Obesity, ChildNCT05858697
Weight Development in Children With Obesity After Declining Treatment
An observational study of Obesity, Child, run by University of Aarhus at 1 site in Denmark.
Trial summary
Childhood obesity is a major health concern and lifestyle intervention is recommended as the cornerstone in the weight loss treatment. However, only limited knowledge exists in relation to characterization and follow-up of children who decline participation in a lifestyle intervention. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Child
- What is being tested?
- Declining participation in the Aarhus intervention and Participation in the Aarhus intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,273 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2010to 25 Apr 2023
- How long will I take part?
- 10 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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: This study will include children with obesity from the city of Aarhus with a baseline visit between January 1st 2010 and June 30th 2020 children.
Who may be able to join
- 5-7 years of age
- obesity at baseline as defined by the International Obesity Task Force (IOTF) as BMI ≥ 30kg/m2 for age and gender.
Who cannot join
- More than 6 months between a baseline visit and the next observation with a BMI z score
- First declining and subsequently accepting the intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Weight Development in Children With Obesity After Declining Participation in a Community-based Lifestyle Intervention.
Childhood obesity is a major health concern and lifestyle intervention is recommended as the cornerstone in the weight loss treatment. However, only limited knowledge exists in relation to characterization and follow-up of children who decline participation in a lifestyle intervention. The aim of this study is to investigate the long-term development in BMI z-score for children with obesity who decline to participate in a lifestyle intervention.
This study identified approximately 170 children with obesity who declined treatment in a community-based lifestyle intervention. The development in BMI z-score for these children will be compared to children enrolled in the lifestyle intervention (i.e. treatment) and children who were never invited.
Data from different sources will be used to answer the research question (intervention registries, health check-ups at school and Danish registries).
Read the detailed description
Childhood obesity has been associated with increased risk of poorer mental health, later non-communicable lifestyle diseases (e.g. prediabetes, sleep apnea), and of continued excess body weight into adulthood. Multi-component family-centered lifestyle intervention seems to be the cornerstone in the treatment. However, only limited knowledge exists regarding weight development in children with obesity who decline to participate in such a lifestyle intervention. The aim of this study is therefore to investigate the long-term development in BMI z-score in children with obesity from 5 to 7 years of age who declined to participate in a lifestyle intervention. The development in BMI z-score for these children will be compared to children accepting the treatment and children who were never invited. A secondary aim is to investigate the potentially modifying effects of socioeconomic status (SES).
The participants:
This cohort study will include children from the city of Aarhus with a baseline visit between January 1st 2010 and June 30th 2020 children. The inclusion criteria are 1) 5-7 years of age and 2) obesity at baseline. Obesity will be defined by the International Obesity Task Force (IOTF) as BMI ≥ 30kg/m2 for age and gender. BMI z-score will be calculated be external reference population (WHO).
The expected number of children included:
- App. 150-170 children with obesity who declined to participate in the Aarhus intervention (Declining group).
- App. 400 children with obesity accepted participation and received treatment in a multicomponent family-centered lifestyle intervention (intervention group).
- App. 700-800 children with obesity living in Aarhus, who were not invited to participate in the lifestyle intervention (Non-intervention group)
Data sources:
- Participants will be identified using data from the municipality register.
- Anthropometrical data will be extracted from TM-Sund (Aarhus). TM-Sund is a database used to store data on anthropometrics obtained at health checks by specialized school nurses, Denmark.
- Data on SES, immigration and psychiatric illness will be obtained from Danish National registries.
Statistics:
A multiple imputation (MI) with chained equations will be applied to replace missing data regarding socioeconomic status and immigration, if missing data causes the models to lose substantial amount of observations, m=100. An adjusted mixed effects model with splines will be used to describe the development in BMI z-score for children declining participation and compare those to the reference and to the intervention groups. Knots will be placed at baseline and after ½, 1, 3 and 10.5 year. The model will be adjusted for age, BMI z-score, gender, family type, highest completed household education, equalized household income, immigration status, psychiatric diagnosis and psychiatric diagnosis (parents), zip code / distance to treatment center at baseline.
Ethics \& permissions:
The local health ethics committee has approved the project, including data transfer (rec.no 1-45-70-27-20).
