Monitoring the Weight Evolution Using a Connected Scale

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of a Personalized Care Path After Bariatric Surgery Based on Monitoring the Weight Evolution Using a Connected Scale

Conditions
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Bariatric Surgery, Long Term Follow-Up, Weight Regain

Intervention / Treatment
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* Other: Control Group
* Other: Intervention Group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multi-centre, randomised, open, controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>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. | Other: Control Group<br>* Clinical visits conducted by a multidisciplinary team every year<br>* Other names: Clinical visits conducted by a multidisciplinary team every year;|
| Experimental: Experimental Group<br>In the intervention group, patients will follow a new care pathway with visits triggered by weight evolution | Other: Intervention Group<br>* Clinical visits are triggered by weight evolution measured by connected balance<br>* Other names: Clinical visits triggered by weight evolution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness of new care pathway | Cost-effectiveness of new care pathway | 3 years | 
| Number of visits made by the multidisciplinary team | Number of visits made by the multidisciplinary team | 3 years | 
| Number of postoperative surgical and / or medical complications | Number of postoperative surgical and / or medical complications that justified hospitalisation | 3 years | 
| Change of nutritional parameters in the blood of vitamines |  | 3 years | 
| Change of nutritional parameters in the blood of minerals |  | 3 years | 
| Change of nutritional parameters in the blood of protein |  | 3 years | 
| Dutch Eating Behavior Questionnaire (DEBQ) | Dutch Eating Behaviour Questionnaire (DEBQ) consists of 33 items and assesses on a 5-point Likert scale, ranging from never to very often external, restraint and emotional eating. For the study, only the 10 items of the external eating subscale will be used. The variable of interest will be the corresponding External eating subscale score. | 3 years | 
| Frequency of Food Consumption Questionnaire | A food frequency questionnaire (FFQ) consists of a finite list of foods and beverages with response categories to indicate usual frequency of consumption over the time period queried. To assess the total diet, the number of foods and beverages queried typically ranges from 80 to 120. | 3 years | 
| Anxiety and depression by Hospital Anxiety and Depression Scale questionnaire (HAD) | Changes of anxiety and depression over three weeks training on a 4-point likert scale scored 0-3. Max 21 Points for each subscale, cut off for anxiety and Depression are set at 7 Points higher values represent more anxiety and Depression. | 3 years | 
| Ricci-Gagnon score | Evaluation of physical activity This score describe the physical profile : inactive, active, very active, at month 4 It is calculated by adding the number of points (1 to 5) corresponding to the box checked for each question. Less than 18=inactive Between 18 and 35=active More than 35=Active | 3 years | 
| Quality of life of SF36 | Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health. | 3 years | 
| Quality of life of questionnaire EQ-5D-5L | The EQ-5D-5L questionnaire will be used to estimate the impact on subjects' health-related quality of life and provides a description of subjects' problems by dimensions (descriptive system), a score for overall self-rated health (visual analogue scale [VAS]) as well as an index score (EQ-5D-5L index). EQ-5D index score range: 0 to 1 and EQ-5D-VAS: range 0 to 100. A higher score indicates better self reported health status. | 3 years |