Obesity, SevereCOMPANCT06133413
Connected Scales to Optimize the Maintenance of Weight Lost After Bariatric Surgery and Limit Failures and Reoperations
A study testing Body Comp Pro connected scale (Withings manufacturer) and Alert generation by remote plateform in people with Obesity, Severe and Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Severe, Surgery
- What is being tested?
- Body Comp Pro connected scale (Withings manufacturer) and Alert generation by remote plateform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Obesity, Severe, Surgery
- Being tested
- Body Comp Pro connected scale (Withings manufacturer), Alert generation by remote plateform
- Keywords
- Obesity surgery, Connected scale, Remote patient monitoring
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Comp Pro connected scale (Withings manufacturer)Device
Use once a week
Alert generation by remote plateformOther
Alert will be generated from weight regain > 5% of baseline weight
| Study group | Role | What they receive |
|---|---|---|
| Standard of care group | No intervention | Standard follow-up |
| Connected scale group | Experimental | Standard follow up + Use weekly of Body Comp Pro connected scale, associated with a remote monitoring by medical team allowing alert generation and early intervention Receives: Device: Body Comp Pro connected scale (Withings manufacturer); Other: Alert generation by remote plateform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Measured: 12 months from inclusion
Secondary outcomes (9)
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
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.
Measured: 6 and 12 months from inclusion
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
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
Measured: 12 months from inclusion
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
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
Measured: 6 and 12 months from inclusion
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
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
Measured: 6 and 12 months from inclusion
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
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
Measured: 6 and 12 months from inclusion
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
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
Measured: 6 and 12 months from inclusion
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
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.
Measured: 6 and 12 months from inclusion
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).
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
Measured: 6 and 12 months from inclusion
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)
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)
Measured: 6 and 12 months from inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start26 Jun 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, SevereStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparative, controlled, randomized 1:1, open, in two parallel arms study
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Withings
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133413
- Sponsor's protocol ID
- APHP230777
- Acronym
- COMPA
- Status last verified
- Jun 2026
- First submitted
- 30 Oct 2023
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connected Scales to Optimize the Maintenance of Weight Lost After Bariatric Surgery and Limit Failures and Reoperations
- ClinicalTrials.gov ID
- NCT06133413
- Acronym / sponsor ID
- COMPA / APHP230777
- Conditions
- Obesity, Severe, Surgery
- Keywords
- Obesity surgery, Connected scale, Remote patient monitoring
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Withings
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparative, controlled, randomized 1:1, open, in two parallel arms study
| Arm | Type | Receives |
|---|---|---|
| Standard of care group | No intervention | –Standard follow-up |
| Connected scale group | Experimental | Device: Body Comp Pro connected scale (Withings manufacturer), Other: Alert generation by remote plateformStandard follow up + Use weekly of Body Comp Pro connected scale, associated with a remote monitoring by medical team allowing alert generation and early intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body Comp Pro connected scale (Withings manufacturer)Use once a week | Device | Connected scale group |
| Alert generation by remote plateformAlert will be generated from weight regain > 5% of baseline weight | Other | Connected scale group |
Primary outcome
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
9 secondary outcomes
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
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Comp Pro connected scale (Withings manufacturer) and Alert generation by remote plateform in people with Obesity, Severe and Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.