Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
3500 participants
INTERVENTIONAL
2024-11-01
2029-03-31
Brief Summary
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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.
Detailed Description
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Early intervention is crucial since childhood obesity is hard to reverse, and infancy presents an opportunity to address modifiable risk factors. It is well-documented that both genetic, behavioral, psychosocial, and environmental factors play key roles. Modifiable risk factors include feeding practices, physical activity, screen use, and sleep. Additionally, growing evidence suggests that psychological stress in early life due to unmet socio-emotional needs may lead to disrupted energy balance homeostasis, resulting in weight gain.
The Bloom Study is designed to address food and meals, motor skills and movement, screen use, sleep, and sense of security in the family. The intervention targets first-time families, with a special focus on reaching all families across varying socio-economic positions and ethnic backgrounds. Also, the Bloom intervention has a strong focus on involving fathers/partners. It is delivered through the established and highly accepted system of community health nurses in Denmark.
The intervention is initiated during pregnancy and continues until the child reaches 30 months of age. The main intervention components include: 1) an extra home visit during pregnancy, 2) an extra home visit when the child ais 18 months, 3) an extra home visit when the child is 30 months, 3) telephone consultations, 4) parent groups, and 5) a video library for parents.
An important element of the implementation strategy is to ensure that the intervention design and implementation are compatible with the existing practices, priorities, and values within the system of Danish community health nurses. Additionally, the implementation of the Bloom Study will be supported by five main activity components: 1) training of community health nurses including a five-day training course, supervision, and a comprehensive implementation manual containing instructions for standardized delivery of the intervention, 2) selection of local program ambassadors among community health nurses in the municipalities, 3) regular contact with the research group including assignment of one main contact person, 4) meeting activities including start-up meetings, network meetings across municipalities, and local staff meetings, and 5) partial economic compensation.
The Bloom Study is evaluated within a cluster-randomized controlled trial (cluster-RCT) with 22 municipalities randomly allocated to intervention (11 municipalities) and control (11 municipalities). The intervention is initiated during pregnancy and continues until the child reaches 30 months of age. Follow-up data are collected at child age of 36 months. Primary outcome is Body Mass Index (BMI) z-score at child age of 36 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Intervention
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.
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.
Control
The families in the control municipalities will receive standard deliveries from the community health nurses
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
0 Months
6 Months
ALL
Yes
Sponsors
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National Institute of Public Health, University of Southern Denmark
UNKNOWN
Danish Centre for Health Economics (DaCHE), University of Southern Denmark
UNKNOWN
University of Copenhagen
OTHER
Danish Research Centre for Migration, Ethnicity and Health, University of Copenhagen
UNKNOWN
Centre for Childhood Health
UNKNOWN
The Centre for Health Economics, University of York
UNKNOWN
University of Southern Denmark
OTHER
Responsible Party
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Principal Investigators
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Camilla T Bonnesen
Role: PRINCIPAL_INVESTIGATOR
National Institute of Public Health, University of Southern Denmark
Locations
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National Institute of Public Health, University of Southern Denmark
Copenhagen, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Camilla T Bonnesen, Researcher
Role: primary
References
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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.
Study Documents
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Document Type: Study Protocol
View DocumentDocument Type: Statistical Analysis Plan
View DocumentOther Identifiers
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H-24032126
Identifier Type: -
Identifier Source: org_study_id