Saga Stories in Health Talks in Primary Child Healthcare

Self Efficacy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05237362
• Other study ID #: 2021-06106-01
• Status: Completed
• Phase: N/A
• Start date: February 2, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: April 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 763
• Est. completion date: January 31, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Self Efficacy

Intervention

Behavioral:
• Saga Stories
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).

Locations

Country	Name	City	State
Sweden	Department of Biosciences and Nutrition, Karolinska Institutet	Huddinge

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Sustainability	Semi-structured interviews with primary child healthcare nurses	One year after implementation
Secondary	Parental satisfaction and usage of Saga Stories	Questionnaire	Post-intervention (i.e., 2 months after baseline assessment)