Evidence mapPaperPMID 40866846Full record

ArticleBMC public health2025

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.

Camilla Thørring Bonnesen, Mette Rasmussen, Lene Kierkegaard, Rikke Rothkegel Carlsson, Marie Pil Jensen, Thilde Risager Ubbesen, Katrine Rich Madsen, Lau Caspar Thygesen, Rikke Fredenslund Krølner, Louise Ayoe Sparvath Brautsch and 5 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMC public health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06705400 (The Bloom Study - a Safe and Healthy Start in Life), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06705400 narecruitingnot on this map

The Bloom Study - a Safe and Healthy Start in Life

TypeinterventionalSponsorUniversity of Southern DenmarkRan2024 to 2029Enrolled3,500ConditionsOverweight, Childhood, Obesity in ChildrenArmsMulti-behavioural
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Camilla Thørring BonnesenNational Institute of Public Health, University of Southern Denmark, Studiestraede 6, Copenhagen, 1455, Denmark. catb@sdu.dk.ORCID http://orcid.org/0000-0003-2807-6712
Mette RasmussenNational Institute of Public Health, University of Southern Denmark, Studiestraede 6, Copenhagen, 1455, Denmark.
Lene KierkegaardNational Institute of Public Health, University of Southern Denmark, Studiestraede 6, Copenhagen, 1455, Denmark.
Rikke Rothkegel CarlssonNational Institute of Public Health, University of Southern Denmark, Studiestraede 6, Copenhagen, 1455, Denmark.
Marie Pil JensenNational Institute of Public Health, University of Southern Denmark, Studiestraede 6, Copenhagen, 1455, Denmark.
Thilde Risager UbbesenNational Institute of Public Health, University of Southern Denmark, Studiestraede 6, Copenhagen, 1455, Denmark.
Katrine Rich MadsenNational Institute of Public Health, University of Southern Denmark, Studiestraede 6, Copenhagen, 1455, Denmark.
Lau Caspar ThygesenNational Institute of Public Health, University of Southern Denmark, Studiestraede 6, Copenhagen, 1455, Denmark.
Rikke Fredenslund KrølnerNational Institute of Public Health, University of Southern Denmark, Studiestraede 6, Copenhagen, 1455, Denmark.
Louise Ayoe Sparvath BrautschNational Institute of Public Health, University of Southern Denmark, Studiestraede 6, Copenhagen, 1455, Denmark.
Johanne Aviaja RosingDepartment of Pediatrics and Adolescent Medicine, Copenhagen University Hospital - Rigshospitalet, Juliane Maries Vej 8, Copenhagen, 2100, Denmark.
Line Planck KongstadDaCHE - Danish Centre for Health Economics, University of Southern Denmark, Campusvej 55, Odense M, 5230, Denmark.
Mette Skovgaard VæverNational Institute of Public Health, University of Southern Denmark, Studiestraede 6, Copenhagen, 1455, Denmark.
Ida EgmoseDepartment of Psychology, University of Copenhagen, Øster Farimagsgade 2A, Copenhagen, 1353, Denmark.
Trine Pagh PedersenNational Institute of Public Health, University of Southern Denmark, Studiestraede 6, Copenhagen, 1455, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChild 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.

methodsThe 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 registrationClinicalTrials.gov ID: NCT06705400. Registered November 21, 2024.

Indexed as

Health PromotionPediatric ObesityChild DevelopmentChild, PreschoolDenmarkFemaleHumansInfantInfant, NewbornMaleRandomized Controlled Trials as TopicCommunity health nursesEffect evaluationHealth economic evaluationHealthy weight developmentInfantsOverweightProcess evaluationRandomized controlled trialStudy designToddlers

Identifiers

PMID40866846
PMCPMC12382212

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.