Weight-loss Treatment Program in Children and Adolescents

NCT ID: NCT05790174

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-01
• Study Completion Date: 2026-03-30

Brief Summary

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.

Conditions

Childhood Obesity; Health Behavior; Weight Loss; Motivation

Study Design

• Observational Model Type: FAMILY_BASED
• Study Time Perspective: RETROSPECTIVE

Interventions

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.

Intervention Type: BEHAVIORAL

Overweight Clinic for Children and Adolescents

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.

Intervention Type: BEHAVIORAL

Family Nutrition Guidance

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Healthy weight in children

Identifier Type: -

Identifier Source: org_study_id