Bariatric SurgeryTELEBARIANCT04639778
Monitoring the Weight Evolution Using a Connected Scale
A study testing Intervention Group in people with Bariatric Surgery and Long Term Follow-Up, run by University Hospital, Lille at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery, Long Term Follow-Up, Weight Regain
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 2 sitesFrance
- Study dates
- 25 Mar 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Ch Boulogne-Sur-Mer - Boulogne Sur Mer
Boulogne-sur-Mer, 62321
0321993333
Marie LEPAGE, MD
- Recruiting
Hop Claude Huriez Chu Lille
Lille, 59037
0320445962
François PATTOU, MD,PhD
About this study
Official title: Evaluation of a Personalized Care Path After Bariatric Surgery Based on Monitoring the Weight Evolution Using a Connected Scale
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.
Read the 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.
- Conditions
- Bariatric Surgery, Long Term Follow-Up, Weight Regain
- Being tested
- Control Group, Intervention Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupOther
Also called Clinical visits conducted by a multidisciplinary team every year
Clinical visits conducted by a multidisciplinary team every year
Intervention GroupOther
Also called Clinical visits triggered by weight evolution
Clinical visits are triggered by weight evolution measured by connected balance
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | 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. Receives: Other: Control Group |
| Experimental Group | Experimental | In the intervention group, patients will follow a new care pathway with visits triggered by weight evolution Receives: Other: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (12)
Cost-effectiveness of new care pathway
Cost-effectiveness of new care pathway
Measured: 3 years
Number of visits made by the multidisciplinary team
Number of visits made by the multidisciplinary team
Measured: 3 years
Number of postoperative surgical and / or medical complications
Number of postoperative surgical and / or medical complications that justified hospitalisation
Measured: 3 years
Change of nutritional parameters in the blood of vitamines
Measured: 3 years
Change of nutritional parameters in the blood of minerals
Measured: 3 years
Change of nutritional parameters in the blood of protein
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start25 Mar 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-centre, randomised, open, controlled study
- Masking
- None (open label)
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- François Pattou, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639778
- Sponsor's protocol ID
- 2017_78
- Other IDs
- 2018-A01946-49
- Acronym
- TELEBARIA
- Status last verified
- Dec 2025
- First submitted
- 28 May 2020
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Personalized Care Path After Bariatric Surgery Based on Monitoring the Weight Evolution Using a Connected Scale
- ClinicalTrials.gov ID
- NCT04639778
- Acronym / sponsor ID
- TELEBARIA / 2017_78
- Conditions
- Bariatric Surgery, Long Term Follow-Up, Weight Regain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multi-centre, randomised, open, controlled study
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Control GroupIn 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 Group | Experimental | Other: Intervention GroupIn the intervention group, patients will follow a new care pathway with visits triggered by weight evolution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control GroupAlso: Clinical visits conducted by a multidisciplinary team every yearClinical visits conducted by a multidisciplinary team every year | Other | Control Group |
| Intervention GroupAlso: Clinical visits triggered by weight evolutionClinical visits are triggered by weight evolution measured by connected balance | Other | Experimental Group |
Primary outcome
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
12 secondary outcomes
Cost-effectiveness of new care pathway
Time frame: 3 years
Number of visits made by the multidisciplinary team
Time frame: 3 years
Number of postoperative surgical and / or medical complications
Time frame: 3 years
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
Frequency of Food Consumption Questionnaire
Time frame: 3 years
Anxiety and depression by Hospital Anxiety and Depression Scale questionnaire (HAD)
Time frame: 3 years
Ricci-Gagnon score
Time frame: 3 years
Quality of life of SF36
Time frame: 3 years
Quality of life of questionnaire EQ-5D-5L
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
François Pattou, MD,PhD principal investigator
University Hospital, Lille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Bariatric Surgery and Long Term Follow-Up, run by University Hospital, Lille at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact François Pattou, MD,PhD (03 20 44 42 73 ext. +33, francois.pattou@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy of new care pathway (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.