Healthy Habits During and After Gestational Diabetes
ConditionGDM
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThai Binh University of Medicine and Pharmacy
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Hybrid intervention
BehavioralThe 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
Standard Care with Passive Web Access
BehavioralParticipants 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
Treatment groups
2,546 Participants
are divided into 2 treatment groupsGroup A: Healthy HabitsExperimental treatment 1 intervention
Group B: Standard Care + Web AccessActive comparator 1 intervention
Trial outcomes
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
Time frame
Day 1-180 after birthSecondary outcomes
1
Secondary outcome: Proportion of exclusive breastfeeding at 180 days (6 months) after birth
Proportion of exclusive breastfeeding (as defined above) at 180 days after birth.
Time frame
180 days (6 months) after birth2
Child fat mass index (FMI) at 24 months after birth
Fat Mass Index (FMI)= Fat mass (kg)/height (m2)
Time frame
24 months after birthOther outcomes
1
Maternal long-term metabolic health
Maternal metabolic health biomarkers comprise measures of glycaemic control (HbA1c, fasting glucose), insulin metabolism (fasting insulin and C-peptide), and lipid metabolism (LDL cholesterol, HDL cholesterol, triglycerides, and total cholesterol).
Time frame
24 months after birth.2
Maternal Informal social support
Maternal perceived availability and adequacy of informal social support from family, friends, and significant others, reflecting the mother's access to emotional, informational, and practical support.
Time frame
Baseline (24-28 weeks' gestation, at the time of the oral glucose tolerance test [OGTT]), 6, 12, and 24 months after birth3
Maternal quality of life
Maternal quality of life, including health-related quality of life, family health, and maternal mental health, reflecting physical, psychological, and social well-being after childbirth
Time frame
Baseline (at the time of the oral glucose tolerance test, performed between 24 and 28 weeks of gestation), 6, 12, and 24 months after birth4
Child socio-emotional development
Child feeding patterns, behaviours, illness patterns, and environmental factors related to obesity risk, including dietary intake and diet quality, sedentary behaviour and screen time, physical activity, sleep duration, parenting practices (feeding, activity, sleep), and household food environment
Time frame
At 6, 12 and 24 months after birthSponsors and contacts
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Source ClinicalTrials.gov
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