DRKS00033045已完成Unknown
Randomised controlled trial to evaluate the App-based Multimodal Obesity-management programme Oviva Direkt für Adipositas” - AMODA - AMODA
Oviva AG0 个研究点目标入组 164 人开始时间: 2023年11月14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
- 164
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 75 Years（—）
- 性别
- All
入选标准
- •BMI 30-45 kg/m²
- •- Confirmed diagnosis of obesity (according to ICD-10 E66)
- •- Own smartphone with a compatible operating system for the „Oviva Direkt” app
- •- Written informed consent
- •- Living in Germany
- •- Good understanding of German Language (at least B2 level or equivalent)
排除标准
- •- Expected poor compliance / adherence to study procedures
- •- Incapacity to consent
- •- Persons in a dependent / employment relationship with the Sponsor or investigator
- •- Cognitive incapacity impeding participation and study compliance
- •- Participation in another clinical examination for weight reduction in obesity
- •- Participation in a structured multimodal weight loss programme within the last 6 months or plan to do so in the next 12 months
- •- Previous or current use of Oviva Direkt or participation in other Oviva programmes
- •- Use of another smartphone app for weight reduction in obesity within the last 6 months or plan to do so in the next 12 months
- •- Vigorous weight fluctuations (> 5 kg) in the last 3 months
- •Recent use of obesity / weight management medications, including those used for glycaemic control (in past 6 months); or planned drug treatment for overweight
- •- Bariatric surgery (post or planned)
- •- Planned absence (e.g. vacation, hospitalisation) for more than 3 weeks during the following 6 months
- •- Planned long-term travel of more than 3 weeks during the first 6 months of study participation
- •- Planned surgery during the trial
- •- Restricted mobility or immobility (resulting in an inability to perform moderate movement as specified in the intervention)
- •- Planned cessation of smoking during study period
- •- Inability to use the app
- •- Related persons who use Oviva Direkt or participate in the study (family members, in partnership, same household)
- •Medical conditions (self-reported):
- •- Diabetes mellitus Type 1
- •- Established cardiovascular disease, severe liver and/or respiratory disease, renal failure
- •- Active cancer (or in remission for <2 years)
- •- Inflammatory bowel disease
- •- Severe chronic infections and/or inflammatory diseases
- •- Severe mental-health disorders
- •- Neurodegenerative disorders
- •- Rare genetic conditions associated with overweight
- •- Endocrine diseases
- •- Eating disorders
- •- Pregnancy and lactation (or planned pregnancy within the next 6 months)
- •- A pacemaker, leading to a restriction in activity
- •- Taking new medication that will influence weight or planning to do so
- •- Drug-induced obesity
- •- Any medical contraindication to losing weight
- •- Drug or alcohol dependency
- •- Morbid (severe) obesity with alveolar hypoventilation
研究者
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