Monitoring the Weight Evolution Using a Connected Scale
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Control Group, Intervention Group.
- Who it may be relevant to
- Registry conditions: Bariatric Surgery, Long Term Follow-Up, Weight Regain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of a Personalized Care Path After Bariatric Surgery Based on 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.
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
Primary outcome measures
- Evaluate the efficacy of new care pathway [Time frame: 3 years]
Secondary outcome measures (12)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 2 centers
- Ch Boulogne-Sur-Mer - Boulogne Sur Mer — Boulogne-sur-Mer
- Hop Claude Huriez Chu Lille — Lille
Identifiers
NCT: NCT04639778 · 2017_78 · 2018-A01946-49