The Bloom Study - a Safe and Healthy Start in Life
NCT06705400 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3500
Last updated 2025-12-22
Summary
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.
Conditions
- Overweight, Childhood
- Obesity in Children
Interventions
- BEHAVIORAL
-
Multi-behavioural
The Bloom Study is implemented in an existing and highly accepted health service delivered by community health nurses. Beyond focusing on food, meals, motor skills and movement, the intervention also target sleep and family sense of security. The intervention commence in pregnancy and continues until the child is 2½ years old.
Sponsors & Collaborators
-
National Institute of Public Health, University of Southern Denmark
collaborator UNKNOWN -
Danish Centre for Health Economics (DaCHE), University of Southern Denmark
collaborator UNKNOWN -
University of Copenhagen
collaborator OTHER -
Danish Research Centre for Migration, Ethnicity and Health, University of Copenhagen
collaborator UNKNOWN -
Centre for Childhood Health
collaborator UNKNOWN -
The Centre for Health Economics, University of York
collaborator UNKNOWN -
University of Southern Denmark
lead OTHER
Principal Investigators
-
Camilla T Bonnesen · National Institute of Public Health, University of Southern Denmark
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 0 Months
- Max Age
- 6 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-11-01
- Primary Completion
- 2029-03-31
- Completion
- 2029-03-31
Countries
- Denmark
Study Locations
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