GDMVALID-IINCT05744856
A Co-created Self-care and Informal Support Intervention Study Among Women With GDM in Vietnam
A study testing Self-care with informal support in people with GDM, run by Thai Binh University of Medicine and Pharmacy at 2 sites in Vietnam.
Trial summary
Gestational Diabetes Mellitus (GDM) is significant public health problem in Vietnam, which is potentially treatable if managed properly by the pregnant women once diagnosed. However, systematic screening for GDM is rarely undertaken in Vietnam, and little is known about how health providers, pregnant women, and their… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- GDM
- What is being tested?
- Self-care with informal support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 435 participants
- Where
- 2 sitesVietnam
- Study dates
- 16 Jan 2023to 20 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnancy < 28 weeks
- Singleton and multiple pregnancies
- Residing in Thai Binh province
- Speaks and reads Vietnamese
- Agree to participate voluntarily (informed consent)
Who cannot join
- Pre-gestational diabetes (type I or type II)
- Severe chronic disease
- Women with GDM in a prior pregnancy are eligible for inclusion into the study.
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
Thai Binh Maternity Hospital
Thái Bình, Thai Binh, 410000
Kim Ngan Clinic
Thái Bình, Thái Bình, 410000
About this study
Official title: Living Together With Chronic Disease: Informal Support for Diabetes Management in Vietnam (VALID) - Gestational Diabetes in Vietnam - Phase II
Gestational Diabetes Mellitus (GDM) is significant public health problem in Vietnam, which is potentially treatable if managed properly by the pregnant women once diagnosed. However, systematic screening for GDM is rarely undertaken in Vietnam, and little is known about how health providers, pregnant women, and their families in today's Vietnam handle the condition. Vietnamese women often depend on their extended family for daily life management and access to social and financial resources, hence, an intervention that focuses on informal support and GDM self-care may increase adherence the standard guidelines among pregnant women with GDM in Vietnam and increase neonatal and maternal health outcomes.
Read the detailed description
Background: Across the globe, diabetes mellitus is attaining epidemic proportions, with low- and middle-income countries confronting particularly high burdens. VALID II focuses on gestational diabetes mellitus (GDM), a transitory form of diabetes that presents during pregnancy.
Objectives: To: i) Determine prevalence and risk factors for GDM among pregnant women in Vietnam's Thai Binh province, ii) Measure the associations between GDM and pregnancy complications and outcomes, iii) Understand how pregnant women with GDM and their informal support persons perceive and handle the condition, iv) Co-create, implement, and assess the feasibility of a intervention aiming to enhance the self-care capacities of pregnant women with GDM.
Study setting: Thai Binh, Vietnam
Study design: Intervention study
Study population: 2,000 pregnant women attending antenatal care.
Methodology: The study will be performed as a pilot parallel 2-arm non-randomized intervention study with a delayed-start for the intervention group. 1000 women will be invited into the study at their first antenatal care visit (gestational week 12) and complete a questionnaire (inclusion questionnaire). All women will be offered a 2-hour oral glucose tolerance test (OGTT) in gestational week 24-28 and complete second questionnaire (OGTT questionnaire) exploring living conditions, lifestyle, risk factors, selfcare, perceived social support, perceived wellbeing, and sign of depression. An estimated 200 women (~20%) will screen positive for GDM by the OGTT according to the World Health Organization (WHO) 2013 diagnostic criteria and receive standard GDM care. These 200 women will serve as the study's control group (study phase I). Among the 200 women who screen positive in phase I, ethnographic interviews will be formed in a subgroup of 20 women. The information from the 20 ethnographic interviews and the 200 questionnaire interviews will help inform a co-created "self-care and informal support" intervention. Subsequently, another 1000 women will be invited into the study at their first antenatal care visit and be offered a 2-hour oral glucose tolerance test (OGTT) in gestational week 24-28 (study phase II). An estimated 200 women (~20%) will screen positive for GDM, and these women will receive the co-created intervention and serve as the study's intervention group.
Additionally, all women (both intervention and control group) will be interviewed in gestational week 32-36 and 8-12 weeks postpartum. Further, information about HbA1c, maternal BMI, gestational weight gain, mode of delivery, neonatal weight as well as obstetric and neonatal complications will be obtained from measurements and the delivery records. The primary endpoint will be large for gestational age. Secondary neonatal endpoints will be macrosomia, preterm birth, stillborn/neonatal death and neonatal hypoglycemia. Secondary maternal outcomes will be HbA1c, hypertensive disorders, gestational weight gain, caesarean section, women's GDM self-care, perceived social support, perceived wellbeing, signs of depression, breastfeeding rates, quality of life, and empowerment. The outcome of this intervention pilot study will determine whether the intervention can be feasibly delivered within the context of a full-scale randomized controlled trial (RCT). Thus, the pilot study will not be powered to detect statistical differences in key clinical outcomes, but the sample sizes have been chosen to highlight problems and confirm the potential to detect differences.
Women may be included in the study all the way up to gestational age 28 depending on when they attend their first antenatal care appointment and receive the OGTT. Further, the point in time of the different questionnaire interviews may vary according to the needs of the pregnant women and when she delivers.
- Conditions
- GDM
- Being tested
- Self-care with informal support
- Keywords
- GDM, Co-creation, Self-care, Vietnam, Low-and-middle-income countries, Informal support, Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-care with informal supportBehavioural
The detailed content of the "self-care with informal support intervention" will be developed at participatory co-creation workshops involving pregnant women with GDM, their informal support persons, and health care staff.
It is expected that intervention will include educational pamphlets regarding GDM and digital GDM education through videos and text messages. Further, digital coaching will be conducted and networking among intervention participants via the Vietnamese messaging app Zalo. In addition, each woman will be invited to include one informal support person in the intervention activities.
GDM education will concern coaching on diet and exercise during pregnancy and after delivery and coaching on breastfeeding and infant/child nutrition.
| Study group | Role | What they receive |
|---|---|---|
| Standard GDM care | No intervention | After being diagnosed with GDM, standard care includes counseling on nutrition and physical activity. All patients are referred to an endocrinologist at the General Hospital, yet this is not covered by insurance unless the patients have received a referral letter from a health station. The endocrinologist will perform blood glucose measurements (venous blood sample) once every four weeks at the General Hospital until gestational week 36, after which it will be monitored once a week until delivery. The cut-off for c-section is 3800g (no matter the mother's GDM status). Treatment recommended by the endocrinologist may include home-monitoring of blood glucose and insulin treatment in the most severe cases. The home-monitoring requires that the women are able to buy the glucometer and test strips themselves. |
| Self-care with informal support | Experimental | Standard care + "Self-care/informal support" intervention
The detailed content of the "self-care/informal support intervention" will be developed at participatory co-creation workshops involving pregnant women with GDM, their informal support persons, and health care staff.
It is expected that intervention will include educational pamphlets regarding GDM and digital GDM education through videos and text messages. Further, digital coaching will be conducted and networking among intervention participants via the Vietnamese messaging app Zalo. In addition, each woman will be invited to include one informal support person in the intervention activities.
GDM education will concern coaching on diet and exercise during pregnancy and after delivery and coaching on breastfeeding and infant/child nutrition. Receives: Behavioral: Self-care with informal support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Large for Gestational Age (LGA)
Number of Participants who delivered newborns with birth weight above or equal to the 90th percentile according to gender and gestational age based on the INTERGROWTH-21st birthweight chart
Measured: Delivery (up to study month 7 after enrolment/Gestational age 40)
Large for Gestational Age (LGA)
Number of Participants who delivered newborns with birth weight above or equal to the 90th percentile according to gender and gestational age based on the INTERGROWTH-21st fetal weight formula.
Measured: Delivery (study month 7 after enrolment/Gestational age 40)
The Feasibility of the Self-care Intervention [Recruitment]
Number of Participants eligible for the study who accepted to be included in the intervention arm.
Measured: Recruitment (study month 0)
The Feasibility of the Self-care Intervention [Retention]
Number of Participants included in the self-care intervention group who completed the study (delivery data and post-partum interview).
Measured: Recruitment to post-partum evaluation (study month 0-10)
The Acceptability of the Self-care Intervention
Acceptability will be measured in a combined quantitative and qualitative study. It will be measured quantitatively via 5-point likert scales among the intervention group [Range: 1-5; Minimum score: 1; Maximum score: 5; Higher score indicates high acceptability]. It will be assessed qualitatively among a sub-group of the intervention group through a ethnographic study.
Measured: Study month 3 to 10 /Gestational age 24 to 12 weeks post-partum
Secondary outcomes (18)
Mode of Delivery
Number of participants with spontaneous vaginal delivery, assisted vaginal delivery, planned c-section or emergency c-section
Measured: Delivery (study month 7/Gestational age 40)
Pre-term Birth Below Gestational Age 37+0
Number of participants with spontaneous preterm birth or medical induced preterm birth
Measured: Delivery (study month 7/Gestational age 40)
Gestational Age
The gestational age of newborns at delivery
Measured: Delivery (study month 7/Gestational age 40)
Birth Weight
Birth weight of newborns measured in grams
Measured: Delivery (study month 7/Gestational age 40)
Macrosomia
Number of newborns with birth weight above 4000g
Measured: Delivery (study month 7/Gestational age 40)
Macrosomia (Vietnam)
Number of newborns with birth weight above 3500g
Measured: Delivery (study month 7/Gestational age 40)
Live-born
Newborns that are live-born (Yes/no)
Measured: Delivery (study month 7/Gestational age 40)
Small for Gestational Age (SGA)
Number of newborns below the 10th percentile for birth weight according to gestational age
Measured: Delivery (study month 7/Gestational age 40)
Apgar Score
The Apgar score of newborns measured 1 and 5 minutes after delivery (score: 0-10)
Measured: Delivery (study month 7/Gestational age 40)
Neonatal Hypoglycemia
Measurement of blood glucose (mmol/l) in newborns
Measured: Delivery (study month 7/Gestational age 40)
Maternal Gestational Weight Gain
Change in delta weight (kilogram) among participants between gestational age 36 minus first measured/pre-gestational weight
Measured: Study month 0 and 6/Gestational age 12 and 36
HbA1c
Change in delta score among participants between gestational age 24 and 40 (delivery)
Measured: Study month 3 and 7/Gestational age 24 and 40 (delivery)
Breast Feeding Practices
Participants' breast feeding practices measured through ad hoc developed questions
Measured: Study month 10 (12 weeks post-partum)
Post-partum Depression
Change in delta score among participants measured through the Edinburgh postpartum depression scale (EPDS) [10 items on 4-point scale ranging from 0-3]
Measured: Study month 3 and 10/Gestational age 24 and 12 weeks postpartum
Perceived Social Support
Change in delta score among participants measured through the Multidimensional Scale of Perceived Social Support scale (MSPSS) [11 item 7-point scale ranging from 1-7]
Measured: Study month 3,6 and 10/Gestational age 24, 36 and 12 weeks postpartum
Well-being
Change in delta scores measured through WHO 5 Wellbeing index [5 items on 6-point scale ranging from 0-5]
Measured: Study month 0, 3, 6 and 10/Gestational age 12, 24, 36 and 12 weeks postpartum
Self-care Agency
Difference in score between intervention and comparator group measured through the Self-care Agency Scale-Revised (ASAS-R) [15 items on 5-point scale ranging from 1-5]
Measured: Study month 3 and 6/Gestational age 24 and 36
Self-care of GDM
Difference in score between intervention and comparator group measured through the Summary of Diabetes Self- Care Activities (SDSCA) [10 items on 8-point scale ranging 0-7]
Measured: Study month 6/Gestational age 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start16 Jan 2023
- Primary completion10 Feb 2025
- Study completion20 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study is parallel 2-arm non-randomized intervention study with a delayed-start for the intervention group. The study population will be recruited in two phases. Over a period of 4 months (phase I) 1000 pregnant women will be screened for GDM among which 200 will be diagnosed with GDM and receive standard GDM care according to national guidelines in Vietnam (control group). During phase I, the "self-care + informal support intervention" will be co-created with local health care staff and a sub-group of the control group. Four months after the recruitment for phase I has finished, recruitment for phase II will start. Over a period of 4 months, another 1000 pregnant will be screened for GDM among which 200 will be diagnosed with GDM. These 200 women will be invited to receive the "self-care + informal support" intervention (intervention group). This pilot study is designed to inform a power calculation and logistics of a future full-scale randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thai Binh University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, University of Southern Denmark
- Responsible party
- Principal investigator, Thanh Duc Nguyen, Thai Binh University of Medicine and Pharmacy
- Investigators
- Thanh Duc Nugyen, MD, Principal investigator, Thain Binh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744856
- Sponsor's protocol ID
- VALID II
- Acronym
- VALID-II
- Status last verified
- Feb 2026
- First submitted
- 21 Dec 2022
- Last updated
- 10 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the articles will be shared after de-identification (text, tables, figures, and appendices). Sharing of data must adhere to the General Data Protection Regulation (GDPR) in Denmark and Vietnam.
Publications
Nguyen AT, Dang NT, Vu TKD, Nguyen TMP, Nguyen TTH, Bygbjerg IC, Gammeltoft TM. Exploring pregnant women's experiences of a digital self-care intervention for gestational diabetes mellitus in Vietnam: a qualitative study. BMC Pregnancy Childbirth. 2026 Jul 17. doi: 10.1186/s12884-026-09651-8. Online ahead of print.
PubMed 42464176Gammeltoft TM, Vu TKD, Dang NT, Nguyen TMP, Nguyen AT, Bygbjerg IC. The 5-C model of digital health accompaniment: empowering women through a gestational diabetes self-care intervention in Vietnam. Front Clin Diabetes Healthc. 2026 May 4;7:1738433. doi: 10.3389/fcdhc.2026.1738433. eCollection 2026.
PubMed 42157808Linde DS, Le HM, Vu DTK, Dang NT, Nguyen AT, Vu TP, Nguyen XB, Nguyen CD, Meyrowitsch DW, Sondergaard J, Vinter CA, Bygbjerg IC, Rasch V, Nguyen TD, Gammeltoft TM, Nguyen DK. A co-created self-care and informal support intervention targeting women with gestational diabetes mellitus in northern Vietnam (VALID-II): a protocol for a two-arm non-randomised feasibility study. Pilot Feasibility Stud. 2025 May 29;11(1):73. doi: 10.1186/s40814-025-01657-x.
PubMed 40442746
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living Together With Chronic Disease: Informal Support for Diabetes Management in Vietnam (VALID) - Gestational Diabetes in Vietnam - Phase II
- ClinicalTrials.gov ID
- NCT05744856
- Acronym / sponsor ID
- VALID-II / VALID II
- Conditions
- GDM
- Keywords
- GDM, Co-creation, Self-care, Vietnam, Low-and-middle-income countries, Informal support, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- Thai Binh University of Medicine and PharmacyUniversity, hospital or other
- Collaborators
- University of Copenhagen, University of Southern Denmark
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Posted 10 Feb 2026
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 significant public health problem in Vietnam, which is potentially treatable if managed properly by the pregnant women once diagnosed. However, systematic screening for GDM is rarely undertaken in Vietnam, and little is known about how health providers, pregnant women, and their families in today's Vietnam handle the condition. Vietnamese women often depend on their extended family for daily life management and access to social and financial resources, hence, an intervention that focuses on informal support and GDM self-care may increase adherence the standard guidelines among pregnant women with GDM in Vietnam and increase neonatal and maternal health outcomes.
Detailed description
Background: Across the globe, diabetes mellitus is attaining epidemic proportions, with low- and middle-income countries confronting particularly high burdens. VALID II focuses on gestational diabetes mellitus (GDM), a transitory form of diabetes that presents during pregnancy.
Objectives: To: i) Determine prevalence and risk factors for GDM among pregnant women in Vietnam's Thai Binh province, ii) Measure the associations between GDM and pregnancy complications and outcomes, iii) Understand how pregnant women with GDM and their informal support persons perceive and handle the condition, iv) Co-create, implement, and assess the feasibility of a intervention aiming to enhance the self-care capacities of pregnant women with GDM.
Study setting: Thai Binh, Vietnam
Study design: Intervention study
Study population: 2,000 pregnant women attending antenatal care.
Methodology: The study will be performed as a pilot parallel 2-arm non-randomized intervention study with a delayed-start for the intervention group. 1000 women will be invited into the study at their first antenatal care visit (gestational week 12) and complete a questionnaire (inclusion questionnaire). All women will be offered a 2-hour oral glucose tolerance test (OGTT) in gestational week 24-28 and complete second questionnaire (OGTT questionnaire) exploring living conditions, lifestyle, risk factors, selfcare, perceived social support, perceived wellbeing, and sign of depression. An estimated 200 women (~20%) will screen positive for GDM by the OGTT according to the World Health Organization (WHO) 2013 diagnostic criteria and receive standard GDM care. These 200 women will serve as the study's control group (study phase I). Among the 200 women who screen positive in phase I, ethnographic interviews will be formed in a subgroup of 20 women. The information from the 20 ethnographic interviews and the 200 questionnaire interviews will help inform a co-created "self-care and informal support" intervention. Subsequently, another 1000 women will be invited into the study at their first antenatal care visit and be offered a 2-hour oral glucose tolerance test (OGTT) in gestational week 24-28 (study phase II). An estimated 200 women (~20%) will screen positive for GDM, and these women will receive the co-created intervention and serve as the study's intervention group.
Additionally, all women (both intervention and control group) will be interviewed in gestational week 32-36 and 8-12 weeks postpartum. Further, information about HbA1c, maternal BMI, gestational weight gain, mode of delivery, neonatal weight as well as obstetric and neonatal complications will be obtained from measurements and the delivery records. The primary endpoint will be large for gestational age. Secondary neonatal endpoints will be macrosomia, preterm birth, stillborn/neonatal death and neonatal hypoglycemia. Secondary maternal outcomes will be HbA1c, hypertensive disorders, gestational weight gain, caesarean section, women's GDM self-care, perceived social support, perceived wellbeing, signs of depression, breastfeeding rates, quality of life, and empowerment. The outcome of this intervention pilot study will determine whether the intervention can be feasibly delivered within the context of a full-scale randomized controlled trial (RCT). Thus, the pilot study will not be powered to detect statistical differences in key clinical outcomes, but the sample sizes have been chosen to highlight problems and confirm the potential to detect differences.
Women may be included in the study all the way up to gestational age 28 depending on when they attend their first antenatal care appointment and receive the OGTT. Further, the point in time of the different questionnaire interviews may vary according to the needs of the pregnant women and when she delivers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is parallel 2-arm non-randomized intervention study with a delayed-start for the intervention group. The study population will be recruited in two phases. Over a period of 4 months (phase I) 1000 pregnant women will be screened for GDM among which 200 will be diagnosed with GDM and receive standard GDM care according to national guidelines in Vietnam (control group). During phase I, the "self-care + informal support intervention" will be co-created with local health care staff and a sub-group of the control group. Four months after the recruitment for phase I has finished, recruitment for phase II will start. Over a period of 4 months, another 1000 pregnant will be screened for GDM among which 200 will be diagnosed with GDM. These 200 women will be invited to receive the "self-care + informal support" intervention (intervention group). This pilot study is designed to inform a power calculation and logistics of a future full-scale randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Standard GDM care | No intervention | –After being diagnosed with GDM, standard care includes counseling on nutrition and physical activity. All patients are referred to an endocrinologist at the General Hospital, yet this is not covered by insurance unless the patients have received a referral letter from a health station. The endocrinologist will perform blood glucose measurements (venous blood sample) once every four weeks at the General Hospital until gestational week 36, after which it will be monitored once a week until delivery. The cut-off for c-section is 3800g (no matter the mother's GDM status). Treatment recommended by the endocrinologist may include home-monitoring of blood glucose and insulin treatment in the most severe cases. The home-monitoring requires that the women are able to buy the glucometer and test strips themselves. |
| Self-care with informal support | Experimental | Behavioral: Self-care with informal supportStandard care + "Self-care/informal support" intervention The detailed content of the "self-care/informal support intervention" will be developed at participatory co-creation workshops involving pregnant women with GDM, their informal support persons, and health care staff. It is expected that intervention will include educational pamphlets regarding GDM and digital GDM education through videos and text messages. Further, digital coaching will be conducted and networking among intervention participants via the Vietnamese messaging app Zalo. In addition, each woman will be invited to include one informal support person in the intervention activities. GDM education will concern coaching on diet and exercise during pregnancy and after delivery and coaching on breastfeeding and infant/child nutrition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnancy < 28 weeks
- Singleton and multiple pregnancies
- Residing in Thai Binh province
- Speaks and reads Vietnamese
- Agree to participate voluntarily (informed consent)
Key exclusion criteria (3 listed)
- Pre-gestational diabetes (type I or type II)
- Severe chronic disease
- Women with GDM in a prior pregnancy are eligible for inclusion into the study.
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 |
|---|---|---|
| Self-care with informal supportThe detailed content of the "self-care with informal support intervention" will be developed at participatory co-creation workshops involving pregnant women with GDM, their informal support persons, and health care staff. It is expected that intervention will include educational pamphlets regarding GDM and digital GDM education through videos and text messages. Further, digital coaching will be conducted and networking among intervention participants via the Vietnamese messaging app Zalo. In addition, each woman will be invited to include one informal support person in the intervention activities. GDM education will concern coaching on diet and exercise during pregnancy and after delivery and coaching on breastfeeding and infant/child nutrition. | Behavioural | Self-care with informal support |
Primary outcome
Large for Gestational Age (LGA)
Time frame: Delivery (up to study month 7 after enrolment/Gestational age 40)
Number of Participants who delivered newborns with birth weight above or equal to the 90th percentile according to gender and gestational age based on the INTERGROWTH-21st birthweight chart
Large for Gestational Age (LGA)
Time frame: Delivery (study month 7 after enrolment/Gestational age 40)
Number of Participants who delivered newborns with birth weight above or equal to the 90th percentile according to gender and gestational age based on the INTERGROWTH-21st fetal weight formula.
The Feasibility of the Self-care Intervention [Recruitment]
Time frame: Recruitment (study month 0)
Number of Participants eligible for the study who accepted to be included in the intervention arm.
The Feasibility of the Self-care Intervention [Retention]
Time frame: Recruitment to post-partum evaluation (study month 0-10)
Number of Participants included in the self-care intervention group who completed the study (delivery data and post-partum interview).
The Acceptability of the Self-care Intervention
Time frame: Study month 3 to 10 /Gestational age 24 to 12 weeks post-partum
Acceptability will be measured in a combined quantitative and qualitative study. It will be measured quantitatively via 5-point likert scales among the intervention group [Range: 1-5; Minimum score: 1; Maximum score: 5; Higher score indicates high acceptability]. It will be assessed qualitatively among a sub-group of the intervention group through a ethnographic study.
