Smart Nutrition, Healthier Communities: A Digital Therapeutic Strategy for Early Obesity Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Body weight
研究概览
简要总结
The project investigates the effect of the health app Lifeness as a digital therapeutic (DTx) and follow-up tool in a municipal setting at a regional Healthy Lives Center in central Norway (Frisklivssentralen Værnesregionen), targeting early intervention for overweight and obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≤27kg/m2 or obesity measured by waist circumference, current weight stability, motivated to lifestyle change using mobile apps, access to smartphone with 5G. Living in the municipallies covered by the Værnes region of central Norway.
排除标准
- •previous bariatric surgery, use of anti-obesity drugs, pregnancy, current or present cancer diagnosis,substance abuse or psychiatric diagnosis (such as eating disorders), or other conditions that can hinder physical activity.
研究组 & 干预措施
Intervention
Standard follow-up at respective Healthy Lives Center with the addition of a digital therapeutic app with a full lifestyle program, including daily logging, tasks, articles and general information and possibility for digital communication with their healthcare provider.
干预措施: Lifestyle Management (Behavioral)
Intervention
Standard follow-up at respective Healthy Lives Center with the addition of a digital therapeutic app with a full lifestyle program, including daily logging, tasks, articles and general information and possibility for digital communication with their healthcare provider.
干预措施: Intervention (Device)
Control
Standard follow-up at respective Healthy Lives Center, including daily logging in the digital therapeutic app.
干预措施: Lifestyle Management (Behavioral)
Control
Standard follow-up at respective Healthy Lives Center, including daily logging in the digital therapeutic app.
干预措施: Control (Device)
结局指标
主要结局
Body weight
时间窗: 12 weeks
Body weight, and weight circumference, will be measured with standard proceduress (medically approved digital Seca scale (kg), and standard measuring band (cm)) wearing light clothing at baseline and after 12 weeks.
次要结局
- Eating behavior and hedonic appetite(12 weeks)
- Weight related quality of life(12 weeks)