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NCT04984421: IMPROVE
IMplementation of the Family Support PRogramme A Healthy School Start to Prevent OVErweight and Obesity (IMPROVE)
NA trial testing Healthy School Start in Pediatric Obesity in 1,634 participants. Completed in 30 September 2024.
30 September 2024
Quick facts
| Lead sponsor | Karolinska Institutet |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 1,634 |
| Start date | 1 September 2021 |
| Primary completion | 30 September 2024 |
| Estimated completion | 30 September 2024 |
| Sites | 3 locations across Sweden |
Drugs / interventions tested
- Healthy School Start
Conditions studied
- Pediatric Obesity — all drugs for Pediatric Obesity →
- Overnutrition, Child — all drugs for Overnutrition, Child →
- Prediabetic State — all drugs for Prediabetic State →
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Sponsor
Karolinska Institutet
Who can join
Adults 5 to 70, any sex, with Pediatric Obesity or Overnutrition, Child. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Interventions to prevent obesity in children aged 5 to 11 years old.
Spiga F, Davies AL, Tomlinson E, Moore TH, et al · · 2024 · cited 40× · PMID 38763517 · DOI 10.1002/14651858.cd015328.pub2 -
Strategies for enhancing the implementation of school-based policies or practices targeting diet, physical activity, obesity, tobacco or alcohol use.
Lee DC, O'Brien KM, McCrabb S, Wolfenden L, et al · · 2024 · cited 11× · PMID 39665378 · DOI 10.1002/14651858.cd011677.pub4 -
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.
Elinder LS, Wiklund CA, Norman Å, Stattin NS, et al · · 2021 · cited 10× · PMID 34488691 · DOI 10.1186/s12889-021-11663-2 -
Contextual factors in the implementation of the family support program A Healthy School Start in three municipalities in Sweden
Annerstedt KS, Kwak L, Andermo S, Patterson E, et al · · 2024 · cited 1× · DOI 10.21203/rs.3.rs-4274322/v1 -
A Multi-Site Study of implementing a School-Based Health Promotion Intervention in Sweden – Changes in Readiness and Implementation Outcomes
Annerstedt KS, Kwak L, Andermo S, Patterson E, et al · · 2026 · DOI 10.21203/rs.3.rs-8410429/v1 -
Comparing tailored implementation strategies to improve intervention fidelity in a school-based obesity prevention program: the IMPROVE hybrid type III trial.
Annerstedt KS, Ahlgren JÁ, Patterson E, Andermo S, et al · · 2025 · PMID 41455974 · DOI 10.1186/s13012-025-01481-0
Verify or expand the search:
- PubMed search for NCT04984421
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Karolinska Institutet trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04984421 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Karolinska Institutet
- Last refreshed: 30 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04984421.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing