Using a connected scale to help keep weight off after bariatric surgery
Connected Scales to Optimize the Maintenance of Weight Lost After Bariatric Surgery and Limit Failures and Reoperations
This study will test whether weekly home weigh-ins with a connected Body Comp Pro scale can help people about one year after sleeve or gastric bypass surgery avoid regaining more than 10% of their lost weight.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 182 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06133413 on ClinicalTrials.gov |
What this trial studies
This open, randomized study will enroll 182 patients about one year after sleeve gastrectomy or Roux-en-Y gastric bypass and follow them for 12 months. Participants are randomized 1:1 to standard follow-up or standard follow-up plus weekly weighing using the Body Comp Pro connected scale with alerts sent to the clinical team through a secure platform. The primary aim is to compare the proportion of patients who experience excessive weight regain (more than 10% of lost weight) between the two groups. The trial uses remote patient monitoring to improve follow-up intensity during the post-nadir weight maintenance period.
Who should consider this trial
Good fit: Adults aged 18 or older who had sleeve gastrectomy or Roux-en-Y gastric bypass about 12 months (±1 month) before enrollment, are covered by social security, and can read and speak French.
Not a fit: Patients who cannot stand on a scale, have a pacemaker, require intensified medical/surgical monitoring at inclusion, are pregnant or planning pregnancy during participation, are legally protected, deprived of liberty, or enrolled in another interventional study are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could help patients maintain weight loss and reduce the need for additional interventions or reoperations.
How similar studies have performed: Remote monitoring with connected scales and weight telemonitoring has shown promise in other weight-management contexts, but its specific effect on post-bariatric surgery weight regain is not yet well established.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Paris
- Hôpital La Pitié Salpêtrière — Paris, France (Recruiting)
Study contacts
- Study coordinator: Laurent GENSER, Dr
- Email: laurent.genser@aphp.fr
- Phone: 01.42.17.56.14
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.