Pediatric ObesityNCT06555380
Childhood Obesity, Lifestyle Interventions 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. This study includes approximately 200 children with obesity aged 5-10 treated within one of two multifactorial family-centered lifestyle intervention in the time-period… 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 one-year intervention and The three-year intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 319 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2024to 1 Jun 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 two municipalities in Denmark between August 1st, 2014, and June 30th, 2020. The children have either received treatment with one of the multifactorial family-centered lifestyle interventions or where never invited into the interventions.
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 a BMI >= 30 kg/m2 adjusted for age and sex.
- Obesity at time of referral as defined by the IOTF guideline as a BMI >= 30 kg/m2 adjusted for age and sex.
- Age between 5 and 10 years at inclusion visit.
- A completed DNWQ within a timeframe of 10 months prior to 2 months after inclusion.
- A completed DNWQ at follow-up (1 to 3 years after inclusion visit).
Who cannot join
- Children declining participation in a community-based lifestyle intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Multifactorial Lifestyle Interventions on Psychosocial Well-being for Children Living With Obesity
Childhood obesity has been associated with an increased risk of impaired psychosocial well-being and the development of depression and anxiety.
This study includes approximately 200 children with obesity aged 5-10 treated within one of two multifactorial family-centered lifestyle intervention in the time-period 2014-2020. Additionally, this study includes 150 children with obesity in the same age group, who were never invited into the multifactorial family-centered lifestyle interventions. During that period the children annually completed the Danish Nation Well-being Questionnaire (DNWQ) in school. The DNWQ is a national questionnaire used to examine the well-being and learning environment in Danish schoolchildren.
Read more
The aim is to investigate the long-term impact on psychosocial well-being in children with obesity following participation in one of two multifactorial family-centered lifestyle interventions: a one-year and three-year intervention. Further, to compare this alteration in psychosocial well-being between the intervention groups and with a reference group of children who were never invited to participate in the interventions.
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
The continuous rise in obesity among children has become a critical public health issue, due to the associated risks of continuous obesity and development of metabolic disorders in adulthood. While these consequences may not become apparent until later in life, the obesity-related complications commonly observed in childhood are associated with impaired psychosocial well-being (i.e. reduced self-image, bullying, and stigmatization). Children and adolescents with obesity have a higher risk of impaired health-related quality of life (QoL) and are more likely to suffer from depression and anxiety, compared to their lean peers. Furthermore, these mental health related complications can typical be observed in childhood opposite the somatic complications.
While there is agreement that obesity is associated with overall reduced psychosocial well-being in children and adolescents, studies comparing how different, or no lifestyle interventions affects psychosocial well-being remain scarce. It is therefore necessary to identify effective lifestyle interventions, that can handle and improve this issue.
The aim of this study is therefore to investigate the long-term impact on psychosocial well-being in children with obesity following participation in one of two multifactorial family-centered lifestyle interventions: a one-year and a three-year intervention. Further, to compare this alteration in psychosocial well-being between the intervention groups and with a reference group of children who were never invited to participate in the interventions. Additionally, the study aims to eliminate the potential impact of weight change on the association between exposure and change in psychosocial well-being.
Study design: This observational cohort study will combine data from obligatory health check-ups at school, the Danish National Registries, and the Ministry of Education for children aged 5-10 with obesity living in two municipalities in Denmark between August 1st, 2014, and June 30th, 2020. The last possible day of follow-up will be February 1st, 2023.
The interventions:
The one-year intervention: A multifactorial family-centered lifestyle intervention offering 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 health care nurses at local treatment centers, at the participants' homes, or in a local clinic.
The three-year intervention: A multifactorial family-centered lifestyle intervention extending up to three years, with clinical visits at local healthcare centers occurring approximately every eight weeks, managed by specialized nurses.
The participants:
Children in the intervention groups were 5 to 10 years of age and participated in one of two different family-centered interventions: a one-year or three-year intervention. Children with obesity living in one of the municipalities, who were never invited to participate in the interventions will act as a reference group for this study. The inclusion visit for this group is defined as the initial observation with obesity.
Obesity will be defined by the International Obesity Task Force (IOTF) guideline as a BMI >= 30 kg/m2 adjusted for age and sex.
The following children will be included in this trial:
- 107 children with obesity treated with the one-year intervention
- 66 children with obesity treated with the three-year intervention
- 146 children with obesity who were not invited to participate in the interventions (non intervention group)
Data-collection and analyses:
Children who participated in one of the two interventions will be identified by using data from TM-Sund and NOVAX. Data recorded at health check-ups at the school containing height and weight will also be extracted from TM-Sund and NOVAX. TM-Sund and NOVAX are data capturing tools used by the community health care nurses employed at the two municipalities. The reference group will be identified in TM-Sund.
