Clinical trial

The Bloom Study - a Safe and Healthy Start in Life

Recruiting now · Not applicable · 1 countries · Registry ID NCT06705400

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age0 Months to 6 Months
SexAll
Healthy volunteersAccepted
ConditionOverweight, Childhood, Obesity in Children

Full registry criteria

Inclusion Criteria: All children born from first-time mothers being in gestation week 20 between November 1st 2024 and October 31st 2025. Exclusion Criteria: Not being able to receive digital post.

Treatments and study arms

Multi-behavioural

Behavioral

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.

Primary outcomes

BMI z-score36 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

National Institute of Public Health, University of Southern Denmark🇩🇰 Copenhagen, Denmark
Camilla T Bonnesen, ResearcherContact