Weight Development in Children With Obesity After Declining Treatment
NCT ID: NCT05858697
Last Updated: 2023-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1273 participants
OBSERVATIONAL
2010-01-01
2023-04-25
Brief Summary
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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).
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Detailed Description
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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
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Study Design
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COHORT
OTHER
Study Groups
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Interventions group
Children with obesity 5-7 years of age who accepted and subsequently received treatment.
Participation in the Aarhus intervention
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.
'Non intervention' group
Children with obesity at age 5-7 years living in Aarhus, who were never invited to participate in the lifestyle interventions.
No interventions assigned to this group
Declining group
Children with obesity 5-7 years of age who were invited to the intervention but declined participation.
Declining participation in the Aarhus intervention
Each year a fraction of the children invited into the Aarhus intervention decline to participated.
Interventions
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Declining participation in the Aarhus intervention
Each year a fraction of the children invited into the Aarhus intervention decline to participated.
Participation in the Aarhus intervention
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.
Eligibility Criteria
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Inclusion Criteria
2. obesity at baseline as defined by the International Obesity Task Force (IOTF) as BMI ≥ 30kg/m2 for age and gender.
Exclusion Criteria
2. First declining and subsequently accepting the intervention.
5 Years
7 Years
ALL
Yes
Sponsors
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Aarhus County, Denmark
OTHER
University of Aarhus
OTHER
Responsible Party
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Locations
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Steno Diabetes Center Aarhus
Aarhus N, , Denmark
Countries
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Other Identifiers
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2022-0367531, 2916
Identifier Type: -
Identifier Source: org_study_id
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