Pediatric ObesityIMPROVENCT04984421
IMplementation of the Family Support PRogramme A Healthy School Start to Prevent OVErweight and Obesity (IMPROVE)
A study testing Healthy School Start in people with Pediatric Obesity and Overnutrition, Child, run by Karolinska Institutet at 3 sites in Sweden.
Trial summary
IMPROVE is an implementation study aiming to explore the effects of two bundled implementation strategies on the intervention fidelity of the Healthy School Start program (primary outcome) while simultaneously monitoring effects on health outcomes of children and parents (secondary outcomes). Read more about this study
- Who is it for?
- Ages 5 to 70 years
- Conditions the study is for
- Pediatric Obesity, Overnutrition, Child, Prediabetic State
- What is being tested?
- Healthy School Start
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,634 participants
- Where
- 3 sitesSweden
- Study dates
- 1 Sep 2021to 30 Sep 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All children and their parents at the included schools. All involved personnel at the included schools
Who cannot join
- No
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Municipality
Huddinge, Stockholm County
Municipality
Sigtuna, Stockholm County
Municipality
Södertälje, Stockholm County
About this study
Official title: IMplementation and Evaluation of the School-based Family Support PRogramme A Healthy School Start to Promote Child Health and Prevent OVErweight and Obesity (IMPROVE) - Study Protocol for a Cluster-randomized Trial
IMPROVE is an implementation study aiming to explore the effects of two bundled implementation strategies on the intervention fidelity of the Healthy School Start program (primary outcome) while simultaneously monitoring effects on health outcomes of children and parents (secondary outcomes). Thirty schools in two municipalities will receive the HSS program reaching about 1400 families per school year, for two years.
Read the detailed description
IMPROVE aims to conduct a hybrid type 3 evaluation design to test the effects of bundled implementation strategies on the intervention fidelity (primary outcome) of the Healthy School Start (HSS) program while simultaneously monitoring effects on health outcomes of children and parents (secondary outcomes). The HSS is a 4-component family support program for children starting school (5-7 years of age) promoting healthy dietary habits and physical activity in the home environment to prevent childhood obesity and parent risk of developing type 2 diabetes.
IMPROVE is a cluster-randomized controlled trial with two arms to evaluate and compare the effects of two different bundles of implementation strategies on intervention fidelity expressed as adherence and responsiveness at 12 and 24 months. Thirty schools in two municipalities will participate in the study reaching about 1400 families per school year. In stakeholder workshops, key implementation determinants were identified according to the domains of the Consolidated Framework for Implementation Research. Through a consensus process with stakeholders, two bundles of implementation strategies were tailored to address context-specific determinants. Schools randomly assigned to group 1 will receive bundle 1 (Basic) and group 2 will receive bundle 1+2 (Enhanced), consisting mainly of external facilitation, fidelity monitoring and feedback strategies. Secondary outcomes will include acceptability, appropriateness, feasibility, organisational readiness as perceived by school staff, child weight status and diet, and parents' risk of type 2 diabetes. Linear and ordinal regression analysis will be used to test the effect on the primary and secondary outcomes, taking clustering into consideration where needed. Process evaluation will be conducted through key stakeholder interviews to investigate experiences of the program and stakeholder perceptions on sustainability.
This systematic approach to investigating the effects of two different bundles of implementation strategies tailored to context-specific determinants on the fidelity of the HSS intervention will provide new insight into feasible implementation strategies and the external supports needed for a school-based health program like the HSS to be effective and sustainable. Results will help inform how to bridge the gap between the research on school-based health programs and routine practice in schools.
- Conditions
- Pediatric Obesity, Overnutrition, Child, Prediabetic State, Diabetes Mellitus, Type 2, Overweight, Childhood
- Being tested
- Healthy School Start
- Keywords
- BMI, Fidelity, Hybrid type 3 design, Health promotion, Implementation strategies, Primary health care, School health care, Nutrition
- Medical subject headings
- Pediatric Obesity, Child Nutrition Disorders, Prediabetic State, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy School StartBehavioural
The Healthy School Start program is a universal 4-component family support program for children starting school (5-7 years of age) promoting healthy dietary habits and physical activity in the home environment to prevent childhood obesity and parents' risk of developing type 2 diabetes. It is targeting both children and parents.
| Study group | Role | What they receive |
|---|---|---|
| Basic | Active comparator | All schools will receive the HSS program. Schools randomly assigned to group 1 will receive implementation strategy bundle 1 (Basic). Receives: Behavioral: Healthy School Start |
| Enhanced | Experimental | All schools will receive the HSS program. Schools randomly assigned to group 2 will receive implementation strategy bundle 1+2 (Enhanced). Receives: Behavioral: Healthy School Start |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fidelity (A) assessed by questionnaire to parents and school staff
Adherence to the four HSS components by indicators developed for this study. Information will be gathered through attendance logs and questionnaires to school staff and parents.
Measured: Measured at 12 and 24 months
Change in fidelity (R) assessed by questionnaire to parents
Responsiveness to the four HSS components by indicators developed for this study. Information will be gathered through questionnaires to parents.
Measured: Measured at 12 and 24 months
Secondary outcomes (11)
Change in acceptability of the HSS program assessed by questionnaire
Feasibility of implementing the intervention as perceived by school staff, measured with the questionnaire developed by Weiner et al.
Measured: Measured at baseline, 12, 24, and 36 months
Change in appropriateness of the HSS program measured by questionnaire
Appropriateness of implementing the intervention as perceived by school staff, measured with the questionnaire developed by Weiner et al.
Measured: Measured at baseline, 12, 24, and 36 months
Change in feasibility of the HSS program measured by questionnaire
Feasibility of implementing the intervention as perceived by school staff, measured with the questionnaire developed by Weiner et al.
Measured: Measured at baseline, 12, 24, and 36 months
Change in Organisational readiness of school principals assessed by questionnaire
Organisational readiness to change as perceived by school principals with the Leader Readiness to Implement Tool (LRIT)
Measured: Measured at baseline, 12, 24, and 36 months
Change in Organisational readiness by school staff assessed by questionnaire
Organisational readiness to change as perceived by school nurses and teachers with the Staff Readiness to Implement Tool (SRIT)
Measured: Measured at baseline, 12, 24, and 36 months
Fidelity to implementation strategies assessed by checklist
Assessment based on checklist developed for this study. Each strategy will be graded as 0=not implemented, 1=partially implemented, 2=fully implemented.
Measured: May each year
Change in child weight status assessed through measurement of height (m) and weight (kg)
Child BMI will be calculated as in kg/m^2. Weight status will be assessed using age-appropriate BMI cut-off values for thinness, overweight and obesity according to the International Obesity Task Force.
Measured: Measured at baseline and after 24 months
Change in child BMI z-score assessed through measurement of height (m) and weight (kg)
Child BMI will be calculated as in kg/m^2. The BMI z-score will be calculated according to a Swedish reference standard (Karlberg).
Measured: Measured at baseline and after 24 months
Change in child diet assessed by parent questionnaire
Dietary indicator foods (fruit, vegetables and energy-dense products) assessed by the diet portion of the Eating and Physical Activity Questionnaire (EPAQ)
Measured: Baseline, 12 months, and 24 months
Change in parental feeding practices assessed by parent questionnaire
Assessed with the Swedish short version of the Comprehensive Feeding Practices Questionnire (CFPQ)
Measured: Baseline, 12 months, and 24 months
Change in parents' risk of type 2 diabetes assessed by FINDRISC questionnaire
The FINDRISC self-evaluation test to calculate risk of developing type 2 diabetes on a scale from 0-26 points
Measured: Measured at Baseline, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start1 Sep 2021
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies 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
- Model description
- Cluster randomized controlled trial with a hybrid type 3 evaluation design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,634 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liselotte Schäfer Elinder, Karolinska Institutet
- Investigators
- Liselotte S Elinder, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984421
- Sponsor's protocol ID
- 2020-01198
- Acronym
- IMPROVE
- Status last verified
- May 2025
- First submitted
- 12 Jul 2021
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Annerstedt KS, Kwak L, Andermo S, Patterson E, Norman A, Raposo S, Elinder LS. A multi-site study of implementing a school-based health promotion intervention in Sweden - changes in readiness and implementation outcomes. BMC Public Health. 2026 Sep 8;26(1):2548. doi: 10.1186/s12889-026-29302-z.
PubMed 42711695Annerstedt KS, Ahlgren JA, Patterson E, Andermo S, Norman A, Raposo S, Kwak L, Elinder LS. Comparing tailored implementation strategies to improve intervention fidelity in a school-based obesity prevention program: the IMPROVE hybrid type III trial. Implement Sci. 2025 Dec 28;21(1):17. doi: 10.1186/s13012-025-01481-0.
PubMed 41455974Elinder LS, Wiklund CA, Norman A, Stattin NS, Andermo S, Patterson E, Hemmingsson E, Cook C, Raposo S, Kwak L. 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. BMC Public Health. 2021 Sep 6;21(1):1630. doi: 10.1186/s12889-021-11663-2.
PubMed 34488691
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMplementation and Evaluation of the School-based Family Support PRogramme A Healthy School Start to Promote Child Health and Prevent OVErweight and Obesity (IMPROVE) - Study Protocol for a Cluster-randomized Trial
- ClinicalTrials.gov ID
- NCT04984421
- Acronym / sponsor ID
- IMPROVE / 2020-01198
- Conditions
- Pediatric Obesity, Overnutrition, Child, Prediabetic State, Diabetes Mellitus, Type 2, Overweight, Childhood
- Keywords
- BMI, Fidelity, Hybrid type 3 design, Health promotion, Implementation strategies, Primary health care, School health care, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,634 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 30 Jul 2021 (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.
IMPROVE is an implementation study aiming to explore the effects of two bundled implementation strategies on the intervention fidelity of the Healthy School Start program (primary outcome) while simultaneously monitoring effects on health outcomes of children and parents (secondary outcomes). Thirty schools in two municipalities will receive the HSS program reaching about 1400 families per school year, for two years.
Detailed description
IMPROVE aims to conduct a hybrid type 3 evaluation design to test the effects of bundled implementation strategies on the intervention fidelity (primary outcome) of the Healthy School Start (HSS) program while simultaneously monitoring effects on health outcomes of children and parents (secondary outcomes). The HSS is a 4-component family support program for children starting school (5-7 years of age) promoting healthy dietary habits and physical activity in the home environment to prevent childhood obesity and parent risk of developing type 2 diabetes.
IMPROVE is a cluster-randomized controlled trial with two arms to evaluate and compare the effects of two different bundles of implementation strategies on intervention fidelity expressed as adherence and responsiveness at 12 and 24 months. Thirty schools in two municipalities will participate in the study reaching about 1400 families per school year. In stakeholder workshops, key implementation determinants were identified according to the domains of the Consolidated Framework for Implementation Research. Through a consensus process with stakeholders, two bundles of implementation strategies were tailored to address context-specific determinants. Schools randomly assigned to group 1 will receive bundle 1 (Basic) and group 2 will receive bundle 1+2 (Enhanced), consisting mainly of external facilitation, fidelity monitoring and feedback strategies. Secondary outcomes will include acceptability, appropriateness, feasibility, organisational readiness as perceived by school staff, child weight status and diet, and parents' risk of type 2 diabetes. Linear and ordinal regression analysis will be used to test the effect on the primary and secondary outcomes, taking clustering into consideration where needed. Process evaluation will be conducted through key stakeholder interviews to investigate experiences of the program and stakeholder perceptions on sustainability.
