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Life sciences · Interventional Study
ClinicalTrials.gov · September 22, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07717515). This is a study registration, not published results. Lead sponsor: Thai Binh University of Medicine and Pharmacy. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 2546 participants (ESTIMATED). Conditions: GDM. Interventions: BEHAVIORAL: Hybrid intervention; BEHAVIORAL: Standard Care with Passive Web Access. Primary outcome measures: Duration of exclusive breastfeeding , Day 1-180 after birth. Brief summary: Gestational diabetes mellitus (GDM) is associated with an increased risk of childhood obesity and other adverse health outcomes. Early-life nutrition, particularly exclusive breastfeeding, plays an important role in reducing this risk. In Vietnam, infant feeding and childcare practices are strongly influenced by family members, including husbands, grandparents, and parents-in-law. The Healthy Habits During and After Gestational Diabetes (VALID III) trial aims to evaluate the effect of a co-created family-based health intervention on improving infant feeding practices and childhood body composition among children born to women with GDM. The intervention includes counseling, peer support, digital health components, educational materials, and follow-up support for nutrition, infant feeding practices, physical activity, and GDM management from pregnancy through 24 months after birth. Participants in the control group will receive standard care together with access to a GDM management website. The primary objective is to evaluate the effect of the intervention on the duration of exclusive breastfeeding during the first 180 days after birth. Secondary objectives include evaluating exclusive breastfeeding at 6 months, child fat mass index at 24 months, and broader maternal and child health and wellbeing outcomes.