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RECRUITING
NCT06705400
NA

The Bloom Study - a Safe and Healthy Start in Life

Sponsor: University of Southern Denmark

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

0 Months - 6 Months

Study Type

INTERVENTIONAL

Enrollment

3500

Start Date

2024-11-01

Completion Date

2029-03-31

Last Updated

2025-12-22

Healthy Volunteers

Yes

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.

Locations (1)

National Institute of Public Health, University of Southern Denmark

Copenhagen, Denmark