A self-efficacy-enhancing physical activity intervention in women with high-risk factors for gestational diabetes mellitus: study protocol for a randomized clinical trial

Trials. 2022 Jun 6;23(1):461. doi: 10.1186/s13063-022-06379-6.

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.

Keywords: Exercise; Gestational diabetes; Physical activity; Protocol; Randomized controlled trial; Self-efficacy.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Blood Glucose
  • Diabetes, Gestational* / diagnosis
  • Diabetes, Gestational* / epidemiology
  • Diabetes, Gestational* / prevention & control
  • Exercise
  • Female
  • Gestational Weight Gain*
  • Humans
  • Infant, Newborn
  • Pregnancy
  • Randomized Controlled Trials as Topic
  • Risk Factors
  • Self Efficacy

Substances

  • Blood Glucose