The Bloom Study - a Safe and Healthy Start in Life

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-6
SponsorUniversity of Southern Denmark

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multi-behavioural

    Behavioral

    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.

Treatment groups

3,500 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
36 months

Secondary outcomes

1

Weight status

Between group difference in prevalence of children with underweight, overweight and obesity based on WHO references. Weight is measured by portable weights (Seca 887) and height is measured by measurement tapes according to a standardized instruction.

Time frame
36 months
2

BMI z-score

Between group difference in BMI z-score based on WHO references. From birth to 10 months weight is measured by portable weights approved for standard use by community health nurses and according to a standardized instruction (journal records). At age 18 and 30 months, weight is measured by portable weights (Seca 887). From birth to 18 months length is measured by a mobile measuring mat (Seca 201) according to a standardized instruction. At age 30 months, height is measured by measurement tapes according to a standardized instruction.

Time frame
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
3

Fat mass (kg)

Between group difference in fat mass measured by bioimpedance analysis. Bioimpedance will be measured by the Impedimed SFB7 device.

Time frame
36 months
4

Fat free mass (kg)

Between group difference in fat free mass measured by bioimpedance analysis. Bioimpedance will be measured by the Impedimed SFB7 device.

Time frame
36 months

Other outcomes

1

Child social-emotional development

Measurement instrument: The Ages \& Stages Questionnaires: Social-Emotional, Second Edition (ASQ:SE-2) (parents' questionnaires). The questionnaire includes a total of 27 (12 months), 31 (24 months) and 36 (36 months) questions each with possible scores of 0, 5, 10 or 15 from which a total sum score is generated. A higher score indicates a higher extent of socio-emotional concerns.

Time frame
12, 24 and 36 months
2

Child mental health

Measurement instrument: Strengths and Difficulties Questionnaire (SDQ, 2-4 years) (parents' questionnaires) The instrument five subscales: Conduct problems (score range from 0-10); emotional symptoms (score range from 0-10); hyperactivity (score range from 0-10); peer problems (score range from 0-10); and prosocial behaviour (score range from 0-10). A total difficulties score can be generated by summing the scores of all scales except the prosocial behaviour scale (score range from 0-40). The extent of difficulties increases with increasing score.

Time frame
24 and 36 months
3

Child eating behaviour

Measurement instrument: Child Eating Behaviour Questionnaire (BEBH) (parents' questionnaires) The questionnaire covers eight domains: Food responsiveness, Emotional over-eating, Enjoyment of food, Desire to drink, Satiety responsiveness, Slowness in eating, Emotional under-eating and Food fussiness. For each item the response categories (including scoring) is: Never=1, Rarely=2, Sometimes=3, Often=4, Always=5, from which a domain mean score is generated. Higher scores indicate more frequent demonstrations of behaviours characterizing the trait of the domain.

Time frame
24 and 36 months
4

Parental feeding practices - < 2 years, milk

Measurement instrument: The Feeding Practices and Structure Questionnaire (\< 2 years, milk) The complete measure comprises a total of 18 items, scored on a 5-point Likert scale with higher scores indicating greater endorsement of that practice. The complete questionnaire covers four domains of non-responsive feeding practices. The following two domains are included at 6 months: Using food to calm (5 items), and Parent-led feeding (6 items).

Time frame
6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southern Denmark

Lead sponsor

Danish Centre for Health Economics (DaCHE), University of Southern Denmark

Collaborator

University of Copenhagen

Collaborator

Danish Research Centre for Migration, Ethnicity and Health, University of Copenhagen

Collaborator

Centre for Childhood Health

Collaborator

The Centre for Health Economics, University of York

Collaborator