Clinical trial NCT04639778: Monitoring the Weight Evolution Using a Connected Scale
Official title: Evaluation of a Personalized Care Path After Bariatric Surgery Based on Monitoring the Weight Evolution Using a Connected Scale
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bariatric Surgery
Long Term Follow-Up
Weight Regain
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2020-11-20
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-centre, randomised, open, controlled study
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Bariatric surgery is developing rapidly. In France, the number of annual interventions increased threefold between 2001 and 2015, from 16,000 to 50,000 per year. This rapid development is explained by the well-demonstrated benefits of surgery: spectacular improvement in the quality of life, reduction in co-morbidities (diabetes, cardiovascular diseases, and steatohepatitis), and significant reduction in mortality linked to severe obesity. However, the benefits of surgery may decrease over time and may be associated with side effects.

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. The current recommendations therefore do not seem adapted to clinical reality. They do not prevent the regain of weight in many patients, which frequently leads to re-operations. Even more worrying is the possible occurrence of late complications, sometimes serious and life-threatening.

This study will assess a new care pathway in which the patients are follow-up according to weight evolution measured by the patient using a connected scale.

Eligibility 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.

Primary outcomes:
measure: Evaluate the efficacy of new care pathway
timeFrame: 3 years
Secondary outcomes:
measure: Cost-effectiveness of new care pathway
timeFrame: 3 years
measure: Number of visits made by the multidisciplinary team
timeFrame: 3 years
measure: Number of postoperative surgical and / or medical complications
timeFrame: 3 years
measure: Change of nutritional parameters in the blood of vitamines
timeFrame: 3 years
measure: Change of nutritional parameters in the blood of minerals
timeFrame: 3 years
measure: Change of nutritional parameters in the blood of protein
timeFrame: 3 years
measure: Dutch Eating Behavior Questionnaire (DEBQ)
timeFrame: 3 years
measure: Frequency of Food Consumption Questionnaire
timeFrame: 3 years
measure: Anxiety and depression by Hospital Anxiety and Depression Scale questionnaire (HAD)
timeFrame: 3 years
measure: Ricci-Gagnon score
timeFrame: 3 years
measure: Quality of life of SF36
timeFrame: 3 years
measure: Quality of life of questionnaire EQ-5D-5L
timeFrame: 3 years
Other outcomes:
Locations:
city: Boulogne Sur Mer
country: France
facility: Ch Boulogne-Sur-Mer - Boulogne Sur Mer
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: François Pattou, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: