A Co-created Self-care and Informal Support Intervention Study Among Women With GDM in Vietnam

NCT05744856 | Completed Results

• 1 other identifier: VALID II
• Study Type: interventional
• Target: 435
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

GDM

Keywords

GDM; Co-creation; Self-care; Vietnam; Low-and-middle-income countries; Informal support; Intervention

Outcome Measures

Primary Outcomes (5)

• 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

  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.

  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.

  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).

  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.

  Study month 3 to 10 /Gestational age 24 to 12 weeks post-partum

Secondary Outcomes (18)

• Mode of Delivery

  Delivery (study month 7/Gestational age 40)

• Pre-term Birth Below Gestational Age 37+0

  Delivery (study month 7/Gestational age 40)

• Gestational Age

  Delivery (study month 7/Gestational age 40)

• Birth Weight

  Delivery (study month 7/Gestational age 40)

• Macrosomia

  Delivery (study month 7/Gestational age 40)

Other Outcomes (11)

• Diet

  Study month 3 and 6/Gestational age 24 and 36

• Physical Activity

  Study month 3 and 6/Gestational age 24 and 36

• Episiotomy

  Delivery (study month 7/Gestational age 40)

Study Arms (2)

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.

Behavioral: Self-care with informal support

Interventions

Self-care with informal support BEHAVIORAL

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.

Self-care with informal support

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnancy \< 28 weeks
• Singleton and multiple pregnancies
• Residing in Thai Binh province
• Speaks and reads Vietnamese
• Agree to participate voluntarily (informed consent)

You may not qualify if:

• Pre-gestational diabetes (type I or type II)
• Severe chronic disease

Sponsors & Collaborators

• Thai Binh University of Medicine and Pharmacy: lead
• University of Copenhagen: collaborator
• University of Southern Denmark: collaborator

Study Sites (2)

Thai Binh Maternity Hospital

Thái Bình, Thai Binh, 410000, Vietnam

Location

Kim Ngan Clinic

Thái Bình, Thái Bình, 410000, Vietnam

Location

Related Publications (1)

• Linde 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.

  PMID: 40442746 DERIVED

MeSH Terms

Interventions

Self Care

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Thanh Nguyen
• Organization: Thai Binh University for Medicine and Pharmacy

bsthanh@hotmail.com

+84 912357575

Study Officials

• Thanh Duc Nugyen, MD

  Thain Binh Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Due to the overt nature of the intervention, it is not possible to blind the participants, healthcare providers nor the investigators.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of International Relations Department

Model Details: 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.

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: February 27, 2023
• Study Start: January 16, 2023
• Primary Completion: February 10, 2025
• Study Completion: April 20, 2025
• Last Updated: February 10, 2026
• Results First Posted: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be available immediately following publication. No end date.
• Access Criteria: All requests for data should be addressed to the sponsor (see contact details under central contact person). The sponsor will will review the request and involve all applicable parties in the decision-making outcome (i.e. all Vietnamese and Danish collaborators). Data will be shared with researchers who provide a methodological sound proposal. New projects that result in data sharing should meet the high standards (quality, ethical, and financial) maintained by this study.

Locations

VN (2)