Comparing two obesity treatment methods for children
Official title: 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.
Run by Holbaek Sygehus · NCT05038683 · Data updated 2026-11-12
This study is testing two different weight loss programs for kids aged 6 to 12 who are overweight to see which one helps them more.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 11 Years |
| Sex | All |
| Enrollment | 554 (estimated) |
| Sponsor | Holbaek Sygehus Academic / other |
| Locations | 5 sites (Ballerup Municipality, Ballerup and 4 other locations) |
| Status | Recruiting |
| Started | October 26, 2022 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | April 20, 2025 |
| Trial ID | NCT05038683 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 6 to under 12 years who are classified as overweight or obese based on BMI percentiles.
✕Probably not a fit
Patients who have participated in multidisciplinary obesity treatment in the past 12 months or have a clinical diagnosis of anorexia or bulimia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The HOT versus COT trial aims to evaluate the effectiveness of two distinct lifestyle interventions for treating childhood overweight and obesity. The Holbæk Obesity Treatment (HOT) focuses on the complex neuroendocrine aspects of obesity, while Conventional Obesity Treatment (COT) emphasizes energy balance and gradual lifestyle changes. This study seeks to minimize bias through an optimal trial design, ultimately aiming to inform clinical practice guidelines in the management of childhood obesity. Participants will be children aged 6 to under 12 years with a BMI at or above the 90th percentile for their age and sex.
Why it matters
Potential benefit: If successful, this study could provide more effective treatment options for childhood obesity, improving health outcomes for affected children.
How similar studies have gone: Other studies have shown varying degrees of success with lifestyle interventions for obesity, but this specific comparison of HOT and COT is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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). * Current or previous clinical diagnosis of either anorexia or bulimia according to ICD-10.
Where it's running
-
Municipality heath center, Ballerup
Ballerup Municipality, Ballerup, Denmark Recruiting -
Municipality health center, Frederikssund Kommune
Frederikssund, Frederikssund, Denmark Recruiting -
Municipality health center, Guldborgsund
Nykøbing Falster, Guldborgsund, Denmark Recruiting -
Municipality heath center, Lejre
Lejre, Denmark Recruiting -
Municipality heath center, Solrød
Solrød Strand, Denmark Recruiting
Study contacts
- Study coordinator: Jens-Christian Holm, Ph.d., MD
- Email: jhom@regionsjaelland.dk
- Phone: +4559484192
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.