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

Surgery Clinical Trial

— COMPA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06133413
• Other study ID #: APHP230777
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: September 2025

Study information

• Verified date: October 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Laurent GENSER, Dr
• Phone: 01.42.17.56.14
• Email: laurent.genser[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 182
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Obesity, Morbid
• Obesity, Severe
• Surgery

Intervention

Device:
• Body Comp Pro connected scale (Withings manufacturer)
Use once a week

Other:
• Alert generation by remote plateform
Alert will be generated from weight regain > 5% of baseline weight

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Withings

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Weight change (in kilos and % of weight lost since the intervention) between the weight at inclusion (12 months post-op) and the weight at 6 and 12 months from inclusion (18 and 24 months post-op ) in both groups of patients.	6 and 12 months from inclusion
Secondary	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	Number of surgical reinterventions (planned or carried out) for excessive weight gain validated in a multidisciplinary consultation meeting between inclusion (12 months post-op) and the visit 12 months from inclusion (24 months post-op) in both patient groups	12 months from inclusion
Secondary	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	Resolution, evolution, recurrence, or occurrence of a comorbidity between inclusion (12 months post-op) and visits at 6 and 12 months from inclusion (18 and 24 months post-op) in the two groups of patients. The comorbidities identified are High blood pressure, Type 2 diabetes and sleep apnea syndrome	6 and 12 months from inclusion
Secondary	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	Evolution of the HAD scale score between inclusion (12 months post-op) and visits at 6 and 12 months from inclusion (18 and 24 months post-op) in the two groups of patients	6 and 12 months from inclusion
Secondary	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	Evolution of the SF-36 quality of life score between inclusion (12 months post-op) and visits at 6 and 12 months from inclusion (18 and 24 months post-op) in the two groups of patients	6 and 12 months from inclusion
Secondary	Compare the number of lost to follow-up at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB) in the two groups of patients	Number of patients lost to follow-up between inclusion (12 months post-op) and visits at 6 and 12 months from inclusion (18 and 24 months post-op) in the two groups of patients	6 and 12 months from inclusion
Secondary	To compare the change in body composition measured by a connected scale at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB) in the two groups of patients	Evolution of body composition (muscle mass, fat mass) measured by the connected scale between the inclusion visit (12 months post-op) and the visits at 6 and 12 months from inclusion (18 and 24 months post-op ) in both groups of patients.	6 and 12 months from inclusion
Secondary	For interventionnal group only : Evaluate the impact of the use of a connected scale on the consumption of additional care at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB).	Number of telephone calls, consultations or hospitalizations in hospital, secondary to an alert generated by the connected scale between the inclusion visit (12 months post-op) and the visits at 6 and 12 months of inclusion (18 and 24 months post-op) for each patient in the interventional group	6 and 12 months from inclusion
Secondary	For interventionnal group only : Evaluate adherence to the use of a connected scale at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB)	Average frequency of use of the connected scale between inclusion (12 months post-op) and visits at 6 and 12 months from inclusion (18 and 24 months post-op) for each patient in the interventional group compared to this which is required of them (i.e. 1 weighing per week)	6 and 12 months from inclusion