Trials / Recruiting
RecruitingNCT06133413
Connected Scales to Optimize the Maintenance of Weight Lost After Bariatric Surgery and Limit Failures and Reoperations
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 182 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Body Comp Pro connected scale (Withings manufacturer) | Use once a week |
| OTHER | Alert generation by remote plateform | Alert will be generated from weight regain \> 5% of baseline weight |
Timeline
- Start date
- 2025-06-26
- Primary completion
- 2026-09-01
- Completion
- 2026-09-01
- First posted
- 2023-11-15
- Last updated
- 2025-10-03
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT06133413. Inclusion in this directory is not an endorsement.