Saga Stories in Health Talks in Primary Child Healthcare

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

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.

Study Overview

• Status: Completed
• Conditions: Self Efficacy
• Intervention / Treatment: Behavioral: Saga Stories

• Study Type: Interventional
• Enrollment (Actual): 763
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Huddinge, Sweden, 141 83
    • Department of Biosciences and Nutrition, Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 5 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Receives the Saga Stories health promotion talk as well as take-home material	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).
No Intervention: Control; 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)

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Health promotion; Primary child healthcare
• Other Study ID Numbers: 2021-06106-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No