Saga Stories in Health Talks in Primary Child Healthcare

Study Overview
=================
Brief Summary
-----------------
Primary child healthcare in Sweden is an important arena for health promotion interventions as nurses regularly meet parents and children from birth to five years of age. To date there is a lack of evidence-based material for child healthcare nurses to use in health promotion talks within primary child healthcare. Therefore, the aims of this study are to: (i) evaluate the effectiveness of Saga Stories in health talks on parental self-efficacy to promote healthy diet, physical activity, and screen time behaviours in 5-year-old children and (ii) evaluate the implementation of Saga Stories in health talks with regards to acceptability, appropriateness, feasibility, fidelity, adoption, sustainability, satisfaction, and usage.

Official Title
-----------------
An Effectiveness-implementation Hybrid Trial to Evaluate a Health Promotion Intervention Within Swedish Primary Child Healthcare: Saga Stories in Health Talks

Conditions
-----------------
Self Efficacy

Intervention / Treatment
-----------------
* Behavioral: Saga Stories


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The parent the accompanies the child to the 5-year check-up at primary child healthcare needs to be able to understand Swedish sufficiently well in order to provide informed consent and partake in the Saga Stories health talk. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Receives the Saga Stories health promotion talk as well as take-home material | Behavioral: Saga Stories<br>* Saga Stories in health talks consists of material for child healthcare nurses to use to facilitate the health talk with both the child and parent(s) and is complemented with take-home material. Every nurse will receive a large flip-chart with colourful pictures and text to facilitate their health talk at the 5-year check-up. The flip-chart will include information and questions regarding food, physical activity and sedentary behaviour, sleep, dental health, as well as bathroom habits. At the conclusion of the check-up the children will receive the book 'Saga Stories: Your amazing body and brain´ as well as games for the child to take home to promote healthy lifestyle behaviours (fruit and vegetable bingo and a physical activity fortune teller).<br>|
| No Intervention: Control<br>Receives standard health promotion talk | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-efficacy | Parental self-efficacy for promoting healthy dietary and physical activity behaviours in their children´ questionnaire | At the end of the intervention which is two months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intake of key dietary indicators as assessed by a questionnaire | Intake of fruits, vegetables, and sugar sweetened drinks (grams/day) | At the end of the intervention which is two months after baseline | 
| Screen time as assessed by a questionnaire | Number of minutes per day spent in front of a screen | At the end of the intervention which is two months after baseline | 
| Acceptability | Acceptability of the Saga Stories intervention by the child healthcare nurses (assessed by the questionnaire by Weiner et al.) It includes four questions assessed on a five point likert scale ranging from completely disagree to completely agree. | 3 months after implementation | 
| Appropriateness | Appropriateness of the Saga Stories intervention by the child healthcare nurses (assessed by the questionnaire by Weiner et al.) It includes four questions rated on a five point likert scale ranging from completely disagree to completely agree. | 3 months after implementation | 
| Feasibility of implementing Saga Stories | Feasibility of the Saga Stories intervention by the child healthcare nurses (assessed with by questionnaire by Weiner et al.) It includes four questions rated on a five point likert scale ranging from completely disagree to completely agree. | 3 months after implementation | 
| Change in the fidelity of the Saga Stories intervention | Assessment based on checklist developed for this study (0, not implemented and 1, implemented) | 2, 4, 6, 8, 10, and 12 months after implementation | 
| Change in the adoption of the Saga Stories intervention | Assessment based on checklist developed for this study (0, not implemented and 1, implemented) | 2, 4, 6, 8, 10, and 12 months after implementation | 
| Sustainability | Semi-structured interviews with primary child healthcare nurses | One year after implementation | 
| Parental satisfaction and usage of Saga Stories | Questionnaire | Post-intervention (i.e., 2 months after baseline assessment) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health promotion, Primary child healthcare