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NCT07857018Not yet recruiting

Long-term Follow-up After Childhood Obesity

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

Source: ClinicalTrials.gov · Last updated 5 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
6100 (estimated)
First submitted
4 Sept 2026
Start date
Sept 2026
Primary completion date
Dec 2039
Lead sponsor
Ulla Toft
Diseases
Obesity
NCT number
NCT07857018

What you commit to

  • Study type: Observational
  • Planned participants: 6100
  • From Sept 2026 to the primary completion date, Dec 2039
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previously declined to be contacted for future research purposes
    • Reference cohort:
  • Previously declined to be contacted for future research purposes

Other

  • Died
  • Living abroad
  • Died
  • Living abroad

Who the study is looking for

  • At least one treatment contact for childhood overweight or obesity at the Children's Obesity Clinic at Holbæk Hospital during 1.1.2008-31.12.2025
  • Age 5 -17 at treatment initiation
  • Age 7 - 30 years at invitation to follow-up
  • Participated in the reference cohort previously established by Holbæk Hospital during year 2010-2016.
  • Age 5-17 at inclusion in reference cohort
  • Age 18-30 years at invitation to follow-up

Criteria the registry did not label

  • Treatment cohort:

Age in the registry: 7 years to 30 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.