Clinical trial NCT06133413: Connected Scales to Optimize the Maintenance of Weight Lost After Bariatric Surgery and Limit Failures and Reoperations
Official title: Connected Scales to Optimize the Maintenance of Weight Lost After Bariatric Surgery and Limit Failures and Reoperations
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity, Severe
Surgery
Keywords: Obesity surgery
Connected scale
Remote patient monitoring
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Withings
First posted: 2023-11-15
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparative, controlled, randomized 1:1, open, in two parallel arms study
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: 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
timeFrame: 12 months from inclusion
Secondary outcomes:
measure: 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
timeFrame: 6 and 12 months from inclusion
measure: 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
timeFrame: 12 months from inclusion
measure: 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
timeFrame: 6 and 12 months from inclusion
measure: 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
timeFrame: 6 and 12 months from inclusion
measure: 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
timeFrame: 6 and 12 months from inclusion
measure: 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
timeFrame: 6 and 12 months from inclusion
measure: 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
timeFrame: 6 and 12 months from inclusion
measure: 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).
timeFrame: 6 and 12 months from inclusion
measure: 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)
timeFrame: 6 and 12 months from inclusion
Other outcomes:
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