Clinical Research Directory

Longitudinal Randomized Controlled Study on the Effectiveness of Nutritional Education During Uncomplicated Pregnancy

The goal of this clinical trial is to evaluate whether a structured nutritional education intervention can improve gestational weight gain outcomes and related maternal and neonatal health indicators in women with uncomplicated pregnancy. The main question it aims to answer is whether a group-based nutritional education program increases the proportion of women achieving gestational weight gain within Institute of Medicine (IOM) recommended ranges compared with standard prenatal care. Researchers will compare a structured nutritional education intervention group to a control group receiving routine prenatal care and a nutritional information brochure to see if the intervention improves gestational weight gain within recommended ranges and affects maternal and neonatal outcomes. Participants in the intervention group will: * Attend three weekly group-based nutritional education sessions delivered by trained healthcare professionals * Attend one practical cooking (show-cooking) session Participants in the control group will: * Receive routine prenatal care and a written nutritional information brochure * Be followed from early pregnancy until 8 weeks postpartum All participants (including control group) will: * Record body weight regularly throughout pregnancy using a telemedicine system * Complete questionnaires on dietary intake and quality of life at multiple time points * Undergo assessments of body composition and urinary biomarkers of oxidative stress during pregnancy

BUMP2.0 Feasibility Study

Most women in the UK gain more weight than recommended during pregnancy, which puts them and their babies at risk of medical complications. Studies which have interviewed women during pregnancy have shown that they recognise that controlling their weight is important, but this is rarely discussed with their clinical team. Some women reported they expected to be weighed during pregnancy, and that regular weighing should be part of routine antenatal care, but it is not. Trials which have trained midwives to regularly weigh women or to ask women to regularly weigh themselves, have not shown beneficial effects on gestational weight gain. However, these trials were either small, or reported low protocol adherence, or did not offer adequate feedback and advice in response to weight gain. A few programmes to manage weight during pregnancy have been effective, but were costly and burdensome for women. Regular self-weighing has been shown to be an effective strategy for weight control outside of pregnancy, and if it can be enacted in pregnancy and help manage weight gain, it could improve health outcomes for women and their babies. The investigators have developed a mobile app to support women to weigh themselves regularly during pregnancy and track their weight gain, to provide feedback on whether weight gain is within, higher, or lower than recommended ranges, and to signpost to resources on weight management during pregnancy. The trial aims to test if it is possible to motivate participants to regularly weigh themselves during pregnancy and how well they engage with the app from early or mid-pregnancy until delivery. The investigators will also examine whether the processes of the study run as planned, whether there is an indication of an impact of the programme on gestational weight gain compared to a control group, and will explore participants' experiences of using the app through optional qualitative interviews. If feasible, after completion of this study, the next step will be a bigger trial to investigate whether this app-based programme is effective in helping women manage their weight gain and improve health outcomes during pregnancy.