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NOT YET RECRUITING
NCT07857018

Long-term Follow-up After Childhood Obesity

Sponsor: Ulla Toft

View on ClinicalTrials.gov

Summary

The goal of this observational study is to learn about the long-term effects on health and well-being of treatment for overweight in childhood or adolescence using the Children's Obesity Clinic Treatment protocol (the Holbæk Model) (HM). The study has two parts: * An active follow-up study, where participants are invited to take part in new measurements and questionnaires * A register-based study, which uses existing data on diagnoses, medication use, and school well-being The submitted protocol primarily focuses on the active follow-up study. The register-based study covers diagnoses, medication use, and school-related well-being and is described in the section "Detailed description". In the active follow-up study, researchers will examine: * Body measurements such as height, weight, and waist circumference * Body composition * Psychosocial well-being and mental health * Eating behaviors in young adults Participants will be followed for up to 20 years after treatment initiation. Where possible, results will be compared with a group of people of the same age from the same area who did not receive this treatment. This will help show whether their development differs from that of the general population. The aim is to use the findings to improve future follow-up care and support for people who were treated for overweight as children. The study includes two groups: 1. A treatment group of individuals treated at the Holbæk Pediatric Department between 2008 and 2025 2. A comparison group from the general population, recruited between 2010 and 2016 The study will take place in two phases: * A pilot phase (about 1.5 years) to test procedures and recruitment * A main phase (about 3 years) Participants are invited to one follow-up visit. During this visit: * Body measurements will be taken * Body composition will be assessed * Participants will complete questionnaires The study team will ensure that all participants are treated respectfully and without stigma. Flexible options, including home visits, are offered to make participation easier.

Official title: Assessing Future Trajectories of Health and Well-being Among Early Childhood Obesity Treatment Recipients

Key Details

Gender

All

Age Range

7 Years - 30 Years

Study Type

OBSERVATIONAL

Enrollment

6100

Start Date

2026-09

Completion Date

2039-12

Last Updated

2026-10-05

Healthy Volunteers

Yes

Interventions

OTHER

The AFTER study - Assessing Future Trajectories of hEalth- and well-being among childhood obesity treatment Recipients

The study design is observational, with a single long-term follow-up measurement and register data. The AFTER study includes long-term follow-up for prior patients treated with "The Holbæk-model" (The Holbaek Study), which is a treatment approach for pediatric obesity developed and implemented since 2008 at the Department of Pediatrics at Holbæk Hospital in Denmark. The Holbæk-model a is family-centered treatment plan to individually balance and mitigate obesity-related risk factors in the child's life by providing individually tailored lifestyle advice in a detailed plan. Patients aged \<20 years with age- and sex-specific body mass index (BMI) above the 99th percentile are eligible for treatment, and these persons are usually referred by their general practitioner or school nurse. Visit frequency is highly variable, depending on the individual patient's needs. The treatment has no time limit, but patients can remain in treatment only until age 24.