Overweight, ChildhoodNCT06705400
The Bloom Study - a Safe and Healthy Start in Life
A study testing Multi-behavioural in people with Overweight, Childhood and Obesity in Children, run by University of Southern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Childhood, Obesity in Children
- What is being tested?
- Multi-behavioural
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,500 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2024to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children born from first-time mothers being in gestation week 20 between November 1st 2024 and October 31st 2025.
Who cannot join
- Not being able to receive digital post.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
National Institute of Public Health, University of Southern Denmark
Copenhagen, 1455
Camilla T Bonnesen, Researcher, +4565507883, catb@sdu.dk
About this study
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.
Read the detailed description
Childhood overweight and obesity are major public health challenges. In Denmark, 14% of children have overweight or obesity at school entry, rising to 19% by school leaving, with higher prevalence levels among children from low socio-economic positions and ethnic minority backgrounds.
Early intervention is crucial since childhood obesity is hard to reverse, and infancy presents an opportunity to address modifiable risk factors. It is well-documented that both genetic, behavioral, psychosocial, and environmental factors play key roles. Modifiable risk factors include feeding practices, physical activity, screen use, and sleep. Additionally, growing evidence suggests that psychological stress in early life due to unmet socio-emotional needs may lead to disrupted energy balance homeostasis, resulting in weight gain.
The Bloom Study is designed to address food and meals, motor skills and movement, screen use, sleep, and sense of security in the family. The intervention targets first-time families, with a special focus on reaching all families across varying socio-economic positions and ethnic backgrounds. Also, the Bloom intervention has a strong focus on involving fathers/partners. It is delivered through the established and highly accepted system of community health nurses in Denmark.
The intervention is initiated during pregnancy and continues until the child reaches 30 months of age. The main intervention components include: 1) an extra home visit during pregnancy, 2) an extra home visit when the child ais 18 months, 3) an extra home visit when the child is 30 months, 3) telephone consultations, 4) parent groups, and 5) a video library for parents.
An important element of the implementation strategy is to ensure that the intervention design and implementation are compatible with the existing practices, priorities, and values within the system of Danish community health nurses. Additionally, the implementation of the Bloom Study will be supported by five main activity components: 1) training of community health nurses including a five-day training course, supervision, and a comprehensive implementation manual containing instructions for standardized delivery of the intervention, 2) selection of local program ambassadors among community health nurses in the municipalities, 3) regular contact with the research group including assignment of one main contact person, 4) meeting activities including start-up meetings, network meetings across municipalities, and local staff meetings, and 5) partial economic compensation.
The Bloom Study is evaluated within a cluster-randomized controlled trial (cluster-RCT) with 22 municipalities randomly allocated to intervention (11 municipalities) and control (11 municipalities). The intervention is initiated during pregnancy and continues until the child reaches 30 months of age. Follow-up data are collected at child age of 36 months. Primary outcome is Body Mass Index (BMI) z-score at child age of 36 months.
- Conditions
- Overweight, Childhood, Obesity in Children
- Being tested
- Multi-behavioural
- 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
- Medical subject headings
- Pediatric Obesity, Overweight, Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-behaviouralBehavioural
Also called Motor skills and movement, Screen use, Sleep, Family sense of security
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Multi-behavioural |
| Control | No intervention | The families in the control municipalities will receive standard deliveries from the community health nurses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (8)
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.
Measured: 36 months
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.
Measured: 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)
Between group difference in fat mass measured by bioimpedance analysis. Bioimpedance will be measured by the Impedimed SFB7 device.
Measured: 36 months
Fat free mass (kg)
Between group difference in fat free mass measured by bioimpedance analysis. Bioimpedance will be measured by the Impedimed SFB7 device.
Measured: 36 months
Fat mass index in kg/m2
Between group difference in fat mass index measured by bioimpedance analysis. Bioimpedance will be measured by the Impedimed SFB7 device.
Measured: 36 months
Fat free mass index (kg/m2)
Between group difference in fat free mass index measured by bioimpedance analysis. Bioimpedance will be measured by the Impedimed SFB7 device.
Measured: 36 months
% Fat mass
Between group difference in % fat mass index measured by bioimpedance analysis. Bioimpedance will be measured by the Impedimed SFB7 device.
