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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02682160 |
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Date of registration:
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05/02/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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Pilot Study to Evaluate the Evolution of Daily Protein Intake in Obese Patients With Recent Bariatric Surgery, Using the Software Protein Assistant. |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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38 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02682160 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Ana Estrade, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Toulouse |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Obesity
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Intervention(s)
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Other: use of Protein Assistant
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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patient's satisfaction
[Time Frame: 3 months after surgery]
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Secondary ID(s)
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14 7310 02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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