Weight-loss Treatment Program in Children and Adolescents

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 2 to 19 years
• All sexes
• Healthy volunteers accepted
• Child, Adult

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.

About this study

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

Conditions

Childhood Obesity, Health Behavior, Weight Loss, Motivation

Being tested

ROS "chubby and healthy" - a multidisciplinary family-based weight-loss treatment program, Overweight Clinic for Children and Adolescents, Family Nutrition Guidance

Keywords

Childhood obesity treatment

Medical subject headings

Pediatric Obesity, Health Behavior, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

  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 AdolescentsBehavioural

  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 GuidanceBehavioural

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

   Measured: December 2022 - February 2026

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted30 Mar 2023
2. Study start1 Jan 2010
3. Primary completion30 Dec 2022
4. Study completion30 Mar 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Childhood ObesityStudies of the same condition, open and under way.
• More trials run by University of AarhusThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.