The Bloom Study - a Safe and Healthy Start in Life
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-6
SponsorUniversity of Southern Denmark
About this trial
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.
Eligibility criteria
Qualifiers
None
Disqualifiers
None
Trial design
Treatments tested in this trial
- Multi-behavioural
Treatment groups
3,500 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Southern Denmark
Lead sponsor
Danish Centre for Health Economics (DaCHE), University of Southern Denmark
Collaborator
University of Copenhagen
Collaborator
Danish Research Centre for Migration, Ethnicity and Health, University of Copenhagen
Collaborator
Centre for Childhood Health
Collaborator
The Centre for Health Economics, University of York
Collaborator
Source ClinicalTrials.gov