Weight-loss Treatment Program in Children and Adolescents

August 29, 2025 updated by: University of Aarhus

Healthy Weight Development Among Children and Adolescents in the Central Denmark Region

The study will evaluate the effect of an existing municipality-based and hospital-based obesity treatment in children and adolescents in relation to weight loss and motivation. This is to ensure that children who have developed obesity have the possibility to obtain a healthier lifestyle, including a healthier body weight during their school years. This study will test whether an obesity treatment program designed for school children can reduce the degree of overweight in children and adolescents with overweight and obesity.

Study Overview

Study Type

Observational

Enrollment (Estimated)

700

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

2 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of children and adolescents with overweight or obesity primarily living in Viborg, Skive, and Holstebro municipalities. Participants were offered either municipality-based treatment or a specialized hospital-based program. Municipality-based programs were delivered at local schools or health centers by health nurses or dietitians. The hospital-based program, offered by the Central Denmark Region, required referral from a general practitioner, school health nurse, or community-based physician.

Description

Inclusion Criteria:

  • 2-18 years old
  • BMI SDS above the 90th percentile

Exclusion Criteria:

  • Reached a BMI SDS below the 75th percentile
  • Attained 19 years of age

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in BMI during weight-loss program of childhood overweight and obesity
Time Frame: December 2022 - February 2026
The primary objective is to investigate the changes in BMI z-score among children and adolescents with overweight or obesity who participated in a municipality-based or hospital-based weight-loss program, and whether existing characteristics of the child and parents at baseline modify this association. In addition we also want to characterize those who do not respond to treatment either because they gain or regain BMI z-score, or drop-out of the weight-loss program.
December 2022 - February 2026

Collaborators and Investigators

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

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)

January 1, 2010

Primary Completion (Actual)

December 30, 2022

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

February 14, 2023

First Submitted That Met QC Criteria

March 16, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Estimated)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 29, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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