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 registries 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. 3518). 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 researchers have no conflict of interest to declare.
- Conditions
- Pediatric Obesity, Psychosocial Well-being
- Being tested
- The one-year intervention, The three-year intervention
- Keywords
- 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 one-year 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.
The three-year interventionBehavioural
A multifactorial family-centered lifestyle intervention extending up to three years, with clinical visits at local healthcare centers which included repeatedly visits (up to 8 times / year). The intervention was managed by specialized nurses.
| Study group | Role | What they receive |
|---|---|---|
| The one-year intervention group | Children aged 5-10 with obesity who participated in the one-year multifactorial family-centered lifestyle intervention. Receives: Behavioral: The one-year intervention | |
| The three-year intervention group | Children aged 5-10 with obesity who participated in the three-year multifactorial family-centered lifestyle intervention. Receives: Behavioral: The three-year intervention | |
| The non-intervention group | Children with obesity living in one of the municipalities who were never invited to participate in the interventions. |
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 questions regarding psychosocial well-being related to school from the DNWQ at time of inclusion and at follow-up.
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 four questions have been selected as our primary outcomes.
- Question: Are you happy with your school?
- Questions: Do you feel lonely at school? (0-3 grade) Do you feel lonely? (4-9 grade)
- Question: Is anyone teasing you so that you feel sad? (0-3 grade) Have you been bullied this school year? (4-9 grade)
- Question:
Does your stomach ache when you are at school? (0-3 grade) How often does your stomach ache? (4-9 grade)
Measured: Annually from August 1st, 2014, to February 1st, 2023)
Secondary outcomes (1)
Change in psychosocial well-being as assessed by the DNWQ, obtained from the Danish agency for IT and Learning (STIL), The ministry of Education.
Same as primary outcome measure, but with other questions chosen from the DNWQ.
The following three questions has been selected as our secondary outcome.
- Question:
Are you good at solving your problems? (0-3 grade) How often can you find a solution to problems, just by trying hard enough? (4-9 grade)
- Question:
Can you concentrate during class?
- Question:
Are you good at helping each other in class? (0-3 grade) Most students in my class are friendly and helpful. (4-9 grade)
Measured: 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 posted15 Aug 2024
- Study start1 Jan 2024
- Primary completion1 May 2024
- Study completion1 Jun 2024
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
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus Municipality, Denmark, Randers Municipality, Denmark
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555380
- Sponsor's protocol ID
- 3518
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 15 Aug 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Multifactorial Lifestyle Interventions on Psychosocial Well-being for Children Living With Obesity
- ClinicalTrials.gov ID
- NCT06555380
- Acronym / sponsor ID
- 3518
- Conditions
- Pediatric Obesity, Psychosocial Well-being
- Keywords
- Lifestyle Intervention, Pediatric Obesity, Psychosocial Well-being, Long-term impact
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus Municipality, Denmark, Randers Municipality, Denmark
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 15 Aug 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.
This study includes approximately 200 children with obesity aged 5-10 treated within one of two multifactorial family-centered lifestyle intervention in the time-period 2014-2020. Additionally, this study includes 150 children with obesity in the same age group, who were never invited into the multifactorial family-centered lifestyle interventions. During that period the children annually completed the Danish Nation 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 is to investigate the long-term impact on psychosocial well-being in children with obesity following participation in one of two multifactorial family-centered lifestyle interventions: a one-year and three-year intervention. Further, to compare this alteration in psychosocial well-being between the intervention groups and with a reference group of children who were never invited to participate in the interventions.
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
The continuous rise in obesity among children has become a critical public health issue, due to the associated risks of continuous obesity and development of metabolic disorders in adulthood. While these consequences may not become apparent until later in life, the obesity-related complications commonly observed in childhood are associated with impaired psychosocial well-being (i.e. reduced self-image, bullying, and stigmatization). Children and adolescents with obesity have a higher risk of impaired health-related quality of life (QoL) and are more likely to suffer from depression and anxiety, compared to their lean peers. Furthermore, these mental health related complications can typical be observed in childhood opposite the somatic complications.
While there is agreement that obesity is associated with overall reduced psychosocial well-being in children and adolescents, studies comparing how different, or no lifestyle interventions affects psychosocial well-being remain scarce. It is therefore necessary to identify effective lifestyle interventions, that can handle and improve this issue.
The aim of this study is therefore to investigate the long-term impact on psychosocial well-being in children with obesity following participation in one of two multifactorial family-centered lifestyle interventions: a one-year and a three-year intervention. Further, to compare this alteration in psychosocial well-being between the intervention groups and with a reference group of children who were never invited to participate in the interventions. Additionally, the study aims to eliminate the potential impact of weight change on the association between exposure and change in psychosocial well-being.
Study design: This observational cohort study will combine data from obligatory health check-ups at school, the Danish National Registries, and the Ministry of Education for children aged 5-10 with obesity living in two municipalities in Denmark between August 1st, 2014, and June 30th, 2020. The last possible day of follow-up will be February 1st, 2023.
The interventions:
The one-year intervention: A multifactorial family-centered lifestyle intervention offering 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 health care nurses at local treatment centers, at the participants' homes, or in a local clinic.
The three-year intervention: A multifactorial family-centered lifestyle intervention extending up to three years, with clinical visits at local healthcare centers occurring approximately every eight weeks, managed by specialized nurses.
The participants:
Children in the intervention groups were 5 to 10 years of age and participated in one of two different family-centered interventions: a one-year or three-year intervention. Children with obesity living in one of the municipalities, who were never invited to participate in the interventions will act as a reference group for this study. The inclusion visit for this group is defined as the initial observation with obesity.
Obesity will be defined by the International Obesity Task Force (IOTF) guideline as a BMI >= 30 kg/m2 adjusted for age and sex.
The following children will be included in this trial:
- 107 children with obesity treated with the one-year intervention
- 66 children with obesity treated with the three-year intervention
- 146 children with obesity who were not invited to participate in the interventions (non intervention group)
Data-collection and analyses:
Children who participated in one of the two interventions will be identified by using data from TM-Sund and NOVAX. Data recorded at health check-ups at the school containing height and weight will also be extracted from TM-Sund and NOVAX. TM-Sund and NOVAX are data capturing tools used by the community health care nurses employed at the two municipalities. The reference group will be identified in TM-Sund.
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 registries 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. 3518). 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 researchers have no conflict of interest to declare.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The one-year intervention group | – | Behavioral: The one-year interventionChildren aged 5-10 with obesity who participated in the one-year multifactorial family-centered lifestyle intervention. |
| The three-year intervention group | – | Behavioral: The three-year interventionChildren aged 5-10 with obesity who participated in the three-year multifactorial family-centered lifestyle intervention. |
| The non-intervention group | – | –Children with obesity living in one of the municipalities who were never invited to participate in the interventions. |
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 two municipalities in Denmark between August 1st, 2014, and June 30th, 2020. The children have either received treatment with one of the multifactorial family-centered lifestyle interventions or where never invited into the interventions.
Key inclusion criteria (6 listed)
- Inclusion visit between August 1st, 2014, and June 30th, 2020.
- Obesity at time of referral as defined by the IOTF guideline as a BMI >= 30 kg/m2 adjusted for age and sex.
- Obesity at time of referral as defined by the IOTF guideline as a BMI >= 30 kg/m2 adjusted for age and sex.
- Age between 5 and 10 years at inclusion visit.
- A completed DNWQ within a timeframe of 10 months prior to 2 months after inclusion.
Key exclusion criteria (1 listed)
- Children declining 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 |
|---|---|---|
| The one-year 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 | The one-year intervention group |
| The three-year interventionA multifactorial family-centered lifestyle intervention extending up to three years, with clinical visits at local healthcare centers which included repeatedly visits (up to 8 times / year). The intervention was managed by specialized nurses. | Behavioural | The three-year 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: Annually from August 1st, 2014, to February 1st, 2023)
The impact on psychosocial well-being will be assessed with responses to specific questions regarding psychosocial well-being related to school from the DNWQ at time of inclusion and at follow-up. 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 four questions have been selected as our primary outcomes. 1. Question: Are you happy with your school? 2. Questions: Do you feel lonely at school? (0-3 grade) Do you feel lonely? (4-9 grade) 3. Question: Is anyone teasing you so that you feel sad? (0-3 grade) Have you been bullied this school year? (4-9 grade) 4. Question: Does your stomach ache when you are at school? (0-3 grade) How often does your stomach ache? (4-9 grade)
1 secondary 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: Annually from August 1st, 2014, to February 1st, 2023)
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 Aug 2024.
- Individual participant dataSharing planned: Undecided. Participant data (IPD) will be available on reasonable request.
Related trials for Pediatric Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
RecruitingPhase 3
Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)
Obesity
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
RecruitingPhase 3
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
Obesity, Overweight
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 6 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 15 Aug 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: 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?
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 Aug 2024.