Childhood Obesity, Lifestyle Interventions and Weight Development

April 25, 2022 updated by: Rasmus Møller Jørgensen, University of Aarhus

Weight Development in Children With Severe Obesity After Participation in Two Different Municipal Family-centered Lifestyle Interventions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Childhood obesity often track into adolescence and adulthood resulting in elevated risk of non-communicable lifestyle diseases (e.g. type 2 diabetes). Furthermore, children with obesity are also at risk for impaired mental health (i.e. reduced cognitive function and happiness) and psychological ill-being (i.e. depression, anxiety) compared to their lean peers. Finding methods to efficiently, and in a sustainable way, to treat childhood overweight or obesity has not yet been described.

The aim of this study is therefore to investigate the long term effects of two well established lifestyle interventions on weight development (BMI z-score) and to compare socioeconomic parameters between the intervention groups and children who did not received treatment.

The interventions:

The Aarhus protocol: A multicomponent family-centered lifestyle intervention including visits at home and an opportunity for weekly supervised training. The duration of the intervention was a maximum of one year. Data is available from January 2010.

The Randers Protocol: A multicomponent family-centered lifestyle intervention including repeated visits (up to 8 times each year). The duration of the intervention was a maximum of three years. Data is available from January 2014.

The participants:

Inclusion criteria were children aged 4-18 years with obesity (BMI z-score above the 99. percentile for gender and age) living in Aarhus or Randers municipality.

Between 2010-2020, the following children were included in this trial:

  • app. 500 children treated with the Aarhus Protocol,
  • app. 300 children treated with the Randers Protocol and
  • app. 2000 children in Aarhus who did not participate in a lifestyle intervention delivered by the municipality.

The children were examined routinely (a minimum of three times during elementary school) by the school nurse and anthropometrics were collected in NOVAX. NOVAX is a broadly used IT system which stores and delivers data on childhood anthropometrics to the national the database.

Data collection & analyses:

The weight development will be assessed using data from the municipality and data from the NOVAX. Socioeconomic status will be assessed using register data from Statistics Denmark.

Ethics & permissions:

The local committee on health ethics have approved the overall project and data transfer (rec.no 1-45-70-27-2) The project is internally reported to the University of Aarhus (rec no. 2596) The project has achieved approval from The Danish Data Protection Agency and the Principal Investigator has been granted accessed to data from registers from Danish Statistics.

The project has been reported to ClinicalTrials.gov. The researchers have no conflict of interest to declare.

Study Type

Observational

Enrollment (Actual)

2898

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Steno Diabetes Center Aarhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No Obesity
  • Treatment started outside the inclusion period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
A multicomponent family-centered lifestyle intervention which included visits at home and weekly supervised physical activity. Intervention duration - one year maximum
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
A multicomponent family-centered lifestyle intervention which included repeatedly visits (up to 8 times / year). Intervention duration - three years maximum
No intervention
Children with obesity who didn't participate in a lifestyle intervention delivered by the municipality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight development as assessed by BMI z-score:
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Socioeconomic differences, subgroup differences
Time Frame: Socioeconomic data will be assessed at the time of inclusion for each subject.

socioeconomic differences between children in the interventions, different subgroups and children with no intervention.

Socioeconomic data will be collected from Danish Statistics.
Socioeconomic data will be assessed at the time of inclusion for each subject.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Randers Municipality, Denmark
Aarhus Kommune

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

April 19, 2022

First Submitted That Met QC Criteria

April 22, 2022

First Posted (Actual)

April 25, 2022

Study Record Updates

Last Update Posted (Actual)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2596

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

participant data (IPD) will be available on reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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