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 clea

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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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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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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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 th

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