This systematic approach to investigating the effects of two different bundles of implementation strategies tailored to context-specific determinants on the fidelity of the HSS intervention will provide new insight into feasible implementation strategies and the external supports needed for a school-based health program like the HSS to be effective and sustainable. Results will help inform how to bridge the gap between the research on school-based health programs and routine practice in schools.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial with a hybrid type 3 evaluation design
| Arm | Type | Receives |
|---|---|---|
| Basic | Active comparator | Behavioral: Healthy School StartAll schools will receive the HSS program. Schools randomly assigned to group 1 will receive implementation strategy bundle 1 (Basic). |
| Enhanced | Experimental | Behavioral: Healthy School StartAll schools will receive the HSS program. Schools randomly assigned to group 2 will receive implementation strategy bundle 1+2 (Enhanced). |
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All children and their parents at the included schools. All involved personnel at the included schools
Key exclusion criteria (1 listed)
- No
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 |
|---|---|---|
| Healthy School StartThe Healthy School Start program is a universal 4-component family support program for children starting school (5-7 years of age) promoting healthy dietary habits and physical activity in the home environment to prevent childhood obesity and parents' risk of developing type 2 diabetes. It is targeting both children and parents. | Behavioural | Basic, Enhanced |
Primary outcome
Change in fidelity (A) assessed by questionnaire to parents and school staff
Time frame: Measured at 12 and 24 months
Adherence to the four HSS components by indicators developed for this study. Information will be gathered through attendance logs and questionnaires to school staff and parents.
Change in fidelity (R) assessed by questionnaire to parents
Time frame: Measured at 12 and 24 months
Responsiveness to the four HSS components by indicators developed for this study. Information will be gathered through questionnaires to parents.
11 secondary outcomes
Change in acceptability of the HSS program assessed by questionnaire
Time frame: Measured at baseline, 12, 24, and 36 months
Change in appropriateness of the HSS program measured by questionnaire
Time frame: Measured at baseline, 12, 24, and 36 months
Change in feasibility of the HSS program measured by questionnaire
Time frame: Measured at baseline, 12, 24, and 36 months
Change in Organisational readiness of school principals assessed by questionnaire
Time frame: Measured at baseline, 12, 24, and 36 months
Change in Organisational readiness by school staff assessed by questionnaire
Time frame: Measured at baseline, 12, 24, and 36 months
Fidelity to implementation strategies assessed by checklist
Time frame: May each year
Change in child weight status assessed through measurement of height (m) and weight (kg)
Time frame: Measured at baseline and after 24 months
Change in child BMI z-score assessed through measurement of height (m) and weight (kg)
Time frame: Measured at baseline and after 24 months
Change in child diet assessed by parent questionnaire
Time frame: Baseline, 12 months, and 24 months
Change in parental feeding practices assessed by parent questionnaire
Time frame: Baseline, 12 months, and 24 months
Change in parents' risk of type 2 diabetes assessed by FINDRISC questionnaire
Time frame: Measured at Baseline, 12 months, and 24 months
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 30 May 2025.
- Derived from this study: PubMed 42711695Annerstedt KS, Kwak L, Andermo S, Patterson E, Norman A, Raposo S, Elinder LS. A multi-site study of implementing a school-based health promotion intervention in Sweden - changes in readiness and implementation outcomes. BMC Public Health. 2026 Sep 8;26(1):2548. doi: 10.1186/s12889-026-29302-z.
- Derived from this study: PubMed 41455974Annerstedt KS, Ahlgren JA, Patterson E, Andermo S, Norman A, Raposo S, Kwak L, Elinder LS. Comparing tailored implementation strategies to improve intervention fidelity in a school-based obesity prevention program: the IMPROVE hybrid type III trial. Implement Sci. 2025 Dec 28;21(1):17. doi: 10.1186/s13012-025-01481-0.
- Derived from this study: PubMed 34488691Elinder LS, Wiklund CA, Norman A, Stattin NS, Andermo S, Patterson E, Hemmingsson E, Cook C, Raposo S, Kwak L. 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. BMC Public Health. 2021 Sep 6;21(1):1630. doi: 10.1186/s12889-021-11663-2.
- Project websiteLink provided by the sponsor.
- 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.
Liselotte S Elinder, PhD principal investigator
Karolinska Institutet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy School Start in people with Pediatric Obesity and Overnutrition, Child, run by Karolinska Institutet at 3 sites 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 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Change in fidelity (A) assessed by questionnaire to parents and school staff (time frame: Measured at 12 and 24 months). The study lists 2 primary outcomes in all. 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 NCT04984421, which also lists 3 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 30 May 2025.