Healthy Habits During and After Gestational Diabetes

Official title

Healthy Habits During and After Gestational Diabetes: A Cluster Randomised Family Intervention Controlled Trial in Northern Vietnam (VALID III)

Overview

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.

Detailed description

Background

Childhood obesity is a major global health burden, with increasing prevalence in many Asian countries, including Vietnam. However, health policies and programs in low- and middle-income countries (LMICs) often rely on evidence generated in settings that may not be directly applicable, limiting the effectiveness of interventions. Exposure to gestational diabetes mellitus (GDM) is associated with an increased risk of childhood obesity, while optimal early-life nutrition, particularly exclusive breastfeeding, may reduce this risk. In Vietnam, family members, including husbands, grandparents, and parents-in-law, have a substantial influence on infant feeding and childcare practices. These contextual factors highlight the need for family-based interventions to support healthy maternal and child behaviors following a pregnancy complicated by GDM.

Objectives

The Healthy Habits During and After Gestational Diabetes (VALID III) trial aims to evaluate the effect of the "Healthy Habits" family-based health intervention on improving infant feeding practices and childhood body composition among children born to women with GDM. The study will also assess the broader effects of the intervention on maternal and child health and wellbeing.

Study Design

This is a two-arm, parallel-group, superiority cluster randomised controlled trial with a 1:1 allocation of communes to either the intervention group (standard care plus the "Healthy Habits" intervention) or the control group (standard care plus access to a GDM management website). Pregnant women diagnosed with GDM between 24 and 28 weeks of gestation and their families will be recruited. Participants will be followed from pregnancy until 24 months after birth.

Intervention

The "Healthy Habits" intervention is a co-created family-based program delivered during pregnancy and continuing until 24 months postpartum. It includes counseling, peer support, digital health components, educational materials, and follow-up support focused on nutrition, infant feeding practices, physical activity, and GDM management, alongside routine clinical care.

Outcome Assessment

The primary outcome is the duration of exclusive breastfeeding during the first 180 days after birth. Secondary outcomes include the proportion of infants exclusively breastfed at 6 months, child fat mass index at 24 months after birth, process outcomes, and broader maternal and child health and wellbeing outcomes.

Interventions

• Behavioral Hybrid intervention
  The VALID III "Healthy Habits" intervention is a culturally tailored, gender-sensitive, intergenerational complex intervention for women with gestational diabetes mellitus (GDM), delivered from diagnosis to 24 months postpartum. It differs from standard care through its extended duration and integrated family- and digital-based approach. It includes five components: (1) nutrition and infant feeding support (diet, breastfeeding, complementary feeding, household practices); (2) physical activity
• Behavioral Standard Care with Passive Web Access
  Participants in this control group receive standard care for GDM according to routine clinical practice in Vietnam (antenatal care, dietary advice, glucose monitoring). In addition, they are provided with a website link (https://www.babaukhoemanh.com/en) for passive access to basic GDM management guidance. They do not receive any proactive messaging, peer support, or family engagement

Primary outcome measures

• Duration of exclusive breastfeeding [Time frame: Day 1-180 after birth]

Secondary outcome measures (2)

• Secondary outcome: Proportion of exclusive breastfeeding at 180 days (6 months) after birth [Time frame: 180 days (6 months) after birth]
• Child fat mass index (FMI) at 24 months after birth [Time frame: 24 months after birth]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Vietnam · 1 center

• Thai Binh University of Medicine and Pharmacy — Thái Bình

Identifiers

NCT: NCT07717515 · VALID III · 26-12-KU

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