Measured: 36 months
% Fat free mass
Between group difference in % fat free mass index measured by bioimpedance analysis. Bioimpedance will be measured by the Impedimed SFB7 device.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Nov 2024
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight, ChildhoodStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Centre for Health Economics (DaCHE), University of Southern Denmark, University of Copenhagen, Danish Research Centre for Migration, Ethnicity and Health, University of Copenhagen, Centre for Childhood Health, The Centre for Health Economics, University of York
- Responsible party
- Sponsor
- Investigators
- Camilla T Bonnesen, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705400
- Sponsor's protocol ID
- H-24032126
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2024
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 40866846
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bloom Study - a Safe and Healthy Start in Life
- ClinicalTrials.gov ID
- NCT06705400
- Acronym / sponsor ID
- H-24032126
- Conditions
- Overweight, Childhood, Obesity in Children
- Keywords
- The Bloom Study, Intervention, Infants, Weight status, Community health nurses, Home-based, Randomized controlled trial, Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Danish Centre for Health Economics (DaCHE), University of Southern Denmark, University of Copenhagen, Danish Research Centre for Migration, Ethnicity and Health, University of Copenhagen, Centre for Childhood Health, The Centre for Health Economics, University of York
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Childhood overweight and obesity are major public health challenges. In Denmark, 14% of children have overweight or obesity at school entry, rising to 19% by school leaving, with higher prevalence levels among children from low socio-economic positions and ethnic minority backgrounds.
Early intervention is crucial since childhood obesity is hard to reverse, and infancy presents an opportunity to address modifiable risk factors. It is well-documented that both genetic, behavioral, psychosocial, and environmental factors play key roles. Modifiable risk factors include feeding practices, physical activity, screen use, and sleep. Additionally, growing evidence suggests that psychological stress in early life due to unmet socio-emotional needs may lead to disrupted energy balance homeostasis, resulting in weight gain.
The Bloom Study is designed to address food and meals, motor skills and movement, screen use, sleep, and sense of security in the family. The intervention targets first-time families, with a special focus on reaching all families across varying socio-economic positions and ethnic backgrounds. Also, the Bloom intervention has a strong focus on involving fathers/partners. It is delivered through the established and highly accepted system of community health nurses in Denmark.
The intervention is initiated during pregnancy and continues until the child reaches 30 months of age. The main intervention components include: 1) an extra home visit during pregnancy, 2) an extra home visit when the child ais 18 months, 3) an extra home visit when the child is 30 months, 3) telephone consultations, 4) parent groups, and 5) a video library for parents.
An important element of the implementation strategy is to ensure that the intervention design and implementation are compatible with the existing practices, priorities, and values within the system of Danish community health nurses. Additionally, the implementation of the Bloom Study will be supported by five main activity components: 1) training of community health nurses including a five-day training course, supervision, and a comprehensive implementation manual containing instructions for standardized delivery of the intervention, 2) selection of local program ambassadors among community health nurses in the municipalities, 3) regular contact with the research group including assignment of one main contact person, 4) meeting activities including start-up meetings, network meetings across municipalities, and local staff meetings, and 5) partial economic compensation.
The Bloom Study is evaluated within a cluster-randomized controlled trial (cluster-RCT) with 22 municipalities randomly allocated to intervention (11 municipalities) and control (11 municipalities). The intervention is initiated during pregnancy and continues until the child reaches 30 months of age. Follow-up data are collected at child age of 36 months. Primary outcome is Body Mass Index (BMI) z-score at child age of 36 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Multi-behaviouralThe 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. |
| Control | No intervention | –The families in the control municipalities will receive standard deliveries from the community health nurses |
Who may qualify
- Ages
- 0 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children born from first-time mothers being in gestation week 20 between November 1st 2024 and October 31st 2025.
Key exclusion criteria (1 listed)
- Not being able to receive digital post.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-behaviouralAlso: Motor skills and movement, Screen use, Sleep, Family sense of securityThe 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. | Behavioural | Intervention |
Primary outcome
BMI z-score
Time frame: 36 months
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.
8 secondary outcomes
Weight status
Time frame: 36 months
BMI z-score
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
Fat mass (kg)
Time frame: 36 months
Fat free mass (kg)
Time frame: 36 months
Fat mass index in kg/m2
Time frame: 36 months
Fat free mass index (kg/m2)
Time frame: 36 months
% Fat mass
Time frame: 36 months
% Fat free mass
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Derived from this study: PubMed 40866846Bonnesen 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Camilla T Bonnesen principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-behavioural in people with Overweight, Childhood and Obesity in Children, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camilla T Bonnesen (+4565507883, catb@sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI z-score (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06705400, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.