Pediatric ObesityNCT06705231
Childhood Obesity, Decided Not to Participate, Lifestyle Intervention and Psychosocial Well-being.
An observational study of Pediatric Obesity and Psychosocial Well-being, run by University of Aarhus at 1 site in Denmark.
Trial summary
Childhood obesity has been associated with an increased risk of impaired psychosocial well-being and the development of depression and anxiety. However, little is known about the long-term psychosocial impact on children with obesity who decided not to participate in lifestyle interventions, representing a critical… Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Pediatric Obesity, Psychosocial Well-being
- What is being tested?
- The Aarhus-intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 403 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2024to 1 Nov 2024
- 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: Children with obesity, 5-10 years of age living in Aarhus municipality between August 1st, 2014, and June 30th, 2020. The children have either received treatment with a one-year multifactorial family-centered lifestyle intervention, decided not to participate in the intervention or where never invited to participate in the intervention.
Who may be able to join
- Inclusion visit between August 1st, 2014, and June 30th, 2020.
- Obesity at time of referral as defined by the IOTF guideline as an iso-BMI >= 30 kg/m2 adjusted for age and sex.
- Age between 5 and 10 years at inclusion visit.
- A measure of weight and height within 6 months before or after time of inclusion
- A completed DNWQ at inclusion:
- The decided not to participate / non-intervention groups - with a timeframe between 6 months prior to and 6 months after inclusion.
- The intervention group - with a timeframe between 10 months prior to and 2 months after inclusion.
- A completed DNWQ at follow-up (1 to 3 years after inclusion visit).
Who cannot join
- Children first decided not to participate, but subsequently accepting the intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Deciding Not to Participate in a Lifestyle Intervention Affect the Long-term Change in Psychosocial Well-being for Children With Obesity?
Childhood obesity has been associated with an increased risk of impaired psychosocial well-being and the development of depression and anxiety. However, little is known about the long-term psychosocial impact on children with obesity who decided not to participate in lifestyle interventions, representing a critical gap in literature.
This study includes approximately 400 children with obesity aged 5-10 years living in Aarhus municipality in the time-period 2014-2020, who either decided not to participate in a lifestyle intervention, were not invited to participate or attended the intervention. During that period the children annually completed the Danish National Well-being Questionnaire (DNWQ) in school. The DNWQ is a national questionnaire used to examine the well-being and learning environment in Danish schoolchildren.
The aim of this study is to investigate the long-term impact on psychosocial well-being for children with obesity deciding not to participate in a family-centered lifestyle intervention compared to children who attended the intervention, and to children never invited to participate in the intervention. The study will combine data from mandatory health check-ups at school, the Danish National Registries, and the Danish agency for IT and Learning (STIL), The ministry of Education.
Read the detailed description
Childhood obesity is increasing worldwide and is associated with an increased risk of developing non-communicable lifestyle diseases later in life, while reduced psychosocial well-being often occurs during childhood. Children living with obesity suffer from poor self-esteem, which have been associated with increased levels of sadness and loneliness. They also experience a higher degree of bullying, have lower quality of life, and a greater risk of depression as compared to their peers living without obesity. Family-centered lifestyle interventions using a multifactorial approach are still considered the first line treatment for addressing childhood obesity. The literature suggests that this type of intervention can stabilize or to some extent reduce weight when treating children with obesity. In addition, various studies have reported positive effects of obesity interventions on psychosocial well-being in children and adolescents.
Previous studies have reported life stressors, societal norms of weight and body size, as well as earlier experiences with the health care system to be the primary determinants for caregivers not letting their children with obesity participate in lifestyle interventions. However, no studies have been able to describe if deciding not to participate in a lifestyle intervention affects the psychosocial well-being in children with obesity.
The aim of this study is therefore to investigate the long-term impact on psychosocial well-being for children with obesity deciding not to participate in a family-centered lifestyle intervention (decided not to participate group) compared to children who attended the intervention (intervention group), and to children never invited to participate in the intervention (non-intervention group). As a secondary objective, we aim to investigate the effect that is not caused by the weight change by adjusting for this.
Study design: This observational cohort study will combine data from mandatory health examinations at school, the Danish National Registries, and the Ministry of Education for children with obesity living in Aarhus municipality, Denmark between August 1st, 2014, and June 30th, 2020. The last possible day of follow-up will be February 1st, 2023.
