Connected Scales to Optimize the Maintenance of Weight Lost After Bariatric Surgery and Limit Fai… (NCT06133413) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Connected Scales to Optimize the Maintenance of Weight Lost After Bariatric Surgery and Limit Failures and Reoperations
France182 participantsStarted 2025-06-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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