Evaluating the Efficacy of the Evira Treatment Tool for Childhood Obesity Treatment - a 26- Week Single Arm Interventional Study in Abu Dhabi, United Arab Emirates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in degree of obesity
研究概览
简要总结
Evira is a digital treatment tool developed for treatment of childhood obesity. Through daily weighings at home using a special scale together with a message function in the Evira application, parents and the clinicians can easily follow the child's weight development. The primary aim of this study is to evaluate its efficacy for childhood obesity treatment in Abu Dhabi, with a secondary objective to establish non-inferiority compared to outcomes in a cohort in Stockholm, Sweden.
详细描述
Obesity remains a critical global health concern. Traditional treatment often yields limited results, necessitating innovative solutions.
In this study, participants aged 6-15.9 years with obesity at the Sheikh Shakabout Medical City in Abu Dhabi, will be asked for participation. If agreed to participate, they will use a digital treatment tool as a complement to behavioral treatment.The treatment is based on outcome goals set by the treatment staff together with the family. Briefly, the families follow the child's weight outcome via daily weight measurements and the outcome is shown graphically in the mobile application as BMI SDS with the BMI SDS weight goals as background. The staff will provide support to the families via the app. The staff is encouraged to react and contact the families if the weight goals are not reached or if they fail to perform the daily weighings. Regular physical visits at baseline, 3 months, and 6 months, alongside questionnaire assessments, will facilitate data collection via electronic case report forms.
The purpose of this study is to evaluate the treatment tools efficacy for childhood obesity treatment in Abu Dhabi. Furthermore, the study aims to establish non-inferiority compared to outcomes in Stockholm, Sweden (referred to as the "Stockholm cohort"), on 107 children and adolescents who were treated with the same treatment method between October 2018 and August 2019 (Clinicaltrials.gov ID: NCT04323215).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >6.0 and <16.0 years of age at inclusion
- •Obesity according to International Obesity Task Force (IOTF)
- •Willingness to participate in an obesity treatment proof of concept trial
- •Family ability to communicate e.g. write and read messages in the mobile application
- •Parents having a smart phone and an email address
排除标准
- •Morbid obesity defined as iso-BMI>40 kg/m2 independently of age
- •Endocrine disorders other than well controlled hypothyroidism
- •Metabolic disorders of importance for weight control
- •Treatment for depression and other psychiatric disorders during the last 6 months before inclusion
- •Pharmacological treatment of importance for weight control
- •Hypothalamic or monogenic obesity, e.g. syndromes and Mb Down
- •Severe neuropsychiatric disorders that could affect study compliance
- •Eating disorders requiring therapy during the last six months before inclusion or observed at the inclusion screening.
结局指标
主要结局
Change in degree of obesity
时间窗: From start of treatment to six months follow-up
Measured by BMI standard deviation score.
次要结局
- Proportion of individuals reaching a clinically significant change in relative weight(From start of treatment to six months follow-up)
- Proportion of individuals in obesity remission(From start of treatment to six months follow-up)
- The use of the support tool - weighings(From start of treatment to six months follow-up)
- The use of the support tool - text messages(From start of treatment to six months follow-up)
- Number of physical visits(From start of treatment to six months follow-up)
- Number of cancelation of physical visits(From start of treatment to six months follow-up)
- Number of patients not showing up to physical visits(From start of treatment to six months follow-up)
- Psycho-social health measures(From start of treatment to six months follow-up)
- Drop-out rate(From start of treatment to six months follow-up)
- Change in degree of obesity. Abu Dhabi cohort vs. Stockholm cohort(From start of treatment to six months follow-up)