The Bloom Study - a Safe and Healthy Start in Life

University of Southern Denmark (SDU)

Status: Enrolling

Conditions: Overweight, Childhood; Obesity in Children

Treatments: Behavioral: Multi-behavioural

Study type: Interventional

Funder types: Other

Identifiers

NCT06705400

H-24032126

Details and patient eligibility

About

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.

Full description

Childhood overweight and obesity are major public health challenges. In Denmark, 14% of children have overweight or obesity at school entry, rising to 19% by school leaving, with higher prevalence levels among children from low socio-economic positions and ethnic minority backgrounds.

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.

Enrollment: 3,500 estimated patients

Sex: All

Ages: Under 6 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Not being able to receive digital post.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,500 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Multi-behavioural

Control

No Intervention group

Description:

The families in the control municipalities will receive standard deliveries from the community health nurses