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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-16

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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

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GDM

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Due to the overt nature of the intervention, it is not possible to blind the participants, healthcare providers nor the investigators.

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Self-care with informal support

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes