Monitoring the Weight Evolution Using a Connected Scale
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille
About this trial
Current guideline recommend yearly multidisciplinary postoperative follow-up after bariatric surgery. However, practices remain very heterogeneous, and only a fraction of patients are still follow-up beyond two years after the operation.
This study will assess a new care pathway in which the patients are follow-up according to the weight evolution measured by the patient using a connected scale.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Control Group
Other interventionClinical visits conducted by a multidisciplinary team every year
Intervention Group
Other interventionClinical visits are triggered by weight evolution measured by connected balance
Treatment groups
390 Participants
are divided into 2 treatment groupsGroup A: Control GroupActive comparator 1 intervention
Group B: Experimental GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the efficacy of new care pathway
The main evaluation criterion is the success rate in terms of weight loss defined by an excess weight loss greater than 50%, in the absence undernutrition. Undernutrition is defined by a BMI \< 21 kg / m2 and / or an albumin level \<35 g /l
Time frame
3 yearsSecondary outcomes
1
Cost-effectiveness of new care pathway
Cost-effectiveness of new care pathway
Time frame
3 years2
Number of visits made by the multidisciplinary team
Number of visits made by the multidisciplinary team
Time frame
3 years3
Number of postoperative surgical and / or medical complications
Number of postoperative surgical and / or medical complications that justified hospitalisation
Time frame
3 years4
Change of nutritional parameters in the blood of vitamines
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Lille
Lead sponsor
Ministry of Health, France
Collaborator
Source ClinicalTrials.gov