The project is internally reported to the University of Aarhus (rec no. 2916) The project has achieved approval from The Danish Data Protection Agency and the Principal Investigator has been granted accessed to register data from Statistics Denmark.
A full plan for analytics has been completed.
- Conditions
- Obesity, Child
- Being tested
- Declining participation in the Aarhus intervention, Participation in the Aarhus intervention
- Keywords
- Lifestyle intervention, refusal of treatment, effect, long term
- Medical subject headings
- Pediatric Obesity, Treatment Refusal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Declining participation in the Aarhus interventionOther
Each year a fraction of the children invited into the Aarhus intervention decline to participated.
Participation in the Aarhus interventionBehavioural
A community-based multicomponent family-centered lifestyle intervention which included visits at home and weekly supervised physical activity. The intervention has a maximum duration of one year.
| Study group | Role | What they receive |
|---|---|---|
| Declining group | Children with obesity 5-7 years of age who were invited to the intervention but declined participation. Receives: Other: Declining participation in the Aarhus intervention | |
| Interventions group | Children with obesity 5-7 years of age who accepted and subsequently received treatment. Receives: Behavioral: Participation in the Aarhus intervention | |
| 'Non intervention' group | Children with obesity at age 5-7 years living in Aarhus, who were never invited to participate in the lifestyle interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The annual change in BMI z-score from baseline for children with obesity declining a lifestyle intervention and the difference in the annual change in BMI z-score compared to children in the intervention and the no-intervention group.
The annual change in BMI z-score from baseline will be modelled by using a mixed effect model with splines and be compared 1) to children accepting the treatment and 2) to children who were never invited to participate. These models will be displayed as both crude analyses and adjusted for child and parent's characteristics at baseline
Measured: Baseline visit between 1st of January 2010 to 30th of June 2020.
Secondary outcomes (1)
Different associations of the annual change in BMI z-score in subgroups (immigration and socioeconomic status) of children declining the intervention compared to children in the intervention and the no-intervention group,
A modification analysis will be applied by adding the dichotomized variables income (dichotomized by the median), education (≤12 vs ≥13 years of education) and immigration status (Danish origin vs immigrant) as interactions term to the mixed model.
Measured: Baseline visit between 1st of January 2010 to 30th of June 2020.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start1 Jan 2010
- Primary completion30 Jun 2020
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildStudies 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
- Other
- Enrolment
- 1,273 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus County, Denmark
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05858697
- Sponsor's protocol ID
- 2022-0367531, 2916
- Status last verified
- Jan 2023
- First submitted
- 26 Apr 2023
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Development in Children With Obesity After Declining Participation in a Community-based Lifestyle Intervention.
- ClinicalTrials.gov ID
- NCT05858697
- Acronym / sponsor ID
- 2022-0367531, 2916
- Conditions
- Obesity, Child
- Keywords
- Lifestyle intervention, refusal of treatment, effect, long term
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,273 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus County, Denmark
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 15 May 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 a major health concern and lifestyle intervention is recommended as the cornerstone in the weight loss treatment. However, only limited knowledge exists in relation to characterization and follow-up of children who decline participation in a lifestyle intervention. The aim of this study is to investigate the long-term development in BMI z-score for children with obesity who decline to participate in a lifestyle intervention.
This study identified approximately 170 children with obesity who declined treatment in a community-based lifestyle intervention. The development in BMI z-score for these children will be compared to children enrolled in the lifestyle intervention (i.e. treatment) and children who were never invited.
Data from different sources will be used to answer the research question (intervention registries, health check-ups at school and Danish registries).
Detailed description
Childhood obesity has been associated with increased risk of poorer mental health, later non-communicable lifestyle diseases (e.g. prediabetes, sleep apnea), and of continued excess body weight into adulthood. Multi-component family-centered lifestyle intervention seems to be the cornerstone in the treatment. However, only limited knowledge exists regarding weight development in children with obesity who decline to participate in such a lifestyle intervention. The aim of this study is therefore to investigate the long-term development in BMI z-score in children with obesity from 5 to 7 years of age who declined to participate in a lifestyle intervention. The development in BMI z-score for these children will be compared to children accepting the treatment and children who were never invited. A secondary aim is to investigate the potentially modifying effects of socioeconomic status (SES).
