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
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