Saga Stories in Health Talks in Primary Child Healthcare

April 3, 2024 updated by: Marie Löf, docent, Karolinska Institutet

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
763

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At the end of the intervention which is two months after baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
At the end of the intervention which is two months after baseline
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
At the end of the intervention which is two months after baseline
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.
3 months after implementation
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.
3 months after implementation
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.
3 months after implementation
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)
2, 4, 6, 8, 10, and 12 months after implementation
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)
2, 4, 6, 8, 10, and 12 months after implementation
Sustainability
Time Frame: One year after implementation
Semi-structured interviews with primary child healthcare nurses
One year after implementation
Parental satisfaction and usage of Saga Stories
Time Frame: Post-intervention (i.e., 2 months after baseline assessment)
Questionnaire
Post-intervention (i.e., 2 months after baseline assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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