Figure 1 shows the four different stages of the Face-it intervention development.
Stage 1 Evidence review, qualitative research and stakeholder consultations
Our systematic review of RCTs evaluating behavioural interventions that aimed to prevent T2DM in women with prior GDM (22) revealed that studies were limited by small sample sizes and substantial heterogeneity in both intervention components and outcome measures. Based on the included studies, it was not possible to identify one specific intervention type as superior, but it was clear that interventions in the first two years after delivery were superior to no intervention. Furthermore, there was a tendency for interventions that started during pregnancy or within the first six weeks after delivery to have poorer outcomes compared to interventions starting later. This informed our decision to initiate the Face-it intervention approximately three months after delivery, which would also allow the baseline data collection for the trial evaluation to align with the timing of the routinely recommended postpartum oral glucose tolerance test.
Our systematic review that explored determinants and barriers for GDM services, including healthy lifestyle after delivery and prevention of future T2DM (13), identified risk perception, self-efficacy and social support as important determinants for engaging in healthy dietary and physical activity behaviours. Consequently, these constructs became determinants that we sought to promote through the intervention. The review also identified a number of barriers, such as lack of time, and suggested that women with prior GDM may be facing emotional distress.
The review on determinants and barriers predominantly identified studies from the U.S., Canada and Australia.
However, the qualitative studies we performed gave us evidence from the local Danish context in which our intervention would be carried out and evaluated. The first of these explored the experiences of five women with previous GDM within the first 3–4 months after the delivery (23). The women in the study described emotional distress as a consequence of the GDM diagnosis, which was similar to the findings of the systematic review. Danish women with prior GDM reported feelings of sadness, guilt and self-blame, and it was apparent that the intervention needed to be sensitive to these feelings and not to assign blame to the mother or induce medicalisation.
The women in our explorative qualitative study also emphasised the importance of social and emotional support in general, and particularly from their partners, to mobilise time and energy to follow a diet and physical activity regime (23). This coincided with a postpartum intervention study from the UK and Canada, which showed that not only did paternal weight correlate with maternal and offspring weight, but having a partner involved in the study was associated with successful study completion (30). This convinced us that we needed to include the partner in our study, both to address his/her cardio-metabolic risk and as a source of social support for the woman with prior GDM. To further examine how this might manifest in a Danish context, we interviewed five male partners of women with prior GDM (31). A key finding from these interviews was that the baby and the family have absolute first priority. Therefore, taking time to, e.g. exercise, was perceived as selfish and associated with feelings of guilt. However, being a good role model for one’s child by being physically active was also highlighted in the interviews. The challenge was thus to create an intervention which promoted healthy behaviours in the context of being a good role model rather than taking away precious time from the family.
Our review also indicated that a lack of knowledge about the risk of T2D after the diagnosis of GDM and guidelines for health service support were a barrier to sustaining a healthy behaviour after delivery (13). Furthermore, women considered postpartum health services to be unsupportive and most women were not aware of postpartum services or did not know how to navigate them:
“I’ve been to my doctor and had my blood sugar tested, but then there are no more [follow-up] after the delivery. I just think it’s easy to fall back into the unhealthy lifestyle again when there isn’t anyone keeping an eye on you anymore […] You are a bit abandoned and left on your own when you’ve delivered” (Woman with prior GDM, quote from Svensson et al 2018 (23))
This finding suggested that poor health literacy and challenges in accessing the healthcare system required further exploration. Therefore, we conducted a third qualitative study; this time focusing on healthcare providers and the health system level (32). The study showed that health visitors, despite playing a key role in health promotion in families in the first years of the baby’s life, had limited knowledge about GDM and its implications. Often, the health visitors were not even aware whether a woman had been diagnosed with GDM or not. Findings also suggested that general practitioners (GPs) often omitted follow-up and long-term risk measurement after GDM. Moreover, we discovered that women received opposing messages from different healthcare providers, which could lead to women neglecting their long-term risk of diabetes. Thus, it was apparent that increasing health visitor skills and knowledge about GDM was required and that knowledge transfer and collaboration across sectors needed to be established to align knowledge about GDM and create a coherent preventive pathway.
From the scientific symposium (21) a key recommendation was to apply a multi-determinant approach and structure the intervention on multiple levels. For example, it was agreed that barriers to healthy behaviour exist and should be addressed at the individual, family and health system levels. Further, it would be necessary to take on a broad and positive understanding of health in line with the WHO definition focusing on social, psychological and physical health (33).
