Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555380
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Childhood Obesity Lifestyle Interventions and Psychosocial Well-being
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Multifactorial Lifestyle Interventions on Psychosocial Well-being for Children Living With Obesity
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 ie 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 kgm2 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 recno 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
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 kgm2 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 recno 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None