Holbæk Obesity Treatment (HOT) Versus Conventional Obesity Treatment (COT) in Children With Overweight or Obesity.
Recruiting · NCT05038683 · Interventional (participants receive a specific treatment) · Lead sponsor: Holbaek Sygehus
View the official record on ClinicalTrials.gov →Interventions studied
Conventional Obesity TreatmentHolbæk Obesity Treatment
What this trial is about
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.
Who can take part
Age range
6 Years to 11 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
5 locations listed.
- Municipality heath center, Lejre - Lejre, Denmark
- Municipality heath center, Solrød - Solrød Strand, Denmark
- Municipality heath center, Ballerup - Ballerup Municipality, Ballerup, Denmark
- Municipality health center, Frederikssund Kommune - Frederikssund, Frederikssund, Denmark
- Municipality health center, Guldborgsund - Nykøbing Falster, Guldborgsund, Denmark