Connected Scales to Optimize the Maintenance of Weight Lost After Bariatric Surgery and Limit Failures and Reoperations

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hôpital La Pitié Salpêtrière
RECRUITING
Paris
Contact Information
Primary
Laurent GENSER, Dr
laurent.genser@aphp.fr
01.42.17.56.14
Backup
Judith ARON WISNEWSKY, Prof
judith.aron-wisnewsky@aphp.fr
01.42.17.75.41
Time Frame
Start Date: 2025-06-26
Estimated Completion Date: 2026-09
Participants
Target number of participants: 182
Treatments
No_intervention: Standard of care group
Standard follow-up
Experimental: 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
Related Therapeutic Areas
Sponsors
Collaborators: Withings
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov