Impact of a healthy lifestyle intervention program during pregnancy on women and newborn: STUDY PROTOCOL for a quasi-experimental study

孕期健康生活方式干预计划对孕妇和新生儿的影响:准实验研究方案

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Abstract

Physical activity during pregnancy assumes an important role in the health of both the pregnant and newborn. Given that physical activity tends to decrease throughout this period, it is essential to inform and encourage pregnant women to acquire healthy lifestyles, enabling them to improve their physical and psychological well-being. This study aims to evaluate the impact of an intervention program on pregnant, newborn, and gestation outcomes, by increasing physical activity levels during this important period of woman's life. This study will be conducted with 410 pregnant women in the first trimester. Participants will be recruited through the central hospital or community centers. Following consent and baseline data collection, pregnant women who do not have any medical or obstetric contraindication for physical exercise, will be assigned to the control or intervention groups. There will be 3 assessment periods: baseline (time 1-between the 7th and 10th week of gestation), after the intervention (time 2-between the 1st and 3rd day after delivery), and follow-up (time 3-1 month after delivery). The intervention group will have an intervention program, which comprises 2 terms: (1) teachers' training delivered by researchers and (2) intervention delivered to pregnant women by trained teachers, which consists in 3 weekly classes of physical exercise (45/50 min each). The control group will have the standard care that is usually provided by health professionals. The research has been approved by the Subcommittee on Ethics for the Life Sciences and Health of the University of Minho (id: SECVS 086/2015) and by the Ethics Committee for Health from the Central Hospital (id: 056/2014). There is a registration in clinical trials.gov, with the reference NCT03045237 (02/2017). This study has the potential to increase pregnant's physical activity levels and contribute to programs and policies developed to optimize lifestyles during pregnancy and with implications in newborn outcomes.

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