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NCT Number: NCT04639778

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.

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Key information

Conditions

Bariatric Surgery Long Term Follow-Up Weight Regain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ch Boulogne-Sur-Mer - Boulogne Sur Mer, Boulogne-sur-Mer, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control Group

Other

Clinical visits conducted by a multidisciplinary team every year

Other names: Clinical visits conducted by a multidisciplinary team every year

Intervention group

Other

Clinical visits are triggered by weight evolution measured by connected balance

Other names: Clinical visits triggered by weight evolution

Primary outcomes

  1. 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 outcomes

  1. Cost-effectiveness of new care pathway

    Time frame: 3 years

    Cost-effectiveness of new care pathway

  2. Number of visits made by the multidisciplinary team

    Time frame: 3 years

    Number of visits made by the multidisciplinary team

  3. Number of postoperative surgical and / or medical complications

    Time frame: 3 years

    Number of postoperative surgical and / or medical complications that justified hospitalisation

  4. Change of nutritional parameters in the blood of vitamines

    Time frame: 3 years

  5. Change of nutritional parameters in the blood of minerals

    Time frame: 3 years

  6. Change of nutritional parameters in the blood of protein

    Time frame: 3 years

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

François Pattou, MD,PhD

CONTACT

[email protected]

03 20 44 42 73 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: TELEBARIA

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2020
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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