Pediatric ObesityNCT06077266
Factors Associated With Changes in Weight-status in Danish School Children With Obesity
An observational study of Pediatric Obesity, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Change of weight class to normal weight
- How many people
- 467 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2023to 1 Jul 2023
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- Children registered in a community-based lifestyle intervention.
- Children registered as having declined participation in a community-based lifestyle intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Associated With Changes in Weight-status in Danish School Children: From Obesity to Overweight or Normal Weight
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.
Read the 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:
- 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).
- 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.
- 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).
- Conditions
- Pediatric Obesity
- Being tested
- Change of weight class to normal weight
- Keywords
- Weight Loss, Body-Weight Trajectory
- Medical subject headings
- Pediatric Obesity, Weight Loss, Body-Weight Trajectory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Normalizing weight | Children classified as having normalized weight (iso-BMI 18.5-25 for age and sex) at the last observation defined by IOTF. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Factors associated persisting obesity in Danish school children (age 5-10 years) compared to children obtaining remission of obesity. Only children with obesity at baseline and minimum 3 years of follow-up will be included. Children treated in or declining treatment in a lifestyle intervention for obesity will be excluded.
Measured: 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.
Factors associated the highest increase in BMI z-score (above the 20th percentile in changes from baseline) in Danish school children (age 5-10 years) compared to children with lower increase or decrease in BMI z-score (below the 20th percentile within the cohort). 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Jan 2023
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 467 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus Municipality, Denmark
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077266
- Sponsor's protocol ID
- Journal no.: 2022-0367531
- Status last verified
- Oct 2023
- First submitted
- 4 Oct 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymized data can be shared upon publication on a reasonable request. However, data from the National registries cannot be shared due to Danish General Data Protection Regulation and legislation.
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Changes in Weight-status in Danish School Children: From Obesity to Overweight or Normal Weight
- ClinicalTrials.gov ID
- NCT06077266
- Acronym / sponsor ID
- Journal no.: 2022-0367531
- Conditions
- Pediatric Obesity
- Keywords
- Weight Loss, Body-Weight Trajectory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 467 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus Municipality, Denmark
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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).
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normalizing weight | – | Other: Change of weight class to normal weightChildren classified as having normalized weight (iso-BMI 18.5-25 for age and sex) at the last observation defined by IOTF. |
| Overweight or obesity | – | –Children classified as having overweight or obesity (iso-BMI 25 ≤ for age and sex) at the last observation defined by IOTF. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Children registered in a community-based lifestyle intervention.
- Children registered as having declined participation in a community-based lifestyle intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Change of weight class to normal weightThe exposure is the change of weight class from obesity to normal weight during a follow-up period without known intervention. | Other | Normalizing weight |
Primary outcome
Factors associated with changes in weight-status in Danish school children: from obesity to normal weight.
Time frame: 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 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.
2 secondary outcomes
Factors associated with persisting obesity in Danish school children with obese.
Time frame: 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.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: Undecided. Anonymized data can be shared upon publication on a reasonable request. However, data from the National registries cannot be shared due to Danish General Data Protection Regulation and legislation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Obesity, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors associated with changes in weight-status in Danish school children: from obesity to normal weight. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.