To gather insights about the range of potentially different parental ECAP information behaviors and preferences and to help develop tailor-made future information materials and communication channels, different groups of parents will be recruited: (1) risk-specific groups (ie, parents with or without a specific risk of their child developing an allergy, based on the parents having or not having a medically confirmed allergy) and (2) life stage–specific groups (ie, expectant, new, and experienced parents).

Overall, a self-developed sampling matrix will be employed for a better overview of the characteristics of recruited participants and to identify parental characteristics that are underrepresented in the overall sample. The matrix will account for the above-mentioned main identifiers—allergy risk and life stage—as well as further, more typical recruitment criteria, including age, gender, educational status, migration background, and familial status (ie, living with or without a partner). The respective information will be queried during the recruitment process using a short questionnaire.

First, a list of contacts was compiled for health professionals (eg, pediatricians, gynecologists, and allergists) and for public and public health institutions (eg, kindergartens, family centers, and community offices) located in both urban and rural areas within a 10-km distance to the project sites in Germany (ie, Hanover, Magdeburg, Freiburg, and Regensburg) to reduce participants’ travel time. Respective contacts were searched for via (1) entries in medical online registers (ie, mainly online physician registries like Arztauskunft Niedersachsen), (2) coordinating bodies within public health (eg, the German Society for Allergy and Clinical Immunology, Landesamt für Gesundheit, and registries on insurance websites), and (3) general directories (eg, municipality websites, registries provided by municipalities for parents to find and choose a kindergarten or nursery, and local citizen administration and service offices). This will be complemented by (4) a Google search (eg, for further childcare institutions in specific cities) and (5) pre-established contacts (ie, mainly health professionals) from each project partner’s previous networks and collaborators of the project lead. From the overall list of contacts, those who can be expected to have the most direct and/or most frequent contact with the target group will be contacted first, such as kindergartens; we will contact further individuals and institutions if necessary. After completion of the search for recruitment agents, health professionals and institutions will be contacted personally to inquire about their support and availability for recruitment.

As described above, parents will be approached via physician practices, public institutions, and a range of additional individual contacts from previously established project networks at the four project sites, in accordance with previous findings on the accessibility of lay target groups [48]. The first phase of recruitment is scheduled to take 1 to 2 months, followed by an assessment (ie, positive and negative recruitment channels) among the four project sites to identify difficulties. The second phase, expected to take 2 to 3 months, will then be conducted based on necessary adaptations.

Regarding recruitment via physician practices, access should be via (1) direct approach by the physician and/or nurses, for example, at the end of an appointment and (2) indirect approach via written information placed, for instance, at the clinic entrance or waiting room.

For recruitment via public institutions and offices, the main approach will be for an employee (eg, a nurse) to directly contact potential participants, for instance, for one hour in the morning, to limit the amount of staff time required. Again, an indirect approach via written information is also necessary to reach more potential participants. In settings where parents may best be reached at specific times of the day (eg, just before scheduled group meetings), project staff can support on-site recruitment. In addition, project sites’ institutions and institutions doing on-site recruitment will also use social media channels to post short messages with links to the project website. In advance, a search for relevant groups and websites was conducted, particularly private groups on Facebook.

Project staff have prepared written information used to inform potential participants about the project across the various recruitment channels. Feedback regarding its appropriateness, structure, and content has been gathered from the partner project on health professionals’ communication of ECAP information. Once participants have been selected, the initial short version of the project information document for participants used for recruitment will be adapted to an electronic version, using the online questionnaire tool SoSci Survey (SoSci Survey GmbH), to provide focus group participants with all necessary details. The electronic survey tool ensures full protection of personal data according to the German General Data Protection Regulation.

A focus group approach seems valuable as it enables exchange among peers [49,50], with the subject of allergy-related prevention of health risks for the child being rather emotional and based on individual preferences, insights, and beliefs and, hence, worth discussing. In turn, this may help the target group reflect on their practices and needs based on others’ contributions and, hence, may stimulate additional input, particularly regarding potential adaptations of ECAP information formats and contents. A focus group manual was drafted and revised according to available research on the overarching subjects of health literacy, parental information behavior, and focus group methodology (see Multimedia Appendix 1) [12-14,16,34,51-54]. From these sources, individual themes were reframed as relevant questions for parents and ECAP. For example, the item “ability to judge the relevance of the information” translates into “When you read ECAP-specific online information, what contributes to your judgement of this information being relevant or not?” A pilot test with focus group participants (n=6) recruited locally in Hanover is scheduled 4 to 8 weeks in advance of the actual start of data collection.

