NCT06705400|Recruiting
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Sponsor study identifier
interventional
3,500
1 country
1
Study Start
November 1, 2024
Actual (reported)Primary Completion
March 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2024
Actual (reported)November 14, 2024
Actual (reported)November 26, 2024
Actual (reported)March 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
BMI z-score
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.
36 months
Weight status
36 months
BMI z-score
Few days after birth, Within first week after returning to home, Within first months, 2 months, 4-6 months, 8-10 months, 18 months, 30 months
The Bloom Intervention adds to standard municipal care (5-6 home visits) with a prenatal visit, visits at 18 and 30 months, up to eight phone consultations, parent groups, and a video library. Home visits: Three extra visits include one in pregnancy week 22-24 to build trust and assess needs using a dialogue tool focused on social and demographic factors. Visits at 18 and 30 months support sustained progress and address new challenges. Phone consultations: Up to eight calls support breastfeeding, bottle-feeding, and complementary feeding. Phone consultations at 12 and 24 months aid in maintaining healthy habits during key transitions, like starting daycare. Parent groups: Encourage shared experiences among parents, with policies promoting father participation. Video library: Includes 62 videos on nutrition, motor skills, sleep, etc., with 48 available in multiple languages for wider access.
The families in the control municipalities will receive standard deliveries from the community health nurses
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
National Institute of Public Health, University of Southern Denmark
Copenhagen, 1455, Denmark
Bonnesen CT, Rasmussen M, Kierkegaard L, Carlsson RR, Jensen MP, Ubbesen TR, Madsen KR, Thygesen LC, Krolner RF, Brautsch LAS, Rosing JA, Kongstad LP, Vaever MS, Egmose I, Pedersen TP. Study protocol for a cluster-randomized controlled trial of a universal home-based, multi-component intervention to promote healthy weight development in children during infancy and toddlerhood in denmark: the bloom study. BMC Public Health. 2025 Aug 27;25(1):2952. doi: 10.1186/s12889-025-24352-1.
Camilla T Bonnesen
University of Southern Denmark
First Submitted
November 14, 2024
First Posted
November 26, 2024
Study Start
November 1, 2024
Actual (reported)Primary Completion
March 31, 2029
EstimatedMy Body is Fit and Fabulous at School Phase II
Fat mass (kg)
36 months
Fat free mass (kg)
36 months
Fat mass index in kg/m2
36 months
Child social-emotional development
12, 24 and 36 months
Child mental health
24 and 36 months
Child eating behaviour
24 and 36 months
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 22, 2025
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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