Weight-loss Treatment Program in Children and Adolescents

NCT05790174 | Active Not Recruiting

• 1 other identifier: Healthy weight in children
• Study Type: observational
• Target: 700
• Locations: 0 countries
• Sites: N/A

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

Keywords

Childhood obesity treatment

Outcome Measures

Primary Outcomes (1)

• 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 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

Interventions

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.

Eligibility Criteria

• Age: 2 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• years old
• BMI SDS above the 90th percentile

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead

Related Publications (1)

• Fogh M, Ostergaard JN, Jorgensen RM, Rossell EL, Eg M, Maindal HT, Toft G, Stovring H, Bruun JM. Long-Term Effect of a Hospital-Based Intervention Program on BMI Trajectories in Danish Children and Adolescents With Overweight and Obesity: A 6-Year Follow-Up. Clin Obes. 2026 Feb;16(1):e70052. doi: 10.1111/cob.70052. Epub 2025 Nov 2.

  PMID: 41177529 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Health Behavior; Weight Loss

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Body Weight Changes

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: March 30, 2023
• Study Start: January 1, 2010
• Primary Completion: December 30, 2022
• Study Completion: March 30, 2026
• Last Updated: September 2, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share