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Healthy Habits During and After Gestational Diabetes

NCT07717515 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2546

Last updated 2026-07-22

No results posted yet for this study

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.

Conditions

  • GDM

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 guidance for pregnancy/postpartum and family active play; (3) intergenerational family engagement involving partners and grandparents; (4) self-care and GDM management including diet advice, blood glucose monitoring, and free clinic testing; and (5) digital support via messaging and educational content. Compared with usual care, the intervention integrates co-created materials, family involvement, and continuous digital engagement to support sustained behavioural change

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

Sponsors & Collaborators

  • Thai Binh University of Medicine and Pharmacy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-15
Primary Completion
2028-05-15
Completion
2030-08-30

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07717515 on ClinicalTrials.gov