Holbæk Obesity Treatment (HOT) Versus Conventional Obesity Treatment (COT) in Children With Overweight or Obesity.
HOT vs COT
1 other identifier
interventional
554
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2021
CompletedFirst Posted
Study publicly available on registry
September 9, 2021
CompletedStudy Start
First participant enrolled
October 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
April 20, 2025
April 1, 2025
4.2 years
September 7, 2021
April 16, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
BMI SDS
BMI SDS assessed according to the International Obesity Task Force cut-offs.
End of intervention (12 months)
Quality of life (PedsQL)
Quality of life assessed by Pediatric Quality of Life Inventory (PedsQL)
End of intervention (12 months)
Other Outcomes (13)
Symptoms of depression and anxiety
End of intervention (12 months)
Serious adverse events (SAE)
End of intervention (12 months)
Anorexia or bulimia
End of intervention (12 months)
- +10 more other outcomes
Study Arms (2)
HOT
EXPERIMENTALHolbæk Obesity Treatment
COT
ACTIVE COMPARATORConventional Obesity Treatment
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Holbaek Sygehuslead
- Copenhagen Trial Unit, Center for Clinical Intervention Researchcollaborator
- University of Copenhagencollaborator
- Statens Serum Institutcollaborator
- University of Floridacollaborator
- Leeds Beckett Universitycollaborator
- University of Minnesotacollaborator
- Hebrew University of Jerusalemcollaborator
- Frederiksberg University Hospitalcollaborator
Study Sites (5)
Municipality heath center, Ballerup
Ballerup Municipality, Ballerup, 2750, Denmark
Municipality health center, Frederikssund Kommune
Frederikssund, Frederikssund, 3600, Denmark
Municipality health center, Guldborgsund
Nykøbing Falster, Guldborgsund, 4800, Denmark
Municipality heath center, Lejre
Lejre, 4330, Denmark
Municipality heath center, Solrød
Solrød Strand, 2680, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jens-Christian Holm, Ph.d., MD
The Children's Obesity Clinic, Department of Pediatrics, Holbæk Hospital, Part of Copenhagen University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Due to the nature of the interventions, it will not be possible to blind the healthcare providers administering the interventions. We will attempt to blind the participants by not informing them about which intervention group we consider experimental and which group we consider control. However, the participants included in HOT will be governed by a digital solution where Dr. Holm will be identifiable and thus revealing the HOT. In all other aspects of the trial, we will employ blinding, incl. outcome assessment. Statisticians, and investigators drawing conclusions will be fully blinded. We will conduct the statistical analyses with the intervention groups coded as eg. 'A' and 'B'. The steering committee will write two abstracts while the blinding is intact; one assuming the experimental intervention group is 'A' and the control intervention group is 'B', and one assuming the opposite. After these two abstracts have both obtained consensus, the code will be broken.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2021
First Posted
September 9, 2021
Study Start
October 26, 2022
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
April 20, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- When the results have been published
- Access Criteria
- Researchers with a protocol for their planned study
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.