Clinical trial NCT06705400: The Bloom Study - a Safe and Healthy Start in Life
Official title: The Bloom Study - a Safe and Healthy Start in Life
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight, Childhood
Obesity in Children
Keywords: The Bloom Study
Intervention
Infants
Weight status
Community health nurses
Home-based
Randomized controlled trial
Children
Multi-component
Health promotion and prevention
Overweight
Obesity
Food habits and meals
Motor skills and movement
Screen use
Sleep
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: National Institute of Public Health, University of Southern Denmark
name: Danish Centre for Health Economics (DaCHE), University of Southern Denmark
name: University of Copenhagen
name: Danish Research Centre for Migration, Ethnicity and Health, University of Copenhagen
name: Centre for Childhood Health
name: The Centre for Health Economics, University of York
First posted: 2024-11-26
Enrollment: 3500
Sex: ALL
Minimum age (years): 0
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: BMI z-score
timeFrame: 36 months
Secondary outcomes:
measure: Weight status
timeFrame: 36 months
measure: BMI z-score
timeFrame: 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
measure: Fat mass (kg)
timeFrame: 36 months
measure: Fat free mass (kg)
timeFrame: 36 months
measure: Fat mass index in kg/m2
timeFrame: 36 months
measure: Fat free mass index (kg/m2)
timeFrame: 36 months
measure: % Fat mass
timeFrame: 36 months
measure: % Fat free mass
timeFrame: 36 months
Other outcomes:
measure: Child social-emotional development
timeFrame: 12, 24 and 36 months
measure: Child mental health
timeFrame: 24 and 36 months
measure: Baby Eating Behaviour
timeFrame: 6 months
measure: Child eating behaviour
timeFrame: 24 and 36 months
measure: Parental feeding practices - < 2 years, milk
timeFrame: 6 months
measure: Parental feeding practices - < 2 years, solid food
timeFrame: 12 months
measure: Parental feeding practices, >= 2 years
timeFrame: 24 and 36 months
measure: Child sleep
timeFrame: Time frame: 6, 12, 24 and 30 months
measure: Parents' self-efficacy related to child sleep
timeFrame: 6, 12, 24 and 30 months
measure: Parents' well-being
timeFrame: 6, 12, 24 and 36 months
measure: Parents' self-efficacy related to parenthood
timeFrame: 6, 12, 24 and 36 months
measure: Parental stress
timeFrame: 6, 12, 24 and 36 months
measure: Sensitive parenting
timeFrame: 6, 12, 24 and 36 months
Locations:
city: Copenhagen
country: Denmark
facility: National Institute of Public Health, University of Southern Denmark
Study officials:
affiliation: National Institute of Public Health, University of Southern Denmark
name: Camilla T Bonnesen
role: PRINCIPAL_INVESTIGATOR
References: