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

NCT05695040 | Recruiting

• 2 other identifiers: AOI 2020 RODA2020-A03239-30
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient's biometric parameters. Muscle function The patient's muscle mass. Undernutrition Nitrogen balance (ancillary ) Medico-economic evaluation

  3, 6 and 12 months

• Qualitative evaluation of the workshop at 12 months

  12 months

Study Arms (2)

dietary workshop conducted on the 15th postoperative day

EXPERIMENTAL

Behavioral: dietary workshop "proteins"

Standard care

NO INTERVENTION

Interventions

dietary workshop "proteins" BEHAVIORAL

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.

dietary workshop conducted on the 15th postoperative day

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

RECRUITING

Study Officials

• Jessica RODA

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

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

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 23, 2023
• Study Start: December 8, 2023
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

FR (1)