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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 Pilot Trial
Ditte S Linde ( dsondergaard@health.sdu.dk )
University of Southern Denmark https://orcid.org/0000-0002-0851-6760
Hieu M Le
Thai Binh University of Medicine and Pharmacy: Thai Binh Medical University
Dung TK Vu
Thai Binh University of Medicine and Pharmacy: Thai Binh Medical University
Ngoc-Anh T Dang
Thai Binh University of Medicine and Pharmacy: Thai Binh Medical University
Ai T Nguyen
Thai Binh University of Medicine and Pharmacy: Thai Binh Medical University
Tuc P Vu
Thai Binh University of Medicine and Pharmacy: Thai Binh Medical University
Xuan-Bai Nguyen
Thai Binh University of Medicine and Pharmacy: Thai Binh Medical University
Cuong D Nguyen
Thai Binh University of Medicine and Pharmacy: Thai Binh Medical University
Dan W Meyrowitsch
University of Copenhagen: Kobenhavns Universitet
Jens Søndergaard
University of Southern Denmark: Syddansk Universitet
Christina A Vinter
Odense University Hospital: Odense Universitetshospital
Ib C Bygbjerg
University of Copenhagen: Kobenhavns Universitet
Vibeke Rasch
University of Southern Denmark: Syddansk Universitet
Thanh D Nguyen
Thai Binh University of Medicine and Pharmacy: Thai Binh Medical University
Tine M Gammeltoft
University of Copenhagen: Kobenhavns Universitet
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Dang K Nguyen
Thai Binh University of Medicine and Pharmacy: Thai Binh Medical University
Research Article
Keywords: GDM, self-care, informal support, Vietnam, co-creation, feasibility, trial, pilot
Posted Date: September 29th, 2023
DOI: https://doi.org/10.21203/rs.3.rs-3140013/v1
License: This work is licensed under a Creative Commons Attribution 4.0 International License.
Read Full License
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Abstract
Background
Gestational diabetes mellitus (GDM) is a transitory form of diabetes that presents during pregnancy with
frequent adverse maternal and neonatal health consequences if left untreated. GDM is rapidly increasing
in low- and middle-income countries such as Vietnam, and early sustainable interventions are important.
The overall aim of this study – henceforth referred to as VALID-II – is to assess the feasibility of a co-
created self-care and informal support intervention targeted pregnant women with GDM and the degree to
which it can reduce maternal and neonatal health complications compared to standard care.
Methods
VALID-II is a two-site, two-arm, non-randomised pilot trial in Thai Binh Province in Northern Vietnam with a
delayed start for the intervention group. In total, 2000 pregnant women will be screened for GDM with
estimated 400 women screening positive according to World Health Organization - International
Association of Diabetes and Pregnancy Study Groups diagnostic criteria. Firstly, 200 women, who screen
positive for GDM, will be assigned to a control group that will receive standard care. Of the 200 women,
20 will take part in an in-depth ethnographic study along with their family members, and the intervention
will be co-created with them. Secondly, once the intervention has been created, 200 women will be
assigned to the intervention group that will receive the intervention plus standard care. Twenty women
and their families from the intervention group will also take part in an ethnographic study. The primary
outcomes are to evaluate how feasible the self-care intervention is (recruitment, retention, and
acceptability) and the number of new-borns born large for gestational age. Secondary outcomes include
other maternal and neonatal health outcomes, prevalence, and risk factors for GDM, self-care agency,
self-care, and breast-feeding practices.
Discussion
This study will provide knowledge of the extent to which an informal/self-care and social support
intervention can enhance maternal and child health outcomes among women with GDM in Northern
Vietnam and the feasibility for a full-scale randomised trial. This may guide decision makers on how to
optimise management of GDM in a low- and middle-income context.
Trial registration:
NCT05744856. Trial status: Recruiting.
Background
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Gestational diabetes mellitus (GDM) is a transitory form of diabetes that presents during pregnancy. It is
the most common endocrinopathy complication among pregnant women (1), and it is dened as
“any
degree of glucose intolerance with onset or rst recognition during pregnancy”
(2). A large body of
evidence has documented associations between GDM and adverse maternal and neonatal outcomes
including caesarean section (c-section) delivery, preeclampsia, preterm birth, macrosomia, birth injuries,
neonatal respiratory distress, and neonatal hypoglycaemia (3, 4). In addition, GDM can also adversely
affect the psychological wellbeing of the affected women, and the risk of developing type 2 diabetes in
the future for both mother and child (5–7).
