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A couple-based physical activity intervention for the prevention of gestational diabetes mellitus: study protocol for a randomized controlled trial

Han RR, Peng J, Zhang L, Jin J, Lin WX, Zheng LJ, Yu Y, Zeng L et al.

BMC pregnancy and childbirth, 2026

244 participants

Abstract

BACKGROUND: Early prevention of Gestational diabetes mellitus (GDM) is critical not only for protecting maternal and infant health but also for reducing the long-term healthcare burden associated with chronic diseases. Physical activity is a well-established modifiable behavior for GDM prevention; however, existing physical activity interventions during pregnancy have shown limited effectiveness. Partner involvement in behaviour change represents a promising approach theoretically, but empirical evidence remains scarce. This study protocol describes a randomized controlled trial designed to evaluate the effectiveness of a couple-based physical activity intervention for the prevention of GDM. METHODS: This single-blind, two-arm, parallel-group randomized controlled trial will be conducted at an obstetrics and gynecology hospital in Guangzhou, China. A total of 244 pregnant individuals at high risk for GDM and their partners will be randomly assigned to either an intervention group receiving a couple-based physical activity intervention or a control group receiving usual antenatal care. The intervention starts at 5–12+ 6 weeks of gestation and continues until 24 weeks. It consists of one face-to-face group dyadic education session, one online group dyadic education session, biweekly online personalized dyadic counseling sessions, and a daily behavior change booster delivered via WeChat. Intervention delivery is supported by a dedicated WeChat Official Account, Pregnancy…

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 244 participants or records.

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