An interventional study of Healthy School Start in Pediatric Obesity, Overnutrition, Child and Prediabetic State, sponsored by Karolinska Institutet. Completed at 3 sites in Sweden. Open to participants aged 5 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Prevention
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Among 13 studies in Pediatric Obesity by Karolinska Institutet — 3 open to participants now, 4 under way, none of them phase 3. Pediatric Obesity · Karolinska Institutet.
Among the 13 studies in Pediatric Obesity by Karolinska Institutet, this one has the largest enrollment of the 10 interventional ones that give a count, is the only one that started in 2021, is one of 10 with no phase, and was the 7th registered.
1,130 studies on the registry are indexed under Pediatric Obesity; 184 are open to participants now.
Browse Pediatric Obesity studies →3 of the 13 studies in Pediatric Obesity by Karolinska Institutet are open now, in 4 countries. Recruiting first, the newest first:
Karolinska Institutet · Sites in Sweden
Ages 12–17
Karolinska Institutet · Sites in Italy, Norway, Poland and 1 more country
Ages 4–17
Karolinska Institutet
Ages 4–12
By country, each count listing its studies:
Of the 121 Pediatric Obesity studies recruiting now, 17 (14%) set no upper age limit and 102 (84%) stop at 75 or younger; 112 take children under 18; 68 take healthy volunteers.
This study: 5 Years to 70 Years · all sexes · no healthy volunteers.
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13 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 1 started in 2021.
This study's enrollment of 1,634 is above the median of 100 across 871 interventional studies indexed under Pediatric Obesity.
Median enrollment 101 across the 10 interventional studies, 312 across the 3 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.
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Karolinska Institutet is the lead sponsor of 1,149 studies on the registry; 277 are open to participants now.
1 of the studies in Pediatric Obesity by Karolinska Institutet that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06836284Karolinska InstitutetThe Evira Study: Additional Support During Obesity Treatment | 2027-04-01 |
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Among the 13 studies in Pediatric Obesity by Karolinska Institutet, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All schools will receive the HSS program. Schools randomly assigned to group 1 will receive implementation strategy bundle 1 (Basic).
Behavioral: Healthy School Start
All schools will receive the HSS program. Schools randomly assigned to group 2 will receive implementation strategy bundle 1+2 (Enhanced).
Behavioral: Healthy School Start
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.
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.
Time frame: 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.
Time frame: Measured at 12 and 24 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Measured at Baseline, 12 months, and 24 months
Plan to share: No
Ran from Sep 2021 to primary completion in Sep 2024, 36 months.
Of 541 non-industry interventional studies with no phase under Pediatric Obesity, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 36 months is above that.
Counting every sponsor, half of 543 studies reached it within 25 months; a quarter within 11 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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