The Bloom Study - a Safe and Healthy Start in Life

NCT06705400 | Recruiting

• 1 other identifier: H-24032126
• Study Type: interventional
• Target: 3,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity in Children; Overweight, Childhood

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

Outcome Measures

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.

  36 months

Secondary Outcomes (8)

• Weight status

  36 months

• BMI z-score

  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

• Fat mass (kg)

  36 months

• Fat free mass (kg)

  36 months

• Fat mass index in kg/m2

  36 months

Other Outcomes (20)

• Child social-emotional development

  12, 24 and 36 months

• Child mental health

  24 and 36 months

• Child eating behaviour

  24 and 36 months

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Multi-behavioural

Control

NO INTERVENTION

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

Interventions

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.

Also known as: Motor skills and movement, Screen use, Sleep, Family sense of security, Food and meals

Intervention

Eligibility Criteria

• Age: 0 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Not being able to receive digital post.

Sponsors & Collaborators

• University of Southern Denmark: lead
• 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
• National Institute of Public Health, University of Southern Denmark: collaborator

Study Sites (1)

National Institute of Public Health, University of Southern Denmark

Copenhagen, 1455, Denmark

RECRUITING

Related Publications (1)

• Bonnesen CT, Rasmussen M, Kierkegaard L, Carlsson RR, Jensen MP, Ubbesen TR, Madsen KR, Thygesen LC, Krolner RF, Brautsch LAS, Rosing JA, Kongstad LP, Vaever MS, Egmose I, Pedersen TP. Study protocol for a cluster-randomized controlled trial of a universal home-based, multi-component intervention to promote healthy weight development in children during infancy and toddlerhood in denmark: the bloom study. BMC Public Health. 2025 Aug 27;25(1):2952. doi: 10.1186/s12889-025-24352-1.

  PMID: 40866846 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Overweight; Obesity; Feeding Behavior

Interventions

Movement; Sleep; Food; Meals

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nervous System Physiological Phenomena; Diet, Food, and Nutrition; Food and Beverages

Study Officials

• Camilla T Bonnesen

  National Institute of Public Health, University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camilla T Bonnesen

CONTACT

+4565507883; catb@sdu.dk

Mette Rasmussen

CONTACT

+4565507319; mera@sdu.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 26, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: A formal application with reasonable request must be approved by the study's management group. Data will only be shared as long as there is a legal basis for the disclosure.

Locations

DK (1)