Holbæk Obesity Treatment (HOT) Versus Conventional Obesity Treatment (COT) in Children With Overweight or Obesity.
NCT ID: NCT05038683
Last Updated: 2025-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
554 participants
INTERVENTIONAL
2022-10-26
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HOT
Holbæk Obesity Treatment
Holbæk 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.
COT
Conventional Obesity Treatment
Conventional Obesity Treatment
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.
Interventions
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Holbæk 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.
Conventional Obesity Treatment
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
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Inclusion Criteria
* Age six to \< 12 years at enrolment.
* Signed informed consent from both parents or legal guardians.
Exclusion Criteria
* 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.
6 Years
11 Years
ALL
No
Sponsors
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Copenhagen Trial Unit, Center for Clinical Intervention Research
OTHER
University of Copenhagen
OTHER
Statens Serum Institut
OTHER
University of Florida
OTHER
Leeds Beckett University
OTHER
University of Minnesota
OTHER
Hebrew University of Jerusalem
OTHER
Frederiksberg University Hospital
OTHER
Holbaek Sygehus
OTHER
Responsible Party
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Principal Investigators
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Jens-Christian Holm, Ph.d., MD
Role: STUDY_CHAIR
The Children's Obesity Clinic, Department of Pediatrics, Holbæk Hospital, Part of Copenhagen University Hospital
Locations
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Municipality heath center, Ballerup
Ballerup Municipality, Ballerup, Denmark
Municipality health center, Frederikssund Kommune
Frederikssund, Frederikssund, Denmark
Municipality health center, Guldborgsund
Nykøbing Falster, Guldborgsund, Denmark
Municipality heath center, Lejre
Lejre, , Denmark
Municipality heath center, Solrød
Solrød Strand, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Lotte Stentz, RN
Role: primary
Bodil M Gjøl, RN
Role: primary
Hanne Ryttesgaard, RN
Role: primary
Susan Tanzer, RN
Role: primary
Marthinne Düring, RN
Role: primary
Other Identifiers
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HOT vs COT trial
Identifier Type: -
Identifier Source: org_study_id
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