The participants:
This cohort study will include children from the city of Aarhus with a baseline visit between January 1st 2010 and June 30th 2020 children. The inclusion criteria are 1) 5-7 years of age and 2) obesity at baseline. Obesity will be defined by the International Obesity Task Force (IOTF) as BMI ≥ 30kg/m2 for age and gender. BMI z-score will be calculated be external reference population (WHO).
The expected number of children included:
- App. 150-170 children with obesity who declined to participate in the Aarhus intervention (Declining group).
- App. 400 children with obesity accepted participation and received treatment in a multicomponent family-centered lifestyle intervention (intervention group).
- App. 700-800 children with obesity living in Aarhus, who were not invited to participate in the lifestyle intervention (Non-intervention group)
Data sources:
- Participants will be identified using data from the municipality register.
- Anthropometrical data will be extracted from TM-Sund (Aarhus). TM-Sund is a database used to store data on anthropometrics obtained at health checks by specialized school nurses, Denmark.
- Data on SES, immigration and psychiatric illness will be obtained from Danish National registries.
Statistics:
A multiple imputation (MI) with chained equations will be applied to replace missing data regarding socioeconomic status and immigration, if missing data causes the models to lose substantial amount of observations, m=100. An adjusted mixed effects model with splines will be used to describe the development in BMI z-score for children declining participation and compare those to the reference and to the intervention groups. Knots will be placed at baseline and after ½, 1, 3 and 10.5 year. The model will be adjusted for age, BMI z-score, gender, family type, highest completed household education, equalized household income, immigration status, psychiatric diagnosis and psychiatric diagnosis (parents), zip code / distance to treatment center at baseline.
Ethics \& permissions:
The local health ethics committee has approved the project, including data transfer (rec.no 1-45-70-27-20).
The project is internally reported to the University of Aarhus (rec no. 2916) The project has achieved approval from The Danish Data Protection Agency and the Principal Investigator has been granted accessed to register data from Statistics Denmark.
A full plan for analytics has been completed.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Declining group | – | Other: Declining participation in the Aarhus interventionChildren with obesity 5-7 years of age who were invited to the intervention but declined participation. |
| Interventions group | – | Behavioral: Participation in the Aarhus interventionChildren with obesity 5-7 years of age who accepted and subsequently received treatment. |
| 'Non intervention' group | – | –Children with obesity at age 5-7 years living in Aarhus, who were never invited to participate in the lifestyle interventions. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study will include children with obesity from the city of Aarhus with a baseline visit between January 1st 2010 and June 30th 2020 children.
Key inclusion criteria (2 listed)
- 5-7 years of age
- obesity at baseline as defined by the International Obesity Task Force (IOTF) as BMI ≥ 30kg/m2 for age and gender.
Key exclusion criteria (2 listed)
- More than 6 months between a baseline visit and the next observation with a BMI z score
- First declining and subsequently accepting the 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 |
|---|---|---|
| Declining participation in the Aarhus interventionEach year a fraction of the children invited into the Aarhus intervention decline to participated. | Other | Declining group |
| Participation in the Aarhus interventionA community-based multicomponent family-centered lifestyle intervention which included visits at home and weekly supervised physical activity. The intervention has a maximum duration of one year. | Behavioural | Interventions group |
Primary outcome
The annual change in BMI z-score from baseline for children with obesity declining a lifestyle intervention and the difference in the annual change in BMI z-score compared to children in the intervention and the no-intervention group.
Time frame: Baseline visit between 1st of January 2010 to 30th of June 2020.
The annual change in BMI z-score from baseline will be modelled by using a mixed effect model with splines and be compared 1) to children accepting the treatment and 2) to children who were never invited to participate. These models will be displayed as both crude analyses and adjusted for child and parent's characteristics at baseline
1 secondary outcome
Different associations of the annual change in BMI z-score in subgroups (immigration and socioeconomic status) of children declining the intervention compared to children in the intervention and the no-intervention group,
Time frame: Baseline visit between 1st of January 2010 to 30th of June 2020.
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 15 May 2023.
- Individual participant dataSharing planned: Undecided
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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 Obesity, Child, 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 2 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 15 May 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?
The annual change in BMI z-score from baseline for children with obesity declining a lifestyle intervention and the difference in the annual change in BMI z-score compared to children in the intervention and the no-intervention group. (time frame: Baseline visit between 1st of January 2010 to 30th 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 15 May 2023.