Study protocol for an effectiveness-implementation hybrid trial to evaluate a health promotion intervention in parents and their 5-year-old child: Saga Stories in health talks in Swedish child healthcare

Unhealthy lifestyle behaviours (e.g., a poor diet, inadequate physical activity, and excessive screen time) have been shown to be established in childhood and track into adulthood [1, 2]. According to the 2021 Generation Pep report, including a representative sample of Swedish children and youth aged 4-17 years, only 10 and 20% of children and youth met the dietary recommendations for fruit and vegetables and fish intake as well as physical activity, respectively. Furthermore, 54% of parents of 4-6 year olds reported 1-2 hours of screen time the previous day and another 14% reported 3-4 hours of screen time [3]. Parental self-efficacy has been found to be associated with children’s dietary, physical activity, and screen time behaviours [4, 5], thus there is a need for health promotion interventions in the pre-school years to aid parents in encouraging healthy behaviours and minimizing unhealthy ones.

Child healthcare (CHC) in Sweden reaches 99% of all children [6] and CHC nurses meet parents and children continuously from birth until 5 years of age at regular check-ups [7]. Thus, this makes CHC an ideal arena for health promotion interventions aimed at promoting healthy lifestyle behaviours in families with young children. Furthermore, the Swedish National Board of Health and Welfare have identified the need for more material, education, and working methods for promoting healthy lifestyle behaviours within CHC [6]. This was further emphasized in a recent study where the majority of Swedish CHC nurses reported not feeling comfortable discussing screen time with parents. They stated that they felt that this is a new topic and do not have enough material to support their discussions [8].

Within CHC in Sweden, health talks and guidance on promoting healthy lifestyle behaviours are part of routine visits from 3 months of age [7]. However, previous research has indicated that lifestyle behaviours such as dietary habits, physical activity, sleep, and screen time are infrequently discussed at routine visits in CHC [9]. As health talks vary depending on the needs of the family, a variety of scientifically evaluated material needs to be available to CHC nurses in order for them to be able to comfortably and effectively have a dialogue with parents and their child regarding lifestyle behaviours.

The aim of this protocol is to describe the study design and methodology of `Saga Stories in health talks´. The main objectives are:

This project will use a hybrid type I effectiveness-implementation trial design, as our primary focus is effectiveness and our secondary focus is implementation [10]. A mixed-methods approach will be used to collect data and the `Outcomes for Implementation Research´ [11] evaluation framework was used to inform the evaluation plan. The study design is shown in Fig. 1.

To date, there is a lack of material for promoting healthy lifestyle behaviours for CHC nurses that have been evaluated with regards to both effectiveness and implementation. Thus, the `Saga Stories in health talks´ trial will investigate whether a working tool plus take-home material at the five-year routine visit can be used to improve parental self-efficacy for promoting healthy lifestyle behaviours as well as children’s diet and screen time behaviours. Furthermore, we aim to evaluate the implementation of `Saga Stories in health talks´ in terms of acceptability, appropriateness, feasibility, fidelity, adoption, sustainability, satisfaction, and usage.

In Sweden, there is a variety of material available for CHC nurses to support the health talks with families at the routine visits at CHC [22]; however, very few have been scientifically evaluated. `The child-centered health dialogue for the prevention of obesity´ has recently been evaluated, where they investigated whether a structured dialogue at the four-year routine visit between the CHC nurse, the child, and the caregiver(s) improved BMI z-scores. The intervention for all four-year-old’s regardless of weight status comprised of using eight animated illustrations on healthy choices plus a discussion around the child’s growth. At the follow-up 1 year later no significant intervention effect was found on children’s BMI z-scores [23]. Furthermore, in non-participant observations during the four-year visit as well as in interviews with the participating children, the authors found that the children seemed to enjoy being actively involved in the conversation, but were not able to interpret the health messages as intended [24]. Therefore, in the current trial we have placed our health talk at the five-year visit in order for the children to hopefully have a better ability to discuss and comprehend the messages that are being discussed.

One of the main strengths of this trial is the type I hybrid-design which allows us to evaluate both effectiveness and implementation outcomes. Collecting both effectiveness and implementation outcomes simultaneously has the potential to expedite the translation of research results into routine care [10]. Additional strengths of this study include the randomized controlled trial design (effectiveness evaluation) and large sample size accounting for clustering on the CHC level. Furthermore, public health interventions are conventionally developed using a top-down approach and do not include the end-users in the development process [25]. A recent systematic review and meta-analysis on international healthcare literature found that co-creation is thought to improve health related outcomes such as health-promoting behaviours [26]. In this case CHC nurses requested material that they could use to facilitate their health talks with families. Thereafter, relevant stakeholders were brought on board to create the material together with the nurses. Thus, even though Saga Stories for use in health talks (i.e., a working tool plus take-home material) was not created using a specific theoretical background it was developed utilizing co-creation through involving end-users (CHC nurses and parents), stakeholders (Generation Pep, dieticians, and pediatricians), and academic researchers in an iterative process. A limitation of this study is that only parent and child dyads that can speak and read Swedish sufficiently well will be included in this study, which will limit the generalizability of the results. In Sweden, approximately 25% of children have a migrant background [27] and at visits within CHC anyone that does not speak Swedish has the right to an interpreter. A study by Ersson et al. [8] with Swedish CHC nurses has previously found that communication through an interpreter may affect how messages are delivered. As the Saga Stories in health talks intervention’s focus is the health dialogue between the nurse, parent(s), and child we have only included Swedish speaking participants to ensure the intervention is delivered as intended. This study is further limited through the use of self-reported outcomes for the effectiveness evaluation. The baseline questionnaire, including questions on both parental self-efficacy for promoting healthy lifestyle behaviours as well as the child’s dietary intake and screen time, will be evaluated at the beginning of the routine five-year check-up at baseline. This, coupled with the lack of blinding of nurses and parents could lead to social desirability bias. The research team carefully discussed theses limitations during the study design process; however, there was no way to avoid these and thus they should be taken into consideration when interpreting the results. It is also important to highlight that researchers with expertise in both clinical and implementation research have designed this trial together in order to optimize the hybrid design. This is important, as using hybrid designs can be challenging due to the use of different constructs, theories, and concepts between clinical and implementation researchers [10].

Following this trial, `Saga Stories in health talks´ has great potential to be nationally available for all nurses to use in health talks with parents. Furthermore, after this trial there is the possibility to translate and culturally adapt the Saga Stories material into the most commonly spoken languages in Sweden (besides Swedish), i.e., English, Somali, and Arabic to further facilitate health talks with non-Swedish speaking families. Overall, if Saga Stories in health talks is found to be effective, appropriate, as well as feasible to implement, it can aid CHC nurses to promote and support healthy lifestyle behaviours in pre-school aged children and their families.