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Monitoring the Weight Evolution Using a Connected Scale

NCT ID: NCT04639778

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-25

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Bariatric Surgery Long Term Follow-Up Weight Regain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multi-centre, randomised, open, controlled study
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type OTHER

Clinical visits conducted by a multidisciplinary team every year

Experimental Group

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

Group Type EXPERIMENTAL

Intervention Group

Intervention Type OTHER

Clinical visits are triggered by weight evolution measured by connected balance

Interventions

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Control Group

Clinical visits conducted by a multidisciplinary team every year

Intervention Type OTHER

Intervention Group

Clinical visits are triggered by weight evolution measured by connected balance

Intervention Type OTHER

Other Intervention Names

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Clinical visits conducted by a multidisciplinary team every year Clinical visits triggered by weight evolution

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François Pattou, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Ch Boulogne-Sur-Mer - Boulogne Sur Mer

Boulogne-sur-Mer, , France

Site Status RECRUITING

Hop Claude Huriez Chu Lille

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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François Pattou, MD,PhD

Role: CONTACT

Phone: 03 20 44 42 73

Email: [email protected]

Facility Contacts

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Role: primary

Role: primary

Other Identifiers

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2018-A01946-49

Identifier Type: OTHER

Identifier Source: secondary_id

2017_78

Identifier Type: -

Identifier Source: org_study_id