Monitoring the Weight Evolution Using a Connected Scale

NCT04639778 | Recruiting

• 2 other identifiers: 2017_782018-A01946-49
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 2

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.

Conditions

Weight Regain; Bariatric Surgery; Long Term Follow-Up

Outcome Measures

Primary Outcomes (1)

• 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

  3 years

Secondary Outcomes (12)

• Cost-effectiveness of new care pathway

  3 years

• Number of visits made by the multidisciplinary team

  3 years

• Number of postoperative surgical and / or medical complications

  3 years

• Change of nutritional parameters in the blood of vitamines

  3 years

• Change of nutritional parameters in the blood of minerals

  3 years

Study Arms (2)

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.

Other: Control Group

Experimental Group

EXPERIMENTAL

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

Other: Intervention Group

Interventions

Control Group OTHER

Clinical visits conducted by a multidisciplinary team every year

Also known as: Clinical visits conducted by a multidisciplinary team every year

Control Group

Intervention Group OTHER

Clinical visits are triggered by weight evolution measured by connected balance

Also known as: Clinical visits triggered by weight evolution

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ministry of Health, France: collaborator
• University Hospital, Lille: lead

Study Sites (2)

Ch Boulogne-Sur-Mer - Boulogne Sur Mer

Boulogne-sur-Mer, 62321, France

RECRUITING

Hop Claude Huriez Chu Lille

Lille, 59037, France

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• François Pattou, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

François Pattou, MD,PhD

CONTACT

03 20 44 42 73; francois.pattou@chru-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-centre, randomised, open, controlled study

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: November 20, 2020
• Study Start: March 25, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

FR (2)