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

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Surgery; Obesity, Severe

Treatments: Device: Body Comp Pro connected scale (Withings manufacturer); Other: Alert generation by remote plateform

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06133413

APHP230777

Details and patient eligibility

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.

Enrollment: 182 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

Standard of care group

No Intervention group

Description:

Standard follow-up

Connected scale group

Experimental group

Description:

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

Treatment:

Other: Alert generation by remote plateform

Device: Body Comp Pro connected scale (Withings manufacturer)