Contributions to the literature
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Comparing the effectiveness of two bundles of implementation strategies tailored to context specific determinants identified by stakeholders
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Adds to the knowledge on hybrid design studies in implementation research
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Adds new perspectives on the construction of a fidelity score in a complex intervention
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Adds knowledge on the form and function for external facilitation support in the school setting
Background
Determinants of implementation and implementation strategies
The Healthy School Start program
Specific aims and hypothesis
Methods
Study design
Setting of the study
Implementation strategies used during the planning stage
Eligibility of families, inclusion criteria
Randomisation and blinding
The Healthy School Start program
Component 1: Health information
Component 2: Motivational interviewing
Component 3: Classroom activities with home assignments
Component 4: Type 2 diabetes risk test online
Standard practice in Swedish school health care
Development of IMPROVE
Step 1: Exploring barriers and facilitators of implementation
CFIR domain | Determinants of implementation | Example of notes made by workshop participants |
---|---|---|
Intervention characteristics (HSS) | 1. Program supported by guidelines and curriculum | “The content/purpose can be linked to the curriculum” |
2. Involvement of parents | “Children and parents can get support for a healthier lifestyle and parents can get help with strategies to reach them. Good with MI for self-motivation” | |
3. Consensus on healthy lifestyle | “Very good with increased and equal knowledge to students and parents about diet, exercise, and health, regardless of background and resources” | |
4. Clarity of material and instructions for use | “Get a teaching plan for an important part of the student’s development towards a healthy life” | |
Outer setting (municipality) | 5. Societal action and cooperation | “That these social institutions work together on the health of the population. Can increase understanding of each other’s mission but also that we share the health mission to reduce social health inequalities” |
6. Environmental factors | “In disadvantaged settings, it can be an economic issue, fruits and vegetables are relatively expensive, junk food cheaper, parents can’t afford to let children practice sports” | |
7. Local policies | “Link to activities and policies that are decided upon” | |
Inner setting #1 (school) | 8. Common goals and collaboration in school | “That the school works towards common goals, school health care and teachers work with health promotion and start from the same point of departure and “language” when talking to children and parents” |
9. Communication and collaboration between school-home | “Good to have increased consensus between school staff and parents regarding good nutrition and practices around this” | |
10. Continuity in staffing and work routines | “That there may be staff changes that make implementation difficult both within school health care and teachers” | |
11. Leadership in school | “Important that all principals endorse the project at their school” | |
12. Visible priority of health | “That the school works towards a common goal and is consistent in its communication with parents” | |
Inner setting #2 (primary care) | 13. Communication within and between primary health care units | “It will be a challenge to communicate to all primary health care centres and to all its individual employees about what the project is about and what help should be offered to those who contact them” |
14. Time for administration in primary health care | “Fear that there will be a lot of administrative work for the caregivers. Important to avoid” | |
15. Collaboration between primary care and school | “Proposal to address IMPROVE at an annual meeting between primary care and school health care” | |
16. New target groups | “At the primary health care centre you can find other health risks in the parents if they have high blood sugar” | |
17. Early prevention | “A good opportunity for primary care to work more with prevention and to reach risk groups in time” | |
Intervention recipients (parents) | 18. Family consensus on healthy lifestyle | “Very good with increased and equivalent knowledge to students and parents about diet, exercise and health regardless of background and preconditions” |
19. Parents’ knowledge and skills | “Parents are included in their children’s homework and together they learn about good habits. Teachers follow up and remind about the homework” | |
20. Socioeconomic and cultural factors, language | “Socio-economically weak areas - risk of lower adherence to homework being completed - high risk of attrition” | |
21. Parents’ perceived need and readiness | “Children with overweight/obesity often have parents with the same problems. Difficult to motivate for lifestyle changes” | |
22. Parents’ engagement in children’s schoolwork | “Poor adherence to homework. The resourceful do tasks with the children but not those who need them” | |
