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

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05695040

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bariatric Surgery Candidate	Behavioral: dietary workshop "proteins"	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dietary workshop conducted on the 15th postoperative day	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.
No Intervention: Standard care

Arm

Intervention/Treatment

Experimental: dietary workshop conducted on the 15th postoperative day

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.

No Intervention: Standard care

Outcome Measures

Primary Outcome Measures

Protein intake [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.

Secondary Outcome Measures

Patient's biometric parameters. Muscle function The patient's muscle mass. Undernutrition Nitrogen balance (ancillary ) Medico-economic evaluation [3, 6 and 12 months]
-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
Qualitative evaluation of the workshop at 12 months [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU clermont-ferrand	Clermont-Ferrand		France

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Investigators

Principal Investigator: Jessica RODA, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Clermont-Ferrand

ClinicalTrials.gov Identifier:

NCT05695040

Other Study ID Numbers:

AOI 2020 RODA
2020-A03239-30

First Posted:

Jan 23, 2023

Last Update Posted:

Jan 26, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 26, 2023