptiometry, and standardised motor tests will be used. Importance and impact: This RCT allows evaluating if a complex, interdisciplinary continuous pre-and postpartum lifestyle and psychosocial intervention leads to an improvement in both maternal and child metabolic and mental health outcomes. This study would also provide relevant findings regarding the understanding of GDM and potential pathways regarding the link between lifestyle, epigenetic mechanisms and metabolic, and mental health. This could result in significant changes in clinical practice and guidelines.