The participants:
This study will include children aged 5-10 years with obesity living in Aarhus municipality, who either decided not to participate in a lifestyle intervention in Aarhus (decided not to participate group), were not invited to participate (non-intervention group), or attended the intervention (intervention group). The inclusion visit will be defined as the day of deciding not to participate in the intervention (decided not to participate group), the first day of attending the intervention (intervention group), or the first observation with obesity (non-intervention group).
Obesity will be defined by the International Obesity Task Force (IOTF) guideline as an iso-BMI >= 30 kg/m2 adjusted for age and sex.
This trial will include:
- Approximately 70 children with obesity deciding not to participate in the intervention (decided not to participate group)
- Approximately 110 children with obesity treated with the one-year lifestyle intervention (intervention group)
- Approximately 230 children with obesity who were not invited to participate in the intervention (non-intervention group)
Data-collection and analyses:
Children who attended, decided not to participate, or were never invited to participate in the intervention will be identified using data from TM-Sund. Data recorded at health check-ups at the school containing height and weight will also be extracted from TM-Sund. TM-Sund is a data capturing tool used by the community health care nurses employed at Aarhus municipality.
The DNWQ data will be obtained from the Danish agency for IT and Learning (STIL), The ministry of Education.
Data on socioeconomic status (SES), immigration, family structure, and psychiatric diagnoses will be obtained from the National Danish Registers through Statistics Denmark.
Ethics \& Permissions:
The local committee on health ethics have approved the overall project and data transfer (rec.no 1-45-70-27-20). The project is internally reported to the University of Aarhus (rec no. 3662). The project has achieved approval from The Danish Data Protection Agency and the Principal Investigator has been granted access to data from registers from Danish Statistics.
The researchers have no conflict of interest to declare.
- Conditions
- Pediatric Obesity, Psychosocial Well-being
- Being tested
- The Aarhus-intervention
- Keywords
- Decided not to Participate, Lifestyle Intervention, Pediatric Obesity, Psychosocial Well-being, Long-term impact
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Aarhus-interventionBehavioural
A multifactorial family-centered lifestyle intervention with a maximum duration of one year, corresponding to three-four visits. Participants were offered complimentary weekly supervised physical activity. The day-to-day intervention was managed by specialized nurses at local healthcare centers, at the participants' homes, or in a local clinic.
| Study group | Role | What they receive |
|---|---|---|
| Decided not participate group | Children aged 5-10 years with obesity from the city of Aarhus, who decided not to participate in the lifestyle intervention in Aarhus municipality. Receives: Behavioral: The Aarhus-intervention | |
| Intervention group | Children aged 5-10 years with obesity who participated in a one-year lifestyle intervention in Aarhus municipality. Receives: Behavioral: The Aarhus-intervention | |
| Non-intervention group | Children aged 5-10 years with obesity from the city of Aarhus, who were never invited to participate in the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in psychosocial well-being as assessed by the DNWQ, obtained from the Danish agency for IT and Learning (STIL), The ministry of Education.
The impact on psychosocial well-being will be assessed with responses to specific items regarding psychosocial well-being related to school from the DNWQ at time of inclusion and at follow-up. At follow-up, we will prioritize completed questionnaires closest to two years from time of inclusion visit.
The DNWQ is a national questionnaire completed annually in primary school and used to examine how primary schoolchildren perceive their well-being and learning environment in school.
The following psychosocial well-being items have been selected:
- Question: Are you happy with your school?
- Questions: Do you feel lonely at school?
- Question: Have you been bullied this school year?
- Question: Does your stomach ache when you are at school?
- Question: Are you good at solving your problems?
- Question: Can you concentrate during class?
- Question:
Are you good at helping each other in class?
Measured: Time Frame: Annually from August 1st, 2014, to February 1st, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Mar 2024
- Primary completion1 Oct 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 403 participants (actual)
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
- NCT06705231
- Sponsor's protocol ID
- 3662
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 26 Nov 2024
- 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.
