Evaluation of a Digital Treatment Tool in Combination With Obesity Medications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Change in BMI SDS
研究概览
简要总结
The goal of this clinical trial is to evaluate the effect of adding a digi-physical treatment tool as a complement to the local treatment with obesity medication in adolescents with obesity. The main question it aims to answer is:
- Can a combination of a digi-physical treatment tool and obesity medication improve treatment outcomes for patients with obesity compared to patients treated with obesity medications alone?
This is a randomized controlled two-arm multicenter study where participants will be randomized to the intervention group (digi-physical treatment+medication) or control group (medication only). Participants will be followed for six months.
详细描述
Obesity is a complex and multifactorial disease, highlighting the need to develop treatment strategies that achieve more sustainable and effective outcomes. Treatments with the medications liraglutide and semaglutide have been tested, showing effects of -0.23 and -1.10 BMI SDS units, respectively, after approximately one year in individuals aged 12-17 years. These results are significantly better than those achieved with conventional treatment, where the effect for adolescents over 12 years is close to zero. However, long-term results indicate that many patients, after discontinuing medication, quickly return to the same degree of obesity they had at the start of the study.
Obesity medications can be effective for many patients, but challenges remain in achieving better treatment outcomes for more individuals. This underscores the need to evaluate whether the effect can be optimized by combining medication with digital treatment tools.
Evira is a digital treatment tool that enables close monitoring of objective treatment outcomes and continuous communication between healthcare professionals and families. The tool includes daily measurements conducted in the home of the patient on a measuring device that do not display any numbers. The device is linked to a mobile app where weight trends are displayed as a moving average in the form of BMI standard deviation score (BMI SDS). The app also provides an individualized target curve, visualizing the expected weight trajectory. Since weight changes in growing children are complex to interpret, BMI SDS is used as a standard metric. Objective data from the measuring device are also automatically transmitted to a clinic interface, enabling direct communication between the clinic and the family via the app.
This study is a randomized controlled two-arm multicenter trial conducted across multiple centers in Sweden that use liraglutide and semaglutide. Patients will be randomized in a 2:1 ratio, with two-thirds allocated to the intervention group and receiving medications combined with the Evira digital treatment tool, and one-third allocated to the control group, receiving medications with standard clinic support. Patients will be followed for six months. Data collection will include physical examinations, background information, and electronically distributed questionnaires administered to both groups.
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
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients offered liraglutide or semaglutide in accordance with the clinic's routines.
- •Aged 12-17 years at the time of inclusion.
- •The family agrees to participate in a clinical study.
排除标准
- •Endocrine disorders other than well-controlled hypothyroidism.
- •Severe neuropsychiatric disorders that may affect adherence to the study.
- •Eating disorder requiring treatment within the last six months before inclusion or observed during screening prior to inclusion.
- •Somatic conditions that may complicate the evaluation of treatment outcomes, such as patients on irregular oral corticosteroid treatment.
- •Hypothalamic or monogenic obesity, and genetic syndromes such as Down syndrome.
- •Patients deemed unsuitable for participation by the responsible physician.
研究组 & 干预措施
Obesity medication liraglutide or semaglutide combined with digi-physical treatment Evira
Patients randomized to this group will receive liraglutide or semaglutide in combination with a digi-physical treatment tool, named Evira. Patients will be provided with a digitless measuring scale intended for daily use at home. They will be able to communicate with clinical staff at pivotal moments.
干预措施: Digi-physical treatment tool, Evira (Device)
Obesity medication liraglutide or semaglutide combined with digi-physical treatment Evira
Patients randomized to this group will receive liraglutide or semaglutide in combination with a digi-physical treatment tool, named Evira. Patients will be provided with a digitless measuring scale intended for daily use at home. They will be able to communicate with clinical staff at pivotal moments.
干预措施: Obesity medication with liraglutide or semaglutide (Drug)
Control group
Patients randomized to this group will receive liraglutide or semaglutide treatment according to the clinic's standard procedures.
干预措施: Obesity medication with liraglutide or semaglutide (Drug)
结局指标
主要结局
Change in BMI SDS
时间窗: From start of treatment to six months follow-up
Weight and height will be combined to report BMI in kg/m\^2 for analyzing change in BMI standard deviation score.
次要结局
- Proportion achieving less favorable reduction in BMI SDS(From start of treatment to six months follow-up)
- Treatment Adherence(From start of treatment to six months follow-up)
- Side effects(From start of treatment to six months follow-up)
- Professionals perception of the digital tool(From start of treatment to six months follow-up)
- Patients perception of the treatment and digital tool(From start of treatment to six months follow-up)
- Patients Quality of life(From start of treatment to six months follow-up)
研究者
Pernilla Danielsson
Principal investigator
Karolinska Institutet