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Monitoring the Weight Evolution Using a Connected Scale (TELEBARIA)

Primary Purpose

Bariatric Surgery, Long Term Follow-Up, Weight Regain

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Control Group
Intervention Group
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bariatric Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ch Boulogne-Sur-Mer - Boulogne Sur MerRecruiting
  • Hop Claude Huriez Chu LilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Experimental Group

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cost-effectiveness of new care pathway
Cost-effectiveness of new care pathway
Number of visits made by the multidisciplinary team
Number of visits made by the multidisciplinary team
Number of postoperative surgical and / or medical complications
Number of postoperative surgical and / or medical complications that justified hospitalisation
Change of nutritional parameters in the blood of vitamines
Change of nutritional parameters in the blood of minerals
Change of nutritional parameters in the blood of protein
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.
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.
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.
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
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.
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.

Full Information

First Posted
May 28, 2020
Last Updated
February 28, 2022
Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT04639778
Brief Title
Monitoring the Weight Evolution Using a Connected Scale
Acronym
TELEBARIA
Official Title
Evaluation of a Personalized Care Path After Bariatric Surgery Based on Monitoring the Weight Evolution Using a Connected Scale
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery, Long Term Follow-Up, Weight Regain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multi-centre, randomised, open, controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm 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.
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
In the intervention group, patients will follow a new care pathway with visits triggered by weight evolution
Intervention Type
Other
Intervention Name(s)
Control Group
Other Intervention Name(s)
Clinical visits conducted by a multidisciplinary team every year
Intervention Description
Clinical visits conducted by a multidisciplinary team every year
Intervention Type
Other
Intervention Name(s)
Intervention Group
Other Intervention Name(s)
Clinical visits triggered by weight evolution
Intervention Description
Clinical visits are triggered by weight evolution measured by connected balance
Primary Outcome Measure Information:
Title
Evaluate the efficacy of new care pathway
Description
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 years
Secondary Outcome Measure Information:
Title
Cost-effectiveness of new care pathway
Description
Cost-effectiveness of new care pathway
Time Frame
3 years
Title
Number of visits made by the multidisciplinary team
Description
Number of visits made by the multidisciplinary team
Time Frame
3 years
Title
Number of postoperative surgical and / or medical complications
Description
Number of postoperative surgical and / or medical complications that justified hospitalisation
Time Frame
3 years
Title
Change of nutritional parameters in the blood of vitamines
Time Frame
3 years
Title
Change of nutritional parameters in the blood of minerals
Time Frame
3 years
Title
Change of nutritional parameters in the blood of protein
Time Frame
3 years
Title
Dutch Eating Behavior Questionnaire (DEBQ)
Description
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.
Time Frame
3 years
Title
Frequency of Food Consumption Questionnaire
Description
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.
Time Frame
3 years
Title
Anxiety and depression by Hospital Anxiety and Depression Scale questionnaire (HAD)
Description
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.
Time Frame
3 years
Title
Ricci-Gagnon score
Description
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
Time Frame
3 years
Title
Quality of life of SF36
Description
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.
Time Frame
3 years
Title
Quality of life of questionnaire EQ-5D-5L
Description
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.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François Pattou, MD,PhD
Phone
03 20 44 42 73
Ext
+33
Email
francois.pattou@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Pattou, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ch Boulogne-Sur-Mer - Boulogne Sur Mer
City
Boulogne Sur Mer
ZIP/Postal Code
62321
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0321993333
First Name & Middle Initial & Last Name & Degree
Marie LEPAGE, MD
Facility Name
Hop Claude Huriez Chu Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0320445962
First Name & Middle Initial & Last Name & Degree
François PATTOU, MD,PhD

12. IPD Sharing Statement

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Monitoring the Weight Evolution Using a Connected Scale

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