An interventional study of Holbæk Obesity Treatment and Conventional Obesity Treatment in Childhood Overweight and Obesity, sponsored by Holbaek Sygehus. Recruiting at 5 sites in Denmark. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2025-04-20.
Sponsored by Holbaek Sygehus · Not applicable, Interventional, and Treatment
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.
Obesity is a chronic, progressive, and severe disease that compromises growth, development, and the general health and well-being of children, adolescents, and adults all around the globe. Current treatment within this field varies considerably, but the prevailing concept is that treatment should be lifelong with a focus on implementing and maintaining changes regarding diet, physical activity, sedentary behavior, sleep, etc. The Holbæk Obesity Treatment (HOT) is built on the understanding that obesity is a complex chronic disease regulated by a neuroendocrine system, where weight-reducing actions initiate counteractive mechanisms to defend fat mass. Conventional obesity treatment (COT) is based on a view that obesity results from energy imbalances and focuses on motivation, few changes at a time, and a narrative approach towards healthy energy intake and physical activity. These two approaches represent fundamentally different treatments of overweight and obesity.
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
This study's planned enrollment of 554 is above the median of 100 across 870 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Holbaek Sygehus is the lead sponsor of 27 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Holbæk Obesity Treatment
Behavioral: Holbæk Obesity Treatment
Conventional Obesity Treatment
Behavioral: Conventional Obesity Treatment
Obesity is a chronic, progressive, severe, recidivistic, and complex disease, which mandates that children and adolescents with overweight or obesity have access to a professional medical healthcare service as other pediatric chronic diseases, implying a lifelong course of treatment. The HOT method is further based on the physiological insight into the endocrine regulation of fat mass; especially on how the body adapts when it is challenged by weight loss. These insights include an understanding where the body shifts into an energy-preserving mode when the individual is initiating weight-reducing actions, such as a reduced caloric intake or an increased level of physical activity, which has numerous impacts on communication and pedagogy. HOT is administered by healthcare nurses and dietitians at healthcare centers in Danish municipalities. Each treatment will be conducted as face-to-face sessions totalling a range of six to 12 hours for 12 months.
Obesity is viewed as a chronic disease that is ultimately thought to result from an imbalance between energy intake and energy expenditure. However, multiple factors, both environmental and genetic, are thought to influence the disease as well. As obesity reflects energy imbalances, the treatment plan should be designed to induce a slightly negative energy balance by focusing on diet, physical activity, and inactivity through behavior change. Taking one step at a time, will in the end lead to the same energy balance result (i.e. weight loss) and will be more sustainable for the participant whose motivation is absolutely pivotal in this process. COT is administered by healthcare nurses and dietitians at healthcare centers in Danish municipalities. Each treatment will be conducted as face-to-face sessions totalling a range of six to 12 hours for 12 months.
BMI SDS
BMI SDS assessed according to the International Obesity Task Force cut-offs.
Time frame: End of intervention (12 months)
Quality of life (PedsQL)
Quality of life assessed by Pediatric Quality of Life Inventory (PedsQL)
Time frame: End of intervention (12 months)
Symptoms of depression and anxiety
Symptoms of depression and anxiety assessed with the questionnaire RCADS.
Time frame: End of intervention (12 months)
Serious adverse events (SAE)
Proportion of participants with one or more SAEs defined as any adverse event that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in persistent or significant disability or incapacity.
Time frame: End of intervention (12 months)
Anorexia or bulimia
Proportion of participants with a clinical diagnosis of anorexia or bulimia
Time frame: End of intervention (12 months)
School absence
Number of days absent from kindergarten and school (excluding holidays).
Time frame: End of intervention (12 months)
Body composition
Body composition, defined as % body fat by using bioelectrical impedance analysis (BIA)
Time frame: End of intervention (12 months)
Waist circumference
Waist circumference
Time frame: End of intervention (12 months)
Systolic blood pressure
Systolic blood pressure
Time frame: End of intervention (12 months)
Diastolic blood pressure
Diastolic blood pressure
Time frame: End of intervention (12 months)
Serum leptin
Concentrations of serum leptin
Time frame: End of intervention (12 months)
Total cholesterol
Concentrations of serum total cholesterol
Time frame: End of intervention (12 months)
Low density lipoprotein (LDL)
Concentrations of serum low density lipoprotein (LDL) cholesterol
Time frame: End of intervention (12 months)
Triglycerides
Concentrations of serum triglycerides
Time frame: End of intervention (12 months)
Insulin
Concentrations of serum insulin
Time frame: End of intervention (12 months)
Plan to share: Yes — After the results have been published, the aim is to make a depersonalised dataset publicly available on e.g. ClinicalTrials.gov and/or the European Union (EU) Zenodo database (https://zenodo.org/). The final choice will reflect which platform(s) that are compliant with current legislation at that time.
Supporting information: Study protocol, Statistical analysis plan
Time frame: When the results have been published
Access criteria: Researchers with a protocol for their planned study
No publications or documents are linked to this record.
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Holbaek Sygehus