NCT03800823: MLEurope

Overweight and Obesity in Preschoolers

Active, enrolled NA Last updated 9 October 2024

What this trial tests

NA trial testing Parent group in Obesity in 300 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

15 February 2019

Primary endpoint
31 December 2022

31 December 2025

Quick facts

Lead sponsor	Karolinska Institutet
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	15 February 2019
Primary completion	31 December 2022
Estimated completion	31 December 2025
Sites	3 locations across Sweden, Romania, Spain

Drugs / interventions tested

• Parent group
• mHealth component
• Standard care — full drug profile →

Conditions studied

• Obesity — all drugs for Obesity →
• Overweight — all drugs for Overweight →

Sponsor

Karolinska Institutet

Who can join

Adults 2 to 6, any sex, with Obesity or Overweight. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Obesity interventions in early childhood are recommended as they have been proven to be more effective than interventions later in life. The overall aim of this study is to assess the effectiveness, feasibility, and acceptance of an overweight and obesity intervention in socially disadvantaged families. Participants will be families with children aged 2-6 years (n = 300) with overweight or obesity and will be recruited from three sites: Stockholm, Sweden (n = 100); Timisoara, Romania (n = 100); and Mallorca, Spain (n = 100).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Planting a seed - child health care nurses' perceptions of speaking to parents about overweight and obesity: a qualitative study within the STOP project.
   Sjunnestrand M, Nordin K, Eli K, Nowicka P, et al · · 2019 · cited 35× · PMID 31706318 · DOI 10.1186/s12889-019-7852-4
2. A randomized controlled trial for overweight and obesity in preschoolers: the More and Less Europe study - an intervention within the STOP project.
   Ek A, Delisle Nyström C, Chirita-Emandi A, Tur JA, et al · · 2019 · cited 23× · PMID 31307412 · DOI 10.1186/s12889-019-7161-y
3. Parents' experiences following conversations about their young child's weight in the primary health care setting: a study within the STOP project.
   Eli K, Neovius C, Nordin K, Brissman M, et al · · 2022 · cited 16× · PMID 35962359 · DOI 10.1186/s12889-022-13803-8
4. Making Childhood Obesity a Priority: A Qualitative Study of Healthcare Professionals' Perspectives on Facilitating Communication and Improving Treatment.
   Serban CL, Putnoky S, Ek A, Eli K, et al · · 2021 · cited 7× · PMID 34336760 · DOI 10.3389/fpubh.2021.652491