Obesity, Severe, Surgery
Conditions
Keywords
Obesity surgery, Connected scale, Remote patient monitoring
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.
Interventions
Use once a week
OTHERAlert generation by remote plateform
Alert will be generated from weight regain \> 5% of baseline weight
Sponsors
Assistance Publique - Hôpitaux de Paris
Withings
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Comparative, controlled, randomized 1:1, open, in two parallel arms study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 12 months from inclusion | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 6 and 12 months from inclusion | 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 |
| 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 | 6 and 12 months from inclusion | 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. |
| 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). | 6 and 12 months from inclusion | 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 |
| 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) | 6 and 12 months from inclusion | 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) |
Countries
France
Outcome results
None listed