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临床试验/DRKS00033906
DRKS00033906已完成Unknown

Digital multimodal weight loss program - Randomized controlled evaluation of a digital health application for individuals with obesity - MOOSE trial

ifeness AS0 个研究点目标入组 248 人开始时间: 2024年3月19日最近更新:
适应症

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
248

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • Confirmed diagnosis of obesity with BMI =30 and <40kg/m2
  • E66.00 Obesity due to excess calories Grade 1 obesity (WHO) in patients aged 18 and over
  • E66.01 Obesity due to excess calories Grade 2 obesity (WHO) in patients aged 18 and over
  • - Individuals who are capable of giving their consent
  • - Smartphone owned and physical as well as psychological and cognitive abilities to use the smartphone
  • - Internet access for the app application and questionnaire response
  • - Motivation to use the app regularly
  • - Email address for registration
  • - Willingness to participate in the collection of data
  • - Possession of an own scale for weight measurement
  • - Sufficient knowledge of the German language

排除标准

  • - Secondary obesity due to known endocrine or neurological disorders
  • - Severe physical comorbidities, physical limitations or other medical conditions that do not allow moderate independent physical activity
  • - History of severe psychiatric illness with suicide attempt
  • - Currently diagnosed severe psychiatric illness with considerable strain or limitations in everyday life due to mental illness or mental problems
  • - Currently ongoing psychotherapeutic treatment
  • - Pregnancy or breast feeding or planned pregnancy within the next 12 months
  • - History of surgical or minimally invasive weight reduction procedure or planned procedure within the interventional period
  • - Current usage of the Lifeness App or comparable digital or non-digital weight management programs or usage of such in the last 3 months and = 3% weight loss in the last 3 months
  • - Started with medication that affects weight within the last 3 month or planned use in the next 12 months (e.g., weight loss medication (e.g., semaglutide), specific insulin, specific antidepressant drugs)
  • - Contraindications of the medical device
  • Current pregnancy
  • Presence of secondary forms of obesity (Cushing syndrome, Prader-Willi syndrome, hypogonadism, etc.)
  • Presence of hypothyroidism if not treated with medication in advance
  • Lack of change resources

研究者

发起方
ifeness AS

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