Our consultations and workshops with midwives and health visitors further strengthened health visitors’ potential as the most optimal group of intervention deliverers. In particular, health visitors provide counselling based the broad WHO concept of health. However, the consultations and workshops also confirmed the qualitative research findings that the health visitors needed additional training. They were not particularly comfortable with addressing risk behaviours and disease prevention in our target group:
“We don't come into parents’ home with a raised finger.
And if one can see that there are a lot of soft drinks on the table in a home, then we may address this in a broader way by paying attention to food and meals in general terms” (Health visitor)
At the symposium, experiences from the Australian MAGDA study demonstrated that a tele- or digital component might hold promise as an approach to improve engagement in the intervention among women with prior GDM (34, 35).
In addition, other studies have identified app-based technology as a possible solution to support people at risk of diabetes (36) and women with prior GDM in particular (37, 38). One argument is the flexibility that such eHealth solutions offer as they can be accessed in people’s own homes and at any time of the day. In this way, eHealth technologies can increase the availability of health promotion to populations that are usually difficult to reach (39, 40). We decided to further explore the potential for involving a digital solution and found a few digital platforms incorporating the interpersonal level, e.g. relying on social support and feedback, which was suggested by the women in our workshops. We identified the Liva app as the best e-solution for adaptation and tailoring to the families in the Face-it intervention (41, 42). The Liva app is an interactive eHealth lifestyle coaching program (long-term Lifestyle change InterVention and eHealth Application [LIVA 2.0]) (43). The app builds on a strong personal relationship between user and a health coach supporting the app through individualised goal-setting and feedback (43). As digital support was suggested by the women themselves in initial interviews, we found that the combination of providing digital support as an addition to home visits aligned with the tailoring of intervention to meet the needs of the target group. The health visitors involved in this stage reported that they could take on the role as health coach as well.
Table 1
Key lessons from stage 1–4
Stages
|
Intervention content
|
Intervention delivery
|
Data sources
|
Stage 1:
Evidence review, qualitative research and stakeholder consultations
|
No intervention type identified as superior
|
Initiate intervention approximately three months after delivery
|
Systematic review: Behavioural interventions targeting women with prior GDM (22)
|
Targeting multiple barriers and determinants for health behaviour
|
Multilevel strategy targeting the individual, family and health system level
|
Systematic review: Barriers and determinants for GDM health services and postpartum follow-up (13)
Scientific symposium with experts (21)
|
Not assigning blame or medicalising of women with prior GDM
|
|
Qualitative study: Danish women with prior GDM to understand the needs and barriers of women with prior GDM (23)
|
Partner involvement to ensure social support / improve intervention uptake and address own risk
|
Include the whole family as the target group
|
Qualitative study: Partners to women with prior GDM (31)
|
Secure a coherent healthcare system to align knowledge transfer and collaboration across sectors and create a coherent preventive pathway
|
|
Qualitative study: Healthcare professionals caring for women with GDM during and after pregnancy (32)
|
Health visitors* as main intervention deliverers
Relationship with health visitor imperative to talk about healthy habits in the family
Intervention needs to be tailored and adapted to individual needs in the family, daily family life (role modelling) and based on a broad positive health concept
Need for education to health visitors addressing risk behaviours and prevention
|
Health visitors as main intervention deliverers
|
Workshops and interviews with families where the mother had GDM
Focus group discussions with teams of health visitors
Scientific symposium with experts (21)
Expert consultations
|
Women expect a digital component to increase engagement and
availability
Introducing the LIVA app as an intervention component
Digital support as a way to prompt individual and family-based health behaviours
|
Digital health coaching
|
Evidence from literature on the potential of digital interventions targeting women with prior GDM
Scientific symposium with experts (21)
|
Stage 2:
Co-production of the intervention
|
Coherent cross-sectional preventive care pathway for the families in healthcare service
Women recommended to contact their own GP for GDM counselling following the intervention
|
Discharge summary from obstetric department to health visitors prior to intervention
|
Workshop meetings with local stakeholders and hospital-based health-care professionals from the obstetric departments at the project hospitals, general practices and leading health visitors
|
Adopt the family wheel as an interactive health pedagogic dialogue tool developed by health visitors
Health visitors take on a health promoting role
|
Home visits in the families by the health visitor as a primary component of the intervention
|
Meetings with leading health visitors
|
Adapting the family wheel including GDM as a category to support talking about future diabetes risk
Adapting the digital health app, making health information available in the app to use for counselling and produce family tailored content in the app
|
Digital coaching by a digital supervisor should motivate realistic, positive goals in the family
|
Co-production workshops with health visitors
Interviews with families where the women had prior GDM
|
Stage 3:
Prototyping, feasibility and pilot testing
|
Health coaches tailoring health information per request from families
Possibility for continuously digital communication with the family online instead of home visits
Ensure strong communication practices between health coach and health visitor
|
Adaption of intervention delivery mode to intervention sites
|
Meetings with local health visitors and GDM experts
Interviews with families where the mother had prior GDM
|
Adapt intervention manuals to support individual practices
Ensure proper training and competences for intervention deliverers
Adaption of family wheel design
|
Support and qualify health visitors to deliver the intervention
|
Expert review of the intervention manuals by researchers, health visitors as intervention deliverers and various health care professionals providing care to women with current and prior GDM
Training days with health visitors
|
Stage 4:
Involvement in developing outcomes for evaluation
|
Realistic and relevant core outcomes for evaluation.
