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

Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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 th

Первичные конечные точки

• BMI SDS [Срок оценки: End of intervention (12 months)]
• Quality of life (PedsQL) [Срок оценки: End of intervention (12 months)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Дания · 5 центров

• Municipality heath center, Ballerup — Ballerup Municipality
• Municipality health center, Frederikssund Kommune — Frederikssund
• Municipality health center, Guldborgsund — Nykøbing Falster
• Municipality heath center, Lejre — Lejre
• Municipality heath center, Solrød — Solrød Strand

Идентификаторы

NCT: NCT05038683 · HOT vs COT trial

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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