Healthy Habits During and After Gestational Diabetes | NCT07717515

NCT07717515

Overview

NCT ID: NCT07717515
Lead Sponsor: Thai Binh University of Medicine and PharmacyOTHER
Official Title: Healthy Habits During and After Gestational Diabetes: A Cluster Randomised Family Intervention Controlled Trial in Northern Vietnam (VALID III)
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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 22, 2026Actual
Start Date: Nov 15, 2026Estimated
Primary Completion Date: May 15, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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 Criteria:

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).

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.

Any other condition that, in the judgment of the investigators, makes participation inappropriate or infeasible, e.g., surrogate mother.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 2,546Estimated
Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Thanh Duc Nguyen, Assoc. ProfContact
bsthanh@hotmail.com+84 91 235 7575

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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