A self-efficacy-enhancing physical activity intervention in women with high-risk factors for gestational diabetes mellitus: study protocol for a randomized clinical trial
Xiao Yang, Ji Zhang, Xiangzhi Wang, Yi Xu, Li Sun, Yingli Song, Ruijuan Bai, Hui Huang, Jing Zhang, Ruixing Zhang, Erfeng Guo, Lingling Gao
Abstract
Abstract Background Gestational diabetes mellitus (GDM) is one of the most common medical disorders in pregnancy. Evidence has demonstrated that moderate-intensity physical activity may reduce the risk of gestational diabetes. However, women at risk of GDM spend most of their time performing sedentary behaviors. Although researchers identified self-efficacy as a mediator to overcome physical activity barriers, exercise intervention during pregnancy based on self-efficacy theory has not been discussed so far. Furthermore, there is conflicting evidence regarding the effects of a physical exercise intervention on the incidence of GDM and other maternal or neonatal outcomes in women at higher risk for GDM. Methods/design A single-center, parallel, randomized controlled trial will be conducted in a maternal–child health care center. A total of 244 pregnant women at high risk for GDM will be randomized into a study group receiving a self-efficacy-enhancing physical activity intervention or a control group receiving the usual care. The intervention will consist of four group sessions and everyday reminders by WeChat (Tencent, Shenzhen, China). The program will begin at approximately 13–14 +6 gestational weeks and end at 36 +6 gestational weeks. The primary outcomes will include the incidence of GDM, blood sugar values, and physical activity. The secondary outcomes will include physical activity self-efficacy, gestational weight gain, maternal outcomes, and neonatal outcomes. Discussion The findings of this research will contribute toward understanding the effects of a self-efficacy theory-oriented physical activity program on the incidence of GDM, blood sugar values, physical activity level, gestational weight gain, physical activity self-efficacy, maternal outcomes, and neonatal outcomes. Trial registration Chinese Clinical Trial Registry (CHiCTR) ChiCTR2200056355 . Registered on February 4, 2022.