Background: Physical activity has been utilized as an effective strategy to prevent gestational diabetes mellitus (GDM). However, most pregnant women with high risk for GDM did not achieve the recommended physical activity level. Furthermore, relevant physical activity protocols have varied without theory-guided and evidence-based tailored to pregnant women with high risk for GDM. This study aimed to develop and pilot test a theory-guided and evidence-based physical activity intervention protocol for pregnant women with high risk for GDM.Methods: The study design was guided by the Medical Research Council Framework for Developing and Evaluating Complex Intervention (the MRC framework). The preliminary protocol for physical activity intervention was developed based on self-efficacy theory, research evidence identified from systematic reviews and clinic trials, stakeholder engagement, context, and economic considerations. The preliminary intervention protocol was validated through a content validity study by an expert panel of 10 experts. A single-blinded randomized controlled trial (RCT) was designed to test the feasibility and acceptability of the intervention.Results: The validity of the preliminary intervention protocol was excellent as consensus was achieved. The final 13 sessions of self-efficacy enhancing physical activity intervention protocol were developed, including knowledge education, exercise clinic visits and video, and group discussions with face-to-face and online blended sessions. In the feasibility study, 34 pregnant women with high risk for GDM were randomized for the intervention (n = 17) or the control group (n = 17). The recruitment and retention rates were 82.9% and 58.9%, respectively. Women in the intervention group had a lower incidence of GDM (26.7% vs. 36.5%) than the control group (P>0.05). All participants were satisfied with the intervention and agreed that the intervention was helpful.Conclusions: The developed self-efficacy-enhancing physical activity intervention is a feasible and acceptable intervention for enhancing physical activity among pregnant women with high risk for GDM and is ready to be tested in a more extensive RCT study.Trial registration: The study was registered on 4 February 2022 (ChiCTR2200056355) by the Chinese Clini Trial Registry (CHiCTR).
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.
This study aimed to explore the current status and latent profiles of physical activity self-efficacy among women with preconception overweight or obesity. A convenience sampling method was employed to recruit 400 pregnant women with a preconception body mass index greater than 24 kg/m2 from a tertiary maternal and child health hospital in Zhengzhou, China, between January and April 2025. Data were collected using the Physical Activity Self-Efficacy Scale and the Social Support for Prenatal Physical Activity Scale. Latent profile analysis was conducted using Mplus 8.3, and univariate and multivariable logistic regression analyses were performed using SPSS 25.0. A total of 388 valid questionnaires were analyzed. Women with preconception overweight/obesity were categorized into three distinct latent profiles: Low Management-Health Education Dependent (45.6%, characterized by reliance on healthcare guidance), Moderate Motivation-Execution Support Limited (44.9%, demonstrating partial self-regulation but constrained by external factors), and High Efficacy-Autonomous Persistence Driven (9.5%, exhibiting strong self-motivation and adherence). Multivariable logistic regression revealed that having an exercise plan during pregnancy, prior knowledge of prenatal exercise, and social support for physical activity were significant influencing factors. Physical activity self-efficacy among women with preconception overweight/obesity was at a moderate level overall, demonstrating distinct classification characteristics.