The initial diagnostic criteria for GDM were established more than 50 years ago, however, diagnostic
guidelines have changed over time and currently vary worldwide. In 2008, the International Association of
Diabetes and Pregnancy Study Groups (IADPSG) Consensus Panel recommended the following threshold
values for diagnosis of GDM: ≥5.1 mmol/L of fasting plasma glucose, a 1-hour plasma glucose of ≥
10.0 mmol/L or a 2-hour plasma glucose of ≥ 8.5 mmol/L after a glucose challenge of 75g. These
criteria were later endorsed by the World Health Organisation (WHO) in 2013 (8). Globally, the prevalence
of GDM vary greatly depending on the country and the diagnostic criteria used, and recent studies have
found that the prevalence may range from 4% to above 20% (9, 10). In Vietnam, it has been found that
GDM affects up to 22.8% of pregnant women (10), and the Ministry of Health has dened the disease as
a signicant public health problem. Yet systematic GDM screening is uncommon due to limited resources
(11). Consequently, Vietnam faces a large number of GDM-related maternal and neonatal health issues
that to a large extent could have been prevented if the disease had been diagnosed and treated during
pregnancy.
Globally, there is growing awareness of the importance of locally grounded, informal self-care
interventions for diabetes management (12). According to the WHO, self-care is “
the ability of individuals,
families and communities to promote health, prevent disease, maintain health, and cope with illness and
disability with or without the support of a health worker
” (13). Previous studies have found that social
support and self-care interventions had a positive impact on the quality of life among women with GDM
(14) and self-ecacy (15, 16), yet, to this date there has been no GDM self-care interventions in Vietnam.
Research on self-care and type 2 diabetes conducted in northern Vietnam shows that people living with
type 2 diabetes mostly rely on their extended family for daily disease management and access to social
and nancial resources (17, 18). However, the practice of informal support and self-care depends on the
type of disease, social characteristics, and cultural practices, hence, it is crucial to develop a self-care
intervention together with the target group and assess the feasibility of it before testing it in a full-scale
trial.
Study objectives
The overall aim of the VALID-II study is to co-create an informal support and self-care intervention with
Vietnamese women with GDM and their informal support persons and evaluate the feasibility of the
intervention and effect of it on maternal and neonatal health outcomes.
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1.
The primary feasibility outcomes
: To evaluate how feasible the self-care intervention is in regard to
recruitment, retention, and acceptability.
2.
The primary neonatal outcome
: To test the effect of the intervention on the number of new-borns
born Large for Gestational Age (LGA) compared to standard care.
3.
Secondary neonatal outcomes
: (1) Apgar score, (2) birth weight, (3) gestational age, (4) live-born, (5)
macrosomia (birth weight above 4000g), (6) macrosomia according to standard practice in the
Maternity Hospital (birth weight above 3500g), (7) neonatal hypoglycaemia, (8) pre-term birth below
gestational age (GA) 37 + 0, and (9) small for gestational age (SGA).
4.
Secondary maternal outcomes
: (1) prevalence of and risk factors for GDM, (2) perceived social
support, (3) self-care agency, (4) self-care of GDM, and (5) personal well-being, (6) gestational weight
gain, (7) mode of delivery, (8) HbA1c-level at time of delivery, (9) breastfeeding practices, (10) post-
partum depression.
5.
Other outcomes
: (1) diet, (2) episiotomy, (3) physical activity, and (4) premature primary rupture of
membranes.
An ethnographic study is imbedded in the trial. The outcomes of the ethnographic study are: (1) Co-
creation of a self-care and informal support intervention, (2) in-depth knowledge of GDM self-care
practices, and (3) understanding of women’s and family members’ perceptions of GDM. This protocol is
reporting according to the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT)
statement and checklist (19, 20) (Supplementary material S1).
Methods
Design
VALID-II is a pilot 2-arm non-randomised intervention study. Pregnant women will be assigned to either a
control group or intervention group with a delayed start. The intervention will be co-created with a sub-
group of women from the control group and their informal support persons.
