Healthy Habits During and After Gestational Diabetes

NCT07717515 | Not Yet Recruiting

• 2 other identifiers: VALID III26-12-KU
• Study Type: interventional
• Target: 2,546
• Locations: 1 country
• Sites: 1

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.

Conditions

GDM

Keywords

Gestational diabetes mellitus; exclusive breastfeeding; infant feeding; pregnancy hyperglycaemia; early-life nutrition; child adiposity; fat mass index; childhood obesity; lifestyle intervention; behavioural intervention; family-based intervention; caregiver involvement; maternal nutrition; physical activity; postpartum health; complementary feeding; Vietnam; low- and middle-income countries

Outcome Measures

Primary Outcomes (1)

• Duration of exclusive breastfeeding

  Exclusive breastfeeding is defined as feeding with no other food or drink, except prescribed medicines, oral rehydration solution, vitamins, and minerals, following the first week of birth. Measured as a continuous variable representing the total number of days each infant was exclusively breastfed during the first 6 months of life. Data will be prospectively recorded by mothers on a weekly basis using a structured hard-copy Infant Feeding Diary kept at home. Research assistants will verify the diaries and capture content in photographs during home visits at 3 and 6 months after birth

  Day 1-180 after birth

Secondary Outcomes (2)

• Secondary outcome: Proportion of exclusive breastfeeding at 180 days (6 months) after birth

  180 days (6 months) after birth

• Child fat mass index (FMI) at 24 months after birth

  24 months after birth

Other Outcomes (6)

• Maternal long-term metabolic health

  24 months after birth.

• Maternal Informal social support

  Baseline (24-28 weeks' gestation, at the time of the oral glucose tolerance test [OGTT]), 6, 12, and 24 months after birth

• Maternal quality of life

  Baseline (at the time of the oral glucose tolerance test, performed between 24 and 28 weeks of gestation), 6, 12, and 24 months after birth

Study Arms (2)

Healthy Habits

EXPERIMENTAL

A co-created intervention delivered during pregnancy and up to two years after birth that includes counselling, peer support, digital health elements, educational materials, and follow-up support on nutrition, infant feeding practices, physical activity, and GDM management provided according to routine clinical practice in the Hung Yen province, Vietnam

Behavioral: Hybrid intervention

Standard Care + Web Access

ACTIVE COMPARATOR

Access to a website with GDM management + standard care

Behavioral: Standard Care with Passive Web Access

Interventions

Hybrid intervention BEHAVIORAL

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

Healthy Habits

Standard Care with Passive Web Access BEHAVIORAL

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

Standard Care + Web Access

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thai Binh University of Medicine and Pharmacy: lead

Study Sites (1)

Thai Binh University of Medicine and Pharmacy

Thái Bình, Hưng Yên Province, Vietnam

Location

MeSH Terms

Conditions

Diabetes, Gestational; Breast Feeding; Pediatric Obesity; Motor Activity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Feeding Behavior; Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Thanh Duc Nguyen, Assoc. Prof

CONTACT

+84 91 235 7575; bsthanh@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of International Relations Department

Model Details: A cluster randomised controlled trial with a parallel design, where clusters are randomly assigned to either the intervention group or the control group

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 21, 2026
• Study Start (Estimated): November 15, 2026
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): August 30, 2030
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)