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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
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Obesity Other: use of Protein Assistant Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. patient's satisfaction [ Time Frame: 3 months after surgery ]
    measured by the % of questionnaire response



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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France
CHU Toulouse
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Ana Estrade, MD University Hospital, Toulouse
Publications of Results:
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02682160    
Other Study ID Numbers: 14 7310 02
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Toulouse:
bariatric surgery