Pediatric ObesityNCT05345353
Childhood Obesity, Lifestyle Interventions and Weight Development
An observational study of Pediatric Obesity, run by University of Aarhus at 1 site in Denmark.
Trial summary
Childhood obesity has been associated with increased risk of both continued excess body weight, development of non-communicable lifestyle diseases and impaired mental health. Approximately 800 children with obesity were treated with a municipality based family-centered lifestyle intervention in the time period… Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Fat For Fight (FFF), The Aarhus Protocol and The Children's Obesity Clinic Treatment (TCOCT), The Randers Protocol
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,898 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2021to 1 Mar 2022
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with obesity, 4-18 years of age living in Aarhus or Randers municipality between 2010-2020. The children have either received treatment with a community based lifestyle intervention or received no treatment.
Who may be able to join
- Obesity (BMI z-score above the 99. percentile for gender and age)
Who cannot join
- No Obesity
- Treatment started outside the inclusion period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Weight Development in Children With Severe Obesity After Participation in Two Different Municipal Family-centered Lifestyle Interventions
Childhood obesity has been associated with increased risk of both continued excess body weight, development of non-communicable lifestyle diseases and impaired mental health.
Approximately 800 children with obesity were treated with a municipality based family-centered lifestyle intervention in the time period 2010-2020. In the same time period, approximately 2000 children with obesity who did not receive any treatment have been identified.
Our aim is to investigate the efficiency of the two interventions and compare those to children not receiving any treatment. We will use data from both the clinical visits at the municipality health care workers and data from Statistics Denmark.
Read the detailed description
Childhood obesity often track into adolescence and adulthood resulting in elevated risk of non-communicable lifestyle diseases (e.g. type 2 diabetes). Furthermore, children with obesity are also at risk for impaired mental health (i.e. reduced cognitive function and happiness) and psychological ill-being (i.e. depression, anxiety) compared to their lean peers. Finding methods to efficiently, and in a sustainable way, to treat childhood overweight or obesity has not yet been described.
The aim of this study is therefore to investigate the long term effects of two well established lifestyle interventions on weight development (BMI z-score) and to compare socioeconomic parameters between the intervention groups and children who did not received treatment.
The interventions:
The Aarhus protocol: A multicomponent family-centered lifestyle intervention including visits at home and an opportunity for weekly supervised training. The duration of the intervention was a maximum of one year. Data is available from January 2010.
The Randers Protocol: A multicomponent family-centered lifestyle intervention including repeated visits (up to 8 times each year). The duration of the intervention was a maximum of three years. Data is available from January 2014.
The participants:
Inclusion criteria were children aged 4-18 years with obesity (BMI z-score above the 99. percentile for gender and age) living in Aarhus or Randers municipality.
Between 2010-2020, the following children were included in this trial:
- app. 500 children treated with the Aarhus Protocol,
- app. 300 children treated with the Randers Protocol and
- app. 2000 children in Aarhus who did not participate in a lifestyle intervention delivered by the municipality.
The children were examined routinely (a minimum of three times during elementary school) by the school nurse and anthropometrics were collected in NOVAX. NOVAX is a broadly used IT system which stores and delivers data on childhood anthropometrics to the national the database.
Data collection \& analyses:
The weight development will be assessed using data from the municipality and data from the NOVAX. Socioeconomic status will be assessed using register data from Statistics Denmark.
Ethics \& permissions:
The local committee on health ethics have approved the overall project and data transfer (rec.no 1-45-70-27-2) The project is internally reported to the University of Aarhus (rec no. 2596) The project has achieved approval from The Danish Data Protection Agency and the Principal Investigator has been granted accessed to data from registers from Danish Statistics.
The project has been reported to ClinicalTrials.gov. The researchers have no conflict of interest to declare.
