NCT05345353

Brief Summary

Childhood obesity has been associated with increased risk of both continued excess body weight, development of non-communicable lifestyle diseases and impaired mental health. Approximately 800 children with obesity were treated with a municipality based family-centered lifestyle intervention in the time period 2010-2020. In the same time period, approximately 2000 children with obesity who did not receive any treatment have been identified. Our aim is to investigate the efficiency of the two interventions and compare those to children not receiving any treatment. We will use data from both the clinical visits at the municipality health care workers and data from Statistics Denmark.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,898

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

April 19, 2022

Last Update Submit

April 25, 2022

Conditions

Keywords

Lifestyle InterventionLong term follow-upWeight developement

Outcome Measures

Primary Outcomes (1)

  • Weight development as assessed by BMI z-score:

    The weight development will be assessed in all children, who participated in one of two different lifestyle interventions compared to children with no intervention. The weight development will also be assessed in subgroups of the cohort, such as children who did not completed the intervention or who not did participation in the exercise part of the interventions.

    The Aarhus Protocol: 1st of January 2010 to 1st of June 2020. The Randers Protocol: 1st of January 2014 to 1st of June 2020. No Intervention: 1st of January 2010 to 1st of June 2020.

Secondary Outcomes (1)

  • Socioeconomic differences, subgroup differences

    Socioeconomic data will be assessed at the time of inclusion for each subject.

Study Arms (3)

The Aarhus Protocol, Aarhus municipality:

Children with obesity who participated in a family-centered multicomponent lifestyle intervention - The Aarhus Protocol, Aarhus Municipality

Behavioral: Fat For Fight (FFF), The Aarhus Protocol

The Randers Protocol, Randers municipality:

children with obesity who participated in a family-centered multicomponent lifestyle Intervention - The Randers Protocol: Randers Municipality

Behavioral: The Children's Obesity Clinic Treatment (TCOCT), The Randers Protocol

No intervention

Children with obesity who didn't participate in a lifestyle intervention delivered by the municipality.

Interventions

A multicomponent family-centered lifestyle intervention which included visits at home and weekly supervised physical activity. Intervention duration - one year maximum

The Aarhus Protocol, Aarhus municipality:

A multicomponent family-centered lifestyle intervention which included repeatedly visits (up to 8 times / year). Intervention duration - three years maximum

The Randers Protocol, Randers municipality:

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children with obesity, 4-18 years of age living in Aarhus or Randers municipality between 2010-2020. The children have either received treatment with a community based lifestyle intervention or received no treatment.

You may qualify if:

  • Obesity (BMI z-score above the 99. percentile for gender and age)

You may not qualify if:

  • No Obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center Aarhus

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

CD36 Antigens

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Platelet Membrane GlycoproteinsMembrane GlycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesFatty Acid Transport ProteinsMembrane Transport ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsMembrane ProteinsReceptors, Cell SurfaceReceptors, ImmunologicScavenger Receptors, Class BReceptors, ScavengerReceptors, LDLReceptors, Lipoprotein

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Medical Doctor, PhD student at Institute for Clinical Medicin, Health, AU

Study Record Dates

First Submitted

April 19, 2022

First Posted

April 25, 2022

Study Start

February 1, 2021

Primary Completion

February 1, 2022

Study Completion

March 1, 2022

Last Updated

April 29, 2022

Record last verified: 2022-04

Locations