Setting
The VALID-II study is conducted in Thai Binh Province in Northern Vietnam. Participants are recruited
from two health facilities: Thai Binh Maternity Hospital and the Kim Ngan Clinic. Thai Binh Maternity
Hospital is a public university hospital with approximately 11,000 deliveries/year where pregnant women
can attend antenatal care and deliveries, whilst Kim Ngan Clinic is a private health clinic where pregnant
women can attend antenatal care only.
Study procedures
Recruitment of study population
Upon a pregnant woman’s rst antenatal care visit to either of the study sites, she is approached by a
study nurse/midwife who informs her about the study and invites her to participate. The timing of the
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rst antenatal care visit may vary from gestational week 5 up to 28, hence, women may be included in the
study on various point of times in their pregnancies. The majority of women have their rst antenatal care
visit around GA 12 and will be included at this time. If a woman consents to participate in the study, she
will participate in a short inclusion questionnaire interview (baseline questionnaire) with the study
nurse/midwife and be scheduled for an OGTT at GA 24–28.
Oral glucose tolerance test and diagnosis of gestational
diabetes mellitus
The pregnant woman will undergo a standard OGTT at GA 24–28 at either of the study sites. She will
arrive fasting in the morning and have a venous blood sample taken that measures her fasting plasma
glucose level. After the rst blood sample, she will intake a 75g dose of glucose whilst sitting and 1- and
2-hours after the glucose challenge, she will have additional blood samples taken. The blood samples will
be analysed at local laboratories at the two study sites which are located at less than 20 meters from the
waiting rooms. At the Kim Ngan Clinic, plasma glucose will be measured using enzymatic reference
method with hexokinase (Cobas 4000; Model: c311; Roche, Mannheim, Germany). At the Maternity
Hospital, the plasma glucose will be measured using enzymatic reference method with oxidase (Analyzer;
Model: BA400; Biosystems, Barcelona; Spain). Diagnosis will be made according to the IADPSG
Consensus Panel recommendations and WHO’s Diagnostic Criteria (2013) (21, 22). GDM will be
diagnosed if the glucose concentration is above one of the following three thresholds:
Fasting plasma glucose: ≥5.1 mmol/L
1-hour plasma glucose: ≥10.0 mmol/L
2-hour plasma glucose of ≥ 8.5 mmol/L
A study nurse/midwife will attend each woman’s OGTT appointment and conduct a second questionnaire
interview with the pregnant woman (OGTT interview) while she waits for her 1-hr and 2-hr blood samples.
Further, height, and weight will be measured at the OGTT visit using medical scales (Model TZ-120,
Shanghai Guangzheng Medical Equipment Co., Shanghai, China). Blood pressure will be measured at all
antenatal care visits using the same machine (Model: JPN600, Omron Healthcare Europe B.V., Hoofddorp,
the Netherlands). If the OGTT shows that the woman does not have GDM, she will not be interviewed any
further and simply participate in the study as a passive control. However, delivery and neonatal outcomes
will be deducted from the woman’s medical record. If she is diagnosed with GDM, she will participate in
an additional questionnaire interview at GA32-40 either in-person at the health facilities or via telephone
and at 8–12 weeks post-partum via a home-visit.
Inclusion and exclusion criteria
Women are included in VALID-II based on the following criteria: (1) Pregnancy ≤ 28 weeks; (2) Singleton
and multiple pregnancies; (3) Residing in Thai Binh province, (4) Speaks and reads Vietnamese, (5)
Agrees to participate voluntarily after informed consent. If a woman has had GDM in a prior pregnancy
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she is eligible for inclusion into the study. Women will be excluded from the study based on the following
criteria: (1) Pre-gestational diabetes (type 1 or type 2), and (2) Severe chronic disease.
Standard care/control
In the rst phase of the trial, all women diagnosed with GDM will be referred to standard care, which is an
invitation for a counselling session with an endocrinologist at Thai Binh Provincial General Hospital
regarding diet, exercises, and blood glucose measurements and monitoring. Standard care entails that
women will be invited for a follow-up check-up in the antenatal care clinic every four weeks until delivery.
If the women do not attend the counselling session, they are not advised about GDM self-care. Since
preliminary research showed that not all women diagnosed with GDM attend the counselling session at
Thai Binh Provincial General Hospital, the VALID-II project set-up includes a phone call to the women by
an endocrinologist at the hospital of Thai Binh University of Medicine and Pharmacy (TBUMP) one week
after the diagnosis. This phone call is made for ethical reasons to ensure that all women diagnosed
under the auspices of the VALID-II project receive basic counselling about GDM. If the women report that
they have received no counselling after the diagnosis, the VALID-II endocrinologist will offer basic
counselling by phone and encourage the women to seek care at Thai Binh Provincial General Hospital.
Intervention
The intervention will be conducted in the second phase of the trial which will occur approximately three
months after the rst phase. Ethnographic research will be conducted among pregnant women
diagnosed with GDM and their informal support persons after which the intervention will be co-created
together with them and with local health care staff. The intervention will include three main components:
1) coaching on diet and exercise during pregnancy and after delivery, and 2) self-monitoring of blood
glucose levels, and 3) coaching on breastfeeding and infant/child nutrition. Nutritional coaching,
including breastfeeding, will be a core component. The intervention design will include written
educational materials, along with other communicative formats such as videos, digital coaching, and
networking among intervention participants via the Vietnamese messaging app Zalo. A process
evaluation of the intervention conducted during its period of operation will provide insights into its
implementation and mechanisms of impact.
Sample size
This pilot study will determine whether the intervention can be feasibly delivered within the context of a
full-scale randomised controlled trial (RCT). Thus, the study is not powered to detect statistical
differences in key clinical outcomes but detection of potential issues and differences between the control
and intervention group. The feasibility outcomes will guide the most ecient and effective
implementation of a future full-scaled randomised trial as well as enable a proper estimation of a sample
size. Approximately, 2000 women will be enrolled into the study, and the women will be invited in
chronological order, starting from the study start date. An expected 400 women will be diagnosed with
GDM of which 200 will be allocated to the control group and 200 to the intervention group. These 400
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women are the primary target population of the study (Fig.1). Among the 200 women in the control arm,
20 women and their informal support persons will be invited to co-create the intervention.
Outcome measures
The primary feasibility outcome measures are recruitment, retention, usability, and acceptability of the
intervention. Recruitment will be estimated by calculating the proportion of eligible participants (pregnant
women with GDM) who accepts to participate in the intervention group (cut-off score: 80%). Retention will
be calculated as the proportion of enrolled participants (1) with delivery data (cut-off score: 75%) and (2)
who completes the postpartum questionnaire in the intervention and control group (cut-off score: 70%).
Usability will be calculated as the proportion of women in the intervention arm who uses the digital
intervention materials, i.e., see the health educative videos/messages, and attend health educative
meetings [explorative: no cut-off]. Acceptability of the intervention will be evaluated via mixed methods;
acceptability will be measured quantitatively via 5-point Likert score (cut-off score: 3) and qualitatively
via a larger ethnographic study that is embedded in the trial where semi-structured individual and family
interviews will be conducted with a sub-group of the intervention group (n = 20, i.e., 10%). The primary
neonatal outcome is LGA. LGA will be dened as new-borns with a birth weight above the 90th percentile
giving gender and gestational age according to the INTERGROWTH-21st charts (23). The denition of all
primary and secondary outcomes and how each outcome is measured are described in Table1. The point
of time of measurement is described in the SPIRIT gure (Fig.2). If the recruitment, retention and
acceptability rate is below the cut-off scores, progression for a full-scale randomised trial cannot be
recommended. However, costs and other outcome measures will also be considered when evaluating the
overall potential for a future scale trial, e.g., whether there is indication for the intervention to be effective
on the clinical outcomes.
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Table 1
Overview of outcome measures
OBJECTIVE* DEFINTION FOR OUTCOME MEASURE TOOL
Primary feasibility outcome measures
Recruitment
The ratio between the number of women eligible for the
intervention study, i.e., invited to participate in the study,
and number of women who accepts to participate in the
study, i.e., completes the inclusion questionnaire [cut-off:
80%]
Inclusion
questionnaire
Retention
The ratio between the number of women who accepts to
participate in the intervention study, i.e., complete the
inclusion questionnaire, and the number of women (1)
with delivery data [cut-off: 75%) and (2) who completes
the post-partum questionnaire [cut-off: 70%]
Inclusion, medical
record, and post-
partum
questionnaire
Acceptability
Acceptability will be measured both quantitatively and
qualitatively. Quantitatively, it will be measured via 5-
point likert scales among the intervention group [Range:
1–5; Minimum score: 1; Maximum 5; cut-off: 3]
[Mixed method] Self-
reported
questionnaire and
semi-structured
individual interviews
and family
interviews
Usability
The number of women in the intervention arm who uses
the digital intervention materials,.e.g. see the health
educative videos/messages and attend health educative
meetings [explorative: no cut-off]
Data deducted from
digital tools
Primary neonatal outcome measure
Large for
Gestational Agea
The number of new-born with a birth weight above the
90th percentile according to the gender and gestational
age [Intergrowth]
Medical record
Secondary outcome measures
Apgar scoreaThe Apgar score of new-borns measured 1 and 5
minutes after delivery (score: 0–10) Medical record
Birth weightaBirth weight of new-borns measured in grams Medical record
*The outcomes markedaare collected for the whole screening population, i.e., approximately 2000
women.
The outcomes markedbare collected for the GDM population, i.e. approximately 400 women.
** The sample size for the co-creation process will be 20 as it will only be developed with a sub-
sample from the control group.
***The expected sample size for the ethnographic study will be 40 participants: 20 from the
intervention and 20 from the control group.
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OBJECTIVE* DEFINTION FOR OUTCOME MEASURE TOOL
Breast feeding
practicesb
Q1-11 in WHO’s breastfeeding scale Self-reported
questionnaire
Gestational ageaThe gestational age of new-borns at delivery Medical record
GDM
pharmacological
therapy and
counsellingb
Nine categorical ad hoc developed items Self-reported
questionnaire
HbA1cbChange in delta score gestational age 24 and 40 Blood sample
Live-born New-borns that are live-born (yes/no) Medical record
Macrosomia
(Global)a
Number of new-borns with birth weight above 4000g Medical record
Macrosomia
(Local context)a
Number of new-borns with birth weight above 3500g. As
the birth weight in most of Asia is lower than the global
birth weight the local standard for macrosomia in the
study setting is 3500g rather than 4000g.
Medical record
Maternal
gestational
weight gainb
Change in delta weight (kilogram) among participants
between gestational age 32–40 minus rst
measured/pre-gestational weight
Scale
Mode of
deliverya
Number of participants with spontaneous vaginal
delivery, assisted vaginal delivery, planned c-section or
emergency c-section
Medical record
Neonatal
hypoglycaemiab
Mmol/l of blood glucose (mmol/l) in newborns Medical record
Perceived social
supportb
Change in delta score measured through the
Multidimensional Scale of Perceived Social Support
scale (MSPSS) [11 item 7-point scale ranging from 1–7]
Self-reported
questionnaire
Preterm birth
below GA 37 +
0a
Number of participants with spontaneous preterm birth
or medical induced preterm birth below gestational age
37 + 0
Medical record
*The outcomes markedaare collected for the whole screening population, i.e., approximately 2000
women.
The outcomes markedbare collected for the GDM population, i.e. approximately 400 women.
** The sample size for the co-creation process will be 20 as it will only be developed with a sub-
sample from the control group.
***The expected sample size for the ethnographic study will be 40 participants: 20 from the
intervention and 20 from the control group.
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OBJECTIVE* DEFINTION FOR OUTCOME MEASURE TOOL
Post-partum
depressionb
Change in delta score at the Edinburgh postpartum
depression scale (EPDS) [10 items on 4-point scale
ranging from 0–3]. A cut-off of 10 will be used to
determine as possible depression.
Self-reported
questionnaire
Self-care
Agencyb
Delta score between intervention and comparator group
measured through the [15 items on 5-point scale ranging
from 1–5]
Self-care Agency
Scale-Revised
(ASAS-R)
Self-care of
GDMb
Delta score between intervention and comparator group
[10 items on 8-point scale ranging 0–7] Summary of
Diabetes Self- Care
Activities (SDSCA)
Small for
gestational age
(SGA)a
Number of new-borns below the 10th percentile for birth
weight according to gestational age Medical record
Social support
for
breastfeedingb
Revised version of the social support for breastfeeding
scale [3 items on 5-point scale range from 1–5, 11
binary items]
Self-reported
questionnaire
Well-beingaChange in delta scores at the WHO 5 Wellbeing index [5
items on 6-point scale ranging from 0–5] Self-reported
questionnaire
Other outcome measures
DietbChange in diet measured through ad hoc developed
questions Self-reported
questionnaire
EpisiotomyaNumber of participants where episiotomy is performed
during delivery Medical record
Physical
activityb
Change in physical activity measured through ad hoc
developed questions Self-reported
questionnaire
Premature
Primary Rupture
of Membranes
(PPROM)b
Number of participants with Premature Primary Rupture
of Membranes Medical record
Prevalence of
GDMa
Proportion of participants with GDM diagnosed
according to WHO criteria OGTT
*The outcomes markedaare collected for the whole screening population, i.e., approximately 2000
women.
The outcomes markedbare collected for the GDM population, i.e. approximately 400 women.
** The sample size for the co-creation process will be 20 as it will only be developed with a sub-
sample from the control group.
***The expected sample size for the ethnographic study will be 40 participants: 20 from the
intervention and 20 from the control group.
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OBJECTIVE* DEFINTION FOR OUTCOME MEASURE TOOL
Risk factors of
GDMb
Number of pre-gestational and gestational risk factors
for GDM prevalent among participants diagnosed with
GDM (risk factor are dened as according to those
known in the literature, e.g., age, BMI, family disposition,
gestational weight gain)
Scale, self-reported
questionnaire
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
Self-reported
questionnaire
Cost Direct economic costs (in Vietnamese Dong/VND and
USD) and indirect costs (human resources measured in
hours) spent on developing the intervention
Direct and indirect
economic deducted
from the project.
Co-creation of intervention**
Co-creation of
self-care and
informal support
intervention
Participants from the pre-intervention control group and
their informal support persons will identify the key
elements for a sustainable informal support/self-care
intervention
Semi-structured
individual and family
interviews
Ethnographic study***
GDM self-care
practices Pregnant women with GDM and their informal support
persons will provide in-depth information about their
GDM self-care practices
Semi-structured
individual interviews
and family
interviews
Perceptions of
GDM Pregnant women with GDM and their informal support
persons will provide in-depth information about their
perception of GDM
Semi-structured
individual interviews
and family
interviews
*The outcomes markedaare collected for the whole screening population, i.e., approximately 2000
women.
The outcomes markedbare collected for the GDM population, i.e. approximately 400 women.
** The sample size for the co-creation process will be 20 as it will only be developed with a sub-
sample from the control group.
***The expected sample size for the ethnographic study will be 40 participants: 20 from the
intervention and 20 from the control group.
Data management and statistical analysis
Quantitative data will be entered and managed through the Research Electronic Data Capture (REDCap)
(24) and exported to STATA v17 (25), SPSS, or R programme (26) for statistical analysis. REDCap
ensures that data are stored at a secured, web-based server at TBUMP in Thai Binh, Vietnam. The
analysis of the quantitative feasibility outcomes will entail a comparison of demographic characteristics
between groups using Student’s t test for continuous data and Pearson’s chi-squared test for categorical
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data. The ethnographic data for feasibility – i.e., acceptability of the intervention – as well as other
ethnographic data will consist of eldnotes, and transcriptions of voice recorded interviews. These will be
systematically coded and synthesised using a content analysis strategy. The analysis for the neonatal
and maternal outcomes will be intention-to-treat and logistic regression analyses will be performed to
assess the potential associations between self-care activities and neonatal and maternal health
outcomes. If imbalance in baseline characteristics and potential confounders exist, adjustments will be
made using propensity score approaches. Data will be analysed according to the intention-to-treat
principle. A p-value < 0.05 will be considered as statistical signicance.
Patient, public, and private sector involvement
Patients and their informal support persons will be involved in designing the content of the intervention
so that it meets their needs and are acceptable to them. Further, to ensure that the intervention is aligned
with national priorities, the Ministry of Health in Vietnam (General Department of Preventive Medicine)
and the Western Pacic Hub of the WHO’s Human Reproduction Programme serves as secondary
partners in the project.
Discussion
This protocol outlines a pilot intervention trial that aims to generate new knowledge and provide new
solutions to the public health problems posed by GDM in Vietnam. The project adopts a multidisciplinary
approach and combines research methods from epidemiology, ethnography, and participatory design.
Cumulatively, this research project will facilitate the incorporation of informal support and self-care into
daily GDM management and provide knowledge of the feasibility of a future full-scale RCT.
Informal support – also known as social support – is becoming a fundamental part of non-
communicable disease management (27). It has been evaluated in various pregnancy studies (28–30),
and it has been found that increased social support is associated with a reduced level of stress and better
pregnancy outcomes (31). However, the effect of social support on pregnancy is moderated by other
social factors such as low well-being (32) and unhealthy nutrient intake (33). Further, it is important to
note that these social factors vary broadly among ethnic groups and countries and are therefore
important to take into consideration when assessing the effect of social support on disease
management. The results of VALID-II will form a theoretical base for understanding the role of social
support among pregnant women in Vietnam and ll in a crucial knowledge gap on the role of informal
support in daily self-care among women living with GDM. In addition, the project will contribute to a far
deeper understanding of the social barriers and supporters that inuence the outcomes of a pregnancy
complicated by GDM in Vietnam. Further, VALID-II will assess the potential benets of a non-
pharmacological intervention focused on facilitating GDM self-care and women’s social support on
maternal and neonatal outcomes, which is likely a sustainable and feasible way of addressing the issue
of GDM in a lower middle-income country, such as Vietnam, in addition to or as a supplement to
pharmacological treatment. As a result, this will advance the current evidence for best-practice
management of GDM in resource-limited settings. The data-driven conclusion of this project will assist
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policymakers and clinicians in the daily management of GDM, and if the intervention is found effective it
may reduce the burden of GDM on individuals, families, and society as a whole. Finally, VALID-II is a
multidisciplinary and multinational collaboration that will also enhance the research capacity and
organisational skills of researchers in Vietnam.
A limitation of this study is that it is a pilot trial and therefore not designed to detect a clinical effect of
the intervention on our primary outcome, but rather the feasibility of a full-scale RCT. Further, although the
effects of self-care practice on the outcome of pregnancy have been reported previously (28, 30), the
research of whether there is any association between self-care and GDM has been scarce, and most
studies have been performed in high-income countries. Thus, a proper sample size calculation was not
made as it would likely not yield a robust and reliable estimate of the sample size required to document
an effect of the intervention among women with GDM in the setting studied. Still, it is believed that this
study will add to the very limited knowledgebase on effect of self-care interventions and social support
among women with GDM in LMICs. The effects of self-care practice on pregnancy have been reported
previously (29, 31), however, the research of whether there is any association between self-care activity
and GDM has been scarce, and this study will add to this limited knowledge-base. Another limitation of
our study is that for ethical reasons, we have had to ensure that all women enrolled into the study and
diagnosed with GDM receive basic GDM counselling, although this may not always be the case in a non-
study context. This may inuence the observed effect of our intervention. Further, potential confounders
may exist when comparing the intervention and the control groups as we have used a non-randomised
design. Hence, we may have to adjust for confounders in our analyses which may limit the power to
detect potential differences between standard care and the intervention. Furthermore, the in-person
community-based recruitment places a restriction on the geographical scope of our project, so the data
and designed intervention may not be representative of other areas in the country.
A strength of this study is that apart from the intervention, the study also assesses a large number of
other GDM-related health outcomes, which will help better understand the issue of GDM and the
consequences of the disease in Vietnam. Additionally, the intervention will be constructed based on
extensive qualitative research with women with GDM and their informal support persons. This will ensure
that the intervention model is tailored to the characteristics of the cohort and the needs and the
perceptions of the recruited women and their families. Moreover, although no outcome of new-borns will
be measured at postpartum interview, the data of this study may be used to establish a cohort of mother-
offspring pairs with a history of GDM for future research projects.
Conclusions
This study will provide information about the consequences of GDM for maternal and child health
outcomes and about the extent to which an informal/self-care and social support intervention is feasible
and may improve maternal and child health in Northern Vietnam. This may guide decision makers on
how to tackle GDM in a low- and middle-income context.
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Study duration/ Trial status
The total duration of the study is anticipated to be three years. Inclusion of the control group started in
January 2023 and is anticipated to nish four months later. The inclusion of the intervention group is
anticipated to start in September 2023. The follow-up period is up to 47 weeks [range 24–47] depending
on the GA at inclusion, which may vary from GA 5 to GA 28. End of study will be in December 2025. The
study has been registered at ClinicalTrials.gov: NCT05744856. Trial status: Recruiting.
