NCT05237362

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
763

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

February 2, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

10 months

First QC Date

January 21, 2022

Last Update Submit

April 3, 2024

Conditions

Self Efficacy

Keywords

Health promotionPrimary child healthcare

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Intake of key dietary indicators as assessed by a questionnaire

    At the end of the intervention which is two months after baseline

  • Screen time as assessed by a questionnaire

    At the end of the intervention which is two months after baseline

  • Acceptability

    3 months after implementation

  • Appropriateness

    3 months after implementation

  • Feasibility of implementing Saga Stories

    3 months after implementation

  • +4 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Receives the Saga Stories health promotion talk as well as take-home material

Behavioral: Saga Stories

Control

NO INTERVENTION

Receives standard health promotion talk

Interventions

Saga StoriesBEHAVIORAL

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).

Intervention

Eligibility Criteria

Age5 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biosciences and Nutrition, Karolinska Institutet

Huddinge, 141 83, Sweden

Location

Related Publications (2)

  • Henstrom M, Delisle Nystrom C, Andermo S, Thomas K, Lof M. 'Saga Stories in health talks' for health promotion in Swedish child healthcare: results from a cluster-randomised hybrid type 1 effectiveness-implementation study. BMC Public Health. 2025 May 2;25(1):1637. doi: 10.1186/s12889-025-22786-1.

    PMID: 40316984DERIVED

  • Delisle Nystrom C, Henstrom M, Andermo S, Almquist-Tangen G, Thomas K, Lof M. 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. BMC Public Health. 2022 Nov 25;22(1):2184. doi: 10.1186/s12889-022-14549-z.

    PMID: 36434605DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 21, 2022

First Posted

February 14, 2022

Study Start

February 2, 2022

Primary Completion

December 1, 2022

Study Completion

January 31, 2023

Last Updated

April 4, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)