A Prospective Pilot Study of the Allurion Digital Behaviour Change Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 4
- 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
研究组 & 干预措施
non-randomized, pilot study
This study is a prospective, non-randomized, pilot study to test the impact of the Allurion Digital Behaviour Change Intervention in participants who have been treated with the Allurion Gastric Balloon System. The study consists of the following segments:
- 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
干预措施: Allurion Digital Behaviour Change Intervention (Device)
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)
- 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)
- Time spent in physical activity steps (daily number of steps)(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)