Pilot Study to Evaluate Daily Protein's Intake Following Bariatric Surgery by Using the Software Protein Assistant
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|ClinicalTrials.gov Identifier: NCT02682160|
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : July 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Other: use of Protein Assistant||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Pilot Study to Evaluate the Evolution of Daily Protein Intake in Obese Patients With Recent Bariatric Surgery, Using the Software Protein Assistant.|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
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.
- 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) [ Time Frame: 3 months after surgery ]
- 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. [ Time Frame: 3 months after surgery ]
- patient's satisfaction [ Time Frame: 3 months after surgery ]measured by the % of questionnaire response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682160
|Toulouse, France, 31059|
|Principal Investigator:||Ana Estrade, MD||University Hospital, Toulouse|