Weight Development in Children With Obesity After Declining Participation in a Community-based Lifestyle Intervention.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 1,273
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief 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. 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)
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 5 Years to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •More than 6 months between a baseline visit and the next observation with a BMI z score
- •First declining and subsequently accepting the intervention.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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,(Baseline visit between 1st of January 2010 to 30th of June 2020.)