- Conditions
- Pediatric Obesity
- Being tested
- Fat For Fight (FFF), The Aarhus Protocol, The Children's Obesity Clinic Treatment (TCOCT), The Randers Protocol
- Keywords
- Lifestyle Intervention, Long term follow-up, Weight developement
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat For Fight (FFF), The Aarhus ProtocolBehavioural
A multicomponent family-centered lifestyle intervention which included visits at home and weekly supervised physical activity. Intervention duration - one year maximum
The Children's Obesity Clinic Treatment (TCOCT), The Randers ProtocolBehavioural
A multicomponent family-centered lifestyle intervention which included repeatedly visits (up to 8 times / year). Intervention duration - three years maximum
| Study group | Role | What they receive |
|---|---|---|
| The Aarhus Protocol, Aarhus municipality: | Children with obesity who participated in a family-centered multicomponent lifestyle intervention - The Aarhus Protocol, Aarhus Municipality Receives: Behavioral: Fat For Fight (FFF), The Aarhus Protocol | |
| The Randers Protocol, Randers municipality: | children with obesity who participated in a family-centered multicomponent lifestyle Intervention - The Randers Protocol: Randers Municipality Receives: Behavioral: The Children's Obesity Clinic Treatment (TCOCT), The Randers Protocol | |
| No intervention | Children with obesity who didn't participate in a lifestyle intervention delivered by the municipality. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight development as assessed by BMI z-score:
The weight development will be assessed in all children, who participated in one of two different lifestyle interventions compared to children with no intervention. The weight development will also be assessed in subgroups of the cohort, such as children who did not completed the intervention or who not did participation in the exercise part of the interventions.
Measured: The Aarhus Protocol: 1st of January 2010 to 1st of June 2020. The Randers Protocol: 1st of January 2014 to 1st of June 2020. No Intervention: 1st of January 2010 to 1st of June 2020.
Secondary outcomes (1)
Socioeconomic differences, subgroup differences
socioeconomic differences between children in the interventions, different subgroups and children with no intervention.
Socioeconomic data will be collected from Danish Statistics.
Measured: Socioeconomic data will be assessed at the time of inclusion for each subject.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Feb 2021
- Primary completion1 Feb 2022
- Study completion1 Mar 2022
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.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 2,898 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus Kommune, Randers Municipality, Denmark
- Responsible party
- Principal investigator, Rasmus Møller Jørgensen, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345353
- Sponsor's protocol ID
- 2596
- Status last verified
- Apr 2022
- First submitted
- 19 Apr 2022
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: participant data (IPD) will be available on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Development in Children With Severe Obesity After Participation in Two Different Municipal Family-centered Lifestyle Interventions
- ClinicalTrials.gov ID
- NCT05345353
- Acronym / sponsor ID
- 2596
- Conditions
- Pediatric Obesity
- Keywords
- Lifestyle Intervention, Long term follow-up, Weight developement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,898 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus Kommune, Randers Municipality, Denmark
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 25 Apr 2022 (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 has been associated with increased risk of both continued excess body weight, development of non-communicable lifestyle diseases and impaired mental health.
Approximately 800 children with obesity were treated with a municipality based family-centered lifestyle intervention in the time period 2010-2020. In the same time period, approximately 2000 children with obesity who did not receive any treatment have been identified.
Our aim is to investigate the efficiency of the two interventions and compare those to children not receiving any treatment. We will use data from both the clinical visits at the municipality health care workers and data from Statistics Denmark.
Detailed description
Childhood obesity often track into adolescence and adulthood resulting in elevated risk of non-communicable lifestyle diseases (e.g. type 2 diabetes). Furthermore, children with obesity are also at risk for impaired mental health (i.e. reduced cognitive function and happiness) and psychological ill-being (i.e. depression, anxiety) compared to their lean peers. Finding methods to efficiently, and in a sustainable way, to treat childhood overweight or obesity has not yet been described.
The aim of this study is therefore to investigate the long term effects of two well established lifestyle interventions on weight development (BMI z-score) and to compare socioeconomic parameters between the intervention groups and children who did not received treatment.
The interventions:
The Aarhus protocol: A multicomponent family-centered lifestyle intervention including visits at home and an opportunity for weekly supervised training. The duration of the intervention was a maximum of one year. Data is available from January 2010.
The Randers Protocol: A multicomponent family-centered lifestyle intervention including repeated visits (up to 8 times each year). The duration of the intervention was a maximum of three years. Data is available from January 2014.
The participants:
Inclusion criteria were children aged 4-18 years with obesity (BMI z-score above the 99. percentile for gender and age) living in Aarhus or Randers municipality.
Between 2010-2020, the following children were included in this trial:
- app. 500 children treated with the Aarhus Protocol,
- app. 300 children treated with the Randers Protocol and
- app. 2000 children in Aarhus who did not participate in a lifestyle intervention delivered by the municipality.
The children were examined routinely (a minimum of three times during elementary school) by the school nurse and anthropometrics were collected in NOVAX. NOVAX is a broadly used IT system which stores and delivers data on childhood anthropometrics to the national the database.
Data collection \& analyses:
The weight development will be assessed using data from the municipality and data from the NOVAX. Socioeconomic status will be assessed using register data from Statistics Denmark.
Ethics \& permissions:
The local committee on health ethics have approved the overall project and data transfer (rec.no 1-45-70-27-2) The project is internally reported to the University of Aarhus (rec no. 2596) The project has achieved approval from The Danish Data Protection Agency and the Principal Investigator has been granted accessed to data from registers from Danish Statistics.
The project has been reported to ClinicalTrials.gov. The researchers have no conflict of interest to declare.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The Aarhus Protocol, Aarhus municipality: | – | Behavioral: Fat For Fight (FFF), The Aarhus ProtocolChildren with obesity who participated in a family-centered multicomponent lifestyle intervention - The Aarhus Protocol, Aarhus Municipality |
| The Randers Protocol, Randers municipality: | – | Behavioral: The Children's Obesity Clinic Treatment (TCOCT), The Randers Protocolchildren with obesity who participated in a family-centered multicomponent lifestyle Intervention - The Randers Protocol: Randers Municipality |
| No intervention | – | –Children with obesity who didn't participate in a lifestyle intervention delivered by the municipality. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with obesity, 4-18 years of age living in Aarhus or Randers municipality between 2010-2020. The children have either received treatment with a community based lifestyle intervention or received no treatment.
Key inclusion criteria (1 listed)
- Obesity (BMI z-score above the 99. percentile for gender and age)
Key exclusion criteria (2 listed)
- No Obesity
- Treatment started outside the inclusion period
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 |
|---|---|---|
| Fat For Fight (FFF), The Aarhus ProtocolA multicomponent family-centered lifestyle intervention which included visits at home and weekly supervised physical activity. Intervention duration - one year maximum | Behavioural | The Aarhus Protocol, Aarhus municipality: |
| The Children's Obesity Clinic Treatment (TCOCT), The Randers ProtocolA multicomponent family-centered lifestyle intervention which included repeatedly visits (up to 8 times / year). Intervention duration - three years maximum | Behavioural | The Randers Protocol, Randers municipality: |
Primary outcome
Weight development as assessed by BMI z-score:
Time frame: The Aarhus Protocol: 1st of January 2010 to 1st of June 2020. The Randers Protocol: 1st of January 2014 to 1st of June 2020. No Intervention: 1st of January 2010 to 1st of June 2020.
The weight development will be assessed in all children, who participated in one of two different lifestyle interventions compared to children with no intervention. The weight development will also be assessed in subgroups of the cohort, such as children who did not completed the intervention or who not did participation in the exercise part of the interventions.
1 secondary outcome
Socioeconomic differences, subgroup differences
Time frame: Socioeconomic data will be assessed at the time of inclusion for each subject.
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 29 Apr 2022.
- Individual participant dataSharing planned: Undecided. participant data (IPD) will be available on reasonable request
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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 1 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 29 Apr 2022. 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?
Weight development as assessed by BMI z-score: (time frame: The Aarhus Protocol: 1st of January 2010 to 1st of June 2020. The Randers Protocol: 1st of January 2014 to 1st of June 2020. No Intervention: 1st of January 2010 to 1st of June 2020.). 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 29 Apr 2022.