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Clinical Trials in France / NCT06133413
Active, not recruiting Not applicable

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

NCT06133413 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2025-06-26
Last updated
2026-06-05

Condition(s) studied

Obesity, SevereSurgery

Investigational drug(s) / intervention(s)

Body Comp Pro connected scale (Withings manufacturer)Alert generation by remote plateform

Body Comp Pro connected scale (Withings manufacturer): Use once a week

Alert generation by remote plateform: Alert will be generated from weight regain \> 5% of baseline weight

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Hôpital La Pitié Salpêtrière Paris France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06133413 on ClinicalTrials.gov ↗ ← All trials in France