NCT05884606已完成不适用
A Prospective Pilot Study of the Allurion Digital Behaviour Change Intervention
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 8
- 主要终点
- Change in percent total body weight loss (percent TBWL)
研究概览
简要总结
The proposed study is a prospective, non-randomized, pilot study to test the impact of the Allurion Digital Behaviour Change Intervention (DBCI) in participants who have been treated with the Allurion™ Gastric Balloon System. The study will include a nested qualitative and quantitative evaluations of the intervention from both the participant and Allurion provider perspective.
详细描述
The study consists of the following:
- Screening and enrolment period (prior to or day of Allurion Gastric Balloon System treatment)
- All participants will take part in the Allurion DBCI for 6 months following study enrolment
- All participants will complete a 6-month follow-up assessment after completion of the Allurion DBCI
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Allurion Gastric Balloon System placement in accordance with the approved Indications for Use
- •Age 18 to 65 years of age
- •Weight < 180 kg
- •Owns an Android or Apple smart phone
- •Willing to download the Allurion App
- •Willing to wear the Allurion Health Tracker Watch for the duration of the study
- •Willing to use the Allurion Scale
- •Proficient in reading the English language
排除标准
- •Any condition contraindicated for the Allurion Gastric Balloon System as specified in the Instructions for Use
结局指标
主要结局
Change in percent total body weight loss (percent TBWL)
时间窗: 6 months
The primary outcome measure for this intervention is the change in percent total body weight loss (percent TBWL).
次要结局
- Engagement with Health Coaching(6 and 12 months)
- Change in mental wellbeing(6 and 12 months)
- Change in quality of life(6 and 12 months)
- Time spent in physical activity steps (daily number of steps)(6 and 12 months)
- Change in anxiety(6 and 12 months)
- Change in loss of control over eating(6 and 12 months)
- Change in self-efficacy(6 and 12 months)
- Engagement with the mobile and web app(6 and 12 months)
- Patient satisfaction(6 and 12 months)
- Change in barriers to exercise(6 and 12 months)
研究者
研究点 (8)
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