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.
1 other identifier
interventional
38
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 5, 2016
CompletedFirst Posted
Study publicly available on registry
February 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedJuly 29, 2020
July 1, 2020
1.3 years
February 5, 2016
July 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
3 months after surgery
Secondary Outcomes (2)
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
Study Arms (1)
Use of Protein Assistant
OTHERpatients can use the Protein Assistant during 2 months to evaluate the quantity of protein's intake.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Toulouse
Toulouse, 31059, France
Related Publications (1)
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.
PMID: 30880355RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ana Estrade, MD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2016
First Posted
February 15, 2016
Study Start
June 1, 2015
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
July 29, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share