Self EfficacyNCT05237362
Saga Stories in Health Talks in Primary Child Healthcare
A study testing Saga Stories in people with Self Efficacy, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 5 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Self Efficacy
- What is being tested?
- Saga Stories
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 763 participants
- Where
- 1 siteSweden
- Study dates
- 2 Feb 2022to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Biosciences and Nutrition, Karolinska Institutet
Huddinge, 141 83
About this study
Official title: 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.
- Conditions
- Self Efficacy
- Being tested
- Saga Stories
- Keywords
- Health promotion, Primary child healthcare
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saga StoriesBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Receives the Saga Stories health promotion talk as well as take-home material Receives: Behavioral: Saga Stories |
| Control | No intervention | Receives standard health promotion talk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy
Parental self-efficacy for promoting healthy dietary and physical activity behaviours in their children´ questionnaire
Measured: 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
Intake of fruits, vegetables, and sugar sweetened drinks (grams/day)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 2, 4, 6, 8, 10, and 12 months after implementation
Sustainability
Semi-structured interviews with primary child healthcare nurses
Measured: One year after implementation
Parental satisfaction and usage of Saga Stories
Questionnaire
Measured: Post-intervention (i.e., 2 months after baseline assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start2 Feb 2022
- Primary completion1 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Self EfficacyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 763 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Löf, docent, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237362
- Sponsor's protocol ID
- 2021-06106-01
- Status last verified
- Apr 2024
- First submitted
- 21 Jan 2022
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40316984Delisle 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.
PubMed 36434605
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Effectiveness-implementation Hybrid Trial to Evaluate a Health Promotion Intervention Within Swedish Primary Child Healthcare: Saga Stories in Health Talks
- ClinicalTrials.gov ID
- NCT05237362
- Acronym / sponsor ID
- 2021-06106-01
- Conditions
- Self Efficacy
- Keywords
- Health promotion, Primary child healthcare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 763 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Saga StoriesReceives the Saga Stories health promotion talk as well as take-home material |
| Control | No intervention | –Receives standard health promotion talk |
Who may qualify
- Ages
- 5 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saga StoriesSaga 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). | Behavioural | Intervention |
Primary outcome
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
9 secondary outcomes
Intake of key dietary indicators as assessed by a questionnaire
Time frame: 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
Acceptability
Time frame: 3 months after implementation
Appropriateness
Time frame: 3 months after implementation
Feasibility of implementing Saga Stories
Time frame: 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
Change in the adoption of the Saga Stories intervention
Time frame: 2, 4, 6, 8, 10, and 12 months after implementation
Sustainability
Time frame: One year after implementation
Parental satisfaction and usage of Saga Stories
Time frame: Post-intervention (i.e., 2 months after baseline assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Derived from this study: PubMed 40316984Henstrom 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.
- Derived from this study: PubMed 36434605Delisle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saga Stories in people with Self Efficacy, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-efficacy (time frame: At the end of the intervention which is two months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05237362, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.