Pharmacological Treatment - An Overview of Its Role in Managing Childhood Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Change in BMI SDS over time
研究概览
简要总结
The aim of the study is to examine the effects of pharmacological treatment for obesity on BMI trajectories and metabolic markers among patients in routine clinical care. A retrospective observational study. By collecting and analysing real-life data from the first children and adolescents in Sweden who have been offered pharmacological treatment for obesity, the results can contribute to a better understanding of how these treatments function in practice.
详细描述
Aim
The aim of this sub-study is to evaluate the impact of liraglutide treatment on the trajectory of body mass index (BMI), including BMI according to International Obesity Task Force (IOTF) criteria and BMI standard deviation score (BMI SDS), as well as its effects on cardiovascular risk markers among children and adolescents treated with liraglutide in two Swedish regions. The study seeks to generate real-world evidence on the effectiveness of liraglutide in routine clinical practice.
Study Design
This is a retrospective, observational study based on medical records of children and adolescents who received multidisciplinary obesity care for at least one year and were treated with liraglutide during 2022-2023 at either the Pediatric Clinic in Region Halland or the Regional Childhood Obesity Center at Queen Silvia's Children's Hospital. The study is non-interventional and does not introduce any additional risks beyond standard clinical care. Participation was voluntary, with informed consent obtained from legal guardians and assent from children.
Participants
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents aged 10-18 years with obesity who were offered pharmacological treatment
- •Provided consent to participate
- •Participants with short treatment duration, early adverse effects, or who proceeded to surgery are also included in baseline data
排除标准
- •Hypothalamic obesity
- •Craniopharyngioma
- •Syndromic obesity / monogenic obesity
结局指标
主要结局
Change in BMI SDS over time
时间窗: The primary outcome, change in BMI SDS, will be evaluated at -12 months (pre-baseline), at baseline (0 months), and at +3-6, +12, and +18 months following treatment initiation.
次要结局
未报告次要终点
研究者
Lovisa Sjogren
MD PhD
Göteborg University