2023-506289-29-00招募中4 期
eHealth Based treatment of AdolescenT obesiTy with Low energy diet and sEmaglutide (eBATTLE Obesity)
Vestfold Hospital Trust6 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2023年11月16日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 6
- 主要终点
- Percentage change in BMI (Time frame: From week 8 to week 60)
研究概览
简要总结
To confirm superiority of once-weekly semaglutide s.c. 2.4 mg versus once-weekly semaglutide s.c. placebo, both as an adjunct to a 52-week blended face-to-face (F2F) and electronic behavioral therapy (eBT) program in treatment-seeking adolescents (12 to <18 years) with obesity on percentage reduction in body weight (% BMI change) [after completion of an initial 8-week blended F2F and electronic LED (eLED)].
研究设计
- 分配方式
- Randomized
- 主要目的
- E Health Based Treatment Of Adolescen T Obesi Ty With Low Energy Diet And S Emaglutide (e Battle Obesity)
- 盲法
- Double (Carer, Monitor, Investigator, Subject, Analyst)
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Informed consent of parent(s) or legally authorized representative (LAR) of subject and assent of adolescent, as appropriate obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- •The trial participant must be above or equal to 12 years and below 18 years of age at the time of signing the informed consent.
- •Treatment seeking male and female adolescent patients with obesity (BMI ≥ IOTF 35 kg/m2) OR BMI ≥ IOTF 30 kg/m2 with at least one weight related comorbidity, risk factor or complication, as considered by the treating physician (44).
- •History of at least one self-reported unsuccessful dietary effort to lose body weight
- •Capable of giving signed informed consent as described in Appendix 3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Prepubertal patients (Tanner stage 1), self-assessed, see 8.2.1, table
- •History of diabetes mellitus (type 1 or type 2) as judged by the investigator
- •Intellectual disability as judged by the investigator
- •Sub-optimal level of spoken Norwegian as judged by the investigator
结局指标
主要结局
Percentage change in BMI (Time frame: From week 8 to week 60)
Percentage change in BMI (Time frame: From week 8 to week 60)
次要结局
- The main secondary endpoints include the number and severity of adverse events, physical activity, sleep, psychiatric symptoms, eating disorder symptoms, and health-related quality of life. In addition, changes in fat mass, fat-free mass, blood glucose, blood lipids, blood pressure, and other cardiometabolic risk factors will be compared between the treatment groups.
研究者
Hormon, overvekt og ernæringsavdelingen - forskning
Scientific
Vestfold Hospital Trust
研究点 (6)
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