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 volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Multi-behavioural
BehavioralThe 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
Fat mass (kg)
Between group difference in fat mass measured by bioimpedance analysis. Bioimpedance will be measured by the Impedimed SFB7 device.
Fat free mass (kg)
Between group difference in fat free mass measured by bioimpedance analysis. Bioimpedance will be measured by the Impedimed SFB7 device.
Other outcomes
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.
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.
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.
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).
Sponsors and contacts
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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