RecruitingNot ApplicableNCT06705400

The Bloom Study - a Safe and Healthy Start in Life


Sponsor

University of Southern Denmark

Enrollment

3,500 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 0 MonthsMax Age: 6 Months

Plain Language Summary

Simplified for easier understanding

The Bloom Study is a large Danish trial testing whether an enhanced support program delivered through community health nurses — starting during pregnancy and continuing until a child is 30 months old — can help children maintain a healthy weight during infancy and early childhood. The program covers feeding, physical activity, screen time, sleep, and emotional wellbeing, with a strong emphasis on reaching all families regardless of background and involving fathers and partners. All first-time mothers in participating Danish municipalities who are at 20 weeks of pregnancy between November 2024 and October 2025 are invited to participate, with the only exclusion being inability to receive digital correspondence. Families in the intervention group will receive extra home visits, phone check-ins, parent group sessions, and access to an educational video library, with the child's BMI measured at 36 months as the main outcome. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMulti-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

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NCT06705400


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