NCT05858697|CompletedDMC
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Sponsor study identifier
observational
1,273
1 country
1
Study Start
January 1, 2010
Actual (reported)Primary Completion
June 30, 2020
Actual (reported)Study Completion
April 25, 2023
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 25, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2010
Actual (reported)June 30, 2020
Actual (reported)April 25, 2023
Actual (reported)April 26, 2023
Actual (reported)May 15, 2023
Actual (reported)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.
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
Baseline visit between 1st of January 2010 to 30th of June 2020.
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.
Children with obesity 5-7 years of age who were invited to the intervention but declined participation.
Children with obesity 5-7 years of age who accepted and subsequently received treatment.
Children with obesity at age 5-7 years living in Aarhus, who were never invited to participate in the lifestyle interventions.
Each year a fraction of the children invited into the Aarhus intervention decline to participated.
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.
This study will include children with obesity from the city of Aarhus with a baseline visit between January 1st 2010 and June 30th 2020 children.
Steno Diabetes Center Aarhus
Aarhus N, 8200, Denmark
1,273 participants (actual enrollment reported by the registry).
First Submitted
April 26, 2023
First Posted
May 15, 2023
Study Start
January 1, 2010
Actual (reported)USDA Healthy Caregivers/Healthy Children: A Childhood Obesity Prevention Program
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 30, 2020
Actual (reported)Study Completion
April 25, 2023
Actual (reported)Last Updated
May 15, 2023
Record last verified: 2023-01
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Source: ClinicalTrials.gov.
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