GDM
Conditions
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
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.
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
BEHAVIORALHybrid 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
BEHAVIORALStandard 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
Thai Binh University of Medicine and Pharmacy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
A cluster randomised controlled trial with a parallel design, where clusters are randomly assigned to either the intervention group or the control group
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of exclusive breastfeeding | Day 1-180 after birth | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary outcome: Proportion of exclusive breastfeeding at 180 days (6 months) after birth | 180 days (6 months) after birth | Proportion of exclusive breastfeeding (as defined above) at 180 days after birth. |
| Child fat mass index (FMI) at 24 months after birth | 24 months after birth | Fat Mass Index (FMI)= Fat mass (kg)/height (m2) |
Countries
Vietnam
Contacts
CONTACTThanh Duc Nguyen, Assoc. Prof
Outcome results
None listed