Biochemical measurements (blood samples), blood pressure, anthropometric measures and a self-administrated questionnaire to assess dimensions of health behaviour, social support, motivation, program delivery and family dynamics among others.
The questionnaire contained both validated scales and self-constructed questions building on the qualitative evidence from the earlier stages of intervention development
The full list of measurements is available in the trial protocol (44)
|
|
Core outcome set for diabetes after pregnancy prevention (45)
Based on the core outcome set, the qualitative interviews performed at stage two and the consensus meetings with core stakeholders
|
Implementing minor adjustments to the questionnaire to avoid assigning blame or stigmatisation and to enhance validity
|
|
Pilot testing of the questionnaire among women with prior GDM
|
*Specialised nurses within postnatal and child health, who conduct home visits to families with a new-born |
Stage 2 Co-production of the intervention
The second stage in the systematic development process was based on continuous development and adaptation of the knowledge gained in stage 1, with the aim of designing an intervention prototype that was ready for testing (15).
Together with health visitors, families and hospital-based healthcare professionals involved in GDM care, we co-produced the intervention content and delivery components.
In particular, we wanted to ensure a smooth and coherent transition from hospital discharge after delivery to the health promotion intervention delivered by municipal health visitors
The cross-sectoral preventive pathway
To ensure a coherent cross-sectoral preventive pathway for the women, both in the trial and in a possible future implementation, the local stakeholders from the three project hospitals, general practices and senior health visitors were invited to local workshops to discuss possible care pathways.
The healthcare professionals in the hospitals were satisfied with systematic information flow across professions in the obstetric department. However, GPs and health visitors felt limited by the lack of information provided to them by the obstetric departments.
We interviewed women and their families about their experiences of GDM-related care among other topics.
The women described a need to leave the GDM diagnosis behind due to the strict treatment regimen they experienced in pregnancy. However, the families also recognised the benefit of the health visitor taking on a health promotion role to motivate health behaviours in the family.
“It is very important that it does not become a raised index finger but becomes motivating. So, you think to yourself "that was a good idea". I think it depends a lot on how your relationship with the health visitor is” (Partner to woman with prior GDM)
We returned to the healthcare professionals with new insights from the families and considered the best ways to secure knowledge transfer from obstetric departments to municipal health visitors. They suggested providing a hospital discharge summary to the health visitor delivering the intervention. In order to create a coherent pathway for the families, the health visitors also suggested that they, by the end of the intervention period, should encourage the women to book and attend the recommended glucose test and counselling with her GP. The idea was that this would strengthen communication and knowledge transfer to the GP and would increase the likelihood of the women being followed-up regularly by their GP as recommended. Thus, engaging closely with the health visitors and hospital staff allowed the identification of a possible solution for a coherent care pathway that lived up to the requests of all stakeholders.
