Weight monitoring with a connected scale after bariatric surgery
Evaluation of a Personalized Care Path After Bariatric Surgery Based on Monitoring the Weight Evolution Using a Connected Scale
This project tests whether using a connected scale to monitor weight can guide follow-up care for people who had Roux-en-Y gastric bypass or sleeve gastrectomy two years earlier.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 390 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 2 sites (Boulogne-sur-Mer and 1 other locations) |
| Trial ID | NCT04639778 on ClinicalTrials.gov |
What this trial studies
Adults who had Roux-en-Y gastric bypass or sleeve gastrectomy two years ago will be enrolled and assigned to either a usual-care control group or an intervention pathway where follow-up is triggered by weight trends measured at home with a connected scale. The intervention uses patients' home weight recordings transmitted over a wired network to tailor the timing and intensity of multidisciplinary follow-up. Primary outcomes will focus on weight regain and healthcare events such as re-operations and late complications, with follow-up over the postoperative long-term period. Inclusion requires home wired internet access and the ability to use remote monitoring equipment, while patients with major cognitive or psychiatric limitations are excluded.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) who had Roux-en-Y or sleeve gastrectomy two years earlier, have home wired internet access, and can use a connected scale.
Not a fit: Patients without reliable home internet or who cannot use remote monitoring devices, and those with conditions requiring immediate in-person care, are unlikely to benefit from this pathway.
Why it matters
Potential benefit: If successful, this approach could detect early weight regain and complications, allowing personalized follow-up that may reduce re-operations and improve long-term outcomes.
How similar studies have performed: Remote weight monitoring and telemedicine have shown benefit for weight management in non-surgical populations, but there is limited evidence specifically demonstrating long-term success for postoperative bariatric follow-up.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients aged\> = at 18 years old Patients who have benefited from a Roux-en-Y Gastric By-Pass or Sleeve Gastrectomy bariatric surgery 2 years ago Preoperative Body Mass Index between 35 kg/m2 and 59 kg/m2 Access to the wired network at home. Social insured patient Patient who signed the informed consent Exclusion Criteria: Lack of autonomy for the use of remote monitoring equipment or psychological or psychiatric disorders making it difficult to optimally use the remote monitoring equipment Administrative reasons: inability to receive informed consent information, inability to participate in the entire study, lack of social security coverage, refusal to sign consent, patient under guardianship or justice system.
Where this trial is running
Boulogne-sur-Mer and 1 other locations
- Ch Boulogne-Sur-Mer - Boulogne Sur Mer — Boulogne-sur-Mer, France (Recruiting)
- Hop Claude Huriez Chu Lille — Lille, France (Recruiting)
Study contacts
- Principal investigator: François Pattou, MD,PhD — University Hospital, Lille
- Study coordinator: François Pattou, MD,PhD
- Email: francois.pattou@chru-lille.fr
- Phone: 03 20 44 42 73
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.