NCT06097208

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
12.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

12.9 years

First QC Date

October 3, 2023

Last Update Submit

August 6, 2024

Conditions

Keywords

ObesityBody Mass IndexChildrenKindergarten

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    2018-2023

Study Arms (2)

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

No-intervention Group

Children who attended usual care kindergartens

Interventions

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.

Intervention Group

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability 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).

You may qualify if:

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

You may not qualify if:

  • \<7 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Health BehaviorPediatric ObesityBody WeightObesity

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2023

First Posted

October 24, 2023

Study Start

January 1, 2010

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

August 7, 2024

Record last verified: 2024-08