Studies

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