Family-based program supporting mothers with gestational diabetes and their infants' feeding
Tests a family-based program on infant feeding in women with gestational diabetes and their children.
Plain-language title generated from the registry record
Registry title: Healthy Habits During and After Gestational Diabetes
Key facts
- Where
- Thái Bình, VietnamSee the site
Where in Vietnam
- Thai Binh University of Medicine and PharmacyThái Bình, VietnamNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Thai Binh University of Medicine and Pharmacy
- Trial code
- NCT07717515
- Record updated
- 22 September 2026
- Original description
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.Read full original descriptionShow less
Healthy Habits During and After Gestational Diabetes: A Cluster Randomised Family Intervention Controlled Trial in Northern Vietnam (VALID III)
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.
Inclusion: Confirmed GDM diagnosis in the current pregnancy according to WHO criteria and enrolled no longer than seven days after diagnosis; Gestational age at enrolment ≤ 28+0 weeks of pregnancy; Maternal age ≥18 years at consent; Pregnancy with singleton gestation; Residence within the study catchment area; Language proficiency sufficient to complete consent and study procedures in Vietnamese; Capacity to provide informed consent and willingness to participate in all trial procedures, including randomisation.
Exclusion: Pregestational diabetes (type 1 or type 2) diagnosed prior to this pregnancy; Severe chronic medical conditions and chronic severe mental health conditions likely to interfere with participation, safety, or outcome assessment (e.g., advanced cardiac, renal, hepatic disease; active malignancy; severe uncontrolled endocrine disease other than GDM, schizophrenia, active psychosis); Any other condition that, in the judgment of the investigators, makes participation inappropriate or infeasible, e.g., surrogate mother; Inability to provide informed consent ; Pregnant women with multiple gestations; Pregnant women where it is biologically impossible for the woman to breastfeed, e.g., the woman has undergone bilateral mastectomy.