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summarize this article in one page to show how use the App in preventive T2D IN the women with GDM please make it simple and clear  

1Sobri NHM, et al. BMJ Open 2021;11:e044878. doi:10.1136/bmjopen-2020-044878

Open access

Protocol for a qualitative study
exploring the perception of need,
importance and acceptability of a digital
diabetes prevention intervention for
women with gestational diabetes
mellitus during and after pregnancy in
Malaysia (Explore- MYGODDESS)

Nur Hafizah Mahamad Sobri ,1 Irmi Zarina Ismail,1 Faezah Hassan ,1
Iliatha Papachristou Nadal,2 Angus Forbes ,3 Siew Mooi Ching ,1
Hanifatiyah Ali,1 Kimberley Goldsmith,4 Helen Murphy,5 Nicola Guess,6
Barakatun Nisak Mohd Yusof,7 Nurul Iftida Basri,8 Mazatulfazura Sf Salim,9
Choiriyatul Azmiyaty,1 Iklil Iman Mohd Sa’id,1 Boon How Chew ,1,10
Khalida Ismail,11 On behalf of the MYGODDESS Project Team

To cite: Sobri NHM, Ismail IZ,
Hassan F, et al. Protocol for
a qualitative study exploring
the perception of need,
importance and acceptability
of a digital diabetes prevention
intervention for women with
gestational diabetes mellitus
during and after pregnancy
in Malaysia (Explore-
MYGODDESS). BMJ Open
2021;11:e044878. doi:10.1136/
bmjopen-2020-044878

? Prepublication history and
additional supplemental material
for this paper are available
online. To view these files,
please visit the journal online.
(http:// dx. doi. org/ 10. 1136/
bmjopen- 2020- 044878).

Received 16 September 2020
Accepted 06 August 2021

For numbered affiliations see
end of article.

Correspondence to
Dr Boon How Chew;
[email protected] upm. edu. my

Protocol

© Author(s) (or their
employer(s)) 2021. Re- use
permitted under CC BY- NC. No
commercial re- use. See rights
and permissions. Published by
BMJ.

ABSTRACT
Introduction Women who develop gestational diabetes
mellitus (GDM) have an increased risk of developing
type 2 diabetes, and to reduce this risk the women have
to adopt healthy behaviour changes. Although previous
studies have explored the challenges and facilitators to
initiate behaviour change among women with GDM, there
is limited data from Malaysian women. Thus, this study
will explore the factors affecting the uptake of healthy
behaviour changes and the use of digital technology
among women and their healthcare providers (HCPs) to
support healthy behaviour changes in women with GDM.
Methods and analysis The study will be modelled
according to the Capability, Opportunity, Motivation and
Behaviour and Behaviour Change Wheel techniques, and
use the DoTTI framework to identify needs, solutions and
testing of a preliminary mobile app, respectively. In phase
1 (design and development), a focus group discussion
(FGDs) of 5–8 individuals will be conducted with an
estimated 60 women with GDM and 40 HCPs (doctors,
dietitians and nurses). Synthesised data from the FGDs will
then be combined with content from an expert committee
to inform the development of the mobile app. In phase 2
(testing of early iterations), a preview of the mobile app
will undergo alpha testing among the team members and
the app developers, and beta testing among 30 women
with GDM or with a history of GDM, and 15 HCPs using
semi- structured interviews. The outcome will enable
us to optimise an intervention using the mobile app as
a diabetes prevention intervention which will then be
evaluated in a randomised controlled trial.
Ethics and dissemination The project has been approved
by the Malaysia Research Ethics Committee. Informed
consent will be obtained from all participants. Outcomes will

be presented at both local and international conferences and
submitted for publications in peer- reviewed journals.

INTRODUCTION
The International Diabetes Federation
states that one in six live births are affected

Strengths and limitations of this study

? A new digital diabetes prevention intervention tool
(mobile application) will be fully contextualised to
the local settings and expectations modelled ac-
cording to the Capability, Opportunity, Motivation and
Behaviour and Behaviour Change Wheel techniques.

? The DoTTI framework approach for web- based in-
formation tools and software is adopted to pilot the
evaluation of the needs assessment, content devel-
opment, app interface designing as well as alpha
and beta testing.

? Respondents of heterogeneous sociodemographic
and professional backgrounds from multiple pub-
lic healthcare facilities are recruited via purposive
sampling.

? Respondents are largely recruited from urban and
more developed regions in Malaysia where the study
is centred and this may cause a lack of representa-
tion of women from lower- income and rural settings
(we will monitor this in the recruitment process).

? Data collected through online meeting platforms
could affect data quality as on online platform limits
the observation of the non- verbal aspects of both
the interviewer and note taker during the interviews.

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2 Sobri NHM, et al. BMJ Open 2021;11:e044878. doi:10.1136/bmjopen-2020-044878

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by gestational diabetes mellitus (GDM), and majority of
the cases are from low- income and middle- income coun-
tries.1 GDM in South East Asia has an estimated preva-
lence rate ranging from 10.3% to 28.5%.1–3 Generally,
GDM is associated with numerous complications that can
affect mothers. For example, women with GDM are more
likely to have pre- eclampsia and three times more likely
to deliver via caesarean section.4 5 Besides, these women
also have a sevenfold increased risk of developing type 2
diabetes (T2D) within 5–15 years of postdelivery,6 7 and
over half of the women will develop pre- diabetes.8

The management of GDM aims for optimal glycaemic
control and weight gain during pregnancy in an effort to
minimise the risk of women from developing T2D. This
requires lifestyle modification which consists of dietary
modification, regular exercise and blood glucose moni-
toring with or without metformin or insulin.7–14 This
intensive management ends after delivery, whereas the
risk of developing T2D remains.14 As a result, women
with a history of GDM are regarded as high- risk individ-
uals to develop T2D in the future. Therefore, there is a
need for postpregnancy diabetes prevention interven-
tions (DPIs).15 DPIs are defined as structured lifestyle
modifications that prevent or delay the onset of T2D.16 In
order to ensure optimal weight loss, good dietary routine
and physical activity habits are introduced during the
management of GDM are continued.16 17 Randomised
controlled trials have proven the effectiveness of DPIs in
preventing or delaying the onset of T2D among women
with a history of GDM by applying lifestyle modifications
and weight loss17 which are found to be as effective as
taking metformin.16 17

However, women with GDM have described a range of
challenges to uptake DPIs18–23 which include lack of infor-
mation and peer support, negative emotional experience
of a medicalised pregnancy and guilt. They also fear that
they are to blame for being diagnosed with GDM which
can potentially harm their baby.20–24 Lack of psycholog-
ical support from healthcare providers (HCPs) has also
been reported by women with newly diagnosed GDM as
one of the challenges to uptake DPIs. These women also
reported that they have received judgemental and crit-
ical comments about their condition from HCPs when
they were in the process of making adjustments to new
life routines, implementing diabetes self- care and making
lifestyle changes.22–25

On the other hand, HCPs have expressed difficulties
in managing women with GDM. These include a lack of
medical knowledge about the biology of GDM, limited
evidence for the most effective lifestyle interventions
and lack of communication skills, self- help resources and
guidance to share with patients.25–28

The challenges reported from face- to- face DPIs proce-
dures have presented an opportunity to develop other
approaches to overcome the issues. One approach is by
using a digitalised DPIs which is usually introduced for
internet, mobile phones or devices, telemedicine and
technology that uses decision support techniques.29 A

mobile app can combine decision support techniques into
a cellular phone.30A review of 12 articles related to usage
of mobile apps among women with GDM found that usage
of such apps is beneficial in increasing the confidence
levels in both the patients and clinicians.31–33 Further-
more, the app can be a platform for sending medication
and diet information, obtaining feedback from clini-
cians33 and sharing blood glucose self- monitoring.34–36 A
high satisfaction level was also reported while using the
platform as it was convenient and engaging.36 However,
not all studies reported that digitalised interventions
using information technology are effective or have signif-
icant benefits among women with GDM. Moreover, no
significant blood glucose control improvement, and no
significant differences were seen in other maternal and
neonatal outcomes.35 To date the evidence is not strong
enough to conclude that digital DPIs are more effective
than standard DPIs for post- GDM women.36 This may be
due to the need for multiple potential active elements
interacting with each other in an effective mobile app.
These included having the mobile apps in local language,
ensuring culturally sensitive content of appropriate
health advice about dietary habits and physical activities,
providing motivational support and having user- friendly
interfaces37 to sustain longer- term effects and outcomes.38

In short, little is known about women’s experiences with
GDM in Malaysia especially regarding their challenges
and facilitators to uptake of DPIs.25 Hence, the objectives
of this study are to:

? Explore the perceptions and factors that influence
the use of existing DPIs including a digitalised DPIs
(through mobile apps) among women with GDM.

? Explore the perceptions and factors influencing
the use of existing DPIs including a digitalised DPI
as a mobile application (app) among the HCPs who
manage women with GDM and a history of GDM.

? Codevelop a mobile app between the research team
members, HCPs from the participating clinics and
hospitals, a hired app vendor, and women with GDM
that are contextualised to the local settings and inte-
grated with local clinical practices in an experience-
based workshop.

? Evaluate the technical quality and the experience of
the mobile app (content and utility) among women
with GDM. See figure 1 for an overview of study
objectives.

Theoretical framework
The research model is based on Capability, Opportu-
nity, Motivation and Behaviour (COM- B) and Behaviour
Change Wheel (BCW) techniques. The COM- B model
states that the complex interaction between three main
factors; capability, opportunity and motivation would
greatly affect the process of behavioural changes later.
The factors that are perceived as challenges or motivators
could affect the outcome of the behavioural change to
be either positive or negative. Thus, these perceived chal-
lenges and facilitators should be addressed when planning

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3Sobri NHM, et al. BMJ Open 2021;11:e044878. doi:10.1136/bmjopen-2020-044878

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an effective behavioural change technique as they can
influence the three factor that create a cycle between
them and behaviour change.39 The factors affecting
behavioural changes will be identified in the interviews
which will be integrated into the design of the BCW,
and these factors will be used for the behaviour change
interventions in the DPI. The BCW consist of policy cate-
gories and intervention functions, but for this DPI, we
would focus primarily on intervention functions at the
provider’s and patient’s level.40 The contents and compo-
nents of the DPI will be modelled using Abraham and
Michie’s taxonomy of Behavioural Change Techniques41
(online supplemental file 1). This is to support moving
from intentions to actions, and from actions to mainte-
nance that include providing information on GDM and
its consequences, prompting intention formation, giving
guidance in challenges identification, setting up specific
goal setting and self- monitoring (biofeedback such as
with self- monitoring blood glucose, weight and blood

pressure readings), agreeing and reviewing behavioural
goals, using follow- up prompts, activating social support
systems and preventing relapse.41 42 We will also include
emotional processing techniques such as ventilation,
reflection and adjustment to reduce distressing experi-
ence of GDM which could lead to avoidance in making
behaviour change.20

METHODS AND ANALYSIS
In planning for the context of the mobile app we will
use the DoTTI development framework43 which has four
phases of development (1) design and development; (2)
testing early iterations; (3) testing for effectiveness; (4)
integration and implementation. This protocol includes
up to phase 2 of the DoTTI framework to achieve the
objectives of the study. The other parts of phase 2 (the
pilot testing) and subsequent phases will be described in
another trial protocol.

Figure 1 An overview of the study flow and how it achieves the four objectives. DPI= diabetes prevention intervention; HCP =
healthcare providers; GDM = gestational diabetes mellitus.

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4 Sobri NHM, et al. BMJ Open 2021;11:e044878. doi:10.1136/bmjopen-2020-044878

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The three stages of assessing needs, content, inter-
face design and development in the first phase will be
conducted concurrently and iteratively. The needs assess-
ment of the target population, women with GDM and
history of GDM, and the HCPs who treat these women will
be identified through interviews. Content development
and consensus of the app content involve inputs from the
expert committee that consist of research team members,
HCPs from the participating sites of various specialties
including endocrinology specialists, obstetrics and gynae-
cology specialists, family medicine specialists, rehabilita-
tion medicine specialist, dietitians and the future target
users. The contents of the app will be verified by these
specialists to ensure that it is based on the established clin-
ical practice guidelines and latest evidence from research.
The app user interfaces will be developed by a hired app
developer, and this will happen iteratively with regular
sprint demonstrations and input from the research team
members.

Testing early iterations of the app will involve alpha
and beta testing on the functions and usability of the app.
Alpha testing involves the testing of the app’s interfaces
such as the presentation (multimedia, wordings) and
the test is usually carried out among the research team
members and the app developer. The beta testing, on
the other hand, will involve HCPs, women with GDM and
women with a history of GDM. This will involve testing a
minimally viable vehicle version of the app (the mock- up
app with full functionalities). The outcome of the alpha
and beta testing will indicate the aspects in the app that
need further improvements.43

Settings
The study will be conducted among three public health
clinics, one government hospital and one university
teaching hospital for a duration of 6–12 months. These
clinics and hospitals are located in the Petaling District
and Federal Territory of Putrajaya. The Petaling district is
in the heart of the state of Selangor with a population of
1.8 million. Almost half of the population in this district is
of Malay ethnicity.44 Selangor has the highest prevalence
of diabetes mellitus (14.37%),45 and almost one- tenth of
the deliveries in 2017 were born to mothers with GDM.46
These health clinics are chosen because the study targets
both urban and suburban population within the district.
Putrajaya is the third federal territory of Malaysia and an
administrative capital of Malaysia. Here, the majority of
the population are Malays. The Putrajaya hospital and
health clinic represents the urban population, which
consists of a mixture of middle- income to high- income
people with 90% of them are government employees.
This population has the highest rate of obesity47 which is
one of the risk factors for developing GDM. The majority
of the population in the Petaling district and Putrajaya
are of Malay ethnicity, followed by Chinese, Indians and
other minorities, and this reflects the Malaysian diverse
population as a whole.

The selected clinics maintain GDM registry formed by
the Ministry of Health Malaysia since 2016. It includes
information such as age, parity, last menstrual period,
estimated due date, premature ovarian ageing, date of
delivery, dates for and taken OGTT (oral glucose toler-
ance test) after delivery and the result of the OGTT. The
GDM registry is monitored by a dedicated team (family
medicine specialist and a nurse) to ensure all data are
accurately and completely entered.

The clinics have an in- house dietitian who provides
dietary counselling to women from different ethnic
groups stated earlier. The chosen hospitals (Putra-
jaya and UPM teaching hospital) have a wider range of
HCPs from different specialities that manage GDM. This
includes obstetricians specialising in fetomaternal care
and endocrinologists who manage uncomplicated and
complicated cases of GDM. Both are referral centres in
their respective areas.

Participants
There will be two categories of participants: (1) women
with GDM and (2) HCPs. The first category of partic-
ipants are women with current diagnosis of GDM and
with previous GDM within 12 months post partum. Both
groups of women who have past experience receiving
DPI and women who refuse DPI will be invited to be the
participants. The participants will be purposively selected
to ensure that they are representative of women from a
variety of backgrounds including all major ethnicities
(Malay, Chinese and Indian), educational status (ranging
from primary school to colleges or universities) and pari-
ties (primiparas and multiparas). The sample frame is the
GDM registry in the respective health clinics. HCPs are
those who treat women with GDM during the antenatal
or/and postnatal period. Table 1 shows the inclusion and
exclusion criteria for women with GDM and HCPs.

Participants will be purposively sampled for maximum
variation; primarily focusing on ethnicity and parity. The
diagnosis of GDM will be in accordance with the 2017
Clinical Practice Guideline: Diabetes in Pregnancy by
Ministry of Health Malaysia.9 Eligible women are iden-
tified by the investigators from the GDM registry and
during clinic visits at the sites (clinic or hospital). Poten-
tial participants will be approached, screened based on
the eligibility criteria (table 1) and invited to a scheduled
interview at the same facility where they receive medical
care. During tightened movement control order (MCO)
due to the COVID-19 pandemic, this participant selec-
tion process will be done in the same manner as that
with the HCP as participants. Participants who are HCPs
at the sites (clinic or hospital) will be identified by key
informants at the respective sites. This will include senior
staff and clinicians, unit heads and those who have joined
this study as the site investigators. The identified partici-
pants will then be approached by the project interviewers
to further confirm eligibility and availability for either
on- site or online interviews.

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5Sobri NHM, et al. BMJ Open 2021;11:e044878. doi:10.1136/bmjopen-2020-044878

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The estimated sample size is 50–60 patients and 30–40
HCPs or until data saturation has been achieved. Data
saturation will be reached when the team finds no further
information, codes or themes emerging from the data.
This will be achieved through regular cross checking of
the data and discussions among the team. The estimated
numbers reflect two types of focus groups, women with
GDM and HCPs at the three public health clinics and
the two hospitals, with 10–20 patients and about 10 HCPs
from each participating clinic and hospital.

Patient and public involvement
Women with a history of GDM will be involved in deciding
the content for the DPI and app. Their opinion is sought
on the best delivery form for the educational content and
all the functionalities in the app. Throughout this study,
volunteers consisting of women with GDM and their
partners, HCPs at the hospital and health clinics will be
engaged to provide a contextual and personal experience
with GDM and care process to model the best approach
for the intervention.

Phase 1: design and development
Needs assessment
To achieve the first two objectives, a qualitative study iden-
tifying the needs, facilitators, challenges and perception
of the participants on a digital DPI will run concurrently
with a systematic review. A systematic review of process
evaluations of interventions for the prevention of T2D
will be conducted by different researchers within the
team to map the features of successful apps for women
with GDM. The researchers will attend joint meetings and
discuss the findings regularly.

In every focus group, the women with GDM and HCPs
will be provided with the context. A topic guide will

consist of open- ended questions to capture the women’s
experience in receiving information and care as well as
other factors that can affect their decisions whether or
not to take up DPIs or make lifestyle changes during ante-
natal and postnatal period. The questions will also delve
into aspects related to competing roles and responsibili-
ties, guilt feeling, cultural and religious beliefs about diet,
social pressures, economic consideration, and suggestions
for a mobile app that may assist in the development of a
healthy lifestyle. Topic guides for HCPs will include their
experience in managing women with GDM and attempts
to support these women in making lifestyle changes,
identifying challenges and facilitators that influence the
implementation of DPIs at healthcare facilities, making
suggestions for the content of the app and improving its
uptake (see online supplemental file 2). Subsequently,
the findings of the mentioned factors will help to further
inform the topic guide on the uptake of DPIs.