Publications
Benjaminsen CR, Bruun JM, Pedersen MJ, Clausen L, Ostergaard JN, Jorgensen RM. Long-term changes in psychosocial well-being in children with obesity deciding not to participate in a lifestyle intervention. Eat Weight Disord. 2026 Mar 16;31(1):39. doi: 10.1007/s40519-026-01840-w.
PubMed 41838215
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Deciding Not to Participate in a Lifestyle Intervention Affect the Long-term Change in Psychosocial Well-being for Children With Obesity?
- ClinicalTrials.gov ID
- NCT06705231
- Acronym / sponsor ID
- 3662
- Conditions
- Pediatric Obesity, Psychosocial Well-being
- Keywords
- Decided not to Participate, Lifestyle Intervention, Pediatric Obesity, Psychosocial Well-being, Long-term impact
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus Municipality, Denmark
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 26 Nov 2024 (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 an increased risk of impaired psychosocial well-being and the development of depression and anxiety. However, little is known about the long-term psychosocial impact on children with obesity who decided not to participate in lifestyle interventions, representing a critical gap in literature.
This study includes approximately 400 children with obesity aged 5-10 years living in Aarhus municipality in the time-period 2014-2020, who either decided not to participate in a lifestyle intervention, were not invited to participate or attended the intervention. During that period the children annually completed the Danish National Well-being Questionnaire (DNWQ) in school. The DNWQ is a national questionnaire used to examine the well-being and learning environment in Danish schoolchildren.
The aim of this study is to investigate the long-term impact on psychosocial well-being for children with obesity deciding not to participate in a family-centered lifestyle intervention compared to children who attended the intervention, and to children never invited to participate in the intervention. The study will combine data from mandatory health check-ups at school, the Danish National Registries, and the Danish agency for IT and Learning (STIL), The ministry of Education.
Detailed description
Childhood obesity is increasing worldwide and is associated with an increased risk of developing non-communicable lifestyle diseases later in life, while reduced psychosocial well-being often occurs during childhood. Children living with obesity suffer from poor self-esteem, which have been associated with increased levels of sadness and loneliness. They also experience a higher degree of bullying, have lower quality of life, and a greater risk of depression as compared to their peers living without obesity. Family-centered lifestyle interventions using a multifactorial approach are still considered the first line treatment for addressing childhood obesity. The literature suggests that this type of intervention can stabilize or to some extent reduce weight when treating children with obesity. In addition, various studies have reported positive effects of obesity interventions on psychosocial well-being in children and adolescents.
Previous studies have reported life stressors, societal norms of weight and body size, as well as earlier experiences with the health care system to be the primary determinants for caregivers not letting their children with obesity participate in lifestyle interventions. However, no studies have been able to describe if deciding not to participate in a lifestyle intervention affects the psychosocial well-being in children with obesity.
The aim of this study is therefore to investigate the long-term impact on psychosocial well-being for children with obesity deciding not to participate in a family-centered lifestyle intervention (decided not to participate group) compared to children who attended the intervention (intervention group), and to children never invited to participate in the intervention (non-intervention group). As a secondary objective, we aim to investigate the effect that is not caused by the weight change by adjusting for this.
Study design: This observational cohort study will combine data from mandatory health examinations at school, the Danish National Registries, and the Ministry of Education for children with obesity living in Aarhus municipality, Denmark between August 1st, 2014, and June 30th, 2020. The last possible day of follow-up will be February 1st, 2023.
The participants:
This study will include children aged 5-10 years with obesity living in Aarhus municipality, who either decided not to participate in a lifestyle intervention in Aarhus (decided not to participate group), were not invited to participate (non-intervention group), or attended the intervention (intervention group). The inclusion visit will be defined as the day of deciding not to participate in the intervention (decided not to participate group), the first day of attending the intervention (intervention group), or the first observation with obesity (non-intervention group).
Obesity will be defined by the International Obesity Task Force (IOTF) guideline as an iso-BMI >= 30 kg/m2 adjusted for age and sex.
This trial will include:
- Approximately 70 children with obesity deciding not to participate in the intervention (decided not to participate group)
- Approximately 110 children with obesity treated with the one-year lifestyle intervention (intervention group)
- Approximately 230 children with obesity who were not invited to participate in the intervention (non-intervention group)
Data-collection and analyses:
Children who attended, decided not to participate, or were never invited to participate in the intervention will be identified using data from TM-Sund. Data recorded at health check-ups at the school containing height and weight will also be extracted from TM-Sund. TM-Sund is a data capturing tool used by the community health care nurses employed at Aarhus municipality.
The DNWQ data will be obtained from the Danish agency for IT and Learning (STIL), The ministry of Education.
Data on socioeconomic status (SES), immigration, family structure, and psychiatric diagnoses will be obtained from the National Danish Registers through Statistics Denmark.
Ethics \& Permissions:
The local committee on health ethics have approved the overall project and data transfer (rec.no 1-45-70-27-20). The project is internally reported to the University of Aarhus (rec no. 3662). The project has achieved approval from The Danish Data Protection Agency and the Principal Investigator has been granted access to data from registers from Danish Statistics.
The researchers have no conflict of interest to declare.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Decided not participate group | – | Behavioral: The Aarhus-interventionChildren aged 5-10 years with obesity from the city of Aarhus, who decided not to participate in the lifestyle intervention in Aarhus municipality. |
| Intervention group | – | Behavioral: The Aarhus-interventionChildren aged 5-10 years with obesity who participated in a one-year lifestyle intervention in Aarhus municipality. |
| Non-intervention group | – | –Children aged 5-10 years with obesity from the city of Aarhus, who were never invited to participate in the intervention. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with obesity, 5-10 years of age living in Aarhus municipality between August 1st, 2014, and June 30th, 2020. The children have either received treatment with a one-year multifactorial family-centered lifestyle intervention, decided not to participate in the intervention or where never invited to participate in the intervention.
Key inclusion criteria (8 listed)
- Inclusion visit between August 1st, 2014, and June 30th, 2020.
- Obesity at time of referral as defined by the IOTF guideline as an iso-BMI >= 30 kg/m2 adjusted for age and sex.
- Age between 5 and 10 years at inclusion visit.
- A measure of weight and height within 6 months before or after time of inclusion
- A completed DNWQ at inclusion:
Key exclusion criteria (1 listed)
- Children first decided not to participate, but 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 |
|---|---|---|
| The Aarhus-interventionA multifactorial family-centered lifestyle intervention with a maximum duration of one year, corresponding to three-four visits. Participants were offered complimentary weekly supervised physical activity. The day-to-day intervention was managed by specialized nurses at local healthcare centers, at the participants' homes, or in a local clinic. | Behavioural | Decided not participate group, Intervention group |
Primary outcome
Change in psychosocial well-being as assessed by the DNWQ, obtained from the Danish agency for IT and Learning (STIL), The ministry of Education.
Time frame: Time Frame: Annually from August 1st, 2014, to February 1st, 2023
The impact on psychosocial well-being will be assessed with responses to specific items regarding psychosocial well-being related to school from the DNWQ at time of inclusion and at follow-up. At follow-up, we will prioritize completed questionnaires closest to two years from time of inclusion visit. The DNWQ is a national questionnaire completed annually in primary school and used to examine how primary schoolchildren perceive their well-being and learning environment in school. The following psychosocial well-being items have been selected: 1. Question: Are you happy with your school? 2. Questions: Do you feel lonely at school? 3. Question: Have you been bullied this school year? 4. Question: Does your stomach ache when you are at school? 5. Question: Are you good at solving your problems? 6. Question: Can you concentrate during class? 7. Question: Are you good at helping each other in class?
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 26 Nov 2024.
- Derived from this study: PubMed 41838215Benjaminsen CR, Bruun JM, Pedersen MJ, Clausen L, Ostergaard JN, Jorgensen RM. Long-term changes in psychosocial well-being in children with obesity deciding not to participate in a lifestyle intervention. Eat Weight Disord. 2026 Mar 16;31(1):39. doi: 10.1007/s40519-026-01840-w.
- 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 and Psychosocial Well-being, 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 8 inclusion and 1 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 26 Nov 2024. 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?
Change in psychosocial well-being as assessed by the DNWQ, obtained from the Danish agency for IT and Learning (STIL), The ministry of Education. (time frame: Time Frame: Annually from August 1st, 2014, to February 1st, 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06705231, which also lists 1 linked publication.
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 26 Nov 2024.