Home visits and an interactive dialogue tool: ‘the family wheel’
We met with the health visitor management in one of the municipalities and presented our current principles on how to promote health in families where the mother had GDM, e.g. focusing on the broad health concept of WHO, social support, motivation, self-efficacy, risk perception and health literacy (44). This led the health visitors to introduce a health pedagogic tool: the family wheel. The family wheel is an interactive dialogue tool, developed by health visitors themselves to support socially vulnerable families in the transition to parenthood both during and after pregnancy. A prior evaluation of the family wheel found that health visitors used it to help structure and professionalise their dialogue with families. The family wheel originally contained relevant themes for a postpartum intervention, including social relations, breastfeeding, living situation etc. We saw great potential in modifying this conversation tool to uphold the health visitors’ usual practice and structure their new role as health promoters for the whole family. Earlier interviews with families had taught us that a close relationship between the families and the health visitor was critical to enable an honest conversation about health, particularly as this often involved sensitive topics such as overweight, future diabetes risk, partner support and specific food and physical activity habits. In workshops with health visitors, we discussed how the increased risk after delivery could be presented in a motivating way by using the family wheel. The health visitors were not used to addressing parents’ health behaviour and expressed concerns about unintendedly stigmatising the families. This focus on making it legitimate and part of standard practice for the health visitors to talk about health risk, led to the first thematic category on the modified family wheel: ‘GDM’. The main topic would be a debriefing of the experiences from the GDM-affected pregnancy and a discussion on the risk of T2DM. When asking the health visitors how to modify the wheel further, they specified the need to touch upon all themes relevant to health:
“When I set it [the family wheel] up, I usually ask them how much they need to talk about that theme. The area in question is pointed out. And I do not follow the manual slavishly. Because it may well be that they have no need to talk about gestational diabetes but have a huge need to talk about childbirth. It may be easier to articulate some topics and to get into some issues if they suggest it themselves” (Health visitor)
It was essential to the health visitors to make the families reflect on their health views and encourage already established health behaviours. We redesigned the wheel through continuous dialogue with the health visitors. The family wheel finally included five topics: 1) GDM, 2) everyday routines, 3) food and meals, 4) physical exercise, and 5) family, friends, and network. As such, health in the family was the main focus and GDM was only one in five themes of the family wheel to be addressed. When we presented the family wheel to the families, they were satisfied with the broad aspect of topics and did not feel that they were defined only by their GDM diagnosis. By making health comprise of multiple and interconnected areas, the families perceived this part of the intervention as welcoming a focus on their daily lives.
The choice to adopt the family wheel in the Face-it intervention helped facilitate a strong collaboration with health visitors. Health visitors expressed ownership across municipalities as they felt acknowledged in their profession by building on similar pedagogical non-directive and non-judgmental methods and gained new knowledge about this high-risk group. Moreover, it strengthened the methodological quality of the intervention by tailoring and qualifying the material to their profession. In this way, the adoption of new themes into the family wheel supported health visitors in taking on a new role as health promotors. They helped the families to navigate health information and services, thus increasing health literacy and facilitating and increasing positive family dynamics and social support around health behavior change.
Digital health promotion counselling through ‘the Liva app’
As a result of the findings from stage one, we wanted to introduce the Liva app as part of the intervention content to families and health visitors. The Liva app includes health behaviour features; however, it was clear that the content was shaped by other target groups e.g. those with diabetes or overweight who reported on medication use and blood sugar values (43). When introducing the app to the health visitors, they were less enthusiastic about the digital solution. The health visitors would usually spend time in home visits encouraging families to reduce their screen time and they felt ambivalent towards promoting an app. As such, the health visitors emphasised the need for the app to promote positive everyday activities:
“It [the app] should follow up on what succeeded for you and not what failed. Because I may have a goal to “run on Wednesday afternoon”, but it did not work out … And I do not think they would benefit from that at all. But look, I went Monday!” (Health visitor)
Through co-production with health visitors, we emphasised the role of the health coach to ensure that the families set goals based on the families’ own wishes, preferences and circumstances. Thus, we decided that the built-in feature of ‘life goals’ should be highlighted in the digital support as a way to prompt individual and family-based health behaviours. A goal could be to ask a friend to go for a walk, read a book, create a shopping list, plan the snacks for the day, or to encourage your partner to go for a walk etc. In accordance with the families’ wishes for an app, a breastfeeding feature was developed and to accommodate a broader understanding of exercise, the category of physical activity was expanded to include activities drawn from everyday life in a family i.e. activities such as ‘walking’, ‘vacuuming’, ‘exercises with baby’ or ‘gardening’.
The Liva app also helped counter some other challenges raised by health visitors at this stage. The health visitors were worried about their ability to provide specific advice on GDM, diet or exercise if requested by the families. By making specific health information available in the app, we wanted to assure the health visitors that they were not expected to be experts in all health-related topics. We tailored materials in the app to families of women with former GDM, such as physical activity and dietary recommendations, exercise charts and shopping lists etc. To finalise the content, we wrote manuals for the family wheel and the Liva app and started recruiting health visitors in the three municipalities.
Stage 3 – Prototyping, feasibility and pilot testing
In stage 3, the core intervention components in the Face-it intervention were ready for modelling and testing as a whole in the municipalities.
At this stage, we involved families, GDM experts and health visitors and health coaches (in two of three setting this was the health visitor) as intervention deliverers aiming to 1) secure testing and tailoring of content, 2) strengthen ownership, 3) adapt intervention delivery to the local context and 4) ensure proper training and competences.
We tested the acceptability of the family wheel and Liva app with two families. The family wheel was assessed to be acceptable while relying on only a few contextual factors. Firstly, its aim to address sensitive subjects in the family depended on a trusting relationship between the family and the health visitor. Secondly, the fact that health visitors would come to the participants’ homes provided more flexibility for the families as they did not have to transport themselves. Thirdly, the families noted a concern regarding the Liva app about the time needed for data registration and the app potentially competing with other digital elements, e.g. watches with step counts. This concern about the app was balanced by the families’ positive attitude towards their ability to easily access a health visitor/health coach and the possibility of receiving tailored health information, e.g. in the form of recipes.
“I would think it would a good idea that someone is pushing me to do it. But I don’t think my husband would use it at all. I think I would choose something like exercise, weight, or diet in the app. My milk production is not very good so it could be very nice to talk about what could help us increase it [through the app]” (Woman with prior GDM)
We held meetings with each municipality to tailor the structure of the intervention to local resources and preferences.
The local municipalities decided themselves how to organise the staff delivering the intervention.
GDM experts (dieticians, nurses, endocrinologists and obstetricians) from the collaborating hospitals were invited to discuss the intervention components and adapt the cross-sectoral pathway with senior health visitors to ensure a coherent preventive pathway at the three intervention sites. The experts raised the issue that women with prior GDM and their partner often varied in their perception of GDM. In contrast, others emphasised the role of inactivity and poor diets and dealt with lack of motivation to change health behaviours. Further, the frequency of the intervention was deemed appropriate by health visitors and experts with three home visits within nine months as long as the health coaching was available between the visits to provide feedback and advice. Thus, the delivery of the intervention demanded continuous tailoring of communication to meet the needs of the families and ensure the intervention deliverers collaborated with the families to support the achievement of behavioural goals.
Lastly, we conducted four full training days for health visitors/health coaches to educate them in intervention delivery. At these training days, we presented the intervention manual consisting of a conversation guide for each theme on the family wheel. Thereafter, the education was problem-based, e.g. the health visitors pointed towards three challenges after the first days training with the family wheel: balancing the conversation of future risk in the family; engaging the partner in the home visit, and getting the families to act on their goals. These three themes became central to the following two training days. One training day was exclusively focused on using the Liva app. Throughout the training days, we pilot-tested the home visits in the intervention by using case descriptions of various families, probing communication strategies and adding suggestions for ‘good questions’ in the intervention manual that could start a conversation. The health visitors found that the visual design of the family wheel, including the colours of the light cross (green, yellow, red), helped them approach certain topics, but also helped the families to assess their own wishes for change within those topics. Some flexibility was allowed in terms of which theme to talk about when and in the approach to addressing topics and posing questions.
Stage 4 – Involvement in developing outcomes for evaluation
In the development of a core outcome set for health promotion in diabetes after pregnancy, the 115 key stakeholders agreed on 19 relevant themes during the final consensus meeting. Core outcomes for the specific intervention depended on the focus of the intervention. These included constructs from behavioural change theory (self-efficacy, motivation, barriers and perceived risk), health behaviour (dietary intake, physical activity, sleep and breastfeeding), cardio-metabolic- and adiposity measures (body mass index, weight, waist circumference, glucose, cholesterol, and blood pressure), offspring outcomes (growth, diabetes), quality of life, knowledge, social support, and program delivery (participation, engagement). The detailed description of the core outcome set has been published elsewhere (29, 45, 46). The involvement of different stakeholders in selecting the outcomes allowed for the inclusion of different perspectives on what was considered important to measure. Particularly, including women with GDM in the process meant that more ‘patient-oriented’ outcomes, e.g. social support and quality of life, were retained in the core outcome set (45).
Based on the core outcome set, the qualitative interviews performed at stage two and the consensus meetings with core stakeholders, the research team made the final decisions on which outcomes to include in the evaluation of the Face-it trial. Data collection covered: biochemical measurements (blood samples), blood pressure, anthropometric measures and a self-administrated questionnaire to assess dimensions of health behaviour, social support, motivation and family dynamics. The questionnaire contained both validated scales and self-constructed questions building on qualitative evidence from the earlier stages of intervention development. The full list of measurements is available in the trial protocol (44). The findings from the previous stages informed the need to include various psychosocial outcomes. The finding that emotional distress was often present in the target group after delivery combined with the results from the core outcome set informed the decision to include questions on quality of life. The findings about the importance of motivation, risk perception, family dynamics and partner support for health behaviour in the child’s first year formed the decision to construct a set of questions on health behaviours in the family context. We also needed to investigate stigmatisation in relation to GDM diagnosis. We therefore developed and pilot-tested a new scale to investigate internalised stigmatisation related to GDM. After identifying the outcomes and finalising the intervention content and modes of delivery, we estimated sample size as well as recruitment and retention rates and finalised the study protocol. The details are available in the published study protocol (44).