Health BehaviorNCT06097208
BMI Development and Risk of Overweight and Obesity in Children
An observational study of Health Behavior and Child Obesity, run by University of Aarhus.
Trial summary
The goal of this observational study is to investigate differences in attained BMI and the proportion of overweight/obesity at school entrance in children who attended kindergartens actively delivering a community-based health promotion and obesity prevention intervention compared to children who attended usual care… Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Health Behavior, Child Obesity, Body Weight
- What is being tested?
- community-based health promotion and obesity prevention intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 to 7 years
- All sexes
- Child
Study population: The present study is based on data from a total of approximately 3000 children (six-year-olds) at school entrance in the period 2021-2022, of whom approximately 2000 children attended the community-based health promotion and obesity prevention intervention in kindergartens (intervention group), from Viborg Municipality, and approximately 1000 children attended usual care kindergarten (no-intervention group), from Skive Municipality, both municipalities located in The Central Denmark Region. Further, a subset of approximately 700 children from the intervention group have been measured with height and weight in kindergartens (three- to four-year-olds).
Who may be able to join
- All children with eligible information on one measure of BMI after school entrance
Who cannot join
- <7 years of age
About this study
Official title: BMI Development and Risk of Overweight and Obesity When Attending a Community-based Health Promotion and Obesity Prevention Intervention in Kindergartens
The goal of this observational study is to investigate differences in attained BMI and the proportion of overweight/obesity at school entrance in children who attended kindergartens actively delivering a community-based health promotion and obesity prevention intervention compared to children who attended usual care kindergartens. Further questions it aims to answer are:
- Explore the prevalence of attainted overweight/obesity in children at six years of age, who attended kindergartens delivering intervention compared with usual care kindergartens.
- Explore the development of obesity, overweight and normal weight in children from three-, four- to six years of age, who attended kindergartens delivering intervention.
- Conditions
- Health Behavior, Child Obesity, Body Weight
- Being tested
- community-based health promotion and obesity prevention intervention
- Keywords
- Obesity, Body Mass Index, Children, Kindergarten
- Medical subject headings
- Health Behavior, Pediatric Obesity, Body Weight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
community-based health promotion and obesity prevention interventionBehavioural
The intervention involving measurements of children aged three- to four-years old in kindergartens, parents of the children had the opportunity of individual contact with a community health nurse, and education to kindergartens manager and employees e.g. pedagogues and kitchen staff. as well to parents of children in kindergartens.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Children who attended kindergartens actively delivering a community-based health promotion and obesity prevention intervention Receives: Behavioral: community-based health promotion and obesity prevention intervention | |
| No-intervention Group | Children who attended usual care kindergartens |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI after school entrance at 6 years of age
Differences in attained BMI after school entrance will be defined as weight and height combined to report BMI in kg/m^2 for sex and age.
Measured: 2018-2023
Proportion of children with overweight/obesity at 6 years of age
The proportion of overweight/obesity after school entrance will be defined as weight and height combined to report BMI in kg/m^2 for sex and age. The proportion of overweight/obesity will be defined as BMIz≥1
Measured: 2018-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study startJan 2010
- Primary completionDec 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097208
- Sponsor's protocol ID
- Healthy weight in kindergarten
- Status last verified
- Aug 2024
- First submitted
- 3 Oct 2023
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BMI Development and Risk of Overweight and Obesity When Attending a Community-based Health Promotion and Obesity Prevention Intervention in Kindergartens
- ClinicalTrials.gov ID
- NCT06097208
- Acronym / sponsor ID
- Healthy weight in kindergarten
- Conditions
- Health Behavior, Child Obesity, Body Weight
- Keywords
- Obesity, Body Mass Index, Children, Kindergarten
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 24 Oct 2023 (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 goal of this observational study is to investigate differences in attained BMI and the proportion of overweight/obesity at school entrance in children who attended kindergartens actively delivering a community-based health promotion and obesity prevention intervention compared to children who attended usual care kindergartens. Further questions it aims to answer are:
- Explore the prevalence of attainted overweight/obesity in children at six years of age, who attended kindergartens delivering intervention compared with usual care kindergartens.
- Explore the development of obesity, overweight and normal weight in children from three-, four- to six years of age, who attended kindergartens delivering intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | – | Behavioral: community-based health promotion and obesity prevention interventionChildren who attended kindergartens actively delivering a community-based health promotion and obesity prevention intervention |
| No-intervention Group | – | –Children who attended usual care kindergartens |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Age groups
- Child
- Study population
- The present study is based on data from a total of approximately 3000 children (six-year-olds) at school entrance in the period 2021-2022, of whom approximately 2000 children attended the community-based health promotion and obesity prevention intervention in kindergartens (intervention group), from Viborg Municipality, and approximately 1000 children attended usual care kindergarten (no-intervention group), from Skive Municipality, both municipalities located in The Central Denmark Region. Further, a subset of approximately 700 children from the intervention group have been measured with height and weight in kindergartens (three- to four-year-olds).
Key inclusion criteria (1 listed)
- All children with eligible information on one measure of BMI after school entrance
Key exclusion criteria (1 listed)
- <7 years of age
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 |
|---|---|---|
| community-based health promotion and obesity prevention interventionThe intervention involving measurements of children aged three- to four-years old in kindergartens, parents of the children had the opportunity of individual contact with a community health nurse, and education to kindergartens manager and employees e.g. pedagogues and kitchen staff. as well to parents of children in kindergartens. | Behavioural | Intervention Group |
Primary outcome
BMI after school entrance at 6 years of age
Time frame: 2018-2023
Differences in attained BMI after school entrance will be defined as weight and height combined to report BMI in kg/m^2 for sex and age.
Proportion of children with overweight/obesity at 6 years of age
Time frame: 2018-2023
The proportion of overweight/obesity after school entrance will be defined as weight and height combined to report BMI in kg/m^2 for sex and age. The proportion of overweight/obesity will be defined as BMIz≥1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Behavior and Child Obesity, run by University of Aarhus.
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: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI after school entrance at 6 years of age (time frame: 2018-2023). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2024.