Focus groups and in-depth interviews
As a qualitative approach to data collection, focus groups
and in- depths interviews will be conducted by trained
researchers. Prior to the focus group, each participant
will complete a short survey on the sociodemographic
information such as age and experiences in using DPIs
in the past. For the HCPs as participants, data will be
collected based on their highest level of education and
duration of clinical experience in managing GDM. The
focus groups will have 5–8 participants, and the outputs
are recorded in the forms of audio recordings as well as
note taking by both the interviewer and note taker. All
interviews may be video- taped if consented or conducted
online. Both the focus groups and interviews are expected
to last around 45–90 min. The audio and video recordings

Table 1 Inclusion and exclusion criteria for the study population

Inclusion criteria Exclusion criteria

Women
with GDM

? Pregnant women diagnosed with GDM
? Women with a history of GDM and within 12 months post
partum

? Aged 18 years and above
? Able to communicate in English or Malay
? Malaysian citizen
? Owns a smartphone (iPhone or Android)

? Pre- existing diabetes (type 1 or type 2) and overt
diabetes

? Chronic diseases such as end- stage renal disease,
heart failure, stroke and cancer

? Mental illnesses such as psychosis, bipolar
disorders or learning difficulties diagnosed by
physicians, on treatment and documented in the
medical records

? Terminal illnesses with less than 2 years of life
expectancy

? Women who are not able to communicate verbally
? Multiple pregnancies with two fetuses and above

HCPs ? Medical officers, family medicine specialists, pharmacist, nurses
and dietitians who are providing direct clinical care to women
with GDM or a history of GDM at the participating public health
clinics OR

? Endocrinologists, obstetricians and midwives working in
secondary care at the participating hospital AND

? HCPs who have been in clinical service for more than 1 year in
their respective facility

? Non- permanent or temporary staff including the
non- Malaysian healthcare providers

? House officers
? HCPs qualified less than 6 months ago

GDM, gestational diabetes mellitus; HCP, healthcare provider.

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are for analysis and will not be copied/sent to any other
individual or used for any other purposes.

Face- to- face interviews may be needed if there is infor-
mation gathered that needs further clarification or if
participants are unable to attend a focus group discus-
sion (FGD). This is to ensure the validity of the data. The
discussion will be facilitated by a topic guide that is avail-
able in both English and Malay language. It will also be
piloted on groups of women with GDM and HCPs and
reviewed by the research team prior to its use. During
the interview and FGD, reflexivity process will be under-
taken constantly. This involves the researchers’ aware-
ness of how they affect the research. For example, how
researchers articulate the social and cultural differences
at the place of the research and in the context of the
research will be taken into consideration. In this process,
constantly revising comprehension of the situation within
the research activities would bring a different under-
standing to it and help to increase the trustworthiness of
the data. Bracketing is a process that is undertaken from
the beginning of the research which allows the researchers
to identify and acknowledge assumptions regarding the
phenomena based on theoretical assumptions as well as
the background knowledge about the research. During
the interviews, discussion will be conducted using the
language preferred by the participants (English, Malay or
mixed). Data collection workflow can be seen in figure 2.

Should the Movement Restriction Order (MCO) be
prolonged in the aftermath of the COVID-19 pandemic,
all standard procedures for data collection may be
conducted online using reliable and secure software/
application. Online procedures will be explained and
pilot- tested with the participants before data collection
begins.

Content consensus
The content of the app is discussed among the expert
committee members mentioned above. Each subcontent
of the app is led by small groups of people headed by an
expert in the field. For example, an obstetrician, a gynae-
cologist and a family medicine specialist are responsible
in collating the content for general information about
GDM. Information on medical therapies for GDM will
be managed by an endocrinologist and a family medicine
specialist while dietitians are responsible for the dietary
content. Content on exercises and physical activity is
organised by a rehabilitation medicine physician; content
on mental health is managed by health psychologists and
a family medicine specialist. This content development is
facilitated through two 1- day sessions for discussion and
review among all the members including the app devel-
oper and women with a history of GDM. Additionally, the
initial draft of the app content is shared with all Malaysia
and UK research team members. The content under
development will be consistently checked for compliance
with clinical practice guidelines and the latest published
evidence.

User interface
It is important that the developed content could be
extracted by the users easily. Using results from the qual-
itative study and a theory- based evaluation framework
(that combines factors such as cr