BMI Development and Risk of Overweight and Obesity in Children

• Sponsor: University of Aarhus (Other)
• Overall Status: Completed
• CT.gov ID: NCT06097208
• Collaborator: (none)
• Enrollment: 3,000
• Actual Duration (Months): 155

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Health Behavior; Child Obesity; Body Weight	Behavioral: community-based health promotion and obesity prevention intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 3000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: BMI Development and Risk of Overweight and Obesity When Attending a Community-based Health Promotion and Obesity Prevention Intervention in Kindergartens
• Actual Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Dec 1, 2022
• Actual Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Intervention Group Children who attended kindergartens actively delivering a community-based health promotion and obesity prevention intervention	Behavioral: 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

Outcome Measures

Primary Outcome Measures

1. BMI after school entrance at 6 years of age [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.

2. Proportion of children with overweight/obesity at 6 years of age [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 7 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• All children with eligible information on one measure of BMI after school entrance

Exclusion Criteria:

• <7 years of age

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Aarhus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT06097208
• Other Study ID Numbers: Healthy weight in kindergarten
• First Posted: Oct 24, 2023
• Last Update Posted: Oct 24, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Aarhus: Obesity; Body Mass Index; Children; Kindergarten
• Additional relevant MeSH terms: Obesity; Overweight; Pediatric Obesity; Body Weight

Study Results

No Results Posted as of Oct 24, 2023