Effect of cognitive behavior therapy (CBT) on lowering of blood glucose levels in gestational diabetes mellitus (GDM) patients: study protocol for a prospective, open-label, randomized controlled trial

BACKGROUND: Gestational diabetes mellitus (GDM) is a common perinatal condition. Convincing evidence has shown that hyperglycemia and other chronic comorbidities of diabetes during the prenatal period increase maternal and fetal risk. Several guidelines have identified lifestyle management as the first-line therapy in GDM patients. To improve the efficacy of lifestyle intervention, cognitive behavior therapy (CBT) is proposed as a solution to improve clinical outcomes. The objective of this trial is to determine the efficacy in treating hyperglycemia of mobile-based CBT interventions in GDM patients, compared with conventional face-to-face interventions. METHODS: This trial is designed as a prospective randomized controlled trial, which enrolled the patients diagnosed with GDM in First People’s Hospital of Kunshan affiliated with Jiangsu University from September 2021 to March 2023 with a 3-month follow-up. The specific randomization method was established and implemented through the central randomization system of EDC clinical trials. The percentage of all blood glucose levels collected within the normal range between the two groups at baseline, during the intervention period, and postpartum infant and maternal outcomes will be measured. Summary statistics for continuous variables will include the number of subjects, mean, median, SD, or the standard error, minimum, and maximum. The chi-square test, t test, and paired-sample t test were used for statistical analysis of differences between groups. DISCUSSION: This trial investigates the effects of mobile-based CBT intervention on blood glucose levels in GDM patients. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2100048527) [registered: 2021/07/09].