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

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.

Study Overview

• Status: Recruiting
• Conditions: GDM
• Intervention / Treatment: Behavioral: Self-care with informal support

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 Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thanh Duc Nguyen, MD; Phone Number: +84 091 235 7575; Email: bsthanh@hotmail.com
• Study Contact Backup: Name: Lê Minh Hieu, MD; Email: drhieuytb@gmail.com

Study Locations

• Vietnam
  • Thai Binh, Vietnam, 410000
    • Recruiting
    • Thai Binh Maternity Hospital
    • Contact: Lê Minh Hieu, MD; Email: drhieuytb@gmail.com
    • Contact: Nguyen Thanh; Phone Number: +84912357575; Email: bsthanh@hotmail.com
  • Thái Bình, Vietnam, 410000
    • Recruiting
    • Kim Ngan Clinic
    • Contact: Pham Thi Kim Ngan, MD; Phone Number: (+84) 981 191 125; Email: phongkhamkimngan325pbv@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard GDM care; 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.
Experimental: Self-care with informal support; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Large for gestational age (LGA)	Number of newborns with birth weight above the 90th percentile according to gender and gestational age (INTERGROWTH)	Delivery (study month 7 after enrolment/Gestational age 40)
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
The feasibility of the self-care intervention [recruitment]	Number of women eligible for the study who accepts to be included in the intervention arm.	Recruitment (study month 0)
The feasibility of the self-care intervention [retention]	Number of included women in the intervention group who completes the study (delivery data and post-partum interview).	Recruitment to post-partum evaluation (study month 0-10)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mode of delivery	Number of participants with spontaneous vaginal delivery, assisted vaginal delivery, planned c-section or emergency c-section	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	Delivery (study month 7/Gestational age 40)
Gestational age	The gestational age of newborns at delivery	Delivery (study month 7/Gestational age 40)
Birth weight	Birth weight of newborns measured in grams	Delivery (study month 7/Gestational age 40)
Macrosomia	Number of newborns with birth weight above 4000g	Delivery (study month 7/Gestational age 40)
Macrosomia (Vietnam)	Number of newborns with birth weight above 3500g	Delivery (study month 7/Gestational age 40)
Live-born	Newborns that are live-born (Yes/no)	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	Delivery (study month 7/Gestational age 40)
Apgar score	The Apgar score of newborns measured 1 and 5 minutes after delivery (score: 0-10)	Delivery (study month 7/Gestational age 40)
Neonatal hypoglycemia	Measurement of blood glucose (mmol/l) in newborns	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	Study month 0 and 6/Gestational age 12 and 36
HbA1c	Change in delta score among participants between gestational age 24 and 40 (delivery)	Study month 3 and 7/Gestational age 24 and 40 (delivery)
Breast feeding practices	Participants' breast feeding practices measured through ad hoc developed questions	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]	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]	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]	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]	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]	Study month 6/Gestational age 36

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diet	Change in diet measured through ad hoc developed questions	Study month 3 and 6/Gestational age 24 and 36
Physical activity	Change in physical activity measured through ad hoc developed questions	Study month 3 and 6/Gestational age 24 and 36
Episiotomy	Number of participants where episiotomy is performed during delivery	Delivery (study month 7/Gestational age 40)
PPROM	Number of participants with Premature Primary Rupture of Membranes	Delivery (study month 7/Gestational age 40)
Prevalence of GDM	Number of participants with GDM diagnosed according to WHO criteria	Study month 3/Gestational age 24
Risk factors of GDM	Number of pre-gestational and gestational risk factors for GDM prevalent among participants diagnosed with GDM (risk factor are defined as according to those known in the literature, e.g. age, BMI, family disposition, gestational weigh gain)	Study month 3/Gestational age 24
Perception of GDM	Ethnographic study conducted among approximately 40 pregnant women with GDM and their informal support persons (20 from intervention group and 20 from control group)	Study month 3 to 7/Gestational age 24 to 40 (delivery)
GDM self-care practices	Ethnographic study conducted among approximately 40 pregnant women with GDM and their informal support persons (20 from intervention group and 20 from control group)	Study month 3 to 7/Gestational age 24 to 40 (delivery)
Perception of "self-care/informal support" intervention	Ethnographic study conducted among approximately 20 pregnant women with GDM and their informal support persons (intervention group)	Study month 3 to 10/Gestational age 24 to 12 weeks post-partum
Family health	The short form version of the Family Health Scale [10 items on a 5-point scale ranging from 1-5]. A total score of 0-5 indicates poor family health, 6-8 indicates moderate family health, and 9-10 indicates excellent family health	Study month 6/Gestational age 36
Costs	Direct economic costs (in Vietnamese Dong/VND and USD) and indirect costs (human ressources measured in hours) spent on developing the intervention	Throughout whole study (study month 0-10)

Collaborators and Investigators

• Sponsor: Thai Binh University of Medicine and Pharmacy
• Collaborators: University of Copenhagen; University of Southern Denmark
• Investigators: Principal Investigator: Thanh Duc Nugyen, MD, Thain Binh Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2023
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 21, 2022
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Estimated): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Intervention; GDM; Vietnam; Self-care; Co-creation; Low-and-middle-income countries; Informal support
• Other Study ID Numbers: VALID II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The data will be available immediately following publication. No end date.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No