The Bloom Study - a Safe and Healthy Start in Life

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 6 months
Healthy Volunteers: t
View:

• All children born from first-time mothers being in gestation week 20 between November 1st 2024 and October 31st 2025.

Locations
Other Locations
Denmark
National Institute of Public Health, University of Southern Denmark
RECRUITING
Copenhagen
Contact Information
Primary
Camilla T Bonnesen
catb@sdu.dk
+4565507883
Backup
Mette Rasmussen
mera@sdu.dk
+4565507319
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 3500
Treatments
Experimental: 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.
No_intervention: Control
The families in the control municipalities will receive standard deliveries from the community health nurses
Related Therapeutic Areas
Sponsors
Collaborators: Centre for Childhood Health, Danish Centre for Health Economics (DaCHE), University of Southern Denmark, University of Copenhagen, The Centre for Health Economics, University of York, National Institute of Public Health, University of Southern Denmark, Danish Research Centre for Migration, Ethnicity and Health, University of Copenhagen
Leads: University of Southern Denmark

This content was sourced from clinicaltrials.gov