Monitoring the Weight Evolution Using a Connected Scale

Overview

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 Title of Study: “Evaluation of a Personalized Care Path After Bariatric Surgery Based on Monitoring the Weight Evolution Using a Connected Scale”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2023

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.

Interventions

  • Other: Control Group
    • Clinical visits conducted by a multidisciplinary team every year
  • Other: Intervention Group
    • Clinical visits are triggered by weight evolution measured by connected balance

Arms, Groups and Cohorts

  • Active Comparator: Control Group
    • 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.
  • Experimental: Experimental Group
    • In the intervention group, patients will follow a new care pathway with visits triggered by weight evolution

Clinical Trial Outcome Measures

Primary Measures

  • Evaluate the efficacy of new care pathway
    • Time Frame: 3 years
    • 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

Secondary Measures

  • Cost-effectiveness of new care pathway
    • Time Frame: 3 years
    • Cost-effectiveness of new care pathway
  • Number of visits made by the multidisciplinary team
    • Time Frame: 3 years
    • Number of visits made by the multidisciplinary team
  • Number of postoperative surgical and / or medical complications
    • Time Frame: 3 years
    • Number of postoperative surgical and / or medical complications that justified hospitalisation
  • Change of nutritional parameters in the blood of vitamines
    • Time Frame: 3 years
  • Change of nutritional parameters in the blood of minerals
    • Time Frame: 3 years
  • Change of nutritional parameters in the blood of protein
    • Time Frame: 3 years
  • Dutch Eating Behavior Questionnaire (DEBQ)
    • Time Frame: 3 years
    • 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.
  • Frequency of Food Consumption Questionnaire
    • Time Frame: 3 years
    • 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.
  • Anxiety and depression by Hospital Anxiety and Depression Scale questionnaire (HAD)
    • Time Frame: 3 years
    • 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.
  • Ricci-Gagnon score
    • Time Frame: 3 years
    • 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
  • Quality of life of SF36
    • Time Frame: 3 years
    • 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.
  • Quality of life of questionnaire EQ-5D-5L
    • Time Frame: 3 years
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Lille
  • Collaborator
    • Ministry of Health, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Fran├žois Pattou, MD,PhD, Principal Investigator, University Hospital, Lille
  • Overall Contact(s)
    • Fran├žois Pattou, MD,PhD, 03 20 44 42 73, francois.pattou@chru-lille.fr

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