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

NCT06133413 | Recruiting

• 1 other identifier: APHP230777
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief 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

Obesity, Severe; Surgery

Keywords

Obesity surgery; Connected scale; Remote patient monitoring

Outcome Measures

Primary Outcomes (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

  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

  12 months from inclusion

Secondary Outcomes (9)

• To compare the weight change at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB) in the two groups of patients

  6 and 12 months from inclusion

• To compare the number of surgical reinterventions (planned or carried out) for weight regain at 24 months post-operative in patients having undergone obesity surgery (SG or RYGB) in the two groups of patients

  12 months from inclusion

• To compare the evolution of comorbidities at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB) in the two groups of patients

  6 and 12 months from inclusion

• To compare anxiety and depression at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB) in the two groups of patients

  6 and 12 months from inclusion

• Compare the quality of life at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB) in the two groups of patients

  6 and 12 months from inclusion

Study Arms (2)

Standard of care group

NO INTERVENTION

Standard follow-up

Connected scale group

EXPERIMENTAL

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

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

Interventions

Body Comp Pro connected scale (Withings manufacturer) DEVICE

Use once a week

Connected scale group

Alert generation by remote plateform OTHER

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

Connected scale group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient aged 18 and over
• Patient affiliated to a social security system (excluding AME)
• Patient having signed free, informed and written consent
• Patient speaking and reading French fluently

You may not qualify if:

• Patient with a pacemaker
• Patient with a pathology or disability preventing them from standing on the scale
• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Withings: collaborator

Study Sites (1)

Hôpital La Pitié Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Laurent GENSER, Dr

CONTACT

01.42.17.56.14; laurent.genser@aphp.fr

Judith ARON WISNEWSKY, Prof

CONTACT

01.42.17.75.41; judith.aron-wisnewsky@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparative, controlled, randomized 1:1, open, in two parallel arms study

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 15, 2023
• Study Start: June 26, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)