The Bloom Study - a Safe and Healthy Start in Life

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• BMI z-score — 36 months
  Between group difference in BMI z-score based on WHO references. Weight is measured by portable weights (Seca 887) and height is measured by measurement tapes according to a standardized instruction.

Trial sites (1)

More University of Southern Denmark trials in Denmark