Individual providers (school and primary care staff) | 23. Providers’ attitudes towards the program | “Motivated preschool teachers who are happy to be involved in development” |
24. Providers’ competence and self-efficacy | “Great increase in skills for staff, raising equality” | |
25. Providers’ experience of workload and responsibility | “Can be experienced by school staff as an increased workload. A change in working routines is always demanding” | |
Process | 26. Time for planning and executing program in school | “It is important that time is given for planning and that it is clear how much time is required for all steps” |
27. Communication and collaboration within school regarding process | “That all material from Karolinska Institutet is sent out before the work at the schools takes place, which creates time for good planning in the classes” | |
28. Sustainability of program | “That the project continues, that it is not dependent on individuals but can continue regardless of what the organisation looks like in schools and in the central administration” |
Step 2: Tailoring of implementation strategies
Implementation strategies (SISTER strategy number) | Determinants targeted | Description of the strategy | Actors | Target |
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Conduct local consensus discussions (23) | 1. Program supported by guidelines and curriculum 5. Societal action and cooperation 8. Common goals and collaboration in school 10. Continuity in staffing and work routines 11. Leadership in school 12. Visible priority of health 23. Providers’ attitudes towards the program 27. Communication and collaboration within school 28. Sustainability of program | Introduction of the HSS to all school personnel with the help of material to create commitment and reach consensus | School principal | School personnel |
Distribute educational materials (42) | 8. Common goals and collaboration in school 24. Providers’ competence and self-efficacy | Order educational material at the beginnning of the new school year (manual, teachers manual, workbook for children, posters etc.) and distribute it | School health team | School personnel |
Listen to educational lectures posted on the HSS website at least once every school year whenever it fits with the schedule | School health team | School personnel | ||
Organize school personnel implementation team meetings (32) | 25. Providers’ experience of workload and responsibility 26. Time for planning and executing the program in school 27. Communication and collaboration within school regarding process | Form a health team including a teacher representative and appoint a coordinator to follow up and reflect on how to devide the practical work with the HSS, the implementation process, knowledge exchange, and how to support one another’s learning | School principal and health team | School health team |
Peer-assisted learning (13) | 3. Consensus on healthy lifestyle 4. Clarity of materials and instructions for use 8. Common goals and collaboration in school 23. Providers’ attitudes towards the program24. Providers’ competence and self-efficacy 26. Time for planning and executing in school 27. Communication and collaboration within school regarding process | Watch the introductory video to the classroom component, discuss a plan for implementation, how to engage parents in the home assignments | Teachers | Teachers |
Exchange of knowledge and experience in MI | School nurses | School nurses | ||
Internal and external meetings for inspiration, knowledge exchange and how to organise the work | School health team | School personnel | ||
Change/alter environment (54) | 6. Environmental factors 7. Local policies | Discussion regarding the possibility to make changes to support healthy lifestyle within and around the school | School health team | Community, school and after-school care |
Prepare families and students to be active participants (55) | 2. Involvement of parents 9. Communication and collaboration school-home 18. Family consensus on healthy lifestyle 19. Parents’ knowledge and skills 20. Socioeconomic and cultural factors, language 21. Parents’ perceived need and readiness 22. Parents’ engagement in the HSS | Announcement that the school is a health promoting school | School principal | Parents |
Introduction of the HSS at the first meeting with new parents through a film, giving the rational for the intervention, in basic Swedish and texted in other common languages | School personnel | Parents | ||
Information sent out in the newsletter to families of the start of the HSS. Encouragement to consult the HSS website for further information and material | School personnel | Parents |
Implementation strategies (SISTER strategy number) | Determinants targeted | Description of the strategy | Actor | Target |
---|---|---|---|---|
Conduct educational outreach visits (38) | 23. Providers’ attitudes towards the program 24. Providers’ competence and self-efficacy | Yearly presentations to schools on topics in public health of their choice and relevant to the intervention | Research team | School personnel |
Promote network weaving (33) | 13. Communication within and between primary health care centres 14. Time for administration in primary health care 15. Collaboration between primary care and school 16. New target groups 17. Early prevention 28. Sustainability of program | Send out yearly information letter to primary health care centres about the HSS program and the IMPROVE study. Encourage yearly meetings to establish social networks, promote information sharing, collaborative problem-solving and shared goals regarding family health | Research team | School health care and primary care |
Provide ongoing consultation/coaching (44) | 23. Providers’ attitudes towards the program 24. Providers’ competence and self-efficacy | Yearly audit and feedback through a written report on the fidelity score and performance of implementation strategies with coaching how to improve. E-mail sent four times per year to the school health team coordinator to offer assistance and help with problem solving | Research team | School personnel |
Obtain and use student and family feedback (8) | 23. Providers’ attitudes towards the program | Yearly feedback on parents’ attitude and perception of the program | Research team | School personnel |
Step 3: Strategies performed by the research team
Step 4: Defining outcomes and data collection methods
Primary outcome
Component | Adherence (%) (yes/no) | Dose (%) | Participant responsiveness (scale 1–5) | Quality of delivery |
---|---|---|---|---|
Brochure with health information | Parents reading the brochure (P)a | NA | Parents’ appreciation of the brochure (P)b | NA |
Motivational Interview (MI) | Parents receiving MI (N)a | NA | Parents’ appreciation of health counselling (P)b | Quality of MI score coded according to MITI 4.2 (C) |
Classroom component | Teachers providing the classroom component (T)a | Proportion of classroom lessons performed (T) Proportion of lesson completion (T) | Teachers’ perceived child involvement and engagement (T) Parent’s appreciation of the homework (P)b | NA |
T2D test | Parents doing the test (P)a Parents with a high risk that subsequently attend health care (P) | NA | Parents’ appreciation of the test (P)b | NA |
Total score | Total sum score (0–4) | NA | Total sum score (4–20) | NA |
Secondary outcomes
Fidelity to implementation strategies
Acceptability, appropriateness, and feasibility
Organisational readiness to implement
Child height and weight
Child intake of indicator foods
Parent outcomes
Indicator | Time of data collection | |||
---|---|---|---|---|
2021 | 2022 | 2023 | 2024 | |
School characteristics | June | |||
Parents’ demographic data Fidelity to HSS components | October (C1) | October (C2) June (C1) | June (C2) | |
Acceptability | September | June | June | June |
Appropriateness | September | June | June | June |
Feasibility | September | June | June | June |
Organisational readiness | September | June | June | June |
Fidelity to implementation strategies | May | May | May | |
Child height and weight | December (C1) | December (C2) | December (C1) | December (C2) |
Child diet | October (C1) | June (C1) October (C2) | June (C1 + C2) | June (C2) |
Parents’ T2D risk | October (C1) | June (C1) October (C2) | June (C1 + C2) | June (C2) |
Parental feeding practices | October (C1) | June (C1) October (C2) | June (C1 + C2) | June (C2) |
Stakeholder interviews
Data management and statistical analysis
Sample size and power calculation
Ethical approval
Discussion
Limitations
WHO trial registration data set
Data category | Information |
---|---|
Primary registry and trial identifying number | ClinicalTrials.gov ID: NCT04984421 |
Date of registration in primary registry | July 30, 2021 |
Secondary identifying numbers | None |
Source(s) of monetary or material support | Swedish Research Council for Health and Working Life and Welfare (FORTE) |
Primary sponsor | Swedish Research Council for Health and Working Life and Welfare (FORTE) |
Secondary sponsor(s) | NA |
Contact for public queries | MSc, PhD Camilla.wiklund@ki.se |
Contact for scientific queries | MSc, PhD, Liselotte Schäfer Elinder, Karolinska Institutet, Stockholm, Sweden |
Public title | IMPROVE |
Scientific title | IMplementation and evaluation of the school-based family support PRogram A Healthy School Start to promote child health and prevent OVErweight and obesity (IMPROVE) – study protocol for a cluster-randomized trial |
Country of recruitment | Sweden |
Health condition(s) or problem(s) studied | Unhealthy diet, low physical activity, overweight and obesity, type 2 diabetes |
Implementation intervention | All schools receive the Heathy School Start intervention. Active: Implementation strategy bundle 1 + 2 (Enhanced) Comparator: Implementation strategy bundle 1 (Basic) |
Key inclusion and exclusion criteria | Inclusion: Public schools in two municipalities in the Stockholm Region. All children in pre-school class 5–7 years in these schools Exclusion: None |
Study type | Parallel group cluster randomised trial |
Date of first enrolment of schools | August 2021 |
Recruitment status | Not started |
Primary outcome(s) | Fidelity to intervention (adherence and responsiveness) |
Key secondary outcomes | Acceptability, appropriateness, feasibility, organizational readiness, fidelity to implementation strategies, child diet, child BMI, child weight status, parent’s risk of T2D, parental feeding practices |