Connected Scales to Optimize the Maintenance of Weight Lost After Bariatric Surgery and Limit Failures and Reoperations
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- Compare the percentage of patients with weight regain > 10% at 24 months post-operative in patients who have undergone obesity surgery (SG or RYGB) in the two groups of patients
研究概览
简要总结
In this research, we hypothesize that post-operative monitoring implemented with a connected scale after the 1st year (weight nadir period) post obesity surgery (i.e. sleeve and RYGB) would reduce the percentage of patients with excessive weight regain (>10% regain of lost weight) by improving the quality of follow-up and long-term results.
To do this, we are carrying out a comparative study on 182 patients, controlled, randomized per patient, ratio 1/1, open, in two parallel arms.
Patients will be followed for 12 months and divided into one of the following two groups:
- Control group: Standard follow-up
- Interventional group: Standard follow-up + weekly weighing with the "Body Comp Pro" connected scale
During their follow-up period, patients in the intervention group will have to weigh themselves at least once a week using the "Body Comp Pro" connected scale. The information will be transmitted to the investigation team via a secure platform available 24 hours a day. Alerts will be generated from a weight regain > 5% of the baseline weight, allowing early management of weight regain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient aged 18 and over
- •Patient operated by a sleeve or RYGB at 1 year (+/- 1 month) from the inclusion visit
- •Patient affiliated to a social security system (excluding AME)
- •Patient having signed free, informed and written consent
- •Patient speaking and reading French fluently
排除标准
- •Patient with medical-surgical complications during inclusion visit justifying specific and reinforced monitoring (at the discretion of the investigator)
- •Patient with a pacemaker
- •Patient with a pathology or disability preventing them from standing on the scale
- •Patient participating in another interventional research at the time of inclusion
- •At the interview, pregnant patient or planning pregnancy during her period of participation in the research
- •Patient deprived of liberty
- •Patient subject to a legal protection measure (guardianship, curatorship)
研究组 & 干预措施
Standard of care group
Standard follow-up
Connected scale group
Standard follow up + Use weekly of Body Comp Pro connected scale, associated with a remote monitoring by medical team allowing alert generation and early intervention
干预措施: Body Comp Pro connected scale (Withings manufacturer) (Device)
Connected scale group
Standard follow up + Use weekly of Body Comp Pro connected scale, associated with a remote monitoring by medical team allowing alert generation and early intervention
干预措施: Alert generation by remote plateform (Other)
结局指标
主要结局
Compare the percentage of patients with weight regain > 10% at 24 months post-operative in patients who have undergone obesity surgery (SG or RYGB) in the two groups of patients
时间窗: 12 months from inclusion
Percentage of patients with weight regain \> 10% between inclusion (12 months post-op) and the 12-month visit (24 months post-op) in the two groups of patients
次要结局
- To compare the weight change at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB) in the two groups of patients(6 and 12 months from inclusion)
- To compare the number of surgical reinterventions (planned or carried out) for weight regain at 24 months post-operative in patients having undergone obesity surgery (SG or RYGB) in the two groups of patients(12 months from inclusion)
- To compare anxiety and depression at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB) in the two groups of patients(6 and 12 months from inclusion)
- Compare the quality of life at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB) in the two groups of patients(6 and 12 months from inclusion)
- To compare the evolution of comorbidities at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB) in the two groups of patients(6 and 12 months from inclusion)
- For interventionnal group only : Evaluate the impact of the use of a connected scale on the consumption of additional care at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB).(6 and 12 months from inclusion)
- For interventionnal group only : Evaluate adherence to the use of a connected scale at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB)(6 and 12 months from inclusion)
- Compare the number of lost to follow-up at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB) in the two groups of patients(6 and 12 months from inclusion)
- To compare the change in body composition measured by a connected scale at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB) in the two groups of patients(6 and 12 months from inclusion)