NCT06077266

Brief Summary

Childhood obesity is increasing worldwide and causes a major health concern. Only limited insight exists into the natural history of childhood obesity at children already classified as obese. It is necessary to identify possible windows of opportunities to initiate treatment and to prevent further weight gain later in life. This observational study follows the natural weight change in younger children with obesity without known intervention. The objective is to identify factors associated with achieving normal weight, having persistent obesity, or reaching higher levels of obesity, when following children age 5-10 years with obesity through childhood and puberty. Data from health check-ups at school and Danish registries will be used to answer the research question.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
467

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

October 4, 2023

Last Update Submit

October 23, 2023

Conditions

Pediatric Obesity

Keywords

Weight LossBody-Weight Trajectory

Outcome Measures

Primary Outcomes (1)

  • Factors associated with changes in weight-status in Danish school children: from obesity to normal weight.

    Factors associated with changes in weight-status in Danish school children (age 5-10 years) from obesity or normal weight. Only children with minimum 3 years of follow-up will be included. Children treated in or declining treatment in a lifestyle intervention for obesity will be excluded.

    Children with a baseline visit between January the 1st 2010 and March the 18nd 2018 will be included. The children will be followed until March the 18nd 2021.

Secondary Outcomes (2)

  • Factors associated with persisting obesity in Danish school children with obese.

    Children with a baseline visit between January the 1st 2010 and March the 18nd 2018 will be included. The children will be followed until March the 18nd 2021.

  • Factors associated with the highest increase in BMI z-score (above the 20th percentile) in Danish school children with obese.

    Children with a baseline visit between January the 1st 2010 and March the 18nd 2018 will be included. The children will be followed until March the 18nd 2021.

Study Arms (2)

Normalizing weight

Children classified as having normalized weight (iso-BMI 18.5-25 for age and sex) at the last observation defined by IOTF.

Other: Change of weight class to normal weight

Overweight or obesity

Children classified as having overweight or obesity (iso-BMI 25 ≤ for age and sex) at the last observation defined by IOTF.

Interventions

Change of weight class to normal weightOTHER

The exposure is the change of weight class from obesity to normal weight during a follow-up period without known intervention.

Normalizing weight

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The population consist of children with obesity from the city of Aarhus, Denmark between January 1st 2010 and March 18nd 2018, but followed until March 18nd 2021.

You may qualify if:

  • Baseline visit between January 1st. 2010 and March 17th 2018.
  • Minimum one observation with obesity
  • Minimum three years of follow-up from baseline
  • Children age 5-10 years

You may not qualify if:

  • Children registered in a community-based lifestyle intervention.
  • Children registered as having declined participation in a community-based lifestyle intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center Aarhus

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Pediatric ObesityWeight LossBody-Weight Trajectory

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2023

First Posted

October 11, 2023

Study Start

January 1, 2023

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

October 25, 2023

Record last verified: 2023-10

Locations

DK(1)