NCT05038683Recruiting
Holbæk Obesity Treatment (HOT) Versus Conventional Obesity Treatment (COT) in Children With Overweight or Obesity.
Holbæk Obesity Treatment (HOT) Versus Conventional Obesity Treatment (COT) in Children With Overweight or Obesity. An Investigator-initiated, Multi-center, Randomized, Parallel Group, Clinical Superiority Trial With Blinded Outcome Assessment. HOT Versus COT Trial.
Source: ClinicalTrials.gov · Last updated 20 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The HOT versus COT trial aims to compare the effectiveness of two different lifestyle interventions for treatment of childhood overweight and obesity with the purpose of informing future clinical practice guidelines within this field. The aim is to conduct this investigation in an optimal trial design with the lowest possible risk of bias.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 554 (estimated)
- First submitted
- 7 Sept 2021
- Start date
- Oct 2022
- Primary completion date
- Jan 2027
- Lead sponsor
- Holbaek Sygehus
- Diseases
- Obesity
- NCT number
- NCT05038683
What you commit to
- Study type: Interventional
- Planned participants: 554
- From Oct 2022 to the primary completion date, Jan 2027
- 5 sites in 1 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
- Current or previous clinical diagnosis of either anorexia or bulimia according to ICD-10.
Other
- Participation in multidisciplinary obesity treatment (i.e. treatment involving more than one type of healthcare profession) within the past 12 months.
- Having a sibling already enrolled in the HOT versus COT trial.
- Both parents or legal guardians unable to communicate in Danish (written or oral).
- Child unable to communicate in Danish (oral).
Who the study is looking for
- Overweight or obesity defined as BMI corresponding to or above the 90th percentile for age and sex (International Obesity Task Force cut-offs).
- Age six to \< 12 years at enrolment.
- Signed informed consent from both parents or legal guardians.
Age in the registry: 6 years to 11 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Municipality heath center, Ballerup Coordinator of this site? Confirm its status | Ballerup Municipality | Denmark | Recruiting |
| Municipality health center, Frederikssund Kommune Coordinator of this site? Confirm its status | Frederikssund | Denmark | Recruiting |
| Municipality heath center, Lejre Coordinator of this site? Confirm its status | Lejre | Denmark | Recruiting |
| Municipality health center, Guldborgsund Coordinator of this site? Confirm its status | Nykøbing Falster | Denmark | Recruiting |
| Municipality heath center, Solrød Coordinator of this site? Confirm its status | Solrød Strand | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.