The Bloom Study - a Safe and Healthy Start in Life

NCT06705400 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3500

Last updated 2025-12-22

No results posted yet for this 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.

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06705400 on ClinicalTrials.gov