Interventional Active not recruiting
NCT06133413 on ClinicalTrials.gov
Connected Scales to Optimize the Maintenance of Weight Lost After Bariatric Surgery and Limit Failures and Reoperations
- Sponsor: Assistance Publique - Hôpitaux de Paris
- Collaborators: Withings
- Enrollment: 182 (Estimated)
- Study start: 2025-06-26 (Actual)
- Primary completion: 2027-02-01 (Estimated)
- Study completion: 2027-02-01 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- InterventionModelDescription: Comparative, controlled, randomized 1:1, open, in two parallel arms study
- Masking: None
- PrimaryPurpose: 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.
Conditions
- Obesity, Severe
- Surgery
Intervention / Treatment
- Device: Body Comp Pro connected scale (Withings manufacturer)
- Other: Alert generation by remote plateform
Primary Outcome Measures
-
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
(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
Countries
France
Locations and Investigators
- Hôpital La Pitié Salpêtrière, Paris, France