Monitoring the Weight Evolution Using a Connected Scale (TELEBARIA)

University Hospital, Lille

Status: Enrolling

Conditions: Weight Regain; Bariatric Surgery; Long Term Follow-Up

Treatments: Other: Intervention Group; Other: Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT04639778

2017_78

2018-A01946-49 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 390 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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390 participants in 2 patient groups

Control Group

Active Comparator group

Description:

In the control group, patients will follow a care pathway respecting the current recommendations : a systematic clinical visit scheduled each year with the multidisciplinary team.

Treatment:

Other: Control Group

Experimental Group

Experimental group

Description:

In the intervention group, patients will follow a new care pathway with visits triggered by weight evolution

Treatment:

Other: Intervention Group