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

NCT ID: NCT06133413

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-26

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity, Severe Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparative, controlled, randomized 1:1, open, in two parallel arms study
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard of care group

Standard follow-up

Group Type NO_INTERVENTION

No interventions assigned to this group

Connected scale group

Standard follow up + Use weekly of Body Comp Pro connected scale, associated with a remote monitoring by medical team allowing alert generation and early intervention

Group Type EXPERIMENTAL

Body Comp Pro connected scale (Withings manufacturer)

Intervention Type DEVICE

Use once a week

Alert generation by remote plateform

Intervention Type OTHER

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

Interventions

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Body Comp Pro connected scale (Withings manufacturer)

Use once a week

Intervention Type DEVICE

Alert generation by remote plateform

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Withings

INDUSTRY

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital La Pitié Salpêtrière

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Laurent GENSER, Dr

Role: CONTACT

01.42.17.56.14 ext. +33

Judith ARON WISNEWSKY, Prof

Role: CONTACT

01.42.17.75.41 ext. +33

Facility Contacts

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Laurent GENSER, MD

Role: primary

+33 0142175614

Other Identifiers

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APHP230777

Identifier Type: -

Identifier Source: org_study_id

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