Evaluation of the Implementation of a Diet Workshop on the 15th Postoperative Day Following Bariatric Surgery

Bariatric Surgery Candidate Clinical Trial

— ADAPT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05695040
• Other study ID #: AOI 2020 RODA
• Secondary ID: 2020-A03239-30
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2023
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
France	CHU clermont-ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1, 3, 6, and 12 months
Secondary	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	3, 6 and 12 months
Secondary	Qualitative evaluation of the workshop at 12 months		12 months