Effectiveness of a Digital Support Intervention (HealthyPregnancy) for Pregnant Women with a BMI At 25 or Above (BMI≥25) in Addition to Standard Care: a Stepped-wedge Cluster Randomized Controlled Trial

Brief Summary

Detailed Description

Being overweight is the most prevailing health issue among women of reproductive age, and in Denmark, the proportion of pregnant women with a body mass index at or above 25 (BMI≥25) is nearing 40%. Women with overweight are at increased risk of complications in pregnancy and labor such as hypertensive disorders, gestational diabetes (GDM), and Cesarean section. Children of women with overweight more often have a high birthweight and are less likely to be breastfed, than children of women with a normal BMI. Both women and offspring, face an increased risk of overweight or obesity later in life. The risk of complications can increase if the pregnant woman gains excessive weight during pregnancy and conversely, reducing pregnancy weight gain can lower the risk of complications. However, more than half (60%) of pregnant women with overweight do not adhere to the pregnancy weight gain recommendations. In addition, only around one third of pregnant women with overweight meet the recommended daily levels of physical activity. This emphasizes a significant potential for prevention strategies focused on promoting healthy weight gain and physical activity during pregnancy. It has previously been established, that interventions focusing on physical activity and nutritional counselling can help women with overweight reduce excessive pregnancy weight gain. However, traditional lifestyle interventions can be both cost-intensive and resource-demanding to implement. With digital technologies, lifestyle interventions have potential to less resource-intensive testing and implementation. New research indicates that a digital application with information on a healthy diet and physical activity may have potential to help women with overweight reduce pregnancy weight gain. At Nordsjaellands Hospital and Slagelse Hospital respectively 37% and 49% of pregnant women are overweight with a BMI≥25. Pregnant women with overweight are offered standard care at Slagelse Hospital and at Nordsjaellands Hospital women with a BMI above 35 receive a minor supplement to standard care. However, both pregnant women and healthcare professionals request tailored and evidence-based care. The aim of the HealthyPregnancy study is to evaluate the effect of a digital care guide offering support and information on diet, physical exercise, and mental well-being on gestational weight gain. The digital care guide will be tested in a stepped wedge cluster randomized controlled trial including 450 pregnant women with a BMI at 25 or above. A secondary aim is to evaluate the effect of the digital care guide on pregnancy and diabetes outcomes among participating women diagnosed with gestational diabetes. HealthyPregnancy is carried out in collaboration between Center for Clinical Research and Prevention, Nordsjaellands Hospital and Slagelse Hospital.

Primary Outcomes

Secondary Outcomes

• Postpartum weight retention(Eight weeks after delivery and one year after delivery.)
• Mental well-being(At inclusion, gestational week 35-37, eight weeks after delivery and one year after delivery.)
• Symptoms of depression(At inclusion, gestational week 35-37, eight weeks after delivery and one year after delivery.)
• Functional ability(At inclusion, gestational week 35-37, eight weeks after delivery and one year after delivery.)
• Digital health competence(At inclusion, gestational week 35-37)
• Maternal sleep(At inclusion, gestational week 35-37 and one year after delivery.)
• Exercise self-efficacy(At inclusion, gestational week 35-37, eight weeks after delivery and one year after delivery.)
• Physical activity in pregnancy(At inclusion, gestational week 35-37, eight weeks after delivery and one year after delivery.)
• Pregnancy complications(2 weeks post partum)
• Sick leave in pregnancy(At inclusion, gestational week 35-37.)
• Antenatal contacts(2 weeks post partum)
• Pregnancy length(2 weeks post partum)
• Onset of labor(2 weeks post partum)
• Use of epidural analgesia(2 weeks post partum)
• Use of oxytocin for augmentation during labor(2 weeks post partum)
• Treatment with antibiotics during labor(2 weeks post partum)
• Mode of delivery(2 weeks post partum)
• Duration of labor(2 weeks post partum)
• Shoulder dystocia(2 weeks post partum)
• Postpartum hemorrhage(2 weeks post partum)
• Birth weight(2 weeks post partum)
• Newborn's well-being at time of delivery (Apgar score)(Delivery)
• Newborn's well-being at time of delivery (pH-value in cord blood)(Delivery)
• Admittance to neonatal intensive care unit in relation to delivery(2 weeks post partum)
• Neonatal re-admittance(2 weeks post partum)
• Hospitalization, length of stay(2 weeks post partum)
• Breastfeeding intention(Gestational week 35-37, eight weeks after delivery and one year after delivery.)
• Intended duration of breastfeeding(Gestational week 35-37, eight weeks after delivery and one year after delivery.)
• Breastfeeding duration(Gestational week 35-37, eight weeks after delivery and one year after delivery.)
• Postpartum oral glucose tolerance test(One year postpartum)
• Self-reported blood glucose values(2 weeks post partum)
• Treatment with insulin during pregnancy(2 weeks post partum)