Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06133413

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity, Severe, Surgery

Full registry criteria

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)

Treatments and study arms

Body Comp Pro connected scale (Withings manufacturer)

Device

Use once a week

Alert generation by remote plateform

Other

Alert will be generated from weight regain \> 5% of baseline weight

Primary outcomes

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 patients12 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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Hôpital La Pitié Salpêtrière🇫🇷 Paris, France

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