18 secondary outcomes
Mode of Delivery
Time frame: Delivery (study month 7/Gestational age 40)
Pre-term Birth Below Gestational Age 37+0
Time frame: Delivery (study month 7/Gestational age 40)
Gestational Age
Time frame: Delivery (study month 7/Gestational age 40)
Birth Weight
Time frame: Delivery (study month 7/Gestational age 40)
Macrosomia
Time frame: Delivery (study month 7/Gestational age 40)
Macrosomia (Vietnam)
Time frame: Delivery (study month 7/Gestational age 40)
Live-born
Time frame: Delivery (study month 7/Gestational age 40)
Small for Gestational Age (SGA)
Time frame: Delivery (study month 7/Gestational age 40)
Apgar Score
Time frame: Delivery (study month 7/Gestational age 40)
Neonatal Hypoglycemia
Time frame: Delivery (study month 7/Gestational age 40)
Maternal Gestational Weight Gain
Time frame: Study month 0 and 6/Gestational age 12 and 36
HbA1c
Time frame: Study month 3 and 7/Gestational age 24 and 40 (delivery)
Breast Feeding Practices
Time frame: Study month 10 (12 weeks post-partum)
Post-partum Depression
Time frame: Study month 3 and 10/Gestational age 24 and 12 weeks postpartum
Perceived Social Support
Time frame: Study month 3,6 and 10/Gestational age 24, 36 and 12 weeks postpartum
Well-being
Time frame: Study month 0, 3, 6 and 10/Gestational age 12, 24, 36 and 12 weeks postpartum
Self-care Agency
Time frame: Study month 3 and 6/Gestational age 24 and 36
Self-care of GDM
Time frame: Study month 6/Gestational age 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42464176Nguyen AT, Dang NT, Vu TKD, Nguyen TMP, Nguyen TTH, Bygbjerg IC, Gammeltoft TM. Exploring pregnant women's experiences of a digital self-care intervention for gestational diabetes mellitus in Vietnam: a qualitative study. BMC Pregnancy Childbirth. 2026 Jul 17. doi: 10.1186/s12884-026-09651-8. Online ahead of print.
- Derived from this study: PubMed 42157808Gammeltoft TM, Vu TKD, Dang NT, Nguyen TMP, Nguyen AT, Bygbjerg IC. The 5-C model of digital health accompaniment: empowering women through a gestational diabetes self-care intervention in Vietnam. Front Clin Diabetes Healthc. 2026 May 4;7:1738433. doi: 10.3389/fcdhc.2026.1738433. eCollection 2026.
- Derived from this study: PubMed 40442746Linde DS, Le HM, Vu DTK, Dang NT, Nguyen AT, Vu TP, Nguyen XB, Nguyen CD, Meyrowitsch DW, Sondergaard J, Vinter CA, Bygbjerg IC, Rasch V, Nguyen TD, Gammeltoft TM, Nguyen DK. A co-created self-care and informal support intervention targeting women with gestational diabetes mellitus in northern Vietnam (VALID-II): a protocol for a two-arm non-randomised feasibility study. Pilot Feasibility Stud. 2025 May 29;11(1):73. doi: 10.1186/s40814-025-01657-x.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the articles will be shared after de-identification (text, tables, figures, and appendices). Sharing of data must adhere to the General Data Protection Regulation (GDPR) in Denmark and Vietnam.
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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. This study is not recruiting at the moment.
Thanh Duc Nugyen, MD principal investigator
Thain Binh Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-care with informal support in people with GDM, run by Thai Binh University of Medicine and Pharmacy at 2 sites 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 10 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Large for Gestational Age (LGA) (time frame: Delivery (up to study month 7 after enrolment/Gestational age 40)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05744856, which also lists 3 linked publications.
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 10 Feb 2026.