NCT07717515Not yet recruiting
Healthy Habits During and After Gestational Diabetes
Healthy Habits During and After Gestational Diabetes: A Cluster Randomised Family Intervention Controlled Trial in Northern Vietnam (VALID III)
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 2546 (estimated)
- First submitted
- 2 Jul 2026
- Start date
- 23 Nov 2026
- Primary completion date
- 15 May 2028
- Lead sponsor
- Thai Binh University of Medicine and Pharmacy
- Diseases
- Obesity
- NCT number
- NCT07717515
What you commit to
- Study type: Interventional
- Planned participants: 2546
- From 23 Nov 2026 to the primary completion date, 15 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pregestational diabetes (type 1 or type 2) diagnosed prior to this pregnancy.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Thai Binh University of Medicine and Pharmacy Coordinator of this site? Confirm its status | Thái Bình | Vietnam | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.