Holbæk Obesity Treatment (HOT) Versus Conventional Obesity Treatment (COT) in Children With Overweight or Obesity.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Childhood Overweight and Obesity

Intervention / Treatment
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* Behavioral: Holbæk Obesity Treatment
* Behavioral: Conventional Obesity Treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HOT<br>Holbæk Obesity Treatment | Behavioral: Holbæk Obesity Treatment<br>* 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.<br>|
| Active Comparator: COT<br>Conventional Obesity Treatment | Behavioral: Conventional Obesity Treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |