Pilot Study to Evaluate Daily Protein's Intake Following Bariatric Surgery by Using the Software Protein Assistant

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: use of Protein Assistant

• Registration Number: NCT02682160
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

The aim of this study is to evaluate the effect of the use of Protein Assistant on the daily protein intake in obese patients who underwent a bariatric surgery (in the 3 months following surgery).

Detailed Description

After a bariatric surgery, food intake is reduced. Patients should favor proteins to avoid loss of muscles. The guidelines recommend a minimal protein's intake of 60g per day. But this goal is achieved only for 55 to 60 % patients 4 months after surgery and 50 à 65 % patients at one year.

Protein assistant is a software which can calculate the amount of proteins eaten per day and can propose solutions if the intake is insufficient.

The main objective of this study is to evaluate the effect of the use of Protein Assistant on the daily protein intake in obese patients who underwent a bariatric surgery (in the 3 months following surgery).

Protein Assistant is suggested 1 month after bariatric surgery on a digital tablet. The patient is educated to use Protein Assistant. The patient has to complete a dietary record every 2 weeks during 2 months. The aim is to intake 60g per day. If the aim is not reached, Protein assistant suggests qualitative and/or quantitative solutions.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-02-05
• Study First Submitted QC: 2016-02-10
• Study First Posted: 2016-02-15
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Patients who underwent a bariatric surgery a month +/- one week ago
• Able to use a digital tablet
• With internet access at home
• Accepting modalities of formation and of digital tablet lending
• When the average of protein intake is under 60g/j on a 3 days dietary record, one month after bariatric surgery

Exclusion Criteria

• Lack of understanding of the use of a digital tablet
• Under the protection of justice
• Person participating to another trial
• Pregnant or breast-feeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Use of Protein Assistant	use of Protein Assistant	patients can use the Protein Assistant during 2 months to evaluate the quantity of protein's intake.

Primary Outcome Measures

Name	Time	Method
The primary outcome is the evolution of the average of protein's intake in grams/day (calculated on a 3 day's dietary record) between the first record and the last one (3 months after surgery)	3 months after surgery

Secondary Outcome Measures

Name	Time	Method
the effect of Protein Assitant's use : evaluation of the % of patients reaching the goal of 60g per day of protein's intake 3 months after surgery and at each dietary record.	3 months after surgery
patient's satisfaction	3 months after surgery	measured by the % of questionnaire response

Trial Locations

Locations (1)

CHU Toulouse; 🇫🇷 Toulouse, France