Following the preparation phase, four to five focus groups will be conducted at each project site, structured around the risk-specific and life stage–specific parent groups (see Figure 2). Focus groups will be led by the project staff assisted by two more researchers to ensure good methodological practice. Each group will be scheduled for about 90 minutes with additional time to complete health literacy surveys (see Quantitative Data Collection section). After the initial conduct of four to five focus groups, potential adaptions regarding format, process, and content will be discussed and the remaining focus groups will be conducted accordingly.

To assess and compare health literacy levels among the focus group participants (approximately N=120), a short version of the European Health Literacy Survey containing 16 items [52] will be applied, distributed, and completed alongside the focus group meetings. It covers three aspects of health along the four main health literacy dimensions, which appear suitable to assess health literacy in a group of parents. The survey comprises questions along the categories as shown in Table 2 as well as general information on each participant (eg, education status and health level), for a total of 25 questions.

To account for potential differences in different parent groups (ie, risk-specific and life stage–specific groups), for instance, regarding when and how they seek ECAP information, the constant comparison method will be applied [55,56]. First, two focus groups will be selected from the risk-specific and life stage–specific parent groups, respectively, for detailed analysis and will be comprised of 6 participants each. Using established qualitative data analysis software, MAXQDA 2018 (Verbi GmbH), two researchers will independently apply open coding to attach codes (ie, descriptors will be applied to the various discussion sections). Codes will be broadly derived from the health literacy framework and focus group guideline items; additional codes will be added inductively as far as is relevant. Second, the various individual codes and respective text passages will be grouped into overarching categories. Next, the categories will be refined and structured around the initial research questions, again by two researchers, and core themes will be described for each. Any disagreement among the two researchers will be discussed with a third researcher, the project lead, to reach consensus. Each of the remaining focus groups will be analyzed using the set of previously built categories. Based on the final coding categories, key similarities and differences regarding information behavior, reasons for information searching, needs, and preferences, among others, will then be summarized and compared between groups.

While the main part of the analysis will focus on the different parent groups, a separate round will be conducted to determine differences due to sociocultural backgrounds. To do so, the respective original transcripts will be screened for specific mentions (eg, preferences for a certain kind of information).

Data from the filled-in surveys will be entered into statistical data analysis software, SPSS Statistics, version 23 (IBM Deutschland GmbH), to allow for a descriptive portrayal of participant characteristics. This will be used mainly during the formulation of practice implications (see Expected Results section) (eg, specifying and characterizing parent groups that demand specific information formats and contents [ie, “Who needs what?”]). Individual health literacy levels will be indicated as percentage shares for items rated as very easy, rather easy, rather difficult, very difficult, and don’t know. Individual ratings will then be displayed as excellent, adequate, insufficient, and problematic according to the differentiation of health literacy levels [15]. Also, health literacy levels will be compared among the different parent groups based on mean values.

Based on our findings, our aim is to determine (1) where ECAP-specific information should be placed to reach more users and what motivates parents to consider information, (2) the topics that create uncertainties (eg, recommendations on allergenic foods) and what parents consider helpful for navigating such challenges, and (3) the preferred information and learning formats and respective variations across parent groups.

To derive practice implications, relevant codes from the analysis will be grouped under each aspect. A preliminary set of implications will be drafted according to the categorization of codes, for which (1) volunteers from the focus groups (n=5) as well as (2) a group of health professionals (n=5) shall be invited to comment on, revise, and consent to the practice implications. The latter will be approached based on one of our neighboring projects within the Health Literacy in Early Childhood Allergy Prevention (HELICAP) research unit, which interviews health professionals from different disciplines regarding their ECAP communication with parents. A final version will be created based on the overall feedback; the exact format (eg, a user-friendly visualized brochure) will be consented to during the development process.

Practice implications will primarily be disseminated to health professionals who inform and consult parents about ECAP (ie, midwives, pediatricians, and allergists) and providers of digital health information. Also, childcare service institutions, such as kindergartens and family centers, will be invited to offer short summaries of the main findings from both provider and user perspectives within their institution. Formats other than written summaries might be necessary here, which still must be agreed upon in the course of the project. To approach the above-mentioned individual actors, a combination of dissemination channels will be employed, particularly the following:

A final step is to transfer the study results and practice implications into a subsequent phase of intervention development and testing. At this point, a set of ECAP-specific information materials would be drafted based on the project described here as well as on the recommendations for evidence-based health information (eg, [63-65]). This could then be piloted via a randomized controlled trial (ie, one group of parents receiving the intervention and another group receiving currently available ECAP information). A specific focus for the information materials (eg, suggestions for dealing with uncertainty) will be specified if the results of this study demonstrate a need for it. Besides constant patient and public involvement during the development stage by a group of parents, the development phase would be further supported by allergy prevention experts. These experts would be approached, for instance, via the associated university hospitals and respective allergy and pediatric clinics at each project site.