GDMVALID IIINCT07717515
Healthy Habits During and After Gestational Diabetes
A study testing Hybrid intervention in people with GDM, run by Thai Binh University of Medicine and Pharmacy at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- GDM
- What is being tested?
- Hybrid intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,546 participants
- Where
- 1 siteVietnam
- Study dates
- 23 Nov 2026to 30 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site
Thai Binh University of Medicine and Pharmacy
Thái Bình, Hưng Yên Province
Thanh Duc Nguyen, Phd, +84 91 235 7575, bsthanh@hotmail.com
About this study
Official title: Healthy Habits During and After Gestational Diabetes: A Cluster Randomised Family Intervention Controlled Trial in Northern Vietnam (VALID III)
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.
Read the 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.
- Conditions
- GDM
- Being tested
- Hybrid intervention, Standard Care with Passive Web Access
- 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
- Medical subject headings
- Diabetes, Gestational, Breast Feeding, Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid interventionBehavioural
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
Standard Care with Passive Web AccessBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Hybrid intervention |
| Standard Care + Web Access | Active comparator | Access to a website with GDM management + standard care Receives: Behavioral: Standard Care with Passive Web Access |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1-180 after birth
Secondary outcomes (2)
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.
Measured: 180 days (6 months) after birth
Child fat mass index (FMI) at 24 months after birth
Fat Mass Index (FMI)= Fat mass (kg)/height (m2)
Measured: 24 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start23 Nov 2026 (estimated)
- Primary completion15 May 2028 (estimated)
- Study completion30 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GDMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,546 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thai Binh University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thanh Duc Nguyen, Thai Binh University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717515
- Sponsor's protocol ID
- VALID III
- Other IDs
- 26-12-KU
- Acronym
- VALID III
- Status last verified
- Sep 2026
- First submitted
- 2 Jul 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to strict data privacy agreements with partnering hospitals and project data ownership policies. Only aggregated, summary-level data will be made available through project reports and publications
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Habits During and After Gestational Diabetes: A Cluster Randomised Family Intervention Controlled Trial in Northern Vietnam (VALID III)
- ClinicalTrials.gov ID
- NCT07717515
- Acronym / sponsor ID
- VALID III / VALID III
- Conditions
- GDM
- Keywords
- Gestational diabetes mellitus, exclusive breastfeeding, infant feeding, pregnancy hyperglycaemia, early-life nutrition, child adiposity, fat mass index, childhood obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,546 participants (estimated)
- Lead sponsor
- Thai Binh University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 23 Nov 2026 (estimated)
- Primary completion
- 15 May 2028 (estimated)
- Study completion
- 30 Aug 2030 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Healthy Habits | Experimental | Behavioral: Hybrid interventionA 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 |
| Standard Care + Web Access | Active comparator | Behavioral: Standard Care with Passive Web AccessAccess to a website with GDM management + standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid interventionThe 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 | Behavioural | Healthy Habits |
| Standard Care with Passive Web AccessParticipants 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 | Behavioural | Standard Care + Web Access |
Primary outcome
Duration of exclusive breastfeeding
Time frame: 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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to strict data privacy agreements with partnering hospitals and project data ownership policies. Only aggregated, summary-level data will be made available through project reports and publications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid intervention in people with GDM, run by Thai Binh University of Medicine and Pharmacy at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thanh Duc Nguyen, Assoc. Prof (+84 91 235 7575, bsthanh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of exclusive breastfeeding (time frame: Day 1-180 after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.