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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 554
- 试验地点
- 10
- 主要终点
- Quality of life (PedsQL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Quality of life (PedsQL)
时间窗: End of intervention (12 months)
Quality of life assessed by Pediatric Quality of Life Inventory (PedsQL)
BMI SDS
时间窗: End of intervention (12 months)
BMI SDS assessed according to the International Obesity Task Force cut-offs.
次要结局
未报告次要终点