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NCT05790174 Clinical Trial

Weight-loss Treatment Program in Children and Adolescents

Weight Loss Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05790174
Other study ID # Healthy weight in children
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date November 30, 2025

Study information
Verified date February 2023
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study will evaluate the effect of an existing 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 400
Est. completion date November 30, 2025
Est. primary completion date December 30, 2022
Accepts healthy volunteers
Gender All
Age group 2 Years to 19 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• ROS "chubby and healthy" - a multidisciplinary family-based weight-loss treatment program
The weight-loss treatment program "ROS" is family-based and delivered by a multidisciplinary team of physicians, nurses, dieticians, and psychologists. The treatment is based on an individualized tailored plan made together with the family. The plan consists of dietary changes, more physical activity, regular weight checks, and motivational conversations. The program includes options of cooking classes, group session with a psychologist and participation in structured physical activity called "ROS sports" twice a week. Follow up visits are scheduled every 2-3 months at the different health care professionals.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in BMI during weight-loss program of childhood overweight and obesity The primary objective is to investigate the changes in BMI z-score among children and adolescents with overweight or obesity who participated in a 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 - December 2025
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