- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05790174
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
Status
Active, not recruiting
Conditions
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Healthy weight in children
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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