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

Thai Binh University of Medicine and Pharmacy

Status: Enrolling

Conditions: GDM

Treatments: Behavioral: Self-care with informal support

Study type: Interventional

Funder types: Other

Identifiers

NCT05744856

VALID II

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Standard GDM care

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Self-care with informal support