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Study protocol for a cluster-randomized controlled trial of a universal home-based, multi-component intervention to
Camilla Thørring Bonnesen1, Mette Rasmussen2, Lene Kierkegaard2
1National Institute of Public Health, University of Southern Denmark, Studiestraede 6, Copenhagen, 1455, Denmark. catb@sdu.dk.
Insights
The Bloom Study evaluates a new intervention to promote healthy weight in Danish children aged 0-3 years. This early childhood obesity prevention program uses home visits, parent groups, and consultations to support healthy development.
Area of Science:
- Public Health
- Pediatrics
- Health Promotion
Background:
- Childhood overweight and obesity are significant public health issues with lifelong health implications.
- Early intervention is crucial for establishing healthy weight development trajectories.
- The Bloom Study addresses these challenges in the Danish context.
Purpose of the Study:
- To evaluate the effectiveness of the Bloom intervention for promoting healthy weight development in infants and toddlers (0-3 years).
- To assess the intervention's impact on key determinants of child weight, including diet, sleep, physical activity, and screen time.
- To inform municipal-level health promotion strategies for early childhood obesity prevention.
Main Methods:
- An open-label, two-arm, cluster-randomized wait-list control trial involving 22 municipalities in Denmark.
- Recruitment of approximately 3200 first-time families, with intervention starting during pregnancy.
- Intervention components include home visits, proactive telephone consultations, parent groups, and a video library, delivered via the community health nursing system.
Main Results:
- The primary outcome is the Body Mass Index (BMI) z-score at 36 months of age.
- Secondary outcomes measure changes in food and meal habits, sleep patterns, physical activity, screen use, and family security.
- A mixed-methods process evaluation and health economic evaluation will also be conducted.
Conclusions:
- The Bloom Study protocol details an evidence-based intervention to foster healthy weight development in early childhood.
- Findings have the potential to guide future public health initiatives and support healthy development at the municipal level.
Background:
Child overweight and obesity are major public health challenges associated with poor physical, psychological, and social health through life. This protocol describes the study design for the Bloom Study, an evaluation of a theory- and evidence-based intervention addressing infancy and toddlerhood (age 0-3 years) to promote healthy weight development among children in Denmark.
Methods:
The Bloom intervention is evaluated through an open-label, two-arm, cluster-randomized wait-list control trial, with 22 municipalities randomly allocated to 11 intervention and 11 control municipalities. All first-time families within one year are invited (approximately 3200 families). The intervention was developed using the Intervention Mapping protocol and a thorough co-creation process. It is delivered through the Danish community health nursing system and includes four main components: (1) Home visits, (2) Proactive telephone consultations, (3) Parent groups for both parents, and (4) A video library. The intervention begins during pregnancy (between weeks 22-24) and continues until the child is 30 months. The primary outcome measure is the BMI z-score at 36 months of age. Secondary outcomes relate to the key determinants of child weight development targeted by the Bloom intervention, including food and meals, sleep, movement and motor skills, screen use, and family sense of security. A comprehensive mixed methods process evaluation and a health economic evaluation will also be conducted.
Discussion:
The protocol outlines the evaluation of a theory- and evidence-based intervention aimed at promoting healthy weight development in infants and toddlers in Denmark. Overall, the study has the potential to inform future health promotion initiatives at the municipal level, supporting healthy weight development during early childhood.
Trial Registration:
ClinicalTrials.gov ID: NCT06705400. Registered November 21, 2024.
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