Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-28 @ 7:23 PM
Study NCT ID:
NCT06077266
Status:
COMPLETED
Last Update Posted:
2023-10-25
First Post:
2023-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Associated With Changes in Weight-status in Danish School Children With Obesity
Sponsor:
University of Aarhus
Organization:
Study Overview
Official Title:
Factors Associated With Changes in Weight-status in Danish School Children: From Obesity to Overweight or Normal Weight
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
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.
High Body Mass Index (BMI) or weight status early in life seems to predict the risk of persisting obesity and indicating BMI as an important predictor for the chance of remission. High birthweight has also been associated with poor chance of normalizing weight, when following children with obesity from kindergarten to the 8th grade, indicating that severe obesity can be detectable from early childhood.
Children with severe obesity (iso-BMI ≥ 35) have been observed to gain weight with a faster rate and with a critical period between 12 to 14 years of age, compared to children with less-severe obesity (iso-BMI \< 35). Another report observes, that having obesity at the age of six was associated with obesity after puberty, while no such association was observed for younger children (six years). Hereby suggesting that children at a younger age have chance of achieving remission of obesity, than children classified as having obesity later in life.
Other factors such as sex, ethnicity and interpersonal skills have also been observed to influence the chance of normalizing weight, when following children with obesity from 5th to 8th grade.
This study aims to identify factors associated with achieving normal weight, when following children age 5-10 yrs. with obesity through childhood and puberty.
In addition, to identify factors associated with having persisting obesity, or reaching a higher level of obesity (highest 20% increase in BMI z-score from baseline)
The participants:
This study includes Danish children 5 to 10 years of age with obesity with minimum three years of follow-up during. Children invited into the local community-based lifestyle intervention will be excluded. The IOTF cut-offs for weight status at the last obtained observation will be used to define the groups.
Data sources:
1. Observations containing anthropometrics have been extracted from TM-Sund for each child. TM-Sund is a database used in Aarhus municipality to store data on anthropomet-rics obtained at health checks at the school (read more on https://www.solteq.com/da).
2. Data on family structure, socioeconomic status (SES), immigration status and psychiatric diagnoses (child and parents) will be obtained from Danish registries at Statistics Den-mark.
3. The local registry at Aarhus Municipality will be used to identify and exclude children 1) treated in or 2) declined participation in a lifestyle intervention.
Statistics:
A logistic regression analysis will be used to identify baseline factors associated with the group of children normalizing weight, persistent obesity and highest increase of BMI z-score (above the 20th centile) at the last observation, respectively. Observations will be weighted by the possible follow-up.
Ethics \& permissions:
The Danish Data Protection Agency and the local committee on health ethics have approved the overall project and data transfer (rec.no 1-45-70-27-2).
High Body Mass Index (BMI) or weight status early in life seems to predict the risk of persisting obesity and indicating BMI as an important predictor for the chance of remission. High birthweight has also been associated with poor chance of normalizing weight, when following children with obesity from kindergarten to the 8th grade, indicating that severe obesity can be detectable from early childhood.
Children with severe obesity (iso-BMI ≥ 35) have been observed to gain weight with a faster rate and with a critical period between 12 to 14 years of age, compared to children with less-severe obesity (iso-BMI \< 35). Another report observes, that having obesity at the age of six was associated with obesity after puberty, while no such association was observed for younger children (six years). Hereby suggesting that children at a younger age have chance of achieving remission of obesity, than children classified as having obesity later in life.
Other factors such as sex, ethnicity and interpersonal skills have also been observed to influence the chance of normalizing weight, when following children with obesity from 5th to 8th grade.
This study aims to identify factors associated with achieving normal weight, when following children age 5-10 yrs. with obesity through childhood and puberty.
In addition, to identify factors associated with having persisting obesity, or reaching a higher level of obesity (highest 20% increase in BMI z-score from baseline)
The participants:
This study includes Danish children 5 to 10 years of age with obesity with minimum three years of follow-up during. Children invited into the local community-based lifestyle intervention will be excluded. The IOTF cut-offs for weight status at the last obtained observation will be used to define the groups.
Data sources:
1. Observations containing anthropometrics have been extracted from TM-Sund for each child. TM-Sund is a database used in Aarhus municipality to store data on anthropomet-rics obtained at health checks at the school (read more on https://www.solteq.com/da).
2. Data on family structure, socioeconomic status (SES), immigration status and psychiatric diagnoses (child and parents) will be obtained from Danish registries at Statistics Den-mark.
3. The local registry at Aarhus Municipality will be used to identify and exclude children 1) treated in or 2) declined participation in a lifestyle intervention.
Statistics:
A logistic regression analysis will be used to identify baseline factors associated with the group of children normalizing weight, persistent obesity and highest increase of BMI z-score (above the 20th centile) at the last observation, respectively. Observations will be weighted by the possible follow-up.
Ethics \& permissions:
The Danish Data Protection Agency and the local committee on health ethics have approved the overall project and data transfer (rec.no 1-45-70-27-2).
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: