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

Pilot Study to Evaluate the Evolution of Daily Protein Intake in Obese Patients With Recent Bariatric Surgery, Using the Software Protein Assistant.

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).

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: use of Protein Assistant

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • Chu Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Use of Protein Assistant; patients can use the Protein Assistant during 2 months to evaluate the quantity of protein's intake.	Other: use of Protein Assistant; The patient has to complete a dietary record every 2 weeks during 2 months (month 2 and 3 after surgery). The aim is to intake 60g per day. If the aim is not reached, Protein assistant suggests qualitative and/or quantitative solutions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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	measured by the % of questionnaire response	3 months after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Ana Estrade, MD, University Hospital, Toulouse

Publications and helpful links

General Publications

• Estrade A, Montastier E, Turnin MC, Buisson JC, du Rieu MC, Tuyeras G, Hernandez G, Berard E, Ritz P. An Application May Help Improve Protein Consumption after Bariatric Surgery. Obes Surg. 2019 Jun;29(6):1982-1983. doi: 10.1007/s11695-019-03816-5.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): October 1, 2016

Study Registration Dates

• First Submitted: February 5, 2016
• First Submitted That Met QC Criteria: February 10, 2016
• First Posted (ESTIMATE): February 15, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: bariatric surgery
• Other Study ID Numbers: 14 7310 02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO