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NCT Number: NCT06133413

Connected Scales to Optimize the Maintenance of Weight Lost After Bariatric Surgery and Limit Failures and Reoperations

In this research, we hypothesize that post-operative monitoring implemented with a connected scale after the 1st year (weight nadir period) post obesity surgery (i.e. sleeve and RYGB) would reduce the percentage of patients with excessive weight regain (>10% regain of lost weight) by improving the quality of follow-up and long-term results.

To do this, we are carrying out a comparative study on 182 patients, controlled, randomized per patient, ratio 1/1, open, in two parallel arms.

Patients will be followed for 12 months and divided into one of the following two groups:

* Control group: Standard follow-up * Interventional group: Standard follow-up + weekly weighing with the "Body Comp Pro" connected scale

During their follow-up period, patients in the intervention group will have to weigh themselves at least once a week using the "Body Comp Pro" connected scale. The information will be transmitted to the investigation team via a secure platform available 24 hours a day. Alerts will be generated from a weight regain > 5% of the baseline weight, allowing early management of weight regain.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity, Severe Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital La Pitié Salpêtrière

Paris, 75013, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patient aged 18 and over
  • Patient operated by a sleeve or RYGB at 1 year (+/- 1 month) from the inclusion visit
  • Patient affiliated to a social security system (excluding AME)
  • Patient having signed free, informed and written consent
  • Patient speaking and reading French fluently

Exclusion criteria

  • Patient with medical-surgical complications during inclusion visit justifying specific and reinforced monitoring (at the discretion of the investigator)
  • Patient with a pacemaker
  • Patient with a pathology or disability preventing them from standing on the scale
  • Patient participating in another interventional research at the time of inclusion
  • At the interview, pregnant patient or planning pregnancy during her period of participation in the research
  • Patient deprived of liberty
  • Patient subject to a legal protection measure (guardianship, curatorship)

Treatment and study plan

Body Comp Pro connected scale (Withings manufacturer)

Device

Use once a week

Alert generation by remote plateform

Other

Alert will be generated from weight regain > 5% of baseline weight

Primary outcomes

  1. Compare the percentage of patients with weight regain > 10% at 24 months post-operative in patients who have undergone obesity surgery (SG or RYGB) in the two groups of patients

    Time frame: 12 months from inclusion

    Percentage of patients with weight regain > 10% between inclusion (12 months post-op) and the 12-month visit (24 months post-op) in the two groups of patients

Secondary outcomes

  1. To compare the weight change at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB) in the two groups of patients

    Time frame: 6 and 12 months from inclusion

    Weight change (in kilos and % of weight lost since the intervention) between the weight at inclusion (12 months post-op) and the weight at 6 and 12 months from inclusion (18 and 24 months post-op ) in both groups of patients.

  2. To compare the number of surgical reinterventions (planned or carried out) for weight regain at 24 months post-operative in patients having undergone obesity surgery (SG or RYGB) in the two groups of patients

    Time frame: 12 months from inclusion

    Number of surgical reinterventions (planned or carried out) for excessive weight gain validated in a multidisciplinary consultation meeting between inclusion (12 months post-op) and the visit 12 months from inclusion (24 months post-op) in both patient groups

  3. To compare the evolution of comorbidities at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB) in the two groups of patients

    Time frame: 6 and 12 months from inclusion

    Resolution, evolution, recurrence, or occurrence of a comorbidity between inclusion (12 months post-op) and visits at 6 and 12 months from inclusion (18 and 24 months post-op) in the two groups of patients. The comorbidities identified are High blood pressure, Type 2 diabetes and sleep apnea syndrome

  4. To compare anxiety and depression at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB) in the two groups of patients

    Time frame: 6 and 12 months from inclusion

    Evolution of the HAD scale score between inclusion (12 months post-op) and visits at 6 and 12 months from inclusion (18 and 24 months post-op) in the two groups of patients

  5. Compare the quality of life at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB) in the two groups of patients

    Time frame: 6 and 12 months from inclusion

    Evolution of the SF-36 quality of life score between inclusion (12 months post-op) and visits at 6 and 12 months from inclusion (18 and 24 months post-op) in the two groups of patients

  6. Compare the number of lost to follow-up at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB) in the two groups of patients

    Time frame: 6 and 12 months from inclusion

    Number of patients lost to follow-up between inclusion (12 months post-op) and visits at 6 and 12 months from inclusion (18 and 24 months post-op) in the two groups of patients

  7. To compare the change in body composition measured by a connected scale at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB) in the two groups of patients

    Time frame: 6 and 12 months from inclusion

    Evolution of body composition (muscle mass, fat mass) measured by the connected scale between the inclusion visit (12 months post-op) and the visits at 6 and 12 months from inclusion (18 and 24 months post-op ) in both groups of patients.

  8. For interventionnal group only : Evaluate the impact of the use of a connected scale on the consumption of additional care at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB).

    Time frame: 6 and 12 months from inclusion

    Number of telephone calls, consultations or hospitalizations in hospital, secondary to an alert generated by the connected scale between the inclusion visit (12 months post-op) and the visits at 6 and 12 months of inclusion (18 and 24 months post-op) for each patient in the interventional group

  9. For interventionnal group only : Evaluate adherence to the use of a connected scale at 18 and 24 months post-operative in patients having undergone obesity surgery (SG or RYGB)

    Time frame: 6 and 12 months from inclusion

    Average frequency of use of the connected scale between inclusion (12 months post-op) and visits at 6 and 12 months from inclusion (18 and 24 months post-op) for each patient in the interventional group compared to this which is required of them (i.e. 1 weighing per week)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Withings

Registry information

Acronym: COMPA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 15, 2023
Registry last updated
Jun 5, 2026

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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