- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06097208
BMI Development and Risk of Overweight and Obesity in Children
August 6, 2024 updated by: University of Aarhus
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
3000
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
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).
Description
Inclusion Criteria:
- All children with eligible information on one measure of BMI after school entrance
Exclusion Criteria:
- <7 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Intervention Group
Children who attended kindergartens actively delivering a community-based health promotion and obesity prevention intervention
|
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.
|
|
No-intervention Group
Children who attended usual care kindergartens
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2018-2023
|
|
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
|
2018-2023
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2010
Primary Completion (Actual)
December 1, 2022
Study Completion (Actual)
December 1, 2022
Study Registration Dates
First Submitted
October 3, 2023
First Submitted That Met QC Criteria
October 23, 2023
First Posted (Actual)
October 24, 2023
Study Record Updates
Last Update Posted (Actual)
August 7, 2024
Last Update Submitted That Met QC Criteria
August 6, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Healthy weight in kindergarten
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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