Weight Development in Children With Obesity After Declining Treatment

NCT05858697 | Completed DMC

• 1 other identifier: 2022-0367531, 2916
• Study Type: observational
• Target: 1,273
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity, Child

Keywords

Lifestyle intervention; refusal of treatment; effect, long term

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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.

Study Arms (3)

Declining group

Children with obesity 5-7 years of age who were invited to the intervention but declined participation.

Other: Declining participation in the Aarhus intervention

Interventions group

Children with obesity 5-7 years of age who accepted and subsequently received treatment.

Behavioral: Participation in the Aarhus intervention

'Non intervention' group

Children with obesity at age 5-7 years living in Aarhus, who were never invited to participate in the lifestyle interventions.

Interventions

Declining participation in the Aarhus intervention OTHER

Each year a fraction of the children invited into the Aarhus intervention decline to participated.

Declining group

Participation in the Aarhus intervention BEHAVIORAL

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.

Interventions group

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• years of age
• obesity at baseline as defined by the International Obesity Task Force (IOTF) as BMI ≥ 30kg/m2 for age and gender.

You may not qualify if:

• More than 6 months between a baseline visit and the next observation with a BMI z score
• First declining and subsequently accepting the intervention.

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus County, Denmark: collaborator

Study Sites (1)

Steno Diabetes Center Aarhus

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Pediatric Obesity; Treatment Refusal

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 15, 2023
• Study Start: January 1, 2010
• Primary Completion: June 30, 2020
• Study Completion: April 25, 2023
• Last Updated: May 15, 2023

Record last verified: 2023-01

Locations

DK (1)