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Completed

NCT Number: NCT05237362

Saga Stories in Health Talks in Primary Child Healthcare

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.

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Key information

Conditions

Age range

5 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biosciences and Nutrition, Karolinska Institutet

Huddinge, 141 83, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saga Stories

Behavioral

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).

Primary outcomes

  1. Self-efficacy

    Time frame: At the end of the intervention which is two months after baseline

    Parental self-efficacy for promoting healthy dietary and physical activity behaviours in their children´ questionnaire

Secondary outcomes

  1. Intake of key dietary indicators as assessed by a questionnaire

    Time frame: At the end of the intervention which is two months after baseline

    Intake of fruits, vegetables, and sugar sweetened drinks (grams/day)

  2. Screen time as assessed by a questionnaire

    Time frame: At the end of the intervention which is two months after baseline

    Number of minutes per day spent in front of a screen

  3. Acceptability

    Time frame: 3 months after implementation

    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.

  4. Appropriateness

    Time frame: 3 months after implementation

    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.

  5. Feasibility of implementing Saga Stories

    Time frame: 3 months after implementation

    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.

  6. Change in the fidelity of the Saga Stories intervention

    Time frame: 2, 4, 6, 8, 10, and 12 months after implementation

    Assessment based on checklist developed for this study (0, not implemented and 1, implemented)

  7. Change in the adoption of the Saga Stories intervention

    Time frame: 2, 4, 6, 8, 10, and 12 months after implementation

    Assessment based on checklist developed for this study (0, not implemented and 1, implemented)

  8. Sustainability

    Time frame: One year after implementation

    Semi-structured interviews with primary child healthcare nurses

  9. Parental satisfaction and usage of Saga Stories

    Time frame: Post-intervention (i.e., 2 months after baseline assessment)

    Questionnaire

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Feb 14, 2022
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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