Abbreviations
C-section Caesarean section
EPDS Edinburgh postpartum depression scale
GA Gestational Age
GDM Gestational Diabetes Mellitus
LGA Large for Gestational Age
MSPSS Multidimensional Scale of Perceived Social Support scale
OGTT Oral Glucose Tolerance Test
RCT Randomised controlled trial
REDCap Research Electronic Data Capture
PPROM Premature Primary Rupture of Membranes
SGA Small for Gestational Age
SDSCA Summary of Diabetes Self- Care Activities
SPIRIT Standard Protocol Items: Reporting Interventional Trials
TBUMP Thai Binh University for Medicine and Pharmacy
WHO World Health Organization
Declarations
Ethical approval and consent to participate
The VALID-II study has been approved by the Ethics Council in Biomedical Research in Thai Binh on 1
December 2022 (IRB – VN01.009). All participants will give written informed consent.
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Consent for publication
All authors consent to publish this study protocol.
Availability of data and data monitoring committee
No data monitoring committee oversees the conduct of this pilot trial. Individual participant data that
underlie the results reported in the articles will be shared after de-identication (text, tables, gures, and
appendices). Sharing of data must adhere to the General Data Protection Regulation (GDPR) in Denmark
and guidelines in Vietnam. The data will be available immediately following publication. No end dates. All
requests for data should be addressed to Thanh Duc Nguyen (contact details stated in Clingov). Thanh
Duc Nguyen will review the request and involve all applicable/relevant 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 nancial) maintained by this study.
Competing interests
The authors declare that they have no competing interests.
Funding
This study is primarily funded by the Ministry of Foreign Affairs of Denmark (DANIDA) (project no. 21-
M03-KU). Further, Novo Nordisk A/S, is a private sector partner that contributes with nancial support for
dissemination activities in the study’s last year. The funders have no inuence on the design of the study.
Author contributions
DSL drafted the manuscript in collaboration withDKN and contributed to conceptualising the study. VR,
TG, ICB, CAV, JS, DWM, TDN, DCN HHL, NTD participated in designing the study and drafting the protocol.
HML, DTKV, TAN, TPHV, XBN, TG, DKN will contribute with collecting data whilst DSL, ICB, VR, CAV, JS,
DWM, TDN, DCN will monitor the data collection. DSL, MHL, DTKV, NAD, TAN, TPC, XBN, DWM, JS, TG,
and DKN will contribute with analysing data. All authors contributed to renement of the study protocol
and approved the nal manuscript.
Acknowledgements
The authors are grateful for the international cooperation between Thai Binh University of Medicine and
Pharmacy, the University of Copenhagen, the University of Southern Denmark, and Odense University
Hospital. The authors would like to thank health authorities in Thai Binh City for supporting the project;
the staff on both study sites for facilitating the project and assisting in recruiting participants; and the
pregnant women and their families for taking part in the research. Particular thanks are due to the
interviewer team collecting the data: Nguyen Thi Hai, Vu Thanh Hong, Tran Thi Hong Dien, Dam Thuy
Nga, Pham Thi Chau Loan, Nguyen Thi Muoi, Bui Thi Thu Ngan, Dao Thi Thu Phuong. Finally, the authors
Page 17/22
would like to thank Novo Nordisk A/S for being a private sector partner, and Danida for funding the
study.
Dissemination
VALID-II aims to produce and disseminate new knowledge reecting scientic excellence, thereby
contributing to a solid platform for policy debate in Vietnam and internationally on how to address NCD-
reproductive health interactions, with a particular focus on GDM. The project’s dissemination strategy
includes three main audiences: (1) the scholarly community; (2) the policy/health service delivery
community; and (3) the general public, including pregnant women as health service users/consumers. To
reach the scholarly community, the project will produce articles for high-impact peer-reviewed scientic
journals, in Vietnam as well as internationally, while also engaging in debate at international conferences
through paper presentations based on research ndings. Further, research capacity building and research-
based education in the Thai Binh Province is a key element of this research project. To reach policy
makers and health service providers, VALID-II will organise two stakeholder meetings in Thai Binh and
one policy-maker roundtable discussion in Hanoi, producing three policy briefs for dissemination to
stakeholders. To communicate research and intervention results to the general public, including pregnant
women, the project will produce at
least three op-eds for Vietnamese newspapers and a short documentary lm for circulation on
social media, portraying pregnancies, and family lives with GDM.
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Figures
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Figure 1
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Figure 2
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