The Bloom Study - a Safe and Healthy Start in Life

The aim of the Bloom Study is to promote healthy weight development among infants through a home-based health promoting intervention implemented in the Danish setting of community health nurses. The intervention begins during pregnancy and runs until the child reaches the age of 30 months. The Bloom Intervention was developed over a six-year period from 2017 to 2023 according to the Intervention Mapping approach and based on a co-creation process. The Bloom Intervention is evaluated in a cluster-randomized trial involving 22 Danish municipalities (11 intervention and 11 control). All children born from first-time mothers over a period of 12 months are invited to participate.

NCT Number	NCT06705400
Lead Sponsor	University of Southern Denmark Collaborators: Danish Centre for Health Economics (DaCHE), University of Southern Denmark, University of Copenhagen, Danish Research Centre for Migration, Ethnicity and Health, University of Copenhagen, Centre for Childhood Health, The Centre for Health Economics, University of York
Conditions	Overweight, Childhood, Obesity in Children
Enrollment	3,500 participants
Start Date	2024-11-01
Primary Completion	2029-03-31 (estimated)
Study Completion	2029-03-31 (estimated)
Updated on ClinicalTrials.gov	2025-12-22