Bariatric Surgery CandidateADAPTNCT05695040
Evaluation of the Implementation of a Diet Workshop on the 15th Postoperative Day Following Bariatric Surgery
A study testing dietary workshop "proteins" in people with Bariatric Surgery Candidate, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The objective of the study was to improve protein intake after the implementation of a dietary workshop performed on the 15th postoperative day following bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- dietary workshop "proteins"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2023to Mar 2028
- 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
- Male or female
- Over 18 years of age
- Scheduled for bariatric surgery such as sleeve gastrectomy or bypass surgery.
- Able to give informed consent to participate in the research.
- Enrolled in a Social Security system.
Who cannot join
- Inability to travel to participate in the workshop.
- Patients with a diet excluding animal proteins (vegetarians, vegans).
- Pregnant and lactating women.
- Inability to comply with protocol recommendations.
- Incapacitated patients.
- Major deprived of liberty
- Refusal to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU clermont-ferrand
Clermont-Ferrand
Lise Laclautre
Jessica RODA
About this study
Official title: Evaluation of the Implementation of a Diet Workshop on the 15th Postoperative Day Following Bariatric Surgery on the Protein Intake of the Patient
The objective of the study was to improve protein intake after the implementation of a dietary workshop performed on the 15th postoperative day following bariatric surgery.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- dietary workshop "proteins"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary workshop "proteins"Behavioural
The workshop will have 2 objectives:
- Information of the importance of protein after bariatric surgery and the different sources of protein in the diet.
- Manipulation of a tool in the form of a real size and shape stomach (before and after surgery) that patients will be able to fill and manipulate in order to visualize the quantities needed to achieve the sensation of satiety.
| Study group | Role | What they receive |
|---|---|---|
| dietary workshop conducted on the 15th postoperative day | Experimental | Not described Receives: Behavioral: dietary workshop "proteins" |
| Standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein intake
Different measurements of protein intake will be performed at 1, 3, 6, and 12 months in order to observe an improvement in the kinetics of protein intake, the objective being to increase protein intake in the year following surgery and not only at a specific time.
Measured: 1, 3, 6, and 12 months
Secondary outcomes (2)
Patient's biometric parameters. Muscle function The patient's muscle mass. Undernutrition Nitrogen balance (ancillary ) Medico-economic evaluation
-Evaluate the effect of the diet workshop at 3, 6 and 12 months on: The patient's biometric parameters. Muscle function The patient's muscle mass. Undernutrition Nitrogen balance (ancillary ) Medico-economic evaluation
Measured: 3, 6 and 12 months
Qualitative evaluation of the workshop at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start8 Dec 2023
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica RODA, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695040
- Sponsor's protocol ID
- AOI 2020 RODA
- Other IDs
- 2020-A03239-30
- Acronym
- ADAPT
- Status last verified
- Dec 2025
- First submitted
- 13 Jan 2023
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Implementation of a Diet Workshop on the 15th Postoperative Day Following Bariatric Surgery on the Protein Intake of the Patient
- ClinicalTrials.gov ID
- NCT05695040
- Acronym / sponsor ID
- ADAPT / AOI 2020 RODA
- Conditions
- Bariatric Surgery Candidate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 23 Jan 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.
The objective of the study was to improve protein intake after the implementation of a dietary workshop performed on the 15th postoperative day following bariatric surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dietary workshop conducted on the 15th postoperative day | Experimental | Behavioral: dietary workshop "proteins" |
| Standard care | No 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)
- Male or female
- Over 18 years of age
- Scheduled for bariatric surgery such as sleeve gastrectomy or bypass surgery.
- Able to give informed consent to participate in the research.
- Enrolled in a Social Security system.
Key exclusion criteria (7 listed)
- Inability to travel to participate in the workshop.
- Patients with a diet excluding animal proteins (vegetarians, vegans).
- Pregnant and lactating women.
- Inability to comply with protocol recommendations.
- Incapacitated patients.
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 |
|---|---|---|
| dietary workshop "proteins"The workshop will have 2 objectives: * Information of the importance of protein after bariatric surgery and the different sources of protein in the diet. * Manipulation of a tool in the form of a real size and shape stomach (before and after surgery) that patients will be able to fill and manipulate in order to visualize the quantities needed to achieve the sensation of satiety. | Behavioural | dietary workshop conducted on the 15th postoperative day |
Primary outcome
Protein intake
Time frame: 1, 3, 6, and 12 months
Different measurements of protein intake will be performed at 1, 3, 6, and 12 months in order to observe an improvement in the kinetics of protein intake, the objective being to increase protein intake in the year following surgery and not only at a specific time.
2 secondary outcomes
Patient's biometric parameters. Muscle function The patient's muscle mass. Undernutrition Nitrogen balance (ancillary ) Medico-economic evaluation
Time frame: 3, 6 and 12 months
Qualitative evaluation of the workshop at 12 months
Time frame: 12 months
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 18 Dec 2025.
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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.
Jessica RODA principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary workshop "proteins" in people with Bariatric Surgery Candidate, run by University Hospital, Clermont-Ferrand 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: looking for participants now, as of the sponsor's last update on 18 Dec 2025. 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?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein intake (time frame: 1, 3, 6, and 12 months). 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 18 Dec 2025.