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OpenTrials
Active, Not Recruiting

NCT Number: NCT05790174

Weight-loss Treatment Program in Children and Adolescents

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ROS "chubby and healthy" - a multidisciplinary family-based weight-loss treatment program

Behavioral

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.

Overweight Clinic for Children and Adolescents

Behavioral

The 'Overweight Clinic for Children and Adolescents' program at the municipal Health Center is based on the family-centered, multidisciplinary protocol developed by the Children's Obesity Clinic (TCOCT) at Holbæk Hospital. The intervention is individualized, informed by medical history and a structured questionnaire-based interview to identify behavioral and lifestyle changes needed to reduce the child's degree of overweight or obesity. The program consists of individual consultations every 6-8 weeks over approximately 12-18 months, with additional follow-up appointments as needed.

Family Nutrition Guidance

Behavioral

This treatment program is based on the Danish Health Authority's recommendations for lifestyle interventions. It follows a family-centered approach tailored to the family's everyday life and habits, focusing on sustainable changes in diet and physical activity. The program provides guidance on healthy eating, physical activity, and strategies for integrating these behaviors into daily routines.

The program included the entire family and began with school-based consultations delivered by health nurses during the first three months, followed by additional sessions at the municipal Health Center when needed. Families were offered 4-6 consultations within the first six months and follow-up sessions twice a year.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2022
Study completion
2026
First posted
Mar 30, 2023
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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