Clinical trial NCT05744856: A Co-created Self-care and Informal Support Intervention Study Among Women With GDM in Vietnam
Official title: Living Together With Chronic Disease: Informal Support for Diabetes Management in Vietnam (VALID) - Gestational Diabetes in Vietnam - Phase II
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: GDM
Keywords: GDM
Co-creation
Self-care
Vietnam
Low-and-middle-income countries
Informal support
Intervention
Lead sponsor: Thai Binh University of Medicine and Pharmacy
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: University of Southern Denmark
First posted: 2023-02-27
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Large for gestational age (LGA)
timeFrame: Delivery (study month 7 after enrolment/Gestational age 40)
measure: The feasibility of the self-care intervention [recruitment]
timeFrame: Recruitment (study month 0)
measure: The feasibility of the self-care intervention [retention]
timeFrame: Recruitment to post-partum evaluation (study month 0-10)
measure: The acceptability of the self-care intervention
timeFrame: Study month 3 to 10 /Gestational age 24 to 12 weeks post-partum
Secondary outcomes:
measure: Mode of delivery
timeFrame: Delivery (study month 7/Gestational age 40)
measure: Pre-term birth below gestational age 37+0
timeFrame: Delivery (study month 7/Gestational age 40)
measure: Gestational age
timeFrame: Delivery (study month 7/Gestational age 40)
measure: Birth weight
timeFrame: Delivery (study month 7/Gestational age 40)
measure: Macrosomia
timeFrame: Delivery (study month 7/Gestational age 40)
measure: Macrosomia (Vietnam)
timeFrame: Delivery (study month 7/Gestational age 40)
measure: Live-born
timeFrame: Delivery (study month 7/Gestational age 40)
measure: Small for gestational age (SGA)
timeFrame: Delivery (study month 7/Gestational age 40)
measure: Apgar score
timeFrame: Delivery (study month 7/Gestational age 40)
measure: Neonatal hypoglycemia
timeFrame: Delivery (study month 7/Gestational age 40)
measure: Maternal gestational weight gain
timeFrame: Study month 0 and 6/Gestational age 12 and 36
measure: HbA1c
timeFrame: Study month 3 and 7/Gestational age 24 and 40 (delivery)
measure: Breast feeding practices
timeFrame: Study month 10 (12 weeks post-partum)
measure: Post-partum depression
timeFrame: Study month 3 and 10/Gestational age 24 and 12 weeks postpartum
measure: Perceived social support
timeFrame: Study month 3,6 and 10/Gestational age 24, 36 and 12 weeks postpartum
measure: Well-being
timeFrame: Study month 0, 3, 6 and 10/Gestational age 12, 24, 36 and 12 weeks postpartum
measure: Self-care Agency
timeFrame: Study month 3 and 6/Gestational age 24 and 36
measure: Self-care of GDM
timeFrame: Study month 6/Gestational age 36
Other outcomes:
measure: Diet
timeFrame: Study month 3 and 6/Gestational age 24 and 36
measure: Physical activity
timeFrame: Study month 3 and 6/Gestational age 24 and 36
measure: Episiotomy
timeFrame: Delivery (study month 7/Gestational age 40)
measure: PPROM
timeFrame: Delivery (study month 7/Gestational age 40)
measure: Prevalence of GDM
timeFrame: Study month 3/Gestational age 24
measure: Risk factors of GDM
timeFrame: Study month 3/Gestational age 24
measure: Perception of GDM
timeFrame: Study month 3 to 7/Gestational age 24 to 40 (delivery)
measure: GDM self-care practices
timeFrame: Study month 3 to 7/Gestational age 24 to 40 (delivery)
measure: Perception of "self-care/informal support" intervention
timeFrame: Study month 3 to 10/Gestational age 24 to 12 weeks post-partum
measure: Family health
timeFrame: Study month 6/Gestational age 36
measure: Costs
timeFrame: Throughout whole study (study month 0-10)
Locations:
city: Thai Binh
country: Vietnam
facility: Thai Binh Maternity Hospital
city: Thái Bình
country: Vietnam
facility: Kim Ngan Clinic
Study officials:
affiliation: Thain Binh Medical University
name: Thanh Duc Nugyen, MD
role: PRINCIPAL_INVESTIGATOR
References: